Intrexon Organizes Around New Synthetic Biology Markets
Nine Collaborations Underway, Company Aligns to Accelerate Business Development in Health, Food, Energy and Environment   Germantown, Maryland, May 9, 2013 – Intrexon Corporation, a leader in synthetic biology that is helping companies design and develop products incorporating its Better DNA™, today announced it has aligned its industry markets to focus on four key sectors: Health, Food, Energy and Environment.   Intrexon currently has nine collaborations in Health and Food to create products embodying engineered bio-based solutions.  The goal of the new market alignment is to accelerate business development across all of Intrexon’s key market sectors using the company’s Exclusive Channel Collaboration (ECC) model.   Since Intrexon’s founding in 1998 the company has developed its core technology, the UltraVector® platform, to accelerate development of genetically-enhanced products at industrial scale.  Using a dynamic library of more than two million diverse, modular genetic components, UltraVector enables the discovery, design, assembly and testing of a wide spectrum of multigenic biological systems.      As part of its new market strategy, Intrexon named the following executives with deep industry experience to lead each market sector: Health will be led by Dr. Samuel Broder, Executive Director of the Intrexon Institute for Biomolecular Research and former Director of the National Cancer Institute. Food will be led by Dr. Thomas Kasser, with more than twenty-five years of senior management experience in agricultural biotechnology and animal health and nutrition, recognized as a Monsanto Fellow for his scientific and technical excellence. Energy will be led by Robert Walsh, with over 30 years of global petroleum and chemical industry experience, including 26 years at Royal Dutch Shell. Environment will be led by Nick Macris, with 15 years in the specialty chemical, water treatment, agricultural chemical and biopesticide industries with many large and small companies including 3M, Rohm and Haas, and FMC Corporation   Chairman and Chief Executive Officer Randal J. Kirk said the new market alignment will help Intrexon achieve its vision to be one of the leading life science companies in the world.   “Our new sector organization, led by an outstanding team of industry veterans, will bring additional focus and rapidity to solving our partners’ toughest synthetic biology problems,” Kirk said.  “It’s a very exciting step toward empowering the bioindustrial revolution with solutions that enhance the quality and diversity of life.” About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on collaborating with companies in Health, Food, Energy and the Environment to create bio-based products that improve the quality of life and the health of the planet.  Through the company’s proprietary UltraVector® platform, Intrexon provides its partners with industrial-scale design and development of multigenic biology.  UltraVector delivers unprecedented control over the quality, reliability, and performance of living cells.  We call it Better DNA™ and we invite you to discover more at www.dna.com.   Trademarks Intrexon, UltraVector, mAbLogix and Better DNA are trademarks of Intrexon and/or its affiliates.  Other names may be trademarks of their respective owners.   Safe Harbor Statement Some of the statements made in this press release are forward-looking statements.  These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business.  Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.   ###   For more information regarding Intrexon Corporation, contact:   Corporate Contact:    Investor Contact: Marie L. Rossi, Ph.D.    The Ruth Group Manager, Technical Communications Intrexon Corporation Tel: +1 301-556-9944 mrossi@intrexon.com      Stephanie Carrington / Nicole Greenbaum Tel: +1 646-536-7017/7009 scarrington@theruthgroup.com ngreenbaum@theruthgroup.com           
Soligenix and Intrexon Pursue Melioidosis Therapy Through Worldwide Exclusive Collaboration
Soligenix to Expand Biodefense and Infectious Disease Product Pipeline Princeton, NJ and Germantown, MD – May 1, 2013 – Soligenix, Inc. (OTCQB: SNGX), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today it will jointly develop a treatment for Melioidosis through a worldwide exclusive collaboration with Intrexon, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function.   Under this collaboration with Intrexon, Soligenix intends to develop and commercialize human monoclonal antibody therapies for new biodefense and infectious disease applications for Melioidosis using Intrexon’s advanced human antibody discovery, isolation and production technologies.   Melioidosis is an often lethal disease that is endemic in Southeast Asia and Northern Australia.  It is also considered a high-priority biodefense threat as defined in the 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy established by the US Department of Health and Human Services (DHHS) with the potential for widespread dissemination through aerosol.   Melioidosis is caused by Burkholderia pseudomallei, a Gram-negative bacteria that is highly resistant to antibiotic treatment regimens. In many parts of Southeast Asia, mortality rates are as high as 40 percent, making Melioidosis the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis.   Under the agreement, Intrexon will provide discovery and development of therapeutic antibody candidates, as well as optimize and expand production of human monoclonal antibodies targeting Melioidosis by applying its proprietary platforms and technologies.  Soligenix will undertake preclinical and clinical development, regulatory and government interactions, as well as the commercialization of therapeutic products.   Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, said the collaboration is unique because the goal is to develop a therapy that will treat both a deadly disease currently affecting millions of people as well as fight a potential biological weapon.   “Our collaboration with Intrexon is consistent with our corporate strategy of building shareholder value through continuous evaluation of new product opportunities and acting upon those that meet Soligenix's mission of delivering disease-modifying therapies in areas of high unmet medical need,” Dr. Schaber said.  “By working with Intrexon we hope to make a potentially life-saving therapy available to patients in endemic regions and include the therapy in the national stockpiling program in case of a biowarfare event.  Intrexon has a very strong track record of adding value both as a collaborator and a committed shareholder.  We are very excited to join the exclusive coterie of Intrexon partner companies.”   Intrexon Chairman and Chief Executive Officer, Randal J. Kirk, said the collaboration with Soligenix reflects the core strengths Intrexon looks for in its exclusive channel collaborations.   “Soligenix has the expertise and highly focused mission we look for in all our collaborations,” Mr. Kirk said.  “Although we are engaging with increasingly larger enterprises in Health, Food, Energy and Environment, we shall continue to explore powerful combinations with smaller, specialized companies that have great teams, grand vision and deep expertise.”   Additional terms under the collaboration agreement include: Soligenix will receive an exclusive, worldwide license to utilize the products of Intrexon’s modular genetic engineering platform for the development of active pharmaceutical ingredient(s) (API) and drug products targeting Melioidosis. Soligenix will leverage Intrexon’s proprietary platforms and technologies, including the UltraVector® and mAbLogix™ platforms, LEAP™ instrument, protein engineering, inducible gene systems, genome engineering, and cell systems engineering to the collaboration’s programs. Soligenix will issue to Intrexon 1,034,483 shares of its common stock, representing 8.5% of Soligenix's issued and outstanding shares. Intrexon will be granted the right to participate in securities offerings that may be conducted by Soligenix in the future as well as the right to make purchases of Soligenix's common stock in the open market. Soligenix will pay development milestones and royalties on net sales derived from the sale of products developed from the channel collaboration. For more information regarding the agreement visit http://www.soligenix.com/invest_secfilings.shtml. Griffin Securities served as financial advisor to Intrexon in connection with this transaction. About Melioidosis Melioidosis is a potentially fatal infection caused by the Gram-negative bacillus, Burkholderia pseudomallei (Bp). Highly resistant to many antibiotics, Bp can cause an acute disease characterized by a fulminant pneumonia and a chronic condition that can recrudesce.  There is no preventive vaccine or effective immunotherapy for melioidosis.  Therefore, there is a significant medical need for improved prevention and therapy.   Bp infection (melioidosis) is a major public health concern in the endemic regions of Southeast Asia and Northern Australia. Moreover, the organism has a worldwide distribution and the full extent of global spread is likely underestimated.  In Northeast Thailand, which has the highest incidence of melioidosis recorded in the world, the mortality rate associated with Bp infection is over 40 percent, making it the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis. Bp activity is seen in Southeast Asia, South America, Africa, the Middle East, India, and Australia. The highest pockets of disease activity occur in Northern Australia and Northeast Thailand with increasing recognition of disease activity in coastal regions of India.  Melioidosis has been under recognized and is likely to be under-reported in China.   Beyond its public health significance, Bp and the closely-related Burkholderia mallei (Bm) are considered possible biological warfare agents by the US Department of Health and Human Services (DHHS) because of the potential for widespread dissemination through aerosol. Bp like its relative Bm, the cause of Glanders, was studied by the US as a potential biological warfare agent, but was never weaponized.  It has been reported that the Soviet Union was also experimenting with Bp as a biological warfare agent.  Both Bp and Bm have been designated high priority threats by the DHHS in its Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy released in 2012 and are classified as Category B Priority Pathogens by the National Institute of Allergy and Infectious Disease (NIAID).   About Intrexon Corporation   Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology.  Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science.  The company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. More information about the Company is available at www.dna.com.   About Soligenix, Inc.   Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.     Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIAID.   For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.   This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts,  including  grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice,  third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business,  or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.   For more information regarding Soligenix, Inc., contact: Joe Warusz, CPA Acting Chief Financial Officer (609) 538-8200 | www.soligenix.com   For more information regarding Intrexon Corporation, contact: Corporate Contact:    Investor Contact: Marie L. Rossi, PhD    The Ruth Group Manager, Technical Communications Tel: +1 301-556-9944 mrossi@intrexon.com    Stephanie Carrington / Melanie Sollid-Penton Tel: +1 646-536-7017/7023 scarrington@theruthgroup.com msollid@theruthgroup.com  
Intrexon Corporation Raises $150 Million for Synthetic Biology Initiatives
Germantown, Maryland, May 1, 2013 – Intrexon Corporation, a next generation synthetic biology company, today announced that it has closed a Series F preferred investment round of $150 million, bringing the company’s total capital raised to $509 million. New investors accounted for the majority of the round, with current investors, including affiliates of Randal J. Kirk, Intrexon’s Chairman and CEO, and Third Security, LLC, taking the balance of the round.   The funding will be used to provide working capital for the establishment of additional exclusive channel collaborations in Intrexon’s core sectors, including Healthcare, Food, Energy, and Environment, continued development of the company’s industry-leading technology platforms, expansion of sales and marketing, and research and development.    "The Intrexon team is committed to delivering results for all of our collaborations,” said Mr. Kirk. “With our proprietary technology platforms, we are helping our collaborators discover, design, develop and ultimately bring to market genetically-enhanced products that hold remarkable promise.”   Mr. Kirk added, “It is especially gratifying to our entire team that, in addition to being our largest investment series to date, a majority of the investment came from new investors who share our vision."   About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology.  Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science.  The company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. More information about the Company is available at www.dna.com.   Safe Harbor Statement Some of the statements made in this press release are forward-looking statements.  These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business.  Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.   ###   For more information regarding Intrexon Corporation, contact:   Corporate Contact:    Investor Contact: Marie L. Rossi, Ph.D.    The Ruth Group Manager, Technical Communications Intrexon Corporation Tel: +1 301-556-9944 mrossi@intrexon.com      Stephanie Carrington / Nicole Greenbaum Tel: +1 646-536-7017/7009 scarrington@theruthgroup.com ngreenbaum@theruthgroup.com   
AmpliPhi Establishes Collaboration with Intrexon
Combined Expertise to Create New Generation of Bacteriophage-Based Therapeutics For Antibiotic Resistant Infections Richmond, VA, and Germantown, MD, April 16, 2013 – AmpliPhi BioSciences Corp. (OTC: APHB), the leader in the development of bacteriophage-based antibacterial therapies to treat drug resistant infections, and Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, today announced the formation of an exclusive channel collaboration (“ECC”) to develop new bacteriophage-based therapies to target specific antibiotic resistant infections, some of the most widespread and deadly types of infections.   The collaboration seeks to develop bacteriophage-containing human therapeutics for use in the treatment of bacterial infections associated with acute and chronic wounds, the treatment of acute and chronic P aeruginosa lung infections, and the treatment of infections of C. difficile.   Philip J. Young, President and Chief Executive Officer of AmpliPhi, said, “The global market for anti-infective therapies is expected to reach $40 billion annually by 2014. Combining Intrexon’s synthetic biology technologies with our phage development expertise gives us the opportunity to develop and bring to market an important new generation of anti-infective therapies that have the potential to save or change the lives of millions of people.”   Randal J. Kirk, CEO and Chairman of the Board of Intrexon, added, “This collaboration with AmpliPhi should at last make practical the long-appreciated therapeutic potential of phage therapies, resulting in an armamentarium of new treatments for infectious diseases. We are delighted to get underway on this exciting program.” Under the terms of the ECC agreement, AmpliPhi will receive an exclusive, worldwide license to utilize Intrexon’s proprietary technology and expertise toward the standardized production of wild type phages, as well as for the design and production of genetically modified bacteriophages. Intrexon will apply its proprietary technologies, including the UltraVector® platform, DNA and RNA MOD engineering, protein engineering, inducible gene systems, genome engineering, and cell systems engineering, to AmpliPhi’s bacteriophage programs. AmpliPhi will issue to Intrexon 24,000,000 shares of its common stock (representing approximately 26% of Ampliphi’s outstanding shares after the issuance). The ECC also includes the potential for development milestones that are payable in equity or cash. In addition, AmpliPhi will pay Intrexon royalties on the net sales of products developed under the ECC   Griffin Securities served as financial advisor to Intrexon in connection with the transaction.   About AmpliPhi BioSciences Corp. AmpliPhi BioSciences Corp. is a biotechnology company focused on the development and commercialization of novel bacteriophage-based therapeutics for difficult to treat infectious diseases. More information about the company is available at www.ampliphibio.com.   About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology.  Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science.  The company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. More information about the company is available at www.dna.com.   Forward-looking statements   Statements in this press release about the potential use of bacteriophages to treat bacterial infections and the development of bacteriophage-based therapies using Intrexon technology are forward looking statements subject to risks and uncertainties, including without limitation the risk that such therapies may not be successfully developed, will require extensive and expensive pre-clinical and clinical testing, may not be safe or efficacious, and may not be approved for marketing by the United States Food and Drug Administration or any foreign regulatory agency.   For more information regarding AmpliPhi BioSciences Corp., contact:       Corporate Contact:    Media Enquiries – College Hill Life Sciences Philip J. Young CEO +1 650-888-2422 IR@ampliphibio.com      ampliphi@collegehill.com   Gemma Howe / Stefanie Bacher - UK +44 20 7457 2020   Sue Charles - Managing Partner - Global +44 (0)7968 726585 (UK) +1 347 448 3210 (USA)       For more information regarding Intrexon Corporation, contact: Corporate Contact:    Investor Contact: Marie L. Rossi, Ph.D.    The Ruth Group Manager, Technical Communications Tel: +1 301-556-9944 mrossi@intrexon.com      Stephanie Carrington / Nicole Greenbaum Tel: +1 646-536-7017/7009 scarrington@theruthgroup.com ngreenbaum@theruthgroup.com     
ZIOPHARM Presents Preclinical Data Supporting DNA-based IL-12 Therapy for Breast Cancer
Immunotherapeutic Strategy Results Presented at AACR 2013 Annual Meeting   NEW YORK, NY – April 9, 2013 – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today the presentation of results from a study in a breast cancer murine model demonstrating the anti-tumor effects and tolerability of Ad-RTS-mIL-12, a viral vector DNA-based therapeutic for the controlled, local expression of IL-12, an important protein for enhancing antitumor immunity.  The data were presented at the American Association for Cancer Research 2013 Annual Meeting (AACR 2013) taking place April 6-10, 2013 in Washington, D.C.  The study was conducted jointly by ZIOPHARM and Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function.  ZIOPHARM is Intrexon’s exclusive channel partner for the development of in vivo therapeutics in oncology.   For the study, intratumoral administration of Ad-RTS-mIL-12 (Ad) was examined in a 4T1 BALB/c mouse breast carcinoma model. Production of murine IL-12 was controlled using Intrexon’s RheoSwitch Therapeutic System® (RTS®) platform and oral administration of the activator ligand INXN-1001 (AL).  Oral administration of AL was found to elicit a dose-related increase in plasma AL levels, which correlated with increasing tumor levels of AL. The increase in tumor AL levels in combination with Ad in turn resulted in a dose-related increase in expression of mIL-12 in the tumor, with minimal increase in serum mIL-12.  This increase in AL-regulated tumor IL-12 levels correlated with an increase in tumor-infiltrating CD4+ and CD8+ T cells in and adjacent to the tumor, concomitant with a decrease in tumor regulatory T cells.  This resulted in a dose-related decrease in tumor growth rate.  Moreover, the therapeutic strategy appears to be well tolerated, as no change in clinical signs or body weight was observed in the treated animals when compared with vehicle alone.    Samuel Broder, M.D., Chairman of Intrexon’s Therapeutic Opportunities Committee and former Director of the NCI (National Cancer Institute), stated, “Two major obstacles for the development of immunotherapeutics in the treatment of cancer are the ability of tumors to evade the anti-cancer capabilities of the immune system and the toxicity often associated with the systemic administration of immunomodulating agents.  To overcome these challenges, we have developed Ad-RTS-IL-12, a DNA-based system for the regulated expression of IL-12, that allows for localized, controlled expression of immunomodulating cytokines and activation of their corresponding anti-tumor effects.  This strategy is now being tested in the clinic, with the recent launch of a Phase 2 Study of Ad-RTS-IL-12 combined with palifosfamide in the treatment of advanced breast cancer.”   Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, commented, “These results support the hypothesis that localized delivery of IL-12 results in an increase in tumor infiltrating lymphocytes concomitant with a reduction in tumor growth.  These findings suggest the applicability of this strategy in the treatment of breast cancer, especially in the context of recent literature addressing the positive correlation of survival with immune response measured in breast cancer tumors treated with non-immune therapies.  This novel synthetic biology approach, which is being explored in several ongoing clinical studies, holds transformative potential for the treatment of cancer.”   About ZIOPHARM Oncology, Inc.:   ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company's clinical programs include:   Ad-RTS-IL-12 is currently being tested in two Phase 2 studies, the first for the treatment of advanced melanoma, and the second in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer.  Ad-RTS-IL-12 uses synthetic biology to enable controlled delivery of therapeutic interleukin-12 (IL-12), a protein important for enhancing the development of an immune response to cancer.  Being developed in partnership with Intrexon Corporation, ZIOPHARM’s DNA synthetic biology platform employs an inducible gene-delivery system that enables controlled delivery of genes that produce therapeutic proteins to treat cancer.  This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological “switch” (the RheoSwitch Therapeutic System® or RTS® platform) to turn on/off the therapeutic protein expression at the tumor site.   Palifosfamide (ZIO-201) is a potent, bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways.  Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide.    Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile.  It is currently being studied in a Phase 1/2 trial in metastatic breast cancer.   Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K.   ZIOPHARM's operations are located in Boston, MA, and New York City.  Further information about ZIOPHARM may be found at www.ziopharm.com.   Forward-Looking Safe Harbor Statement:   This press release contains certain forward-looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and future performance.  All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, and our other therapeutic products will be successfully marketed if approved; whether any of our other therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our collaboration agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for our therapeutic products; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the fiscal year ended December 31, 2012.  Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.   Contact:   For ZIOPHARM David Pitts or Lourdes Catala Argot Partners 212-600-1902 ziopharm@argotpartners.com   Media Contacts: David Schull or Lena Evans Russo Partners, LLC 858-717-2310 212-845-4262 david.schull@russopartnersllc.com lena.evans@russopartnersllc.com  
ZIOPHARM Oncology Initiates Phase 2 Study of Ad-RTS IL-12 and Palifosfamide Combination for Treatment of Advanced Breast Cancer
NEW YORK, NY – March 11, 2013 – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the initiation of a randomized, open label Phase 2 clinical study of Ad-RTS IL-12 in combination with palifosfamide to treat patients with non-resectable recurrent or metastatic breast cancer. The two-part, multi-center U.S. study will enroll up to 68 patients with non-resectable, recurrent or metastatic breast cancer who have visible lesions or lesions accessible by injection. The study is designed to assess the safety and efficacy of the drug combination of Ad-RTS IL-12 and palifosfamide. Ad-RTS IL-12 is a targeted and controlled DNA-based therapeutic designed to express interleukin-12 (IL-12), a protein important for an immune response to cancer. Palifosfamide is a potent bi-functional DNA alkylating agent. Part one of the two-part study will consist of a safety assessment for Ad-RTS IL-12 and palifosfamide, alone or in combination. Part two will consist of an efficacy evaluation of the Ad-RTS IL-12 only arm and the combination arm. The primary endpoint of the study is rate of progression-free survival at 16 weeks. Secondary endpoints include objective response rate, duration of response and evaluation of pharmacodynamic tumor markers. “Several recent breakthroughs in cancer treatment are based on the hypothesis that the immune system plays a central role in suppressing both cancer’s growth and metastasis,” said John Nemunaitis, M.D., lead investigator and Executive Medical Director, Mary Crowley Medical Research Center. “For breast cancer, the positive correlation of survival with immune response in the tumor elicited by non-immune treatments has only recently been elucidated, and this understanding hints at the potential for exciting new breakthroughs in this still underserved population. We look forward to participating in this study and to gaining further insight regarding the combined effect of Ad-RTS IL-12, a selectively controlled immunotherapy, and palifosfamide, a potent bi-functional DNA alkylating agent.” Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, added, “This study has exciting potential, both for this difficult-to-treat indication and for our synthetic biology platform, in which Ad-RTS IL-12 is the lead program. Building on preclinical work supporting a synergistic effect between Ad-RTS IL-12 and palifosfamide, and the clinical findings from our ongoing Phase 2 melanoma study, we believe the combination of Ad-RTS IL-12 and palifosfamide has the potential to be quite impactful in breast cancer.” About ZIOPHARM Oncology, Inc.: ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company’s clinical programs include: Palifosfamide (ZIO-201) is a potent bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for the treatment of first-line metastatic soft tissue sarcoma and is also in a pivotal Phase 3 trial (MATISSE) for first-line metastatic small cell lung cancer. Additionally, the Company is developing an oral capsule form of palifosfamide. Ad-RTS IL-12 is currently being tested in two Phase 2 studies, the first for the treatment of advanced melanoma, and the second in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer. Ad-RTS IL-12 uses synthetic biology to enable controlled, local delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. ZIOPHARM’s DNA synthetic biology platform is being developed in partnership with Intrexon Corporation and employs an inducible gene-delivery system that enables controlled, local delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological “switch” (the RheoSwitch Therapeutic System®, RTS®) to turn on/off the therapeutic protein expression at the tumor site. Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer. Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K. ZIOPHARM’s operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com. Forward-Looking Safe Harbor Statement: This press release contains certain forward-looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether Palifosfamide, Ad-RTS-IL-12, Darinaparsin, Indibulin, or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether Palifosfamide, Ad-RTS-IL-12, Darinaparsin, Indibulin, and our other therapeutic products will be successfully marketed if approved; whether any of our other DNA-based biotherapeutics discovery and development efforts will be successful; our ability to achieve the results contemplated by our collaboration agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for DNA-based biotherapeutics; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. Contact: For ZIOPHARM Nicole Jones ZIOPHARM Oncology, Inc. 617-778-2266 njones@ziopharm.com Media Contacts: David Schull or Lena Evans Russo Partners, LLC 858-717-2310 212-845-4262 david.schull@russopartnersllc.com lena.evans@russopartnersllc.com
Intrexon and AquaBounty to Collaborate on Leveraging Synthetic Biology to Increase Productivity Across the Aquaculture Arena
-Exclusive Channel Collaboration Driven by Need to Meet Growing World Food Demand -Intrexon Proposes to invest up to $6.0 million in AquaBounty   Germantown, MD and Maynard, MA – February 15, 2013 - Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, and AquaBounty Technologies, Inc. (AIM:ABTX.L), a biotechnology company focused on enhancing the productivity in aquaculture, today announced the formation of an exclusive channel collaboration (ECC) to enhance productivity in aquaculture and develop products that decrease the time to market and address growing environmental issues. As part of the ECC, Intrexon has proposed investing up to $6 million in AquaBounty to fund its operations and research.  The investment is subject to shareholder approvals including the waiver of pre-emptive rights. Thomas Kasser, President of Intrexon’s Animal Science Division, said, “Today’s developing world population is faced with increasing demand across a broad spectrum of markets including food, fuel and healthcare.   Intrexon’s mission is to apply its synthetic biology expertise and know how to provide solutions to these major global issues.  Our agreement with AquaBounty demonstrates this commitment and focus in the food arena. “The ECC with AquaBounty places Intrexon in strong position to revolutionize the aquaculture industry with faster growing, environmentally friendly products to meet the strong and growing demand for finfish.  Our priority will be to develop the next generation of AquaBounty’s existing product, AquAdvantage® Salmon, and to identify other products where our synthetic biology can implement leading edge technology to advance the sustainability and efficiency of fish production.  AquAdvantage® Salmon is capable of reaching marketable size in about half of the conventional time, reduced from approximately 28 to 36 months to 18 months, with a 30% reduction in feed required to reach market weight.  The FDA has published a draft Environmental Assessment and a preliminary draft of a Finding of No Significant Impact as one of the last steps in the approval process. The public comment period for these documents will close on April 25, 2013.” Ron Stotish, Chief Executive Officer of AquaBounty commented “This collaboration with Intrexon is a transformative event for AquaBounty by providing access to one of the most innovative genetic sciences in the world today.  It allows us to produce the next generation of existing products and new finfish products that meet today’s demand for global consumption and environmental challenges.” Under terms of the agreements: AquaBounty will utilize Intrexon’s UltraVector® platform and other technologies to research, develop, manufacture and market products involving key synthetic biology tools to improve the value of finfish intended for human consumption AquaBounty will pay Intrexon quarterly 16.66% of the gross profits calculated for each collaboration product and pay 50% of quarterly revenue obtained from a sublicensor in the event of a sublicensing agreement AquaBounty will reimburse Intrexon for the costs, on a full time equivalent basis, of certain services provided under the aquaculture program AquaBounty also announced the appointment to its board of directors of three individuals designated by Intrexon.  The appointed board members are Thomas Barton, Managing Partner, White Rock Capital Management, L.P., Thomas R. Kasser, Ph.D., President of Intrexon’s Animal Sciences Division, and James C. Turk, Jr., Partner, Harrison & Turk, P.C. About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology.  Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science.  The company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. More information about the Company is available at www.dna.com. About AquaBounty Technologies AquaBounty Technologies is a biotechnology company focused on improving productivity in commercial aquaculture, a $100 billion industry and the fastest growing segment of the worldwide food industry. The company’s objective is the application of biotechnology to ensure the availability of high quality seafood to meet global consumer demand.  The company is developing products to address critical production constraints in the most popular farmed species, focusing initially on salmon, trout and shrimp.  Its AquAdvantage® fish program is based upon a single, specific molecular modification in fish that results in more rapid growth in early development.   For Intrexon Corporation Corporate Contact: Marie L. Rossi, Ph.D., 301-556-9944 mrossi@intrexon.com or Investor Contact: The Ruth Group Stephanie Carrington / Nicole Greenbaum, 646-536-7017 / 7009 scarrington@theruthgroup.com ngreenbaum@theruthgroup.com
Intrexon Completes Mandatory Tender Offer for AquaBounty Technologies Shares
Blacksburg, Virginia – January 7, 2013 - Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, today announced that it has elected not to extend the mandatory tender offer that it was required to make for the outstanding shares not already owned by it in AquaBounty Technologies, Inc. (AIM:ABTX), a biotechnology company focused on enhancing the productivity in aquaculture.  As a result, the tender offer expired at 1:00 p.m. London time on January 4, 2013.  The offer satisfied a requirement of AquaBounty’s charter triggered by Intrexon’s previously announced acquisition of AquaBounty stock from Linnaeus Capital Partners B.V. and Tethys Ocean B.V.  Because the number of shares tendered would not result in Intrexon holding more than 50% of the outstanding shares, the shares tendered into the offer will not be accepted for payment or acquired by Intrexon.  Forms of acceptance, relevant share certificates and other documents of title tendered into the offer will be returned to the relevant shareholders in accordance with the terms of the offer. Thomas Kasser, President of Intrexon’s Animal Science Division, stated, “We continue to look forward to working with the AquaBounty team to improve aquaculture productivity and expand the reach of their molecular modification technology.  In light of the recent FDA announcement concerning AquaBounty’s AquAdvantage® Salmon, we are excited by the potential for AquaBounty’s pioneering work to contribute to our efforts to play a leading role in solving the world’s emerging food shortages.” About AquaBounty Technologies AquaBounty Technologies is a biotechnology company focused on improving productivity in commercial aquaculture, a $100 billion industry and the fastest growing segment of the worldwide food industry. The company’s objective is the application of biotechnology to ensure the availability of high quality seafood to meet global consumer demand.  The company is developing products to address critical production constraints in the most popular farmed species, focusing initially on salmon, trout and shrimp.  Its AquAdvantage® fish program is based upon a single, specific molecular modification in fish that results in more rapid growth in early development. About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology.  Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science.  The company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. More information about the Company is available at www.dna.com. For Intrexon Corporation Corporate Contact: Donald P. Lehr, 301-556-9809 Chief Legal Officer dlehr@intrexon.com or Investor Contact: The Ruth Group Stephanie Carrington / Nicole Greenbaum, 646-536-7017 / 7009 scarrington@theruthgroup.com ngreenbaum@theruthgroup.com
Sanford-Burnham Medical Research Institute and Intrexon Corporation Establish Collaboration to Accelerate Stem Cell Research
Combines Sanford-Burnham’s renowned scientific team and Intrexon’s proprietary discovery platforms to accelerate human induced pluripotent stem cell (iPSC) research   LA JOLLA, Calif., January 3, 2013 – Sanford-Burnham Medical Research Institute, a nonprofit research institution and one of the largest iPSC generators in the world, and Intrexon Corporation, a leading synthetic biology company, today announced a new collaboration to accelerate stem cell research. Under the agreement, Sanford-Burnham will gain access to sophisticated proprietary cellular selection and gene regulation technologies that are not currently on the market, including Intrexon’s Laser-Enabled Analysis and Processing (LEAP™) instrument and RheoSwitch Therapeutic System® (RTS®). As part of the agreement, Intrexon may obtain commercial and intellectual property rights resulting from technological advances made under the collaboration.   “I’m looking forward to merging and melding our expertise,” said Evan Y. Snyder, M.D., Ph.D., professor and director of Sanford-Burnham’s Stem Cell Research Center and Stem Cell and Regenerative Biology Program. “We’ll bring our iPSC and gene therapy expertise to the table. Likewise, our colleagues at Intrexon will share their knowledge of how best to use the technologies. We envision we’ll be meeting with them frequently and sharing insights to further advance the platforms for stem cell applications.”   Sanford-Burnham is currently building the world’s largest collection of human iPSCs generated from individual patients and healthy volunteers. The Stem Cell Research Center’s expertise and resources are available to all Sanford-Burnham scientists, as well as other researchers at nonprofit and for-profit research organizations around the world.   LEAP™ for induced pluripotent stem cells   The LEAP™ instrument is an automated system that provides high-throughput cell imaging coupled with versatile laser-based cell processing. The instrument’s applications include rapid and accurate in situ purification of adherent cells and cell colonies, features that are particularly useful when working with complex human iPSC cultures. The LEAP™ instrument enables scientists in Sanford-Burnham’s Stem Cell Research Center to improve and accelerate their methods for generating human iPSCs and their differentiated progeny, which are used in the study of a variety of diseases. iPSCs are stem cells derived from adult cells—a research advance that garnered the 2012 Nobel Prize in Physiology or Medicine.   “Intrexon’s LEAP™ instrument will allow us to isolate high-quality human iPSCs while eliminating non- or partially-reprogrammed cells or other undesirable cell types in the culture—a laborious process that previously took a trained technician a lot of time,” explained Yang Liu, Ph.D., manager of Sanford-Burnham’s Stem Cell Research Center. “Together with other automated equipment available in our facility, the new capabilities will free up valuable resources, allowing us to provide an even greater level of service to our internal and external users.”   “We are big believers in iPSCs and their potential for use in new therapeutic modalities,” said Fred Koller, Ph.D., vice president and executive director of the Intrexon Institute for Biomolecular Research. “It’s exciting for us to use our technology collaboratively with Sanford-Burnham’s team of premier scientists. We look forward to applying LEAP™, RTS® and other Intrexon tools in this stem cell research, and are proud to assist in the diverse medical advancements enabled by this collaborative effort with Sanford-Burnham.”   Controlling gene expression with RTS®   RTS® technology, a proprietary biological “switch” that enables inducible controlled gene expression by administering an activator ligand, will give Sanford-Burnham scientists a new method to regulate when certain genes are turned on or off in cells. The system also provides more accurate delivery of new therapeutic candidates to specific tissues in animal models.   “We’re interested in the RTS® technology because it will help us to turn genes on or off in stem cells that have been transplanted. For example, it can be used for therapeutic protein expression in stem cells that home to and help eradicate brain tumors,” said Snyder.   “New cell-based therapies may someday result from our LEAP™ and RTS® technologies,” Koller said. “Working with leaders in the field of academic stem cell research will leverage both parties’ technologies to get there faster.”   About Sanford-Burnham Medical Research Institute Sanford-Burnham Medical Research Institute is dedicated to discovering the fundamental molecular causes of disease and devising the innovative therapies of tomorrow. The Institute consistently ranks among the top five organizations worldwide for its scientific impact in the fields of biology and biochemistry (defined by citations per publication) and currently ranks third in the nation in NIH funding among all laboratory-based research institutes. Sanford-Burnham utilizes a unique, collaborative approach to medical research and has established major research programs in cancer, neurodegeneration, diabetes, and infectious, inflammatory, and childhood diseases. The Institute is especially known for its world-class capabilities in stem cell research and drug discovery technologies. Sanford-Burnham is a U.S.-based, non-profit public benefit corporation, with operations in San Diego (La Jolla), California and Orlando (Lake Nona), Florida. For more information, news, and events, please visit us at sanfordburnham.org.   About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology.  Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science.  The company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. More information about the Company is available at www.dna.com. Media Contact: Corporate Contact: Heather Buschman, Ph.D. Marie L. Rossi, Ph.D. Sanford-Burnham Medical Research Institute Intrexon Corporation hbuschman@sanfordburnham.org mrossi@intrexon.com (858) 795-5343 (301) 556-9944
Synthetic Biologics and Intrexon Corporation Initiate Development of Monoclonal Antibodies for Whooping Cough (Pertussis)
-- The University of Texas at Austin to Join in Pertussis Research Efforts -- Rockville, MD, and San Francisco, CA, December 20, 2012 – Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, and Intrexon Corporation, a leading synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, announced today that they have initiated development of a monoclonal antibody (mAb) therapy for the treatment of pertussis, more commonly known as whooping cough. Each year, Bordetella pertussis (B. pertussis) infection causes an estimated 294,000 deaths worldwide, primarily among young, unvaccinated children.[i] Recent reports indicate that the pertussis vaccine introduced in the 1990s does not provide long-term protection and, as a result, whooping cough cases are increasing to a 60-year high in the U.S.[ii],[iii] To aid in the management of the rising number of pertussis cases, Synthetic Biologics intends to develop a mAb therapy, SYN-005, designed to neutralize the pertussis toxin, thereby reducing the mortality rate in infants and potentially shortening the chronic cough in adults.   The initiation of mAb development for the treatment of pertussis is the second of three infectious disease indications Synthetic Biologics intends to pursue as part of its August 2012 collaboration with Intrexon. To further the development of this potential therapy for pertussis, Synthetic Biologics has entered into an agreement with The University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. These research efforts are being conducted at the Cockrell School of Engineering in the laboratory of Assistant Professor, Jennifer A. Maynard, Ph.D., the Laurence E. McMakin, Jr. Centennial Faculty Fellow in the McKetta Department of Chemical Engineering. Dr. Maynard brings to the project her expertise in defining the key neutralizing epitopes of pertussis toxin to optimize the potential efficacy of antibody therapeutics.   Dr. Maynard stated, “I am very excited to be working with Synthetic Biologics on the development of this important new treatment for whooping cough, with the potential to protect infants from this devastating disease, and to treat adults who suffer from the disease later in life.”   B. pertussis is a gram-negative bacterium that infects the respiratory tract of humans, causing uncontrollable, violent coughing. Antibiotic treatment does not have a major effect on the course of pertussis, because while it can eliminate the B. pertussis bacteria from the respiratory tract, it does not neutralize the pertussis toxin. Infants with pertussis often require hospitalization in pediatric intensive care units, frequently necessitating mechanical ventilation. Pertussis in adults generally leads to a chronic cough referred to as the “cough of 100 days.” The increased incidence of pertussis is associated with exposure of unvaccinated and under-vaccinated individuals, especially infants who are not yet fully vaccinated and individuals whose immunity has diminished over time, as well as individuals who are carriers with bacteria present in their lungs but may or may not have the active disease. Unlike antibiotics, SYN-005 will be designed to neutralize the pertussis toxin and reverse the course of the disease.   “We are pleased to begin work on a mAb therapy to treat pertussis with our infectious disease collaborator, Intrexon, as well as with the experts at The University of Texas at Austin. Dr. Maynard has been researching and developing specific pertussis toxin targets for more than five years and her experience should accelerate our development timelines,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics, Inc. “A steady increase in outbreaks of pertussis has become a serious threat to some of the most vulnerable members of our society, especially infants, and to individuals who are unvaccinated or whose vaccine failed to provide lasting immunity. Across the nation this year, doctors have reported twice as many cases of pertussis as there were in 2011. The risk to individuals and to public health caused by outbreaks of pertussis support the pursuit of a new therapeutic option such as our mAb therapy.”   Collaboration with Intrexon   In August 2012, Synthetic Biologics entered into a worldwide exclusive channel collaboration with Intrexon for the development and commercialization of mAb therapies to treat certain infectious diseases. Under this collaboration, the Company intends to utilize Intrexon’s comprehensive suite of proprietary technologies, including the mAbLogix™ and LEAP™ platforms, to develop mAbs to specifically and rapidly neutralize/clear pathogens that cause infectious diseases. While the Synthetic Biologics has initiated mAb development for two of three initial targets, Acinetobacter infection and pertussis, the collaboration may optionally be expanded to include up to a total of eight infectious disease indications.   About Monoclonal Antibodies (mAbs)   Acting as the body's army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses, bacteria and toxins. MAbs can be designed and produced as therapeutic agents, utilizing protein engineering and recombinant production technologies. The mAbs being developed under the Synthetic Biologics’ collaboration with Intrexon are intended to supplement a patient's own immune system by providing the means to specifically and rapidly neutralize and/or clear specific pathogens and toxins of interest in a process known as “passive immunity.” Many pathogens that cause infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. Synthetic Biologics intends to utilize Intrexon’s comprehensive suite of proprietary mAb design and recombinant protein production technologies to efficiently create a potent candidate mAb (SYN-005) for human testing and use to specifically treat pertussis.   About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology. Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The Company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. More information about the Company is available at www.dna.com.   About Synthetic Biologics, Inc.   Synthetic Biologics is a biotechnology company focused on the development of product candidates for serious infections and diseases. Synthetic Biologics is developing a biologic for the prevention of C. diff infection, and a series of monoclonal antibodies (mAbs) for the treatment of serious infectious diseases, including Acinetobacter and pertussis. The Company is also developing a synthetic DNA-based therapy for the treatment of pulmonary arterial hypertension (PAH) in collaboration with Intrexon. In addition, the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and designing a clinical development pathway for the treatment of amyotrophic lateral sclerosis (ALS). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.   mAbLogix™ and LEAP™ are registered trademarks of Intrexon Corporation.   This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding Synthetic Biologics’ intent to develop and commercialize multiclonal antibody therapies for the treatment of infectious diseases such as pertussis, the timeline for such development, its use of Intrexon’s technologies and the intended results of such use, the opportunity presented by the number of affected patients, the anticipated results to be derived from the  mAb research conducted at The University of Texas at Austin and the potential expansion of the Intrexon collaboration. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, a failure of Synthetic Biologics’ monoclonal antibodies for the treatment of infectious diseases to be successfully developed or commercialized, a failure of the Intrexon’s intellectual property to create potent candidate mAbs, an inability to obtain regulatory approval of the infectious disease product candidates, a failure of the results of clinical trials to support the efficacy or safety of product candidates, a failure of the preclinical or clinical trials to proceed on schedules that are consistent with Synthetic Biologics’ current expectations or at all, Synthetic Biologics’ inability to protect its intellectual property and freedom to operate without interference of the patents of others, inability to maintain the effectiveness of the exclusive collaboration agreement, its reliance on third parties to develop its product candidates, the insufficiency of existing capital reserves to fund continued operations for a particular amount of time and uncertainties regarding Synthetic Biologics’ ability to obtain additional financing to support its operations thereafter and other factors described in Synthetic Biologics’ report on Form 10-K/A for the year ended December 31, 2011 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.   For further information, please contact: Synthetic Biologics, Inc. Kris Maly Vice President, Corporate Communication (734) 332-7800, Ext. 22 For Intrexon Corporation: Donald P. Lehr, Chief Legal Officer, Intrexon Corporation, +1-301-556-9809, dlehr@intrexon.com; Investor: The Ruth Group, Stephanie Carrington / Nicole Greenbaum, +1- 646-536-7017 / 7009, scarrington@theruthgroup.com, ngreenbaum@theruthgroup.com [i] World Health Organization. Pertussis: immunization surveillance, assessment and monitoring. http://www.who.int/immunization_monitoring/diseases/pertussis/en/index.html. [ii] Misegades LK, Winter K, Harriman K, Talarico J, Messonnier NE, Clark TA, Martin SW, Association of childhood pertussis with receipt of 5 doses of pertussis vaccine by time since last vaccine dose, California, 2010. JAMA, 2012 Nov 28;308(20):2126-32. [iii] Centers for Disease Control and Prevention. Pertussis Epidemic – Washington, 2012. Morbidity and Mortality Weekly Report. July 20, 2012.
ZIOPHARM Oncology Presents Systemic, DNA/Cell Plasmid Therapy Showing Long-Term Persistence and Anti-Tumor Effects at EORTC-NCI-AACR Meeting
NEW YORK, NY – November 7, 2012 – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company employing small molecule and synthetic biology approaches to cancer therapy, announced today results from a preclinical study demonstrating the long-term persistence and anti-tumor effects of a new synthetic biology approach (DNA/cell plasmid) to controlled protein production in vivo. This embedded controlled bioreactor study was presented at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics, taking place November 6-9 in Dublin, Ireland, and was conducted jointly by ZIOPHARM and Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, ZIOPHARM’s exclusive channel partner for the development of DNA therapeutics. “These data demonstrate the potential of our disruptive technologies, including UltraVector®, RTS®, and our cell engineering capabilities,” said Samuel Broder, M.D., Chairman of Intrexon’s Therapeutic Opportunities Committee and former Director of the NCI (National Cancer Institute). “By using tightly controlled, purpose-built, cellular protein factories, we open up therapeutic windows for a broad array of proteins. This study demonstrates the long-term persistence of this approach, with sustained protein production and therapeutic anti-tumor efficacy drawing from only a single intramuscular administration of plasmid DNA.” Hagop Youssoufian, M.D., President of Research and Development and Chief Medical Officer of ZIOPHARM, said, “These data are very exciting, as they provide us with another systemic approach for the delivery of therapeutic proteins to a target cancer using engineered DNA transgenes. We have already seen the potential in the clinic of delivering these transgenes using dendritic cells and viral vectors. Each approach gives us a means of optimizing the timing, concentration and location of therapeutic proteins; ultimately allowing us to dislocate cancer’s signaling networks with minimal interference to our natural systems. We look forward to further our study of therapeutic anti-cancer proteins delivered via this revolutionary technology.” For this study, a RheoSwitch®-regulated (RTS®) interferon alpha (IFNα) plasmid transgene was evaluated as a means of widening the therapeutic window of IFNα in a melanoma mouse model. DNA vectors for the controlled expression of murine or human IFNα were optimized using Intrexon’s UltraVector® platform, then transfected into human fibrosarcoma cells or myoblasts, forming RTS-IFNαplasmids. These plasmids were subsequently electroporated into the skeletal muscle of normal or melanoma tumor-bearing mice, and then activated using an oral activator ligand (AL). A single intramuscular electroporation of RTS-IFNα combined with daily oral activator ligand treatment led to significant tumor growth inhibition, comparable to chemotherapy or repeated bolus injection with recombinant mIFNα protein, but without overt toxicity, as assessed by body weight change and survival. Treatment with pRTS-IFNα resulted in sustained serum and tumor expression of mouse IFNα for approximately 4 months (study termination), as well as expression of the angiogenic biomarker IP-10, and activation of T cells (CD4 and CD8), NK cells, and dendritic cells. About ZIOPHARM Oncology, Inc.: ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company's clinical programs include: Palifosfamide (ZIO-201) is a potent bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for the treatment of first-line metastatic soft tissue sarcoma and is also in a pivotal Phase 3 trial (MATISSE) for first-line metastatic small cell lung cancer. Additionally, the Company is developing an oral capsule form of palifosfamide. Ad-RTS IL-12 is currently being tested in a Phase 2 study. Ad-RTS IL-12 uses synthetic biology to enable controlled, local delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. ZIOPHARM's DNA synthetic biology platform is being developed in partnership with Intrexon Corporation and employs an inducible gene-delivery system that enables controlled, local delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological “switch” (the RheoSwitch Therapeutic System®, RTS®) to turn on/off the therapeutic protein expression at the tumor site. Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer. Darinaparsin (ZIO-101) is a novel mitochondrial- and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K. ZIOPHARM's operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com. Forward-Looking Safe Harbor Statement: This press release contains certain forward-looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, and our other therapeutic products will be successfully marketed if approved; whether any of our other DNA-based biotherapeutics discovery and development efforts will be successful; our ability to achieve the results contemplated by our collaboration agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for DNA-based biotherapeutics; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. Contact: For ZIOPHARM: Nicole Jones ZIOPHARM Oncology, Inc. 617-778-2266 njones@ziopharm.com Media Contacts: David Schull or Lena Evans Russo Partners, LLC 858-717-2310 212-845-4262 david.schull@russopartnersllc.com lena.evans@russopartnersllc.com
Intrexon to Acquire 48% Stake in AquaBounty Technologies
- Utilizing Biotechnology to Improve Productivity in Aquaculture Blacksburg, Virginia – October 31, 2012 - Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, today announced that it has entered into a definitive purchase agreement to acquire an approximately 48% interest in AquaBounty Technologies, Inc. (AIM:ABTX), a biotechnology company focused on enhancing the productivity in aquaculture, from existing shareholders.  Pursuant to the purchase agreement, Intrexon will purchase 48,631,444 shares from Linnaeus Capital Partners B.V. and its affiliate, Tethys Ocean B.V., for $6 million (US) in cash, or approximately $0.123 per share in cash, which is equivalent to approximately £0.0764 per share[1].  This represents a premium of approximately 49% to the mid-market closing price of AquaBounty’s common stock on the date immediately preceding this announcement.  Upon the closing of the sale, the founder of Linnaeus Capital, Kakha Bendukidze and three other directors nominated by Linnaeus Capital will resign their seats on AquaBounty’s board of directors. In accordance with provisions of AquaBounty’s charter, following the close of the transaction Intrexon is required to commence a tender offer for any and all of the other outstanding shares of AquaBounty.  Intrexon’s tender only will be conditional on receiving acceptances in respect of shares which, together with the shares acquired from Tethys Ocean and Linnaeus, will result in Intrexon Corporation holding shares representing more than 50% of the remaining outstanding shares in AquaBounty.  The offer price per share in the tender will be equal to the per share price paid by Intrexon in its acquisition of shares from Linnaeus Capital and Tethys Ocean. Further details on the tender will be provided following the close of the acquisition of shares pursuant to the purchase agreement.   Thomas Kasser, President of Intrexon’s Animal Science Division, stated, “This transaction will accelerate our efforts to play a leading role in solving the world’s emerging food shortages through biotechnology. AquaBounty’s pioneering work in genetically modified fish is an initial step toward creating a large-scale, efficient and environmentally safe and sustainable global aquaculture market. We look forward to working with the AquaBounty team to improve aquaculture productivity and expand the reach of their molecular modification technology.”   As a condition to executing the definitive agreement with Linnaeus Capital, Intrexon and AquaBounty executed an agreement restricting AquaBounty’s ability to issue additional securities prior to, and during, the tender offer, and certain other provisions.  Intrexon and AquaBounty expect to negotiate and execute, prior to the closing of the stock acquisition, a relationship agreement containing provisions consistent with the rights of a significant holder of an AIM listed company.   This press release is for informational purposes only and is not a recommendation, an offer to purchase, a solicitation of an offer to purchase or a solicitation of consents with respect to any securities. The tender offer will be made solely pursuant to an offer to purchase and related letters of transmittal that will be distributed to AquaBounty security holders.   The availability of the tender offer to shareholders of AquaBounty who are not resident in and citizens of the United Kingdom may be affected by the laws of the relevant jurisdictions in which they are located or of which they are citizens.  Persons who are not resident in the United Kingdom should inform themselves of, and observe, any applicable legal or regulatory requirements of their jurisdictions.  Further details will be contained in the tender offer document.   The release, publication or distribution of this announcement in jurisdictions other than in the United Kingdom may be restricted by law and therefore any persons who are subject to the laws of any jurisdiction other than the United Kingdom should inform themselves about, and observe, any applicable requirements.  Any failure to comply with the applicable restrictions may constitute a violation of the securities laws of any such jurisdiction.  To the fullest extent permitted by applicable law, Intrexon disclaims any responsibility or liability for violation of such restrictions by any person. About AquaBounty Technologies AquaBounty Technologies is a biotechnology company focused on improving productivity in commercial aquaculture, a $100 billion industry and the fastest growing segment of the worldwide food industry. The company’s objective is the application of biotechnology to ensure the availability of high quality seafood to meet global consumer demand.  The company is developing products to address critical production constraints in the most popular farmed species, focusing initially on salmon, trout and shrimp.  Its AquAdvantage® fish program is based upon a single, specific molecular modification in fish that results in more rapid growth in early development. About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology.  Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science.  The company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells.   For Intrexon Corporation Corporate Contact: Donald P. Lehr, 301-556-9809 Chief Legal Officer dlehr@intrexon.com or Investor Contact: The Ruth Group Stephanie Carrington / Nicole Greenbaum, 646-536-7017 / 7009 scarrington@theruthgroup.com ngreenbaum@theruthgroup.com   [1] Based on an exchange rate of £0.621 per US$.
ZIOPHARM Oncology Announces Compelling Clinical Activity in Phase 1 Study of Ad-RTS IL-12 in Advanced Melanoma and Dosing of First Patient in Phase 2 Study
NEW YORK, NY – October 25, 2012 – ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that compelling clinical activity was seen in its Phase 1 study of Ad-RTS IL-12, a novel DNA-based therapeutic candidate, in advanced melanoma. Based on early activity, and determination of a biologically effective dose, the Company also announced that the study has advanced to Phase 2 in which the first patient has been dosed. Initiation of the Phase 2 study follows the successful, dose-escalation Phase 1 study in which clinical activity was observed in 5 of 7 (71%) patients dosed at the two highest dose levels. The data also showed a correlation between T-cell immune responses and clinical outcome, with no dose-limiting toxicities reported. A total of 13 patients were enrolled in the Phase 1 study, and were treated with a range of doses of an orally administered activator ligand. Three serious adverse events (SAE) were reported: two related to therapy (pyrexia and cytopenia), and one unrelated (deep vein thrombosis). Unrelated to the study therapy, one patient death was reported due to bacterial sepsis and progression of disease. The Company expects to submit full results of the study for presentation at a major medical meeting. The Phase 2 multi-center, single-arm, open-label expansion study will enroll up to 15 patients with unresectable Stage III or IV melanoma and further evaluate the safety and efficacy of intratumoral injections of Ad-RTS IL-12 in combination with an oral activator ligand. Data from this study are expected in the first half of 2013. “ZIOPHARM, working with our DNA therapy platform, is ushering in a paradigm shift in how we treat cancer, one that transforms our ability to deliver therapy, leading to better, safer treatment and ultimately, to cures,” said Samuel Broder, M.D., Chairman of Intrexon Therapeutic Opportunities Committee and former Director of the NCI (National Cancer Institute). “We look forward to seeing additional data as ZIOPHARM expands the Ad-RTS IL-12 DNA program into multiple indications, including breast cancer, and to the introduction of the next generation of DNA-based therapeutic candidates for oncology.” “This Phase 1 study demonstrates that IL-12 dosing, delivered and controlled through a pioneering DNA therapeutic strategy, is both tolerable and clinically active,” stated Hagop Youssoufian, M.D., President of Research and Development and Chief Medical Officer of ZIOPHARM. “An important early sign of this effect was manifested in lesions not injected with Ad-RTS IL-12, where clinical response was observed, indicating systemic, anti-cancer immune activity. We also saw activity in patients who had been previously exposed to ipilimumab, as well as other forms of immunotherapy, suggesting that Ad-RTS IL-12 may provide benefit for patients with advanced disease.” In connection with the achievement of this milestone, ZIOPHARM announced today that it will issue 3,636,926 shares of the Company’s common stock to Intrexon Corporation in accordance with the terms of the Exclusive Channel Partner Agreement (ECP) between the companies entered into in January 2011. All of the shares issued to Intrexon will be unregistered but certain registration rights in accordance with the Registration Rights Agreement entered into by the companies at the time of the ECP. About ZIOPHARM Oncology, Inc.: ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company's clinical programs include: Palifosfamide (ZIO-201) is a potent bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for the treatment of first-line metastatic soft tissue sarcoma and is also in a pivotal Phase 3 trial (MATISSE) for first-line metastatic small cell lung cancer. Additionally, the Company is developing an oral capsule form of palifosfamide. Ad-RTS IL-12 is currently being tested in a Phase 2 study. Ad-RTS IL-12 is a novel DNA therapeutic that is delivered to the patient's tumor thereby localizing expression of the therapeutic modality, interleukin-12 (IL-12), a protein important for an immune response to cancer. ZIOPHARM's DNA therapeutics are being developed in partnership with Intrexon Corporation employing a revolutionary synthetic biology platform that permits targeted, controlled production of therapeutic proteins in humans. This is achieved by placing IL-12 under the control of a proprietary biological “switch” (the RheoSwitch Therapeutic System®, RTS®) to turn on/off the therapeutic protein expression at the tumor site. Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer. Darinaparsin (ZIO-101) is a novel mitochondrial- and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K. ZIOPHARM's operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com. Forward-Looking Safe Harbor Statement: This press release contains certain forward-looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, and our other therapeutic products will be successfully marketed if approved; whether any of our other DNA-based biotherapeutics discovery and development efforts will be successful; our ability to achieve the results contemplated by our collaboration agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for DNA-based biotherapeutics; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. Contact: For ZIOPHARM Nicole Jones ZIOPHARM Oncology, Inc. 617-778-2266 njones@ziopharm.com Media Contacts: David Schull or Lena Evans Russo Partners, LLC 858-717-2310 212-845-4262 david.schull@russopartnersllc.com lena.evans@russopartnersllc.com
Fibrocell Science, Inc. Announces $45 Million Private Placement and Enters Strategic Collaboration with Intrexon
-- Proceeds to Support Commercial Launch of LAVIV and Expand Development of their Proprietary Fibroblast Platform -- Strategic Collaboration with Intrexon to Advance Development and Commercialization of Next Generation Fibroblast Platform Programs   EXTON, PA, October 8, 2012 ([BUSINESS WIRE]) – Fibrocell Science, Inc. (FCSC.OB), a biotechnology company focused on commercializing LAVIV, the first and only FDA-approved personalized cell therapy in aesthetic dermatology, and on developing innovative autologous cell therapies for additional aesthetic, medical and scientific applications, today announced that it has entered into a securities purchase agreement for a private placement financing with a select group of institutional investors and high net worth individuals, including NRM VII Holdings I, LLC, a Third Security, LLC affiliated fund. Upon the closing of the transaction, Fibrocell will receive gross proceeds of $45.0 million from the sale of 450 million shares of common stock at a price of $0.10 per share. Concurrent with the closing of this transaction, the outstanding Series D and Series E Convertible Preferred Stock will be converted into common stock, leaving no remaining shares of preferred stock outstanding.  Also concurrent with the closing, approximately $2.1 million in principal amount of the Company’s outstanding convertible notes will also be converted into common stock at a conversion price of $0.10 per share and the remaining $1.5 million in principal amount of the outstanding convertible notes will be redeemed for cash with the proceeds from the transaction.  The outstanding convertible notes shall be converted and redeemed in the amount of outstanding principal, accrued interest and interest scheduled to maturity.  There will be no debt outstanding at the closing of the transaction. Concurrent with this transaction, Fibrocell announced that it has entered into a strategic collaboration with Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, for the development and commercialization of the next generation of genetically modified and non-genetically modified autologous fibroblasts and autologous dermal cells in the U.S.  Intrexon will make available its proprietary platforms and technologies, including UltraVector®, DNA and RNA MOD engineering, protein engineering, transcription control chemistry, genome engineering, cell processing, and cell system engineering, to the Fibrocell program. As consideration, Intrexon will receive an upfront technology access fee of $3.2938 million payable by Fibrocell in common stock at the price paid in this financing. Fibrocell will engage Intrexon for support services for the development of new products under this agreement and will reimburse Intrexon for these activities. Upon commercialization of any of the products generated with Intrexon technology under the agreement, Fibrocell will pay quarterly cash royalties to Intrexon.   David Pernock, Chief Executive Officer of Fibrocell, stated, “This is a transformative and strategic financing for Fibrocell.  With this capital we can unlock the power of our fibroblast platform to improve the lives of patients and to create value for stockholders. We now have a strong, simplified balance sheet, and we believe the investment will allow us to accomplish our key objectives: expand capacity to meet demand for LAVIV, improve our manufacturing efficiency and COGS, and further our clinical programs for potential new indications. The new relationship with Intrexon is exciting and strategically important by granting us access to their cutting edge technology so that we can continue to innovate and maintain our leadership in cell-based therapy. We warmly welcome our new investors and new board members and thank our existing stockholders for their participation in helping shape the future of the company.”   RJ Kirk, Chairman of Third Security and of Intrexon, stated, “We believe Fibrocell is poised to lead in an important new category of therapeutic arts.  The Company has an excellent management team, deep technical expertise, and proven production and commercial platforms. With the capital this raise provides for expansion and growth, we expect great success for LAVIV.  And, through access to Intrexon’s technology and the ability to innovate on top of an established and approved platform, such that even early experiments may be conducted within a GMP operating system, we expect the Company to establish a leadership role in creating additional high-value cellular therapeutics for underserved health needs.  We are committed to our partnerships with Fibrocell and look forward to working with David and his team.” The private placement is expected to close no later than October 11, 2012 and is subject to the satisfaction of customary closing conditions. The available proceeds from the private placement will provide Fibrocell with the resources to expand the commercial launch of  LAVIV, its first FDA-approved product for the treatment of nasolabial folds, to expand manufacturing capacity and implement process improvements, and to advance further development of LAVIV into other high unmet need indications such as the treatment of severe restrictive burn scars, vocal cord scarring and acne scars. In conjunction with this financing transaction, Marcus E. Smith, Senior Managing Director and General Counsel of Third Security, LLC, and Julian P. Kirk, Managing Director of Third Security, LLC, will join Fibrocell’s Board of Directors. The Company’s stockholders approved a proposed amendment to its Certificate of Incorporation to effect a reverse stock split of the outstanding shares of common stock, as determined by the Board, if the Board believes such action will facilitate the listing of the Company’s common stock on a national securities exchange.  The Board does not have a timetable for any such reverse stock split, but the amendment requires such reverse stock split, if it occurs, to be effective prior to July 31, 2013. The Company believes that the closing of this transaction is an important step in the Board’s determination of whether to effectuate such reverse stock split and seek listing of the common stock on a national securities exchange. MTS Securities, LLC acted as strategic advisor to the Company on the transaction.  Barclays and MTS Securities, LLC acted as lead placement agents and John Carris Investments, LLC acted as co-placement agent on the transaction. About LAVIV™ (azficel-T) LAVIV was approved by the FDA on June 21, 2011 for the improvement of the appearance of moderate-to-severe nasolabial fold wrinkles in adults and is the first and only personalized cell therapy approved by the FDA for aesthetic use. LAVIV is now available in major metropolitan areas throughout the U.S., exclusively through board-certified dermatologists and plastic surgeons who have been trained by Fibrocell Science on the treatment process. A list of trained and certified physicians is available at www.mylaviv.com and will be continually updated as new physicians are trained and begin offering LAVIV in their practice. Fibrocell Science is conducting research to identify other potential uses of LAVIV and their proprietary fibroblast technology. There is no timeline regarding when Fibrocell Science will seek FDA regulatory approval for additional uses. Important Safety Information About LAVIV™ (azficel-T) LAVIV is made especially for you from your own skin cells. Using someone else’s cells can cause a serious reaction. Prior to injection, confirm with your physician that your information on the LAVIV vial is correct. The most common side effects of LAVIV are at the injection-site, including redness, bruising, swelling, pain, bleeding, lumps, irritation, and itchiness. In clinical trials with LAVIV, most injection-site adverse reactions resolved within one week and most required no treatment. Your health care provider will help you to decide whether you are a candidate for LAVIV and may help you avoid some of the adverse reactions from LAVIV. Before getting LAVIV, tell your healthcare provider if you have any medical problems including allergic reactions to any drugs or food, bleeding disorders or take blood-thinning medicines like aspirin, ibuprofen, or Coumadin® (warfarin sodium), keloids or excessive scarring, skin cancer or any malignancy, genetic disorders affecting your skin, immune problems or take medicines that affect your immune system, or any other illness or medical problem. The full Prescribing Information for LAVIV includes additional warnings about adverse reactions that occurred in less than 1% of patients following LAVIV treatment in clinical trials. Talk to your healthcare provider about these warnings. Please tell your healthcare provider if you are allergic to the antibiotics amphotericin or gentamicin, bovine materials (products made from cattle), or dimethyl sulfoxide (DMSO). Do not use LAVIV if you have a skin infection on your face because LAVIV treatment can make the infection worse. Please see the accompanying full prescribing information for LAVIV contraindications, warnings, precautions and adverse events or visit www.mylaviv.com. About Fibrocell Science, Inc. Fibrocell Science, Inc. (FCSC.OB) is an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well as its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com. Forward-Looking Statements All statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, without limitation, the Company’s ability to close the financing transaction prior to October 11, 2011.  While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company’s control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011, as updated in “Item 1A. Risk Factors” in the Company’s Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company’s public filings with the SEC.   This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
Synthetic Biologics Initiates Development of Monoclonal Antibodies for Treatment of Acinetobacter Infections
-- Acinetobacter Infections Pose Growing Concern in Hospitals, and in Military and Natural Disaster Trauma Centers -- Company Engages Former Pfizer/Wyeth Global Infectious Disease Pharmaceutical Executive to Provide Expertise on Advancing Infectious Disease Pipeline   Ann Arbor, MI, September 18, 2012 – Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious diseases and unmet medical needs, today announced that it has initiated efforts to develop a monoclonal antibody (mAb) therapy for the treatment of acinetobacter infections. Many strains of Acinetobacter are multidrug-resistant and pose an increasing global threat to hospitalized patients, wounded military personnel and those affected by natural disasters. The Company also announced that it has engaged Lewis (Lew) Barrett, former Assistant Vice President, Established Products at Pfizer and Vice President Global Business Manager, Infectious Diseases at Wyeth Pharmaceuticals, to bring his expertise in the development, commercialization and launch of infectious disease product candidates to the Synthetic Biologics’ team.   Acinetobacter is a difficult to treat pathogen due to its rapid and well-established resistance to most antibiotics, making it a multidrug-resistant pathogen[1]. In addition, as a biofilm-forming pathogen, Acinetobacter has the ability to survive up to twice as long as non-biofilm-forming pathogens[2]. In the U.S., Acinetobacter has been reported to be the cause of up to 2.6% of hospital acquired infections, 1.3% of bloodstream infections and 7% of ICU respiratory tract infections[3], and more than half of the Acinetobacter isolates are multidrug-resistant[4]. Patients with infections caused by Acinetobacter have been reported having mortality rates ranging from 7.8% to 43% in the hospital and in the ICU[5]. While Acinetobacter is a well-documented pathogen in the hospital setting, this pathogen also poses an increasing danger to wounded servicemen and women in military treatment centers[6] and to those treated in trauma centers following natural disasters[7].   The initiation of mAb development for the treatment of acinetobacter infection is the first of the three initial targeted infectious diseases the Company intends to pursue as part of its most recent collaboration with Intrexon Corporation. In August 2012, Synthetic Biologics entered into a worldwide exclusive channel collaboration with Intrexon Corporation for the development and commercialization of mAb therapies to treat certain infectious diseases not adequately addressed by existing therapies. Under this collaboration, the Company intends to utilize Intrexon’s comprehensive suite of proprietary technologies, including the mAbLogix™ and LEAP™ platforms, to develop fully human mAbs to specifically and rapidly neutralize/clear acinetobacter pathogens. The collaboration may optionally be expanded to include up to an additional five infectious disease indications.   “We are pleased to begin work on a mAb therapy to treat acinetobacter infections. Acinetobacter has developed an increased resistance to antibiotics and other drugs over time, and a new therapeutic option is needed to treat infectious diseases caused by this bacteria,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics, Inc. “Our collaboration with Intrexon provides access to state-of-the-art platforms that have tremendous potential to produce a broad spectrum of fully human antibodies to fight against Acinetobacter where other options have failed.”   Mr. Riley concluded, “We welcome Lew Barrett to our team and look forward to benefiting from his many years of experience around the development and commercialization of anti-infectives, as we develop mAbs for the treatment of acinetobacter infections. We also look forward to disclosing additional infectious disease indications we intend to pursue in the near future.”   During his 25-year career at Wyeth (acquired by Pfizer in 2009), Mr. Barrett successfully led, co-chaired or served as the senior marketing executive on teams that focused on infectious diseases, oncology, transplantation, and hemophilia. He brings to Synthetic Biologics his expertise in U.S. and global strategy, domestic/global branding, clinical development, medical affairs, supply chain, business development and strategic alliance management. He built the brand and led global commercialization efforts for Wyeth’s in-line IV antibiotic, Zosyn®/Tazocin® (the second IV antibiotic to achieve $1 billion+ in sales), and managed the U.S. launch of Wyeth’s broad-spectrum IV antibiotic, Tygacil®. In 2010, Mr. Barrett formed LL Barrett Biopharmaceutical Consulting, LLC, and utilizing his depth of experience in the anti-infective, hospital and biopharma fields, provides strategic consultation to the global life sciences field with a particular focus on brand strategy, lifecycle strategy, business development, and strategic communications.   “Acinetobacter has consistently demonstrated its ability to rapidly develop resistance to antibiotics. We believe the threat of this pathogen coupled with a scarcity of new antibiotics creates a perfect storm. Novel biologic therapies such as Synthetic Biologics’ mAbs, with new targets and mechanisms, are especially exciting,” stated Mr. Barrett. “I look forward to working with the Company as they work toward developing new therapeutic candidates for a field of medicine where the availability of effective interventions has declined.”   About Monoclonal Antibodies (mAbs)   Acting as the body's army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses and bacteria and their associated toxins. MAbs can also be designed and produced as therapeutic agents, utilizing protein engineering and recombinant production technologies. The mAbs being developed under the Synthetic Biologics’ collaboration with Intrexon are intended to supplement a patient's own immune system by providing the means to specifically and rapidly neutralize and/or clear specific pathogens and toxins of interest in a process known as “passive immunity”. Many pathogens that cause infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. Synthetic Biologics intends to utilize Intrexon’s comprehensive suite of proprietary mAb design and recombinant protein production technologies to efficiently create potent candidate mAbs for human testing and use to specifically treat certain infectious diseases for which current therapies are unavailable or inadequate.   About Synthetic Biologics, Inc.   Synthetic Biologics is a biotechnology company focused on the development of product candidates to address serious diseases and unmet medical needs. Synthetic Biologics is developing the following synthetic biologic candidates: a series of monoclonal antibodies (mAbs) for the treatment of serious infectious diseases not adequately addressed by existing therapies and a synthetic DNA-based therapy for the treatment of pulmonary arterial hypertension (PAH). The Company is also developing drug candidates for the treatment of relapsing-remitting multiple sclerosis (MS), cognitive dysfunction in MS, amyotrophic lateral sclerosis (ALS) and fibromyalgia (partnered with Meda AB). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.   mAbLogix™ and LEAP™ are registered trademarks of Intrexon Corporation.   Zosyn®, Tazocin® and Tygacil® are registered trademarks of Pfizer or its affiliates.   This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding Synthetic Biologics’ intent to develop and commercialize multiclonal antibody therapies for infectious diseases, its use of Intrexon’s technologies, the opportunity presented by Acinetobacter’s ability to resist antibiotic therapy and the expected contributions of Lewis Barrett. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, a failure of Synthetic Biologics’ monoclonal antibodies for the treatment of infectious diseases to be successfully developed or commercialized, a failure of the Intrexon’s intellectual property to create potent candidate mAbs, an inability to obtain regulatory approval of the infectious disease product candidates, a failure of the results of clinical trials to support the efficacy or safety of product candidates, a failure to successfully integrate newly engaged team members, a failure of the preclinical or clinical trials to proceed on schedules that are consistent with Synthetic Biologics’ current expectations or at all, Synthetic Biologics’ inability to protect its intellectual property and freedom to operate without interference of the patents of others, inability to maintain the effectiveness of the exclusive collaboration agreement, its reliance on third parties to develop its product candidates, the insufficiency of existing capital reserves to fund continued operations for a particular amount of time and uncertainties regarding Synthetic Biologics’ ability to obtain additional financing to support its operations thereafter and other factors described in Synthetic Biologics’ report on Form 10-K/A for the year ended December 31, 2011 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. For further information, please contact: Synthetic Biologics, Inc. Kris Maly Vice President of Corporate Communication (734) 332-7800, Ext. 22 [1] Roca, I, Espinal, P, Vila-Farres, X, and Vila, J. The Acinetobacter baumannii oxymoron: commensal hospital dweller turned pan-resistane menace. Frontiers in Microbiology, April 2012, Vol. 3, Article 148. [2] Espinal P, Martí S, Vila J. Effect of biofilm formation on the survival of Acinetobacter baumannii on dry surfaces. J Hosp Infect. 2012 Jan; 80(1):56-60. Epub 2011 Oct 4. [3] Jones, M, et al. Emerging resistance among bacterial pathogens in the intensive care unit – a European and North American Surveillance study (2000-2002). Ann Clin Microbiol Antimicrob. 3(14).; Wisplinghoff, H, et al. Nosocomial Bloodstream Infections in US Hospitals: Analysis of 24,179 Cases from a Prospective Nationwide Surveillance Study. Clin Infect Dis. 2004; 39(3): 309-17.; Wachter, K. Step Aside, MRSA, Here Comes Acinetobacter. OB. GYN. News, January 15, 2006. [4] The Center for Disease Dynamics, Economics & Policy. http://cddep.org/ResistanceMap/overview. Trends by U.S. Census Divisions for Multidrug-resistant Acinetobacter baumannii (2010). [5] Falagas, ME, Bliziotis, LA, and Siempos, II. Attributable mortality of Acinetobacter baumannii infections in critically ill patients: a systematic review of matched cohort and case-control studies. Critical Care 2006, 10:R48. [6] Camp, C and Tatum, OL. A Review of Acinetobacter baumannii as a Highly Successful Pathogen in Times of War.  LABMEDICINE. November 2010, Vol. 41, Number 11. [7] Camp, C and Tatum, OL. A Review of Acinetobacter baumannii as a Highly Successful Pathogen in Times of War. LABMEDICINE. November 2010, Vol. 41, Number 11.
Synthetic Biologics and Intrexon Corporation Enter Worldwide Exclusive Collaboration for Infectious Diseases
Collaboration Harnesses Monoclonal Antibodies to Address Unmet Medical Needs Joint Conference Call Scheduled for Today, Wednesday, August 8, 2012 at 5:00pm(ET)/2:00pm(PT) Rockville, MD, and San Francisco, CA, August 8, 2012 – Synthetic Biologics, Inc. (NYSE Amex: SYN), a developer of synthetic biologics and innovative medicines for unmet medical needs, and Intrexon Corporation (Intrexon), a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, today entered into a second worldwide exclusive channel collaboration through which Synthetic Biologics intends to develop and commercialize a series of monoclonal antibody (mAb) therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies. Utilizing Intrexon’s comprehensive suite of proprietary technologies, including the mAbLogix™ platform for rapid discovery of fully human mAbs, Synthetic Biologics’ initial efforts will target three infectious disease indications.  The collaboration may optionally be expanded to include up to an additional five infectious disease indications. Synthetic Biologics intends to disclose selected indications from time to time as business and commercial considerations dictate.   Jeffrey Riley, Chief Executive Officer of Synthetic Biologics, Inc., stated, “Through this second worldwide exclusive collaboration, we are pleased to strengthen our relationship with Intrexon and develop new therapeutics for unmet medical needs, in an effort to build value for our shareholders. Intrexon has state-of-the-art technologies and efficient processes that have tremendous potential for the production of a broad spectrum of fully human antibodies. This expanded relationship gives us access to this paradigm-changing platform.”   Saiid Zarrabian, President of Intrexon’s Protein Production Division, said, “We are very pleased to expand our relationship with Synthetic Biologics. Intrexon is committed to building a molecular toolkit and the scientific expertise needed to take on the challenges of developing new treatments for unmet medical needs. Intrexon’s collaboration with Synthetic Biologics represents the culmination of important acquired and internally developed technologies.  Intrexon’s core technology, the UltraVector® platform for design, construction, and testing of genetic components, integrated with the mAbLogix™ platform for in vitro B‑cell library production and the LEAP™ cell processing station, will allow for the rapid end-to-end development from fully human antibody discovery to therapeutic.”   Mr. Riley concluded, “We look forward to applying Intrexon’s competencies to the development of a series of monoclonal antibodies for the treatment of infectious diseases that take a tremendous worldwide toll on human life, and to disclosing more about our discovery targets in the near future.” Under terms of the transaction agreements: Synthetic Biologics will have broad access within the target indications to Intrexon’s comprehensive suite of proprietary technologies, including UltraVector®, DNA and RNA MOD engineering, protein engineering, transcription control chemistry, genome engineering, mAbLogix™ human antibodies, LEAP™-based cell processing and cell system engineering. Synthetic Biologics will issue to Intrexon approximately 3.6 million shares of its common stock as a technology access fee upon execution of the agreement; together with previously issued shares, immediately following this transaction Intrexon will own approximately 18% of Synthetic Biologics. Synthetic will pay to Intrexon an additional fee, in cash or additional shares of common stock, should it elect to broaden the collaboration beyond the three initial disease indications. Upon certain milestones (i.e., the filing of an Investigational New Drug application with the FDA and governmental approval/the initiation of commercial sales), Synthetic Biologics will pay Intrexon a milestone fee in cash or additional shares of common stock. Subject to certain expense allocations, Synthetic Biologics will pay Intrexon quarterly royalties in cash on annualized worldwide net sales. If the NYSE Amex approval of the issuance of the securities described above is not received within 120 days of the date of the execution of the exclusive channel agreement, Intrexon has the right to terminate the exclusive channel collaboration. Joint Synthetic Biologics/Intrexon Corporation Conference Call Synthetic Biologics and Intrexon will hold a conference call this afternoon, Wednesday, August 8, 2012, at 5:00pm (ET)/2:00pm (PT). Jeffrey Riley, Chief Executive Officer of Synthetic Biologics and Saiid Zarrabian, President of Intrexon’s Protein Production Division and Senior Vice President will host the call. Mr. Riley and Mr. Zarrabian will discuss the second worldwide exclusive channel collaboration through which Synthetic Biologics intends to develop and commercialize a platform of mAbs for the treatment of certain serious infectious diseases. Interested parties should call toll free 1-800-860-2442 (U.S.) or 1-866-605-3852 (Canada), or from outside North America +1 412-858-4600, fifteen minutes before the start of the call to register and identify themselves as registrants of the 'Synthetic Biologics' Conference Call. Any registered caller on the toll free line may ask to be placed in the queue for the Question & Answer session. The call will be simulcast on the web at http://www.videonewswire.com/event.asp?id=88858. If you are unable to participate during the live conference call, the webcast will be available for replay at the same URL (http://www.videonewswire.com/event.asp?id=88858) for 30 days after the call.   About Monoclonal Antibodies Acting as the body's army, antibodies are proteins generally found in the blood that detect and destroy invaders, such as viruses and bacteria and their associated toxins. Monoclonal antibodies (mAbs) are designed and made utilizing protein engineering and recombinant production technologies. The mAbs being developed under this collaboration are intended to supplement a patient's immune system by providing infected individuals with the means to specifically and rapidly neutralize and/or clear specific pathogens and toxins of interest in a process known as “passive immunity”. Many infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. Synthetic Biologics intends to utilize Intrexon’s comprehensive suite of proprietary mAb design and recombinant protein production technologies to efficiently create potent candidate mAbs for human testing and use to specifically treat certain infectious diseases for which current therapies are unavailable or inadequate.   About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology. Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The Company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. More information about the Company is available at www.dna.com.   About Synthetic Biologics, Inc.   Synthetic Biologics is a biotechnology company focused on the development of product candidates to address serious diseases and unmet medical needs. Synthetic Biologics is developing the following synthetic biologic candidates: a series of monoclonal antibodies (mAbs) for the treatment of  infectious diseases not adequately addressed by existing therapies and a synthetic DNA-based therapy for the treatment of pulmonary arterial hypertension (PAH) in collaboration with Intrexon. The Company is also developing drug candidates for the treatment of relapsing-remitting multiple sclerosis (MS), cognitive dysfunction in MS, amyotrophic lateral sclerosis (ALS) and fibromyalgia (partnered with Meda AB). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.   UltraVector®, mAbLogix™, and LEAP™ are registered trademarks of Intrexon Corporation.   This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding Synthetic Biologics’ intent to develop and commercialize multiclonal antibody therapies for infectious diseases and Synthetic Biologics’ belief that the new product opportunity and collaboration will build shareholder value. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, a failure of Synthetic Biologics’ monoclonal antibodies for the treatment of infectious diseases to be successfully developed or commercialized, a failure of the Intrexon’s intellectual property to create potent candidate mAbs, an inability to obtain regulatory approval of the infectious disease product candidates, a failure of the results of clinical trials to support Synthetic Biologics’ claims, a failure of the preclinical or clinical trials to proceed on schedules that are consistent with Synthetic Biologics’ current expectations or at all, Synthetic Biologics’ inability to protect its intellectual property and freedom to operate without interference of the patents of others, inability to maintain the effectiveness of the exclusive collaboration agreement, its reliance on third parties to develop its product candidates, the insufficiency of existing capital reserves to fund continued operations for a particular amount of time and uncertainties regarding Synthetic Biologics’ ability to obtain additional financing to support its operations thereafter and other factors described in Synthetic Biologics’ report on Form 10-K/A for the year ended December 31, 2011 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. For further information, please contact: Synthetic Biologics, Inc. Kris Maly Vice President of Corporate Communication (734) 332-7800, Ext. 22   Intrexon Corporation Corporate Contact:    Investor Contact: Donald P. Lehr Chief Legal Officer Intrexon Corporation Tel: 301-556-9809 dlehr@intrexon.com    The Ruth Group Stephanie Carrington / Nicole Greenbaum Tel: 646-536-7017 / 7009 scarrington@theruthgroup.com ngreenbaum@theruthgroup.com
BioLife Cell Bank and Intrexon Corporation Establish Worldwide Exclusive Collaboration for Spinal Muscular Atrophy (SMA)
Dallas, Texas & Germantown, Maryland - August 2, 2012 - BioLife Cell Bank, Inc., the leader in cryogenic storage of adipose (fat) tissue and adult mesenchymal stem and regenerative cells, and Intrexon Corporation, a synthetic biology company that utilizes its proprietary products to provide control over cellular function, announced today the formation of a global exclusive research collaboration.  Under the collaboration, BioLife, with its extensive physician network and stem cell experience coupled with Intrexon’s innovative technology, will strive to produce new treatments for Spinal Muscular Atrophy (SMA).   “With the tremendous potential of this collaboration, we are more than excited for the SMA community,” said John A. Carbona, Chief Executive Officer of BioLife.  “Intrexon’s impressive suite of technologies will give researchers access to unprecedented resources including new techniques and processes which could rapidly propel us toward the development of new treatments and products to help treat children with SMA.” Carbona continued, “I am happy to help realize the dream of our founders, Dr. David G. Genecov and John D. Harkey Jr., to make a positive and sustainable impact in health care. We’re elated by our new collaboration with Intrexon and will undertake immediately the establishment of relationships with the world’s leading scientists in SMA research such as: Dr. Arthur Burghes of Ohio State, Dr. Brian Kaspar of Nationwide Children’s Hospital, Dr. Charlotte Sumner of Johns Hopkins, Dr. Chris Lorson at the University of Missouri, and Dr. Kathy Swoboda at the University of Utah.  BioLife, through its ongoing relationships with Intrexon and these dedicated individuals, hopes for great strides toward lessening the impact of this terrible disease, if not curing it completely—which, of course, is our ultimate goal.” Thomas D. Reed, Ph.D., Founder and Chief Science Officer of Intrexon, said, “Intrexon's mission is to invent, acquire, and integrate the diverse technology platforms required to modulate cellular behavior through genome re-engineering.  We are dedicated to building the molecular toolbox and scientific expertise needed to empower clinicians to treat previously intractable diseases.  SMA is a devastating genetic disorder that requires a gene rescue paradigm.  Intrexon looks forward to working with BioLife and their growing network of clinical specialists to define, explore, and develop several different cell therapy approaches for treating SMA.”  Under the collaboration, Intrexon, acting through its Human Therapeutics Division, will be applying its technologies to the discovery of autologous, genetically-modified stem cell therapeutics.  BioLife will be supplying the collaboration with stem cells and clinical expertise. BioLife also will be responsible for conducting preclinical and clinical development of candidate SMA therapeutic products that may be advanced out of the collaboration, as well as for aspects of manufacturing and regulatory approval. About Spinal Muscular Atrophy Spinal Muscular Atrophy (SMA) is an autosomal-recessive genetic disorder characterized by progressive weakness of the lower motor neurons.  SMA is caused by a genetic defect in the SMN1 gene which codes SMN, a protein necessary for survival of motor neurons. SMA kills more infants than any other genetic disease in today’s world.   About BioLife As part of their core business, BioLife Cell Bank, Inc. offers individuals a way to safely store their adipose (fat) tissue and/or their adipose-derived stem and regenerative cells—giving patients and physicians easy, multi-use access to cells and tissue for future cosmetic, reconstructive, and regenerative therapies. Tissue is extracted via liposuction and sent to BioLife in a collection kit (validated to E.T.L. standards). Tissue is processed using proprietary technology and Cytori Therapeutics’ (NASDAQ: CYTX) products. Tissue is cryogenically preserved, and may be stored indefinitely. BioLife is registered with the FDA as a processing bank and complies with FDA regulations and guidance including current Good Tissue Practice (cGTP). BioLife is based in Dallas, Texas, at Forest Park Medical Center. For more information: www.biolifecellbank.com.   About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology.  Intrexon is deploying its extensive capabilities to rapidly design and produce novel and enhanced biological products and processes across multiple industry sectors, including: human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science.  The company's advanced bioindustrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly, and optimization to enable unprecedented control over the function and output of living cells. For BioLife   Corporate Contact: John A. Carbona, 972-331-1905 Chief Executive Officer jcarbona@biolifecellbank.com Media Contact: Kristin Laminack, 972-331-9626 Director, Marketing and Media kristin@biolifecellbank.com     For Intrexon Corporation   Corporate Contact:  Donald P. Lehr, 301-556-9809 Chief Legal Officer dlehr@intrexon.com Investor Contact: The Ruth Group Stephanie Carrington / Nicole Greenbaum, 646-536-7017 / 7009 scarrington@theruthgroup.com / ngreenbaum@theruthgroup.com
Oragenics and Intrexon Announce Worldwide Exclusive Collaboration for Lantibiotics
Oragenics and Intrexon Announce Worldwide Exclusive Collaboration for Lantibiotics, a Novel Class of Broad Spectrum Antibiotics For Immediate Release Tampa, FL, & Germantown, MD, June 6, 2012– Oragenics, Inc. (OTCBB: ORNI) (the “Company”), a leader in the area of oral care probiotics and a developer of therapeutic products including novel antibiotics, and Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, announced today the formation of a global exclusive channel collaboration through which Oragenics intends to develop and commercialize lantibiotics, a novel class of broad spectrum antibiotics, as active pharmaceutical ingredients (API) for the treatment of infectious diseases in humans and companion animals. John N. Bonfiglio, Ph.D., President and Chief Executive Officer of Oragenics, stated, “We are excited about the tremendous potential that the collaboration brings to the Company and we look forward to working with Intrexon. Intrexon’s state-of-the-art science will allow us access to new techniques and processes which could rapidly allow us to move toward commercialization of this exciting and novel class of antibiotics.”   Randal J. Kirk, CEO and Chairman of the Board of Intrexon, said, “Intrexon thrives on accepting challenges and solving problems that have proved resistant to the efforts of its predecessors.  As was the case with our recombinant human alpha 1-antitrypsin (rHuA1AT) project, the production of lantibiotics through bioindustrial process has been a high-value goal that we now take on with confidence and commitment.  We are pleased to be working with the Oragenics team on this high-value opportunity.” Under the collaboration, Oragenics will utilize Intrexon's advanced transgene and cell engineering platforms for the development and production of lantibiotics, a class of peptide antibiotics that naturally are produced in Gram-positive bacteria and contain the characteristic polycyclic thioether amino acids lanthionine and methyllanthonine. Lantibiotics have shown broad-spectrum antibiotic properties against Gram-positive bacterial infections, such as MRSA and VRE in pre-clinical studies, yet their development as commercially viable products continues to be subject to significant technological hurdles.   Intrexon will be responsible for technology discovery efforts, cell-engineering development, and certain aspects of the manufacturing process. Oragenics will be responsible for conducting preclinical and clinical development of candidate lantibiotics, as well as for other aspects of manufacturing and the commercialization of the product(s). Under terms of the transaction agreements: Oragenics will receive an exclusive, worldwide license to utilize the products of Intrexon’s modular genetic engineering platform for the development of API and drug products involving the direct administration to humans or companion animals of a lantibiotic for the prevention or treatment of infectious disease. Intrexon will apply its proprietary platforms and technologies, including UltraVector®, DNA and RNA MOD engineering, protein engineering, transcription control chemistry, genome engineering, and cell system engineering, to Oragenics’ lantibiotics program. Oragenics is responsible for funding the further anticipated development of lantibiotics toward the goal of commercialization. Oragenics will issue to Intrexon 4,392,425 shares of its common stock upon execution of the agreement along with the potential for additional development milestones. Subject to certain expense allocations, Oragenics will pay Intrexon 25% of the gross quarterly profits derived from the sale of products developed from the channel collaboration.  Griffin Securities served as financial advisor to Intrexon in connection with the transaction. About Oragenics, Inc. Oragenics, Inc. develops, markets and sells proprietary probiotics specifically designed to enhance oral health for humans and pets, under the brand names Evora® and ProBiora3® in over 13 countries worldwide.  In addition, Oragenics develops therapies designed to treat infectious diseases. More information about the company is available at www.oragenics.com.   About Intrexon Corporation Intrexon Corporation is a privately held synthetic biology company that employs modular DNA control systems to enhance capabilities, improve safety and lower cost in human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The company’s advanced transgene engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly and optimization.  More information about the company is available at www.dna.com.   Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect Oragenics’ current views with respect to future events and financial performance. These forward-looking statements are based on the management of Oragenics’ beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to Oragenics’ ability to raise additional capital to sustain its operations beyond June 30, 2012 , Oragenics’ ability to raise additional capital to develop and commercialize lantibiotics,  Oragenics’ ability to successfully develop or commercialize lantibiotics, any inability to obtain regulatory approval of the  lantibiotic candidates, any  failure of the results of clinical trials to support lantibiotic candidates, any  failure of the preclinical or clinical trials to proceed on schedules that are consistent with Oragenics’ current expectations or at all, and any inability of Oragenics to maintain the effectiveness of the exclusive collaboration agreement and those set forth in Oragenics’ most recently filed annual report on Form 10-K and quarterly report on Form 10-Q, and other factors detailed from time to time in filings with the U.S. Securities and Exchange Commission. Oragenics expressly disclaims any responsibility to update forward-looking statements.   For more information regarding Oragenics, contact:       Corporate Contact:    Investor Contact: Michael Sullivan Chief Financial Officer Oragenics, Inc 3000 Bayport Drive, Suite 685 Tampa, Fl 33607 Tel: 813-286-7900 x246 Direct: 813-786-6431 msullivan@oragenics.com    Robert Giordano President LaunchPad IR 880 Third Avenue, 6th Floor New York NY 10022 Tel: 1-800-625-2236 x7770 Direct: 917-327-3938 rgiordanonyc@gmail.com       For more information regarding Intrexon Corporation, contact:   Corporate Contact:    Investor Contact: Donald P. Lehr Chief Legal Officer Intrexon Corporation Tel: 301-556-9809 dlehr@intrexon.com      The Ruth Group Stephanie Carrington / Josh Drumm Tel: 646-536-7017 / 7006 scarrington@theruthgroup.com jdrumm@theruthgroup.com    
Experienced Life Sciences Executive to Join Intrexon as Chief Operating Officer
Krish S. Krishnan, M.S., M.B.A., appointed Chief Operating Officer Blacksburg, Virginia, December 5, 2011. Intrexon Corporation, a privately held synthetic biology engineering company, today announced the appointment of Krish S. Krishnan, M.S., M.B.A., to Chief Operating Officer. Mr. Krishnan will have overarching executive responsibility for all of Intrexon’s operating divisions. Mr. Krishnan brings many years of experience in the life sciences industry, having held key executive roles at several companies including, most notably, his tenure as Chief Financial Officer, Chief Operating Officer and board member of New River Pharmaceuticals, Inc. Mr. Krishnan started his career as an engineer with E.I. Dupont de Nemours in Wilmington, Delaware. He received a B.S. in Mechanical Engineering from the Indian Institute of Technology, a M.S. in Engineering from The University of Toledo, and an M.B.A. in Finance from The Wharton School at the University of Pennsylvania. Intrexon’s Chairman and CEO Randal J. Kirk welcomes Mr. Krishnan stating, “Krish has an exceptional talent for driving smart execution of high value biotech strategies, as evidenced by the fast trajectory and tremendous upside return we realized together at New River Pharmaceuticals. Krish joins Intrexon at a time when his engineering and operational leadership skills can be applied across many such opportunities and drive the robust success of our partnerships and collaborations.” Kirk continues, “I have no doubt that he will bring an even greater industrial engineering discipline to the design and metrics of our processes and, in so doing, deliver further scalability, deeper cost reductions and even faster turnaround times. It is my great pleasure to welcome Krish to the Intrexon leadership team and the opportunity to go well beyond the previous level of achievement we have attained together.” Mr. Krishnan echoed the comments of Mr. Kirk, and added, “I am very excited to join Intrexon, and look forward to working closely with RJ to drive strong execution of this game changing biotech strategy and business model.” About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology. Intrexon is deploying its extensive engineering platform and capabilities to rapidly design and produce novel biofunctions and applications for human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The company’s advanced industrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly and optimization. More information about the company is available at www.DNA.com. Contact: Andrew Udell Intrexon Corporation Phone: 301-556-9850 E-mail: audell@intrexon.com
Prior CEOs of Monsanto and Pfizer join Intrexon Board of Directors
Blacksburg, Virginia, November 28, 2011. Intrexon Corporation, a privately held synthetic biology engineering company, today announced the appointments of Robert B. Shapiro and Jeffrey B. Kindler to the Intrexon Board of Directors. Mr. Shapiro brings extensive experience in the biochemical and biological sciences industry where he served as former Vice President, President, and CEO of Monsanto, in addition to serving as Chairman and CEO of the NutraSweet subsidiary of GD Searle & Company. He received a B.A. from Harvard University in 1959 and J.D. from Columbia University School of Law in 1962. Mr. Kindler joins the Intrexon Board following his immediate past tenure as Chairman and CEO of Pfizer, Inc. Preceding his leadership of Pfizer, Mr. Kindler served as the Executive Vice President and General Counsel of McDonald’s Corporation. He received a B.A. from Tufts University in 1977, followed by a J.D. magna cum laude from Harvard University in 1980. Intrexon’s Chairman and CEO Randal J. Kirk welcomes Mr. Shapiro and Mr. Kindler stating, “Intrexon has reached a strategic execution phase that will be greatly enhanced by guidance from Bob and Jeff. I am very pleased that executives of this caliber and experience have accepted our invitation and look forward to gaining the full benefit of their experience and insights.” About Intrexon Corporation Intrexon Corporation is a privately held biotechnology company focused on the industrial engineering of synthetic biology. Intrexon is deploying its extensive engineering platform and capabilities to rapidly design and produce novel biofunctions and applications for human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The company’s advanced industrial engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly and optimization. More information about the company is available at www.dna.com. Contact: Andrew Udell Intrexon Corporation Phone: 301-556-9850 E-mail: audell@intrexon.com
Adeona and Intrexon Announce Worldwide Exclusive Collaboration for PAH Therapy
Adeona Pharmaceuticals and Intrexon Announce Worldwide Exclusive Collaboration for Synthetic DNA-based Therapy for Pulmonary Arterial Hypertension For Immediate Release Ann Arbor, MI, & Germantown, MD, November 21, 2011 – Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative disease-modifying medicines for serious illnesses, and the Human Therapeutics Division of Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function, announced today the formation of a global exclusive channel collaboration through which Adeona intends to develop and commercialize a DNA-based therapeutic using Intrexon's UltraVector® platform and RheoSwitch Therapeutic System® for the treatment of pulmonary arterial hypertension (PAH). Under the collaboration, Adeona will utilize Intrexon's advanced transgene engineering platform for the controlled, precise and continuous in vivo cellular production of prostaglandin synthase (PGIS), a specific effector enzyme that regulates the production of prostacyclin. PGIS expression is decreased in the lungs of PAH patients and deficiency in prostacyclin production is strongly implicated in PAH. Prostacyclin is a short-acting vasodilator and inhibitor of platelet aggregation that has demonstrated a survival benefit in primary pulmonary hypertension patients when administered by continuous central venous catheter infusion (p<0.003).  DNA-based in vivo expression of PGIS has demonstrated the ability to increase prostacyclin levels and improve survival in animal models of PAH. Intrexon employs its modular genetic engineering platform in the areas of therapeutics, protein production, animal sciences, industrial products, and agriculture products. The exclusive channel collaboration between Intrexon and Adeona has been established specifically for the in vivo production of PGIS for PAH. Under the collaboration, Intrexon will be responsible for technology discovery efforts and managing the patent estate as well as for certain aspects of manufacturing. Adeona will be responsible for conducting preclinical and clinical development of candidates, as well as for other aspects of manufacturing and the commercialization of the candidate product. Intrexon's core synthetic biology technology is designed to create Better DNA™ at industrial scale, enabling unprecedented control over the function and output of living cells by providing external control over in vivo activation and regulation of potent effectors. This platform, called UltraVector®, provides speed, flexibility, consistency and precision to the design, production and testing of rationally designed complex transgenes and their encoded genetic circuits. These qualities allow an iterative and rational approach to transgene design, which can be continually engineered until the host cell performance is optimized. Through this process, Intrexon is able to overcome the challenges inherent in current therapeutic strategies, including recombinant protein therapies and constitutive gene therapies, thereby enhancing capabilities, improving safety and lowering cost for human therapeutics. “Our collaboration with Intrexon is consistent with Adeona’s strategy of building shareholder value through continuous evaluation of new product opportunities and acting upon those that meet Adeona’s mission of delivering disease-modifying therapies for serious illnesses. We believe that this product opportunity and collaboration far and away exceeds these criteria, and we are pleased to be working with Intrexon to make this important new therapy available to PAH patients,” stated Adeona’s Chairman, Jeffrey Riley. “Current sales of approved therapies for PAH are an estimated $3 billion per year. While current therapies may improve quality of life, they have for the most part shown only modest improvements in survival, if any. We believe that by having the ability to correct what is considered to be a critical pathophysiological defect in PAH, namely reduced expression of prostaglandin synthase, we may have the opportunity to fundamentally change the course of PAH. We further believe that the ‘second generation’ rational nature of Intrexon’s genetic engineering technology provides the enabling technology necessary to make this goal a practical reality for PAH patients. We are pleased to be working with Intrexon in this exciting and potentially disease changing collaboration,” stated James S. Kuo, M.D., M.B.A., Chief Executive Officer of Adeona. "We are very pleased to collaborate with Adeona in this further demonstration of the breadth of Intrexon's UltraVector® platform and embedded controllable bioreactor approach to novel therapeutics. We are impressed with Adeona’s demonstrated ability to operate efficiently and decisively and we believe these qualities will serve both parties well as we navigate through the drug development process and commercialization," stated Glenn Nedwin, President, Human Therapeutics Division at Intrexon. Under terms of the agreement: •    Subject to the pre-approval of the NYSE Amex, Adeona will issue to Intrexon at $0.001 par value per share, 3,123,558 shares of its common stock, representing 9.995% of Adeona's issued and outstanding shares following and after taking into account such issuance; Adeona has agreed to issue to Intrexon an equal number of additional shares of its common stock at $0.001 par value per share, representing an additional 9.995%, upon dosing of the first patient in an Adeona-sponsored U.S. Phase II clinical trial of the candidate product using Intrexon technology; •    Intrexon has been granted the right to purchase up to 19.99% of securities offerings that may be conducted by Adeona in the future, subject to certain conditions and limitations; •    Intrexon has been granted the right to make purchases of Adeona’s common stock in the open market up to an additional 10% of Adeona’s common stock; and •    Subject to certain expense allocations, Adeona will pay Intrexon 50% of the cumulative net quarterly profits derived from the sale of products developed from the channel collaboration. “Because of the very wide breadth of applications that our technologies may enable, we believe that we can play a democratizing role among companies within traditional life science industries and among those in other industries that look to life science to supply solutions that their existing industrial processes have been otherwise unable to provide,” stated RJ Kirk, Intrexon’s Chairman and CEO. “In therapeutics, in particular, we see many opportunities for game changing strategies to be deployed against indications both large and small, complex and simple. In consequence, and as part of our business strategy, we look for opportunities to align ourselves with smaller, more entrepreneurial companies around focused opportunities that may be fully explored at costs and on timelines that previously were not available. Our new collaboration with Adeona around PAH exemplifies such an alignment and we celebrate our partner’s entrepreneurial spirit, vision and dedication to the service of patients as we begin the work of producing a meaningful improvement to the lives of people with this unfortunate but theoretically treatable condition.” If the NYSE Amex approval of the issuance of the securities described above is not received within 60 days of the date of the execution of the exclusive channel agreement, Intrexon has the right to terminate the exclusive channel collaboration. Griffin Securities served as financial advisor to Intrexon in connection with the transaction. About Pulmonary Arterial Hypertension (PAH) Pulmonary arterial hypertension is a progressive, disabling and life-threatening disorder characterized by abnormally high blood pressure (hypertension) in the pulmonary artery, the blood vessel that carries blood from the heart to the lungs. Hypertension occurs when most of the very small arteries throughout the lungs narrow in diameter, which increases the resistance to blood flow through the lungs. To overcome the increased resistance, pressure increases in the pulmonary artery and in the heart chamber that pumps blood into the pulmonary artery (the right ventricle). Signs and symptoms of pulmonary arterial hypertension occur when increased pressure cannot fully overcome the elevated resistance and blood flow to the body is insufficient. Shortness of breath during exertion and fainting spells are the most common early symptoms of pulmonary arterial hypertension. Despite current treatments, the outcome of PAH is generally very poor and associated with high rates of mortality within three to five years of diagnosis. About Intrexon Corporation Intrexon Corporation is a privately held synthetic biology company that employs modular DNA control systems to enhance capabilities, improve safety and lower cost in human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The company’s advanced transgene engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly and optimization.  More information about the company is available at www.DNA.com. About Adeona Pharmaceuticals, Inc. Adeona is a pharmaceutical company focused on the development of innovative disease-modifying medicines for serious illnesses. Adeona is developing, or has partnered the development of, drug product candidates to treat primary pulmonary hypertension, multiple sclerosis, fibromyalgia, amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. For more information, please visit Adeona's website at www.adeonapharma.com. This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding Adeona’s intent to develop and commercialize a DNA-based therapeutic for PAH, Adeona’s belief that the new product opportunity and collaboration will build shareholder value, Adeona’s ability to use the technology to develop a product that will correct a biological defect in PAH and the benefits to be derived from Intrexon’s genetic engineering technologies. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure of Adeona’s DNA-based therapeutic for the treatment of PAH to be successfully developed or commercialized, an inability to obtain regulatory approval of the PAH product candidates, a failure of the results of clinical trials to support Adeona’s claims, a failure of the preclinical or clinical trials to proceed on schedules that are consistent with Adeona’s current expectations or at all, Adeona’s inability to protect its intellectual property and freedom to operate without interference of the patents of others, inability to maintain the effectiveness of the exclusive collaboration agreement, its reliance on third parties to develop its product candidates, the insufficiency of existing capital reserves to fund continued operations for a particular amount of time and uncertainties regarding Adeona’s ability to obtain additional financing to support its operations thereafter and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2010 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. For more information, contact: Jeffrey Riley Chairman Adeona Pharmaceuticals, Inc. Tel: (734) 332-7800 i Humbert M, Sitbon O, Simonneau G., Treatment of pulmonary arterial hypertension, N Engl J Med. 2004 Sep 30;351(14):1425-36. ii Ito T, Okada T, Mimuro J, Miyashita H, Uchibori R, Urabe M, Mizukami H, Kume A, Takahashi M, Ikeda U, Sakata Y, Shimada K, Ozawa K. Adenoassociated virus-mediated prostacyclin synthase expression prevents pulmonary arterial hypertension in rats. Hypertension. 2007 Sep;50(3):531-6.
Intrexon Acquires Immunologix, Inc.
Novel fully human antibody development group joins top synthetic biology company Blacksburg, Virginia, October 24, 2011. Intrexon Corporation, a privately held synthetic biology company, today announced the acquisition of Immunologix, Inc., of Charleston, SC. Immunologix specializes in transforming naïve B-cells to produce 100% human monoclonal antibodies that can target all antigen types including, but not limited to cancer cells, viruses, bacteria, toxins, plus those epitopes related to autoimmune diseases such as diabetes, lupus, rheumatoid arthritis and multiple sclerosis. Terms of the transaction were not disclosed. From its exclusive patent license from the Medical University of South Carolina, Immunologix developed mAbLogix™ platform to deliver a key unmet need in antibody-based therapeutics. Importantly, the mAbLogix™ technology platform enables the unique ability to derive fully human antibodies using a 100% in vitro system – thus avoiding the substantial limitations and time consuming requirements of animal-derived antibodies. The Charleston-based Immunologix scientific team is now part of Intrexon’s Protein Production Division, headquartered in Foster City, CA. According to Gerardo A. Zapata, PhD, President of Intrexon’s Protein Production Division, the current market for therapeutic and diagnostic antibodies is estimated to exceed $40B per year worldwide and many of the current marketed antibodies are not fully human. “There are many high value areas that are either underserved or in need of significant efficacy and safety improvement by using fully human antibodies,” commented Zapata. “Acquisition of the mAbLogixTM technology and know-how, coupled with the cell processing capabilities of Intrexon’s recently announced Cell Engineering Unit, provides us with a much faster, better, and less expensive process from discovery to the scale-up of valuable, fully human therapeutic antibodies.” Ryan Fiorini, PhD, former COO and Co-Founder of Immunologix, and now Vice President of Antibody Development for the Intrexon Protein Production Division, expressed his enthusiasm for combining the mAbLogix™ platform and team within the overall matrix of Intrexon’s capabilities. States Fiorini, “We have made substantial strides on our own, as evident by the high specificity and affinity of our antibodies, and the client relationships we have established over the past several years with our service model. However, the opportunity to unleash the full power of our platform within Intrexon’s overall capabilities and substantial resources was too good to pass up. We were highly impressed from day one by how Intrexon has systematically brought together the core synthetic biology platforms for delivering compelling commercial applications and products.” Continues Fiorini, “We were highly motivated when we realized how rapidly our antibodies could be selected, sequenced, and inserted into Intrexon’s complex transgenes that control the timing and super-secretion of antibodies within production cell lines. That core capability, coupled with the proven, downstream bioprocessing expertise of their Protein Production Division, made the unparalleled case for the merger. We are very excited to become part of the overall Intrexon team and are eager to contribute to their top-tier value proposition.” Concludes Zapata, “We are rapidly deploying the mAbLogix™ platform as part of our human antibody value proposition to industry partners. I am very pleased to welcome the Immunologix team to Intrexon and look forward to unleashing the full potential of the exceptional technology on behalf of our current and future partners.” About Intrexon Corporation Intrexon Corporation is a privately held synthetic biology company that employs modular DNA control systems to enhance capabilities, improve safety and lower cost in human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The company’s advanced transgene engineering platform enables Better DNA&trade; technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly and optimization. More information about the company is available at www.DNA.com. Contact Andrew Udell Intrexon Corporation Phone: 301-556-9850 E-mail: audell@intrexon.com
Intrexon Launches Cell Engineering Unit
Blacksburg, Virginia, October 11, 2011. Intrexon Corporation, a privately held synthetic biology company, today announced the formation and launch of its Cell Engineering Unit (CEU) in San Diego, CA. The new unit will be under the leadership of the company’s Chief Science Officer and Founder, Thomas D. Reed, Ph.D. As part of the launch, Intrexon simultaneously announced the acquisition of GT Life Sciences, Inc. and the purchase of assets comprising the LEAP cell-processing platform from Cyntellect, Inc. The two transactions provide the foundational technology, facilities, exclusive IP portfolios, and team for the new scientific unit. Terms of the transactions were not disclosed.
FierceBiotech Names Intrexon a 2011 Fierce 15 Biotech
Blacksburg, Virginia, September 6, 2011. Intrexon Corporation, a privately held synthetic biology company, today announced being named by FierceBiotech as one of 2011’s Fierce 15, designating it as one of the most promising private biotechnology companies in the industry. “Intrexon is dedicated to realizing the exceptional advantages of our Better DNA™ technology in a variety of host cell applications and to expanding the possibilities of what can be accomplished through the engineering of biology. Being named a Fierce 15 company is an appreciated recognition of both our advanced technology and the dedication of our nearly 300 team members,” stated Intrexon Corporation Chairman and CEO, Randal J. Kirk. “Everybody talks about revolution in the tech world, but Intrexon’s Randal Kirk is marshaling the troops around the banner of synthetic biology, promising to forge a whole new approach to drug development and upending the apple cart on the manufacturing end,” says John Carroll, editor-in-chief of FierceBiotech. “Right now he’s looking for just the right set of partners to help make it all happen. And the companies that Intrexon chooses to partner with help define what the Fierce 15 is all about.” An internationally recognized daily newsletter reaching more than 90,000 biotech and pharma industry professionals, FierceBiotech evaluates hundreds of private companies for its annual list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position. The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. A complete list of “Fierce 15” companies—the online newsletter’s ninth annual selection--is available online at www.fiercebiotech.com. About Intrexon Corporation Intrexon Corporation is a privately held synthetic biology company that employs modular DNA control systems to enhance capabilities, improve safety and lower cost in human therapeutics, protein production, industrial products, agricultural biotechnology, and animal science. The company’s advanced transgene engineering platform enables Better DNA™ technology by combining revolutionary DNA control systems with corresponding advancements in modular transgene design, assembly and optimization. More information about the company is available at www.DNA.com. About FierceBiotech FierceBiotech is the biotech industry's daily monitor - a free email newsletter and web resource providing the latest biotech news, articles, and resources related to clinical trials, drug discovery, FDA approval and regulation, biotech company deals and more. More than 90,000 top biotech professionals rely on FierceBiotech for an insider briefing on the day’s top stories. Sign up is free at www.fiercebiotech.com. Contact: Andrew Udell Intrexon Corporation Phone: 301-556-9850 E-mail: audell@intrexon.com
ZIOPHARM Oncology Announces First Patient Dosed in Phase I Study of ZIN ATI-001 in Advanced Melanoma
NEW YORK, NY (August 30, 2011) — ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) today announced that the first patient has been dosed in a Phase 1 clinical study of ZIN ATI-001, a novel DNA-based therapeutic candidate, in patients with advanced melanoma. ZIN ATI-001 is the second clinical oncology product candidate from the ZIOPHARM-Intrexon Corporation exclusive synthetic biology channel partnership. The multi-center, single-arm, open-label, dose-escalation study, treating patients with unresectable Stage III or IV melanoma, will assess the safety and tolerability of intratumoral injections of ZIN ATI-001 (Ad-RTS-IL-12 or INXN-2001). Secondary endpoints include a determination of the recommended Phase 2 dose, an evaluation of T cell immunity markers, and preliminary anti-tumor activity. “ZIN ATI-001 demonstrates the ability to engineer complex, controllable transgenes whose properties cannot be reproduced through traditional therapeutic approaches,” said John Nemunaitis, MD, Executive Medical Director, Mary Crowley Medical Research Center. “ZIN ATI-001 is designed to express a potent anti-cancer cytokine with a known ability to stimulate the immune system against cancer directly within tumor cells and under the control of an ‘oral activator drug’. Melanoma is a cancer particularly susceptible to immune-modulating therapy and this early, melanoma-focused study will provide a preliminary understanding of the properties of this DNA-based therapeutic. Such results may then allow for an accelerated clinical program in other cancer types.” About ZIN ATI-001: ZIN ATI-001 employs an adenoviral vector to deliver, directly into the patient's own cells, a gene which expresses Interleukin-12 (IL-12), a potent, naturally occurring anticancer cytokine that is central to the initiation and regulation of cellular anti-cancer immune responses. Production of IL-12 within cells is then tightly regulated by the Intrexon RheoSwitch Therapeutic System® (RTS®), a "gene switch" controlled by an orally administered activator ligand (AL). Preclinical studies have shown that the immunological mechanism of action of ZIN ATI-001 is similar to that of ZIN-CTI-001 (DC-RTS-IL-12 + AL), ZIOPHARM's most advanced DNA-based therapeutic candidate, currently in a nearly completed Phase 1b trial. Positive clinical data of ZIN-CTI-001, the first-ever to demonstrate small molecule-controlled production of an anticancer protein in humans, were recently presented at the 2011 Annual Meeting of the American Society of Clinical Oncology. About ZIOPHARM Oncology, Inc.: ZIOPHARM Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer therapeutics. The Company is currently focused on several clinical programs. Palifosfamide (Zymafos™ or ZIO-201) is a novel DNA cross-linker in class with bendamustine, ifosfamide, and cyclophosphamide. ZIOPHARM is currently enrolling patients in a randomized, double-blinded, placebo-controlled Phase 3 trial with palifosfamide administered intravenously for the treatment of metastatic soft tissue sarcoma in the front-line setting. The company is also currently conducting a Phase 1 intravenous study of palifosfamide in combination with standard of care addressing small cell lung cancer and an oral form of the drug for treatment of solid tumors is currently in the advanced preclinical stage of development. Darinaparsin (Zinapar™ or ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) being developed intravenously for the treatment of relapsed peripheral T-cell lymphoma likely with a two-stage potentially pivotal study expected. An oral form is in a Phase 1 trial in solid tumors. Indibulin (Zybulin™ or ZIO-301) is a novel, oral tubulin binding agent that is expected to have several potential benefits including oral dosing, application in multi-drug resistant tumors, no neuropathy and a quite tolerable toxicity profile. It is currently being studied in Phase 1/2 in metastatic breast cancer. ZIOPHARM is also pursuing the development of novel DNA-based therapeutics in the field of cancer pursuant to an exclusive channel partnership with Intrexon Corporation. The partnership includes two existing clinical-stage product candidates, both of which are currently in Phase 1 study. ZIOPHARM's operations are located in Boston, MA and Germantown, MD with an executive office in New York City. Further information about ZIOPHARM may be found at www.ziopharm.com. ZIOP-G Forward-Looking Safe Harbor Statement: This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause ZIOPHARM Oncology's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of ZIOPHARM Oncology's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of ZIOPHARM Oncology's product candidates, the risk that the results of clinical trials may not support ZIOPHARM Oncology's claims, the risk that pre-clinical or clinical trials will proceed on schedules that are consistent with ZIOPHARM Oncology's current expectations or at all, risks related to ZIOPHARM Oncology's ability to protect its intellectual property and its reliance on third parties to develop its product candidates, risks related to the sufficiency of existing capital reserves to fund continued operations for a particular amount of time and uncertainties regarding ZIOPHARM Oncology's ability to obtain additional financing to support its operations thereafter, as well as other risks regarding ZIOPHARM Oncology's that are discussed under the heading "Risk Factors" in ZIOPHARM Oncology's filings with the United States Securities and Exchange Commission. Forward-looking statements can be identified by the use of words such as "may," "will," "intend," " should," "could," "can," "would," "expect," "believe," "estimate," " predict," "potential," "plan," "is designed to," "target" and similar expressions. ZIOPHARM Oncology assumes no obligation to update these forward-looking statements, except as required by law. Contacts: For ZIOPHARM: Tyler Cook ZIOPHARM Oncology, Inc. 617-259-1982 tcook@ziopharm.com Media: David Pitts Argot Partners 212-600-1902 david@argotpartners.com
ZIOPHARM Oncology to Host Analyst & Institutional Investor Meeting on June 23, 2011
NEW YORK--(BUSINESS WIRE)-- ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today that the Company will host an analyst and institutional investor meeting on Thursday, June 23, 2011, from 5:00 to 6:30 PM Eastern Time in New York City.
ZIOPHARM Oncology Announces Acceptance of Investigational New Drug Application for ZIN ATI-001 (Ad-RTS-IL-12), a Novel DNA-Based Oncology Therapeutic Candidate
NEW YORK, NY (June 10, 2011) — ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company employing small molecule and synthetic biology approaches to cancer therapy, announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application to begin clinical study of ZIN ATI-001, a novel DNA-based therapeutic candidate also known as Ad-RTS-IL-12 + AL (INXN 2001/1001), in oncology. When initiated, the Phase I study will evaluate safety in addition to immunological and biological effects of the therapeutic candidate in patients with melanoma. ZIN ATI-001 is the second clinical oncology product candidate from the ZIOPHARM-Intrexon Corporation exclusive synthetic biology channel partnership.
ZIOPHARM Announces Initial Positive Data Presented at 2011 ASCO Annual Meeting from First-Ever Treatment Demonstrating Small Molecule-Controlled Production of Anticancer Protein in Humans
CHICAGO, IL (June 6, 2011) – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that Douglas J. Schwartzentruber, MD, FACS, of the Indiana University Health Goshen Center for Cancer Care, presented initial positive clinical results from the first-ever treatment demonstrating control over transgene encoding of a therapeutic anticancer protein in humans using a small molecule activator ligand. These results were presented at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 3 – 7, in Chicago, IL.
Halozyme and Intrexon Announce Collaboration to Develop First Subcutaneous Recombinant Alpha 1-Antitrypsin Replacement Therapy
SAN DIEGO and FOSTER CITY, Calif., June 6, 2011 — Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Intrexon Corporation, today announced the signing of a worldwide exclusive licensing agreement for the use of rHuPH20 (recombinant human hyaluronidase) in the development of a subcutaneous (under the skin) injectable formulation of Intrexon Corporation’s recombinant human alpha 1-antitrypsin (rHuA1AT). Under terms of the agreement, Halozyme may receive up to $63 million, commencing with an upfront payment of $9 million and total potential future milestone payments of $54 million dependent upon the achievement of clinical and regulatory targets, plus up to 11% royalty on future sales of the combination of rHuA1AT with rHuPH20. The license provides Intrexon Corporation, a next generation synthetic biology company, with exclusivity to alpha 1-antitrypsin, for the indications resulting from A1AT deficiency. Additional terms of the transaction have not been disclosed.
Intrexon Corporation Raises $100 Million for Synthetic Biology Initiatives
Blacksburg, Virginia, May 31, 2011. – Intrexon Corporation, a next generation synthetic biology company, today announced that it has closed a Series E preferred investment round of $100 million, bringing the company’s total capital raised to more than $259 million. New investors took the majority of the round while existing investors, including Randal J Kirk, Intrexon’s Chairman and CEO, and Third Security, LLC, took the remainder. Perella Weinberg Partners acted as Intrexon’s exclusive financial advisor and placement agent.
ZIOPHARM and Intrexon Announce Preclinical Study Results at 2011 ASGCT Meeting from Controlled In Vivo Expression of Genes with Broad and Potent Antitumor Activity
SEATTLE, WA (May 20, 2011) – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), and Intrexon Corporation announced today that results from two preclinical studies examining the tightly controlled, intra-tumoral expression of a novel protein, interleukin-12 (IL-12), in melanoma, colon, lung, leukemia, breast and pancreatic cancer models in mice, were presented at the 2011 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), held May 18 – 21 in Seattle, Washington.
ZIOPHARM Oncology Files Investigational New Drug Application for Ad-RTS-IL-12, a Novel DNA-Based Oncology Therapeutic Candidate
NEW YORK--(BUSINESS WIRE)--ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company employing small molecule and synthetic biology approaches to cancer therapy, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) to begin clinical study of Ad-RTS-IL-12 (INXN 2001/1001), a novel DNA-based therapeutic candidate. When initiated, the Phase I study will evaluate safety in addition to immunological and biological effects of the therapeutic candidate in patients with melanoma. Ad-RTS-IL12 is the second clinical oncology product candidate from the ZIOPHARM/Intrexon Corporation’s exclusive, synthetic biology channel partnership.
Intrexon Launches Animal Science Division
Germantown, Maryland, April 27, 2011. Intrexon Corporation, a next generation synthetic biology company, today announced the launch of its Animal Science Division and appointment of Thomas R. Kasser, Ph.D. as Division President and a Senior Vice President of the Corporation. The Division is located in Germantown, Maryland, and focused on pioneering novel approaches that protect and enhance the health of companion and production animals, improve production animal efficiency, and enable more relevant animal research models.
Intrexon Acquires Neugenesis Corporation and Establishes Industrial Products Location
Burlingame, CA, April 21, 2011. Intrexon Corporation, a next generation synthetic biology company, today announced the acquisition of Neugenesis Corporation, a California-based company that has developed recombinant technologies and production systems related to Neurospora crassa, an exceptionally versatile fungal organism capable of producing a wide spectrum of proteins and metabolites of commercial interest. Intrexon also announced that the former Neugenesis facility is now the headquarters for Intrexon’s Industrial Products Division.
Intrexon Corporation to Present at J.P. Morgan Healthcare Conference
Blacksburg, VA, January 07, 2011. — Intrexon Corporation today announced that Randal J. Kirk, Chairman and Chief Executive Officer, will be presenting a corporate overview at the 29th Annual J.P. Morgan Healthcare Conference. Intrexon's presentation will take place at 4:00 p.m. PST on Monday, January 10, 2011 at The Westin St. Francis hotel, San Francisco, CA.
ZIOPHARM Oncology and Intrexon Announce Worldwide Partnership for Synthetic Biology DNA-based Oncology Therapeutics
NEW YORK, NY and GERMANTOWN, MD (January 6, 2011) – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next generation synthetic biology company, announced today a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon’s UltraVector® Technology. Under the partnership, ZIOPHARM will utilize Intrexon’s advanced transgene engineering platform for the controlled and precise cellular production of anti-cancer effectors. ZIOPHARM will have rights to Intrexon’s entire human in vivo effector platform within the field of oncology which includes two lead clinical-stage product candidates, one which is in an advanced Phase I study and another which will be the subject of an Investigational New Drug (“IND”) filing during the first half of 2011. ZIOPHARM and Intrexon will host a conference call and audio webcast today, Thursday, January 6th at 5:00 p.m. ET to discuss the global exclusive channel partnership.
Intrexon Appoints Former NIH Investigator to Identify High Value Therapeutic Opportunities
Germantown, Maryland, October 7, 2010 – Intrexon Corporation, a privately held synthetic biology company, today announced the appointment of William E. Fogler, Ph.D., as Senior Director of Portfolio Analysis and Planning for its Human Therapeutics Division. Dr. Fogler’s efforts will focus on identifying high value therapeutic opportunities for which Intrexon’s proprietary technologies and capabilities confer an unparalleled advantage.
Intrexon Announces Purchase of Industry-Leading Bioassay Operation
Maryland facility will also be the headquarters of company’s Human Therapeutics Division Blacksburg, Virginia, September 1, 2009 – Intrexon Corporation, a privately held life sciences company focused on modular DNA control systems for biotherapeutics and other industry sectors, today announced the purchase of assets and operations of Avalon Pharmaceutical, Inc., a wholly-owned subsidiary of Clinical Data, Inc. As part of the transaction, Intrexon has purchased substantially all of the equipment and assumed the lease of Avalon’s industry-leading bioassay facility in Germantown, MD, while Clinical Data retains rights to Avalon’s intellectual property, including rights to the AvalonRx® biomarker discovery platform and oncology programs. In addition, Intrexon has entered into an agreement that enables Clinical Data to continue to advance programs that are currently in progress at the Avalon facility. A number of Avalon scientists and technicians will be joining Intrexon and continuing to work at the Maryland location. “This is a defining transaction for Intrexon and potentially our industry,” stated Thomas Reed, Ph.D., the company’s Founder and Chief Science Officer. “It brings together two highly advanced platforms that are also highly complementary.” According to Reed the Avalon operational platform is capable of rapidly processing large sets of complex bioassays using sophisticated automation systems and know-how. He emphasized, “Avalon did an outstanding job of building the most advanced bioassay platform available. It hits the sweet spot between high volume and bioassay complexity.” Reed continued, “This is an ideal match for Intrexon’s upstream UltraVector® platform which enables the high volume, modular design and production of complex transgenes. The integration of the two platforms creates an unparalleled, end-to-end capacity to rapidly design, produce, test and optimize a broad spectrum of candidate biologics, including controllable transgene systems, reprogrammed cell lines and many different types of recombinant proteins.” Sunil Chada, Ph.D., Intrexon’s Senior Vice-President of Translational Medicine, provided further commentary from a clinical development perspective, “We have many biotherapeutic candidates currently in the preclinical evaluation phase, with numerous others entering our pipeline. The integration of the two platforms will enable us to test those candidates at a much faster rate and against a much larger number of high value targets. Our overall objective is to substantially reduce the time and cost required to identify our most promising lead candidates while also capturing very robust data sets in support of our anticipated regulatory filings.” The Maryland site will become the location for Intrexon’s Human Therapeutics Division. The company has already located its Protein Production Division in San Francisco with ready access to the area’s top-tier bioprocessing resources and capabilities. According to Marcelo Quiroga, Intrexon’s Chief Operating Officer, such geographic positioning enables world-class execution at the division level. “We want our commercial divisions to function as fully empowered business units with access to the best and brightest in their respective disciplines, “ he emphasized. “This requires being centered in the very best locations for executing their divisional strategies and associated recruiting plans.” Quiroga indicated that the company is currently forming two additional divisions focused on agricultural biotech and industrial enzymes. The locations of those divisions have not been disclosed. He concluded, “Meanwhile, we continue to expand and enhance our modular DNA vector design and production facility in Blacksburg, which remains at the core of our R&D initiatives and provides ongoing services to all of our commercial divisions.” About Intrexon Corporation Intrexon Corporation is a privately held life sciences company that employs modular DNA control systems to enhance capabilities, improve safety and lower cost in human therapeutics, protein production, industrial enzymes and ag/bio. The company's advanced transgene engineering platform enables a new level of biotech - combining breakthroughs in DNA control systems with corresponding advancements in modular transgene design, assembly and optimization. The company is currently using these advanced capabilities to solve foremost challenges across the life sciences spectrum. More information about the company is available at www.DNA.com. Contact: Robert Beech Intrexon Corporation Phone: 301-556-9850 E-mail: rbeech@intrexon.com