Intrexon Corporation Initiates Phase 1b Clinical Trial in Advanced Melanoma
Blacksburg, Virginia, May 11, 2009 – Intrexon Corporation announces that it has initiated treatment of the first patient in its Phase 1B
clinical trial of INcell-1001/AD-1001 in patients with Stage III/IV melanoma. INcell-1001/AD-1001 is Intrexon’s most advanced immunomodulatory
therapy. INcell-1001 is intended to control and enhance the immune-modulating performance of dendritic cells to treat solid tumor cancers. The trial
is an open-label, dose-escalation study evaluating the safety, tolerance, transgene function, pharmacokinetics and immunological effects of
intratumoral injection of transduced dendritic cells (INcell-1001). INcell-1001 has been engineered for inducible expression of human Interleukin 12
(hIL-12) using regimented dosing of an orally administered small molecule (AD-1001).
The primary endpoints of the Phase 1B study are the safety and tolerability of INcell-1001 induced by escalating doses of the activator AD-1001.
Secondary endpoints include the pharmacodynamics of the AD-1001/INcell-1001 combination, as represented by hIL-12 expression levels, plus anti-tumor
activity, as represented by cellular immune responses within the target tumor, draining lymph nodes and peripheral circulation.
Further information regarding this Phase 1B study can be obtained using the search identifier NCT00815607 at the NIH clinical trials website: www.clinicaltrials.gov.
Therapeutic Strategy
The INcell-1001/AD-1001 combination represents a first-in-class therapeutic strategy that utilizes Intrexon’s RheoSwitch Therapeutic System™ to
control the in situ timing and level of cytokine expression subsequent to the intratumoral injection of reprogrammed autologous dendritic cells.
Preclinical studies by Intrexon and its collaborators support the prospective importance of in situ induction when compared to historical methods
utilizing constitutive (“always on”) expression of known anti-tumor cytokines.
About the Phase 1A Study
AD-1001 is Intrexon’s lead activator ligand designed to tightly control the RheoSwitch Therapeutic System™ and its regulated expression
domain. AD-1001 was the subject of a previous Phase 1A randomized, double-blinded, placebo-controlled, dose-escalation, safety study in 65 normal
healthy male and female volunteers. Results demonstrated that AD-1001 was well tolerated at all dose levels studied, achieved steady-state
pharmacokinetics, attained high serum bioavailability levels, and yielded a metabolic half-life consistent with once-a-day dosing.
About Intrexon
Intrexon Corporation is a privately held life sciences company whose Therapeutics Division is focused on the research and development of
biotherapeutic control systems to reduce toxicity while enhancing clinical outcomes. The company’s technology employs special genetic components and
activator ligands to tightly control the delivery, targeting, activation, regulation and location of biologics. The company is headquartered at the
Virginia Tech Corporate Research Center in Blacksburg, Virginia, with additional R&D operations in Valley Forge, Pennsylvania. More information is
available at www.DNA.com.
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Contact:
Robert Beech
Intrexon Corporation
Phone: 301.556.9812
E-mail: rbeech@intrexon.com
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