Products
Intrexon is currently focusing its modular DNA controls, UltraVector® system,
and advanced transgene engineering capabilities toward three major product areas:
cancer immunotherapeutics, human protein production and embedded bioreactors. The
former areas face well-known challenges related to performance, safety and cost.
Embedded bioreactors represent a very promising therapeutic strategy for diseases
in which protein biologics have proven overly toxic or not adaptable to scalable
external manufacturing.
Modular Inducible Cancer Immunotherapeutics (MICI) Intrexon's next
generation immunomodulatory therapeutic approach is intended to control and enhance
the immune-modulating performance of dendritic cells to treat solid tumor cancers.
The company's current Phase 1b clinical 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 engineered for inducible expression of human Interleukin-12
using regimented dosing of our orally administered activator ligand. We are currently
expanding our MICI preclinical studies to evaluate
over 100 different combinations of cytokines and other adjuvants.
Regulated Protein Secretion Systems (RPSS) Intrexon is leveraging
its modular DNA controls, UltraVector® system and protein optimization capabilities
to develop inducible super-secretor cell lines that will substantially reduce COGS,
enhance yields and simplify downstream requirements related to the external production
of human therapeutic proteins. We are currently expanding our RPSS studies to evaluate
over 50 biosimilar and bionew candidates against a progressive series of in vitro
and in vivo screening assays. Prospective product offerings will include
super-secretor cell lines and clinical-grade proteins.
Embedded Controllable Bioreactors (ECB) Intrexon's modular DNA
control technologies and transgene/protein optimization capabilities represent an
unparalleled opportunity to develop protein production systems that can be embedded
inside a patient's body and then regulated through the dosing of our external small
molecule activator ligand. ECB's offer the potential to overcome the substantial
production, dosing and toxicity challenges related to proteins derived from external
bioreactors, including:
- Continuous, regulated secretion of endogenous or exogenous proteins at lower dosing
levels versus bolus dosing of ex vivo
derived proteins.
- Removing the need for ex vivo or in vivo synthetic stabilization
of naturally occurring proteins.
- Real-time, auto-regulation of protein secretion using conditional switch promoters.
- Avoidance of contamination, purification, degradation and host of other external
production challenges.
We are currently expanding a series of research and preclinical studies related
to the in vivo delivery and regulation of ECB's across a spectrum of protein
candidates.