Intrexon Corporation Initiates Phase 1b Clinical Trial in Advanced Melanoma

BLACKSBURG, Va.--(Business Wire)--
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.

Intrexon Corporation
Robert Beech, 540-808-2620
E-mail: rbeech@intrexon.com

Copyright Business Wire 2009