Intrexon Corporation Initiates Phase 1b Clinical Trial In Advanced Melanoma

Main Category: Melanoma / Skin Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 13 May 2009 - 0:00 PDT

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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: http://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 http://www.DNA.com.

Source
Intrexon Corporation

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