Intrexon Corporation 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 tumour 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-tumour activity, as represented by cellular immune responses within the target tumour, 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-tumour cytokines.

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.