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Intrexon Corporation Initiates Phase 1b Clinical Trial in Advanced Melanoma

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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.