Bellicum Pharmaceuticals starts phase I/II trial of novel advanced prostate cancer vaccine

Bellicum Pharmaceuticals, Inc. today announced dosing of the first patient in a Phase I/II clinical trial of BP-GMAX-CD1, a novel pharmacologically regulated dendritic cell vaccine for the treatment of prostate cancer. The disease-specific trial is being conducted under a Bellicum Investigational New Drug application allowed by the FDA in 2008. The company anticipates reporting initial results of the study in 2010.

BP-GMAX-CD1 is a novel cancer vaccine that can be precisely activated at an optimal time and location in the body. It is produced by genetically modifying autologous antigen-loaded dendritic cells to express an inducible costimulatory CD40 (iCD40) receptor. Twenty-four hours after intradermal administration, these genetically modified dendritic cells are activated in draining lymph nodes by intravenous administration of AP1903, a small-molecule dimerizer agent developed by ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA). In this way, the immune system's innate homeostasis is overridden and a potent and durable antigen-specific T cell response may be generated.

The dose-escalation trial will evaluate the safety of BP-GMAX-CD1 and AP1903 in a minimum of 24 patients with androgen independent prostate cancer (also known as castrate resistant prostate cancer or CRPC). Six doses will be administered on a weekly or every other week schedule, with responses assessed at week 13. Patients whose disease has not progressed at the end of this acute phase will be eligible to receive booster vaccinations every eight weeks for up to one year. Exploratory efficacy endpoints include prostate-specific antigen dynamics, circulating tumor cell count, antigen-specific immune response, and clinical response. Additional information can be found at www.clinicaltrials.gov.

Bellicum Founder, President and Chief Medical Officer, Kevin M. Slawin, M.D., stated, "This first clinical trial of BP-GMAX-CD1 is designed to establish proof of principle for our core iCD40 technology, which has been engineered to overcome the critical potency limitations of previous cancer vaccine strategies. Dosing the first patient is an exciting and significant milestone in our quest to deliver safer and more effective therapies to patients with advanced cancer."

The small-molecule dimerizer, AP1903, and the ARGENT(TM) cell-signaling regulation technology underlying BP-GMAX-CD1 were licensed from ARIAD Pharmaceuticals, Inc. AP1903 is designed to bring together two proteins and activate them. In the case of BP-GMAX-CD1, administration of AP1903 to patients leads to controlled activation of the ARGENT-regulated protein iCD40. AP1903 was previously shown by ARIAD to be well-tolerated with defined pharmacokinetics in a Phase 1 clinical trial.

"This is an exciting application of ARIAD's dimerizer technology, with the potential for therapeutic benefit linked to precise control of signaling events inside cells," stated Timothy P. Clackson, Ph.D., Senior Vice President and Chief Scientific Officer of ARIAD. "We congratulate Bellicum on this first application of the dimerizer technology in cancer patients."

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