Bellicum Pharmaceuticals Initiates Clinical Trial with Novel Controlled Dendritic Cell Immunotherapy in Metastatic Castrate Resistant Prostate Cancer

HOUSTON, July 9, 2013 /PRNewswire/ -- Bellicum Pharmaceuticals, Inc. announced today it has initiated treatment of the first patient in a study of BPX-201 dendritic cells in combination with activating agent AP1903. The Phase I dose escalation trial in patients with metastatic castrate resistant prostate cancer (mCRPC) was designed to evaluate the safety, tolerability and clinical outcomes of BPX-201 and AP1903, which incorporate the Company's second generation DeCIDe™ immunotherapy technology.

"We're pleased to initiate this important clinical study evaluating dendritic cells modified with our latest cell signaling 'switch' designed to improve the effectiveness of cancer immunotherapy," said Tom Farrell, CEO of Bellicum Pharmaceuticals. "We believe the ability to strategically delay immune activation until the trained cells have migrated to the lymph nodes may result in a more potent immune response."

BPX-201 contains the patient's own matured dendritic cells engineered with the DeCIDe "on switch," and trained to target prostate cancer cells. The small molecule drug AP1903 is administered the day after the modified cells have been infused into the patient, activating the "on switch" in the injected cells and marshaling the body's T cells to attack the cancer. By waiting until the modified dendritic cells have migrated to nearby lymph nodes before activation, a more potent and durable antigen-specific T cell immune response may result.

Study Details
The Phase I trial, protocol #BP-002, will enroll 18 adult males from three U.S. centers with progressive metastatic castrate resistant prostate cancer who have not received prior chemotherapy.

The trial consists of 3 cohorts of 6 patients each receiving escalating doses (10 million, 20 million and 40 million cells) of BPX-201, respectively, over 6 treatment cycles. Patients are treated every other week with BPX-201, followed by infusion of activating agent AP1903 approximately 24-hours after each treatment. Patients will be evaluated for safety, PSA response (prostate specific antigen), progression-free survival and reduction in circulating tumor cells.

For more information about the BP-002 study, visit clinicaltrials.gov.

BPX-201 includes Bellicum's second generation DeCIDe technology. The first generation used in BPX-101 provided remote control of CD40 activation signaling, while the second generation adds control of toll like receptor (TLR) co-stimulation signaling, which helps achieve a more potent antitumor effect.

About Metastatic Castrate Resistant Prostate Cancer
Prostate cancer is the most common non-cutaneous (non skin-related) malignancy among American men. According to the American Cancer Society, about 1 in 6 men will be diagnosed with prostate cancer in his lifetime. In 2013, it is estimated that about 238,590 new cases of prostate cancer will be diagnosed and over 29,000 men will die from the disease.

Metastatic castrate resistant prostate cancer (mCRPC) is an aggressive form of the disease that metastasizes, or spreads, to other parts of the body and is no longer responsive to hormone therapy. Despite the growing number of treatments for mCRPC, patients have a poor prognosis, with the majority developing metastases within 9 months and facing a median survival of 16-24 months.

About Bellicum Pharmaceuticals  
Bellicum Pharmaceuticals, Inc. is dedicated to improving the treatment of cancers and other serious, life-threatening diseases with safer and more effective cell therapies. By giving physicians control over cells and immune activity inside the body, the Company's CID technology is designed to improve clinical outcomes while greatly expanding the numbers of patients who are eligible for treatment.

Bellicum currently has two programs in clinical development. The lead product in its CaspaCIDe™ T Cell Immunotherapy program is a combination of BPX-501 T cells and the small molecule drug AP1903, being developed to improve hematopoietic stem cell transplantation and reduce incidence and severity of Graft versus Host Disease (GvHD). The lead product in its DeCIDe™ Dendritic Cell Immunotherapy program is a combination of BPX-201 dendritic cells and the small molecule drug AP1903, being evaluated for the treatment of metastatic castrate resistant prostate cancer. For more information, visit www.bellicum.com

SOURCE Bellicum Pharmaceuticals, Inc.




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