Bellicum Pharmaceuticals, Inc. has started 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.

The phase I trial, protocol #BP-002, will enroll 18 adult males from three US centres with progressive metastatic castrate resistant prostate cancer who have not received prior chemotherapy.

The trial consists of three cohorts of six patients each receiving escalating doses (10 million, 20 million and 40 million cells) of BPX-201, respectively, over six 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 tumour cells.

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.

Prostate cancer is the most common non-cutaneous (non skin-related) malignancy among American men.

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 nine months and facing a median survival of 16-24 months.

Bellicum Pharmaceuticals, Inc. is dedicated to improving the treatment of cancers and other serious, life-threatening diseases with safer and more effective cell therapies.