Houston-based Bellicum Pharmaceuticals recently initiated treatment of its first patient in a study of BPX-201 dendritic cells in combination with activating agent AP1903 through two related programs. BPX-501, which is used in combination with AP1903 to reduce the severity and intensity of Graft Versus Host Disease (GvHD) and to improve the hematopoietic stem cell transplantation, is being tested in Bellicum’s CaspaCIDe(TM) T Cell Immunotherapy program, while the company’s other current initiative, the DeCIDe(TM) Dendritic Cell Immunotherapy program, utilizes BPX-201 dendritic cells in combination with the small molecule drug AP1903 for the management of metastatic castrate resistant prostate cancer.
Just recently, the company has announced the initiation of the BPX-201 dendritic cells study in combination with activating agent AP1903. The Phase I dose escalation trial is designed to ascertain the efficacy, safety, and clinical outcome of AP1903 and BPX-201 in metastatic castrate resistant prostate cancer (mCRPC) patients. These two agents incorporate the Company’s second generation DeCIDe(TM) immunotherapy technology.
Tom Farrell, CEO of Bellicum Pharmaceuticals, commented:
“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. 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 is designed to target prostate cancer cells and contains the matured dendritic cells of the patient himself that are engineered with the DeCIDe “on switch.” The complementing small molecule drug AP1903 is introduced to the patient one day after the infusion of modified cells in the patient that helps in activating the “on switch” in the injected cells. The BPX-201 combined with AP1903 together attack the cancer by stimulating the patient’s T cells. With the help of modified dentritic cells and activation under lymph glands of the body, a much potent antigen-specific T cell immune response can be expected.
Details of the study:
As part of the phase I trial, protocol #BP-002, 18 adult male patients are being enrolled from three U.S. centers. All these participants have a history of progressive metastatic castrate resistant prostate cancer with no history of prior chemotherapy.
In the trial, 3 cohorts will be constructed (with 6 patients in each cohort receiving BPX-201 in the dose of about 10 million, 20 million and 40 million cells) for 6 treatment cycles. The dosing frequency of BPX- 201 is once every other week, which will be followed by an infusion of activating agent AP1903 after 24 hours. All the study participants will be assessed for safety, efficacy, therapeutic effects like PSA response (prostate specific antigen), quality of survival, and reduction in circulating tumor cells.
BPX-201 is classified under second generation of Bellicum’s DeCIDe technology that has a toll like receptor (TLR) co-stimulation signaling, to achieve a much more potent antitumor effect. BPX-101, the first generation provided remote control CD40 activation signaling.
About Metastatic Castrate Resistant Prostate Cancer:
Prostate cancer is the second most commonly occurring cancer after lung cancer among American men. According to the statistics reported by American Cancer Society, the prevalence of prostate cancer is very high and the risk increases with advancing age (current prevalence is about 1 in 6 men). According to estimates, 238,590 new cases of prostate cancer will be diagnosed in 2013 and over 29,000 men will die from the disease.
The most aggressive form of prostate cancer is metastatic castrate resistant prostate cancer (mCRPC), which has a very high metastatic potential and does not respond to hormone therapy. Despite advancements in the therapeutic potential, the prognosis is poor with a median survival of 16-24 months.