On February 21, 2017 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported it has dosed the first patient with BPX-601, the first CAR T-cell product candidate to enter clinical studies that is designed to enable control over the expansion and stimulation of the cells (Press release, Bellicum Pharmaceuticals, FEB 21, 2017, View Source;p=RssLanding&cat=news&id=2247590 [SID1234517795]). BPX-601 targets solid tumors that express PSCA (prostate stem cell antigen), with an initial indication in non-resectable pancreatic cancer.
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"We believe the initiation of the BPX-601 clinical study is an important milestone in the advancement of CAR T therapies," said Rick Fair, Bellicum’s President and CEO. "The ability to control the intensity and duration of a cell-based treatment may help address the limitations that current CAR T therapies face, especially when targeting solid tumors. While our first study is in pancreatic cancer where there is great need for improved treatments, we intend to explore BPX-601 in other tumors known to express PSCA, including prostate, ovarian, bladder, esophageal and gastric cancers."
BPX-601 incorporates GoCAR-TTM, a CAR T-cell modified to include Bellicum’s proprietary dual costimulatory domain MC (inducible MyD88/CD40) activation switch. With GoCAR-T, the level of stimulation and proliferation of BPX-601 cells can be refined by adjusting the administration schedule of rimiducid, a small molecule activator agent.
"This clinical trial is an important step in our ongoing research efforts to improve patient outcomes in one of the deadliest forms of cancer," said Carlos Becerra, MD, Interim Chief of Oncology, Baylor University Medical Center at Dallas and principal investigator of the study. "The pancreatic cancer patients who will be eligible to participate in the study have progressed after standard treatments and have limited options. We hope that this trial will be an important step in developing safe and effective CAR T-cell therapy for solid tumors."
About the BP-012 Study
The Phase 1 BP-012 study is an open-label, non-randomized, dose-finding trial designed to evaluate the safety and activity of BPX-601 and rimiducid in up to 30 patients with non-resectable pancreatic adenocarcinoma. Its purpose is to determine the safety of the administration of BPX-601, the safety of the rimiducid infusion and the persistence of the CAR T cells over time. The first of its kind trial for pancreatic cancer patients will take place at Baylor University Medical Center at Dallas, which is home to Baylor Scott & White Research Institute, one of the top translational research centers in the world. To learn more about the trial, visit clinicaltrials.gov.
About GoCAR-T
Bellicum developed GoCAR-T to increase the efficacy and safety of CAR T-cell therapies in more challenging cancers, including solid tumors. Standard CAR T cells depend on the presence of cancer antigens for activation and proliferation. In GoCAR-T cells, a costimulatory signal is engineered into a rimiducid-controlled switch. This is designed to enable T-cell survival in the absence of antigen signaling, and full activation and proliferation in the presence of cancer antigens. In the event of side effects, the level of activation of GoCAR-T cells may be attenuated by reducing the rimiducid dosing schedule.