Bellicum Pharmaceuticals to discontinue GoCAR-T trials, evaluate alternatives

Bellicum Pharmaceuticals announced its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. The trials for BPX-601 and BPX-603 are being discontinued following the company’s assessment of the risk/benefit profile of BPX-601 in combination with rimiducid. The most recent patient treated in the Phase 1/2 trial of BPX-601 in metastatic castration-resistant prostate cancer, or mCRPC, experienced serious immune-mediated adverse events including Grade 4 cytokine release syndrome, or CRS, the second dose-limiting toxicity observed in this cohort of dose escalation. The company paused enrollment in its clinical studies and conducted a thorough review of the risk/benefit observed to date. While clinically meaningful efficacy has been observed-including 5 of 9 mCRPC patients treated achieving PSA50 response, 4 of whom achieved PSA90 response-the Company believes it does not have the necessary resources to optimize either the clinical dose and schedule of BPX-601 cells and the activating agent rimiducid, or the design of the BPX-601 cell construct to achieve a favorable risk/benefit profile. The company is communicating with clinical trial sites and regulatory agencies regarding its decision to discontinue its trials, and an evaluation of the company’s strategic alternatives is underway.