Bellicum halts trials for both pipeline drugs following adverse events

March 15, 2023

Texas-based Bellicum Pharmaceuticals says it is discontinuing its ongoing phase 1/2 clinical trials evaluating the safety and efficacy of its only two pipeline candidates in heavily pre-treated cancer patients following serious adverse events in one of the studies.

The company's proprietary GoCAR-T technology is designed to power the immune system’s innate capacity for tumor destruction to attack more types of cancers — delivering the potential to treat solid tumors that traditional CAR-T therapies cannot reach.

But Bellicum is halting the trials for both of its GoCAR-T immunotherapy candidates, BPX-601 and BPX-603, following the company’s assessment of the risk/benefit profile of BPX-601 in combination with rimiducid. According to the biopharma, the most recent patient treated in the phase 1/2 trial of BPX-601 in metastatic castration-resistant prostate cancer (mCRPC) experienced serious immune-mediated adverse events including Grade 4 cytokine release syndrome (CRS), the second dose-limiting toxicity observed in this cohort of dose escalation. CRS, an acute inflammatory response,  is the most significant complication associated with CAR T-cell therapy; Grade 4 is life-threatening.

Bellicum says it is communicating with clinical trial sites and regulatory agencies regarding the decision to discontinue its trials — and an evaluation of the company’s "strategic alternatives" is currently underway.