Bellicum Weighs Options After Serious Safety Concerns Halt Only Trials

Physician holds up hand in a stop sign signal/Courtesy of Shutterstock

Physician holds up hand in a stop sign signal/Courtesy of Shutterstock

Bellicum Pharmaceuticals has ended the only clinical trials evaluating its GoCAR-T cell product in combination with rimiducid following serious safety concerns

The Houston-based biotech has discontinued testing for GoCAR-T BPX-601 and BPX-603 after the most recent patient treated with BPX-601 experienced serious immune-mediated adverse events.

The metastatic castration-resistant prostate cancer (mCRPC) patient experienced negative side effects including Grade 4 cytokine release syndrome. This triggered a pause in the clinical studies and a risk/benefit review for all patients to date.

Bellicum will share final results and details regarding its decision to cancel the studies with clinical trial sites and regulatory agencies. The company has launched an evaluation of strategic alternatives.

Despite showing clinically meaningful efficacy in Phase I, the company stated in a press release it lacks the necessary resources to either improve the clinical dose and schedule of BPX-601 cells and rimiducid or the drug’s design.

Bellicum presented positive early Phase I results at the ASCO GU Cancers Symposium in February. Of nine mCRPC patients treated, five achieved PSA50 responses, four of whom attained PSA90 responses.

BPX-601 GoCAR-T was designed to treat solid tumors with prostate stem cell antigen (PSCA). This cancer antigen is expressed in multiple solid tumor indications.  

The product increases cell proliferation and persistence and immunomodulatory cytokine production and allows the CAR-T to nullify vital immune inhibitory mechanisms, like PD-1 and TGF-beta.

GoCAR-T was Bellicum's only clinical-stage asset. 

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