Amid a record bad year, Bellicum keeps taking its lumps as FDA slams trial hold on CAR-T hopeful
It’s been no less than a disastrous year for Houston biotech Bellicum Pharmaceuticals after taking a scalpel to its pipeline and dumping a vast majority of its staff. Now, in an already-doomed trial of one of Bellicum’s next-gen oncology hopefuls, the FDA is doling out even more lumps.
Bellicum divulged on Monday that the FDA had placed a clinical hold on its Phase I/II trial for CAR-T candidate BPX-601 after a pancreatic cancer patient’s death in the early-stage test.
The death wasn’t related to treatment with BPX-601, Bellicum said in a scant release, or rimiducid, a protein-switching adjuvant that is believed to spur better uptake in patients’ T cells. The hold also wasn’t a broad indictment of the rest of Bellicum’s clinical pipeline, and the company is moving ahead with enrollment on a separate Phase I/II trial of BPX-603, another CAR-T candidate hunting HER2-positive expressing tumors.
With the hold in place, Bellicum plans to work “diligently” with the FDA to clear BPX-601’s name, the company said in a release, but the latest bad news is just another ugly mark on the Houston-based biotech’s record amid an ignominious run.
Back in October, Bellicum unveiled plans to slice away 54 team members — 79% of its staff — after an early readout from that same Phase I/II trial of BPX-601 came back less than impressive. The company was frank in its assessment of the trial at the time: “Clinically meaningful efficacy as measured by RECIST criteria was not observed.”
Even with efficacy out the window, Bellicum intended to use the BPX-601 trial as a trail marker for the safety of its GoCAR-T platform, which hopes to induce high levels of T cell proliferation and cytokine production to allow for greater immunomodulatory control by the CAR-T itself.
The same month it slashed stuff numbers, CEO Rick Fair said Bellicum would hold out hope on the pre-existing safety cohort in the BPX-601 trial and start enrolling a new metastatic castration-resistant prostate cancer group into the study.
BPX-601 was one of three key programs remaining for Bellicum after the biotech effectively gutted its pipeline, putting its BCMA GoCAR-NK program on pause and paring back its early-stage R&D and product development teams.
The company is not only pursuing BPX-603, which hasn’t yet had its day in the clinic, but also stem-cell transplant adjunct BPX-501, or rivo-cel, which has had its own struggles with the FDA. Back in 2018, the FDA put an early study of the therapy on hold after the trial’s investigators forwarded ahead three cases of encephalopathy in the patient pool.
Bellicum eventually got that hold lifted in April 2018 after amending the study’s protocols to better scope neurological issues in patients, but it later admitted it was looking for outside partners to take the lead program into later-stage testing.