Though still struggling, Bellicum can resume trial on CAR-T hopeful after FDA lifts clinical hold
After a disastrous 2020 that included axing nearly 80% of its staff amid struggling clinical results for the few molecules remaining in its pipeline, Houston biotech Bellicum finally got a piece of good news Thursday.
The FDA, Bellicum said in a press release, lifted a clinical hold on a Phase I/II trial of BPX-601 and rimiducid — a treatment candidate for prostate and pancreatic cancer tumors — implemented after a pancreatic cancer patient in the trial died in an early-stage test.
The death was classified as unrelated to the drug or the trial, but Bellicum has had to work with the FDA since the hold’s issuance on Dec. 7 to evaluate patient enrollment and dosage standards. The review apparently went positively, as the FDA required no protocol changes upon lifting the clinical hold.
“I am pleased that our team was able to address the FDA’s clinical hold questions in a timely manner, enabling us to evaluate BPX-601 in a cohort of patients with previously treated metastatic prostate cancer,” Rick Fair, Bellicum’s CEO, said in a statement. “I remain optimistic about the safety and potential clinical benefit of our BPX-601 product candidate in these patients.”
The potential clinical benefit of BPX-601, though, remains to be seen. The aforementioned staff cuts at Bellicum came after an October early readout of Phase I/II trial data 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.”
After that readout, Fair said Bellicum would shift the focus of the trial to continue testing the molecule’s safety while enrolling a new metastatic castration-resistant prostate cancer group into the study.
That direction seems to still be the focus, and with the trial’s resumption, clinical data on the efficacy of BPX-601 in treating metastatic castration-resistant prostate cancer are expected either late this year or in early 2022. The equity analyst firm Ladenburg Thalmann said to watch for that data, as well as potential first-in-human data on BPX-603, a Bellicum molecule for HER2+ solid tumors, as possible key catalysts for the biotech.
Bellicum $BLCM stock shares have stayed mostly steady since the hold was lifted, and currently sit at $3.84.