Bellicum halts trials after serious adverse event, looks for 'strategic alternatives'
Bellicum Pharmaceuticals is halting the Phase I/II trials for the only two candidates in its pipeline after reporting a serious adverse event — and is now evaluating “strategic alternatives” for the company after a rocky few years.
The company announced Tuesday that the ongoing trials for its two GoCAR-T cell candidates in combination with rimiducid in pre-treated cancer patients, BPX-601 and BPX-603, are coming to a halt. This comes after a patient on BPX-601 experienced serious side effects, including grade 4 cytokine release syndrome. This was the second dose-limiting toxicity in the dose-escalation cohort.
Bellicum $BLCM shares dropped roughly 40% in pre-market trading Wednesday.
The BPX-601 trial was studying the safety and preliminary efficacy of the candidate in patients with metastatic castration-resistant prostate cancer. BPX-603 targeted HER2-positive solid tumors.
“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 press release reads.
There seemed to be hope in February when president and CEO Rick Fair said there were “encouraging” early data from BPX-601. The company also reported other adverse events at the time, however, such as myelosuppression, grade 3 cytokine release syndrome and grade 4 immune effector cell neurotoxicity syndrome.
It’s been a long road for Bellicum, which laid off 79% of its staff in 2020 after it reported disappointing results for BPX-601 in pancreatic cancer. It also stopped discovery research and new product development that year. At the time, the company said it would focus on BPX-601, BPX-603 and a third candidate that’s no longer in development.