The US Food and Drug Administration (FDA) has placed a clinical hold on patient enrollment and dosing in Bellicum Pharmaceuticals’ ongoing Phase I/II dose-escalation clinical trial analysing BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer.
Bellicum noted that the FDA’s action comes after a pancreatic cancer patient died in the trial that was reported to the agency.
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The patient death has been classified as unrelated to BPX-601 and rimiducid by the clinical investigator and Bellicum.
BPX-601 is a GoCAR-T product candidate, which has the company’s inducible co-activation domain, inducible MyD88/CD40 (iMC).
iMC has been designed to provide a boost to T cell proliferation and persistence, immunomodulatory cytokine production and facilitate the CAR-T to override key immune inhibitory mechanisms such as PD-1 and TGF-beta.
The candidate is being analysed as a treatment for pancreatic and prostate tumours expressing prostate stem cell antigen (PSCA).
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By GlobalDataThe company intends to work with the agency to address its queries and fulfil the requirements for the trial resumption.
In August, Bellicum reported interim data from a dose-escalation trial of BPX-601 in patients with relapsed/refractory metastatic pancreatic cancer.
Results showed that the first four patients treated with BPX-601 followed by repeat rimiducid dosing demonstrated evidence of rimiducid-mediated CAR-T cell activation.
The latest development will not affect Bellicum’s plans to begin enrolment in the Phase I/II clinical trial of a dual switch GoCAR-T, BPX-603, in patients with HER2+ solid tumours by the year-end.
Designed to be more efficacious CAR-T cell products, Bellicum’s GoCAR-T product candidates, BPX-601 and BPX-603 can potentially override key immune inhibitory mechanisms.
In 2017, Bellicum began dosing in its Phase I clinical trial (BP-012) of BPX-601 for the treatment of patients with non-resectable pancreatic adenocarcinoma.
