FDA Lifts Clinical Hold on Phase 1/2 Trial Evaluating BPX-601 for Metastatic Pancreatic, Prostate Cancer

The FDA has lifted the clinical hold on patient enrollment and dosing for an ongoing phase 1/2 dose-escalation clinical trial (NCT02744287) evaluating the GoCAR-T product candidate BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer, according to the agent’s developer, Bellicum Pharmaceuticals.¹

In response to the clinical hold, Bellicum indicated it worked with the FDA over the past 2 months and was informed by the agency that it has satisfactorily addressed all clinical hold issues. The company can now begin enrolling patients again without modification to the study protocol and plans to work with clinical investigators to do so.

“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, president and CEO of Bellicum Pharmaceuticals, said in a press release. “I remain optimistic about the safety and potential clinical benefit of our BPX-601 product candidate in these patients.”

The clinical hold was previously placed on the phase trial due to the death of a patient with pancreatic cancer, which was disclosed by Bellicum to the FDA.² However, the clinical investigator and the company also reported that the patient death was unrelated to treatment with BPX-601 and rimiducid.

BPX-601, the company’s first GoCAR-T product candidate, incorporates Bellicum’s inducible coactivation domain, inducible MyD88/CD40 (iMC). iMC is intended to provide a boost to T-cell proliferation and persistence, production of immunomodulatory cytokines, and allow the CAR-T to override key immune inhibitory mechanisms, including PD-1 and TGF-beta. BPX-601 is currently being evaluated as a treatment for both pancreatic and prostate tumors which express prostate stem cell antigen.

References:

1. Bellicum Reports FDA Lifted Clinical Hold on BPX-601 Phase 1/2 Clinical Trial. News release. Published January 28, 2021. Accessed January 29, 2021. https://ir.bellicum.com/news-releases/news-release-details/bellicum-reports-fda-lifted-clinical-hold-bpx-601-phase-12

2. Bellicum Reports Clinical Hold Placed on BPX-601 Phase 1/2 Clinical Trial. News release. Bellicum. Published December 7, 2020. Accessed January 29, 2021 https://www.globenewswire.com/news-release/2020/12/07/2140457/0/en/Bellicum-Reports-Clinical-Hold-Placed-on-BPX-601-Phase-1-2-Clinical-Trial.html