Bellicum Discontinues Phase 1/2 Trials and Initiates Evaluation of Strategic Alternatives

Rhea-AI Summary

Bellicum Pharmaceuticals (BLCM) has announced the discontinuation of its Phase 1/2 clinical trials for GoCAR-T cell products BPX-601 and BPX-603, assessing treatment for heavily pre-treated cancer patients. This decision follows a review of the risk/benefit profile, particularly after a serious adverse event occurred in the BPX-601 trial, where a patient experienced Grade 4 cytokine release syndrome. Although some efficacy was seen, with a notable response in prostate cancer patients, the company lacks resources to refine the treatment protocol. Bellicum is currently engaging with trial sites and regulatory bodies regarding this change while exploring strategic options.

Positive

• Efficacy observed in the trial, with 5 of 9 patients achieving PSA50 and 4 achieving PSA90 responses.

Negative

• Discontinuation of Phase 1/2 trials for BPX-601 and BPX-603 due to unfavorable risk/benefit profile.
• Serious immune-mediated adverse event experienced by a patient in the BPX-601 trial.
• Insufficient resources to optimize clinical dose and schedule for BPX-601.

HOUSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), today announced its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. The trials for BPX-601 and BPX-603 are being discontinued following the Company’s assessment of the risk/benefit profile of BPX-601 in combination with rimiducid.

The most recent patient treated in the Phase 1/2 trial of BPX-601 in metastatic castration-resistant prostate cancer (mCRPC) experienced serious immune-mediated adverse events including Grade 4 cytokine release syndrome (CRS), the second dose-limiting toxicity observed in this cohort of dose escalation. The company paused enrollment in its clinical studies and conducted a thorough review of the risk/benefit observed to date. 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 Company is communicating with clinical trial sites and regulatory agencies regarding its decision to discontinue its trials, and an evaluation of the Company’s strategic alternatives is underway.

More information about Bellicum can be found at www.bellicum.com.

Source: Bellicum Pharmaceuticals

Investors:
Robert H. Uhl
Managing Director
ICR Westwicke
858-356-5932
Robert.uhl@westwicke.com

FAQ

Why did Bellicum Pharmaceuticals discontinue its clinical trials for BPX-601 and BPX-603?

Bellicum discontinued the trials due to an unfavorable risk/benefit profile following serious adverse events and the lack of resources to optimize the treatment.

What were the results of the BPX-601 trial before its discontinuation?

In the BPX-601 trial, 5 out of 9 patients achieved a PSA50 response, and 4 achieved a PSA90 response, indicating some level of efficacy.

What serious event occurred during the BPX-601 trial?

A patient in the BPX-601 trial experienced Grade 4 cytokine release syndrome, which prompted the company to reassess the trial's risk/benefit profile.

What steps is Bellicum Pharmaceuticals taking after discontinuing the trials?

Bellicum is communicating with clinical trial sites and regulatory agencies about the discontinuation while exploring strategic alternatives for the company.