Bellicum Discontinues Phase 1/2 Trials and Initiates Evaluation of Strategic Alternatives
15 March 2023 - 7:30AM
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. UhlManaging DirectorICR
Westwicke858-356-5932Robert.uhl@westwicke.com
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