Bellicum Reports Clinical Hold Placed on BPX-601 Phase 1/2 Clinical Trial
Bellicum Pharmaceuticals (NASDAQ:BLCM) has announced a clinical hold on its Phase 1/2 trial of BPX-601, following a patient death deemed unrelated to the treatment. The FDA has placed this hold to review safety concerns. Despite this setback, Bellicum plans to continue with plans to initiate enrollment for its BPX-603 trial targeting HER2+ solid tumors by year-end. BPX-601, designed to treat pancreatic and prostate cancers, leverages a next-generation CAR-T technology for enhanced immune response.
- Plans to initiate enrollment for BPX-603 trial by year-end.
- BPX-601 incorporates advanced CAR-T technology aimed at overcoming immune inhibition.
- FDA imposed a clinical hold on the BPX-601 trial due to a patient death.
- The patient death, though classified as unrelated to treatment, raises safety concerns.
HOUSTON, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer. The FDA is taking this action due to the death of a pancreatic cancer patient in the trial reported to the agency by the company. The clinical investigator and Bellicum classified the patient death as unrelated to BPX-601 and rimiducid.
The company plans to work diligently with the FDA to address the agency’s questions and fulfill the requirements for resuming the trial. The clinical hold does not affect the company’s plans to initiate enrollment in the Phase 1/2 clinical trial of BPX-603, a dual switch GoCAR-T®, in patients with HER2+ solid tumors by the end of the year.
About BPX-601
BPX-601, the company’s first GoCAR-T® product candidate, incorporates iMC, Bellicum’s inducible co-activation domain. iMC (inducible MyD88/CD40) is designed to provide a powerful boost to T cell proliferation and persistence, production of immunomodulatory cytokines and enable the CAR-T to override key immune inhibitory mechanisms, including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for pancreatic and prostate tumors expressing prostate stem cell antigen (PSCA).
About Bellicum Pharmaceuticals
Bellicum is a clinical stage biopharmaceutical company striving to deliver cures through controllable cell therapies. The company’s next-generation product candidates are differentiated by powerful cell signaling technologies designed to produce more effective CAR-T cell therapies. Bellicum’s GoCAR-T® product candidates, BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell products capable of overriding key immune inhibitory mechanisms. More information about Bellicum can be found at www.bellicum.com.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Bellicum may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our efforts with the FDA to resume the BPX-601 clinical trial and our plans to initiate enrollment in the Phase 1/2 clinical trial of BPX-603. Various factors may cause differences between Bellicum’s expectations and actual results as discussed in greater detail under the heading “Risk Factors” in Bellicum’s filings with the Securities and Exchange Commission, including without limitation our quarterly report on Form 10-Q for the three months ended September 30, 2020 and our annual report on Form 10-K the year ended December 31, 2019. Any forward-looking statements that Bellicum makes in this press release speak only as of the date of this press release. Bellicum assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Source: Bellicum Pharmaceuticals
Investors:
Robert H. Uhl
Managing Director
Westwicke ICR
858-356-5932
Robert.uhl@westwicke.com
FAQ
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