BriaCell Receives Green-Light from Data Safety Monitoring Board for its Phase 3 Study in Metastatic Breast Cancer
Rhea-AI Summary
BriaCell Therapeutics (Nasdaq: BCTX) received positive safety review from the Data Safety Monitoring Board (DSMB) for its pivotal Phase 3 study of Bria-IMT™ plus immune checkpoint inhibitor in metastatic breast cancer. The DSMB recommended continuation of the study without modifications, marking a significant milestone for the company's FDA Fast Track Designated trial. The independent review board found no safety concerns in enrolled patients, supporting BriaCell's advancement of its novel immunotherapy combination treatment.
Positive
- DSMB found no safety concerns in Phase 3 trial
- Study continues without required modifications
- Maintains FDA Fast Track Designation status
Negative
- None.
Insights
The DSMB safety clearance for BriaCell's Phase 3 trial represents a important milestone in the development of Bria-IMT™. The continuation recommendation without protocol modifications suggests strong initial safety data for the immunotherapy combination with checkpoint inhibitors. This is particularly significant given the Fast Track Designation from the FDA, which could accelerate the approval process.
The trial's focus on metastatic breast cancer, a challenging indication with significant unmet medical needs, positions BriaCell in an important therapeutic space. While this safety review is positive, investors should note that efficacy data is still pending and will be the key determinant of commercial potential. The company's
- The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus an immune check point inhibitor in metastatic breast cancer
- The pivotal Phase 3 study is currently under Fast Track Designation with the Food and Drug Administration (FDA)
PHILADELPHIA and VANCOUVER, British Columbia, Dec. 02, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces that the Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, has completed its first review of safety events in patients enrolled in BriaCell’s pivotal randomized Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor (CPI) combination regimen (NCT06072612). The DSMB issued a statement recommending continuation of the study in metastatic breast cancer patients. BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).
“We are pleased with the DSMB’s recommendation for the continuation of BriaCell’s Phase 3 study without any protocol modification as a significant milestone towards clinical advancement of our novel immunotherapy as a safe and effective treatment option for metastatic breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO.
“We strongly believe in the potential of our novel immunotherapy to transform cancer care for metastatic breast cancer patients, and the positive DSMB review reinforces our confidence in the potential use of the combination regimen in metastatic breast cancer patients,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer.
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell’s clinical advancement of Bria-IMT™ as a safe and effective treatment option for metastatic cancer patients; the ability of Bria-IMT™ to transform cancer care in metastatic breast cancer patients; and the potential use of the combination regimen for metastatic breast cancer patients are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
FAQ
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