Data Safety Monitoring Board (DSMB) Recommends Continuing BriaCell’s Phase 3 Metastatic Breast Cancer Study
An independent safety board again found no concerns and backed uninterrupted continuation of BriaCell’s Fast Track Phase 3 breast cancer trial.
Rhea-AI Summary
BriaCell Therapeutics (BCTX) reported that an independent Data Safety Monitoring Board (DSMB) issued its seventh consecutive positive recommendation for the pivotal Phase 3 Bria-ABC study evaluating Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (NCT06072612). Following review of clinical data, the DSMB noted no safety or other clinical concerns and advised that the trial continue without modifications. DSMB meetings are held quarterly under the study protocol. The ongoing Phase 3 trial is being conducted under FDA Fast Track designation, which the company states reflects the substantial unmet medical need in metastatic breast cancer. BriaCell describes this DSMB outcome as a milestone in advancing its novel immunotherapy approach for patients with urgent unmet needs.
Positive
- Seventh consecutive positive DSMB review for the Phase 3 Bria-ABC study
- DSMB reports no safety or other clinical concerns and no protocol changes
- Phase 3 Bria-IMT plus CPI study proceeds under FDA Fast Track designation
Negative
- None.
Key Figures
- DSMB recommendation count
- Seventh consecutive positive recommendation
- Pivotal Phase 3 Bria-ABC study
- Study phase
- Phase 3
- Bria-IMT plus immune checkpoint inhibitor in metastatic breast cancer
Previous Clinical trial Reports
-
Study expanded to Memorial Sloan Kettering while an independent DSMB recommended continuation.
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Sixth consecutive positive DSMB recommendation found no safety concerns and supported continuation.
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Key Terms
dsmb medical
immune checkpoint inhibitor medical
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Independent DSMB reports no safety concerns to date and recommends continuing BriaCell's pivotal Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor
- Seventh consecutive positive DSMB recommendation reinforces the favorable safety and tolerability of BriaCell's novel immunotherapy approach
- Phase 3 study is being conducted under FDA Fast Track designation, underscoring the substantial unmet need in metastatic breast cancer
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 14, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces that the independent Data Safety Monitoring Board (DSMB) has issued its seventh consecutive positive recommendation following review of clinical data from BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).
Following its review, the DSMB raised no safety or other clinical concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell’s ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.
“We are very encouraged by the DSMB’s seventh consecutive positive recommendation to continue BriaCell’s pivotal Phase 3 Bria-ABC study,” said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. “This milestone represents continued progress in developing BriaCell’s novel immunotherapies for patients with urgent unmet medical needs.”
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 the DSMB’s seventh consecutive positive recommendation, the favorable safety and tolerability profile of Bria-IMT™ plus an immune checkpoint inhibitor, the continued advancement of BriaCell’s pivotal Phase 3 Bria‑ABC study under FDA Fast Track designation, and Bria-IMT’s potential as a transformative immunotherapy for patients with metastatic breast cancer, 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
Investor Relations Contact:
investors@briacell.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What treatment is being tested in BriaCell’s Phase 3 Bria-ABC trial?
The Phase 3 Bria-ABC study is evaluating Bria-IMT, BriaCell’s lead immunotherapy candidate, in combination with an immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer.
How often does the DSMB review safety data for the Bria-ABC study?
DSMB meetings for the pivotal Phase 3 Bria-ABC trial occur quarterly in accordance with the study protocol.
What does FDA Fast Track designation mean for this trial?
The company states that the ongoing Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration, which in the company’s view reflects the significant unmet medical need in metastatic breast cancer.
What is the clinical trial identifier for BriaCell’s Phase 3 study?
The pivotal Phase 3 Bria-ABC study in metastatic breast cancer is registered under the identifier NCT06072612.