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- Over 230 patients screened and over 160 patients enrolled in BriaCell's pivotal Phase 3 study in metastatic breast cancer (MBC)
- Enrollment exceeding expectations with strong clinical site and patient interest
- Topline interim data readout expected in 1H2026
- Phase 3 combination regimen continues under FDA Fast Track designation
briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to announce its Phase 3 clinical study has screened over 230 and enrolled over 160 patients. BriaCell anticipates reporting topline data as early as 1H2026.
Interim data will be analyzed once 144 patient events (deaths) occur. Positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT™ in patients with metastatic breast cancer.
BriaCell's pivotal Phase 3 clinical study is evaluating BriaCell's lead clinical candidate, Bria-IMT, plus an immune check point inhibitor versus physician's choice in a dvanced metastatic b reast c ancer (Bria-ABC).
"The pace of patient enrollment in our pivotal Phase 3 study has exceeded expectations underscoring the strong engagement of participating sites and the high level of interest from patients and investigators," stated Dr. William V. Williams, BriaCell's President & CEO. "We look forward to collecting, analyzing and sharing the Phase 3 data with the U.S. FDA in the coming months as we continue working to bring hope to patients with metastatic breast cancer who face an urgent medical need."
About BriaCell's Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
BriaCell's pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.
Interim data from BriaCell's ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor in metastatic breast cancer will be analyzed once 144 patient events (deaths) occur. This interim analysis will assess overall survival (OS) as the primary endpoint, comparing patients treated with the Bria-IMT combination regimen to those receiving physician's choice therapy. Positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT in patients with metastatic breast cancer. The Bria-IMT combination regimen has been granted FDA Fast Track designation.
For additional information on BriaCell's pivotal Phase 3 study, please visit ClinicalTrials.gov NCT06072612 .
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 Company's timeline for analyzing and reporting interim and topline data in its ongoing pivotal Phase 3 clinical study; the Company's anticipated timeline for collecting, analyzing and sharing the Phase 3 data with the U.S. FDA; and the Company's beliefs regarding Bria-IMT receiving full approval and marketing authorization 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
Investor Relations Contact:
investors@briacell.com
