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- 79 clinical sites across 23 US states are currently enrolling patients in BriaCell's pivotal Phase 3 study in metastatic breast cancer (MBC)
- Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University have now joined BriaCell's extensive national network
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, is pleased to announce the addition of several key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612 ), notably Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University. BriaCell anticipates reporting top line data as early as H1-2026.
The extensive national effort already includes the following noteworthy clinics: Mayo Clinic, Los Angeles Cancer Network, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center.
BriaCell's pivotal Phase 3 clinical study is evaluating BriaCell's lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician's choice of treatment in a dvanced metastatic b reast c ancer (Bria-ABC).
"We are encouraged by the strong engagement from major academic and leading community cancer centers which underscores confidence in BriaCell's novel technology," stated Dr. William V. Williams, BriaCell's President & CEO. "We expect the addition of these clinical sites will further accelerate patient enrollment in BriaCell's pivotal Phase 3 study of Bria-IMT regimen in MBC and support our mission to bring this therapy to patients with significant unmet medical needs."
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 will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician's choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. The Bria-IMT combination regimen has received FDA Fast Track designation.
For additional information on BriaCell's pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, 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 anticipated expansion of patient enrollment; the Company's anticipated timeline for analyzing and reporting interim and top line data in its ongoing pivotal Phase 3 clinical study; and the Company's beliefs regarding its ability to bring their novel immunotherapy to patients with unmet medical needs; 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.
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Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
