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- Sunnybrook's Odette Cancer Centre, a world-class cancer center in Toronto, Ontario, Canada, joins BriaCell's pivotal Phase 3 clinical trial in metastatic breast cancer
- BriaCell Phase 3 trial featured in Nature Medicine as one of "Eleven clinical trials that will shape medicine in 2026"
briacell therapeutics corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announced that the Odette Cancer Centre at Sunnybrook Health Sciences Centre, a leading cancer center in Toronto, Ontario, Canada, has joined BriaCell's ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612).
In the United States, BriaCell's Phase 3 study now has over 80 active clinical sites across 15 states, including Penn Medicine's Abramson Cancer Center, Mayo Clinic, Smilow Cancer Hospital at Yale New Haven, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Sylvester Comprehensive Cancer Center (University of Miami), Texas Oncology-Baylor Charles A. Sammons Cancer Center, and the University of Arizona.
"There are a limited number of effective treatment options for patients with metastatic breast cancer and, unfortunately for most patients, standard treatments eventually stop working," commented Katarzyna Jerzak, MD, MSc, FRCPC, Medical Oncologist and Clinician Investigator at Sunnybrook's Odette Cancer Centre, and Associate Professor in the Department of Medicine, University of Toronto. "We are excited to evaluate BriaCell's innovative immunotherapy approach and to offer these patients the opportunity to access a potentially effective new treatment."
"Opening our first Canadian clinical site for BriaCell's pivotal Phase 3 study is an important milestone," stated Dr. William V. Williams, BriaCell's President & Chief Executive Officer. "Sunnybrook is a world-class cancer center, and its participation expands access to our Bria-IMT regimen to patients in Canada, as we work to accelerate development of this our novel immunotherapy for patients with metastatic breast cancer."
BriaCell's pivotal Phase 3 clinical study is evaluating BriaCell's lead clinical candidate, Bria-IMT™, in combination with an immune checkpoint inhibitor (CPI), compared with physician's treatment of physician's choice in patients with advanced metastatic breast cancer (the Bria-ABC study). The study's primary endpoint is overall survival (OS). An interim analysis is planned after 144 patient deaths have occurred, comparing mortality in patients treated with the Bria-IMT combination regimen versus those treated with physician's choice.
BriaCell recently received a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the Phase 3 Study in metastatic breast cancer. At ASCO 2026, BriaCell reported positive Phase 2 survival data in a similar metastatic breast cancer patient population treated with the same Bria-IMT combination regimen. 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 checkpoint 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 regarding the participation of Sunnybrook's Odette Cancer Centre in BriaCell's ongoing pivotal Phase 3 study, the continued enrollment, advancement and outcomes of the Phase 3 study, the continued development and potential commercialization of Bria-IMT, and the potential benefits of Bria-IMT 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 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
