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briacell therapeutics corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care is pleased to announce the addition of NYU Langone Health's Laura and Isaac Perlmutter Cancer Center, a renowned cancer center in New York City, as a clinical trial site in its ongoing pivotal Phase 3 clinical study (Bria-ABC).
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BriaCell has enjoyed a marked uptick in interest from premier cancer centers and patient enrollment numbers following the prominent independent feature of its Phase 3 clinical trial in Nature Medicine's publication, "Eleven clinical trials that will shape medicine in 2026", linked here.
BriaCell's pivotal Phase 3 clinical study in Advanced Breast Cancer (Bria-ABC) is evaluating BriaCell's lead clinical candidate, Bria-IMT™, plus an immune check point inhibitor versus treatment of physician's choice in advanced metastatic breast cancer.
"At NYU Langone Health's Perlmutter Cancer Center, we are dedicated to offering state-of-the-art treatments to patients with difficult-to-treat cancers," stated Nancy Chan MD, Director, Breast Cancer Clinical Research, NYU Langone Health's Perlmutter Cancer Center. "We look forward to helping accelerate the development of Bria-IMT, a novel immunotherapy with the potential to improve outcomes for patients with advanced metastatic breast cancer."
"We are thrilled to partner with clinical experts at the renowned NYU Langone Health's Perlmutter Cancer Center, a patient-focused, NCI-designated Comprehensive Cancer Center, to further expand patient access to our novel immunotherapy treatment," said Dr. Giuseppe Del Priore, BriaCell's Chief Medical Officer. "We continue to advance the study and look forward to sharing interim data in the coming months."
Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor versus physician's choice in patients with advanced metastatic breast cancer. Importantly, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.
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 addition of a new clinical site in the ongoing pivotal Phase 3 clinical study of Bria‑IMT, and expectations regarding patient enrollment, interim analysis timing and the potential clinical benefits of the Bria‑IMT combination regimen, 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
