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- FDA clearance of Investigational New Drug (IND) application enables BriaCell to initiate Phase 1/2a clinical study of Bria-PROS+ in prostate cancer
- Bria-PROS+ is BriaCell's next generation personalized immunotherapy for prostate cancer and incorporates additional immune activating components designed to enhance clinical efficacy
- Bria-PROS+ program previously awarded $2 million grant from the US National Cancer Institute
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 U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for Bria-PROS+ and issued a Study May Proceed letter, clearing the way for clinical evaluation of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for prostate cancer.
"We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer," stated Dr. William V. Williams, BriaCell's President & CEO. "Bria-PROS+ is designed to activate multiple components of the immune system, which we believe has the potential to support meaningful therapeutic benefit with a favorable safety profile. We look forward to advancing Bria-PROS+ into the clinic as we work to develop new treatment options for patients with advanced prostate cancer."
In August 2025, BriaCell was awarded a $2 million non-dilutive grant from the US National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+.
As reported in BriaCell's preclinical poster presentation, at the American Association of Cancer Research (AACR) Annual Meeting, Bria-PROS+ demonstrated activation of both adaptive and innate immune responses including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with prostate cancer.
BriaCell's Bria-PROS+ builds on the Company's oncology platform with its Bria-IMTâ„¢ program, currently in its Phase 3 pivotal trial for metastatic breast cancer, its Bria-OTSâ„¢ breast cancer clinical program, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and its Bria-BRES+â„¢ program, which recently received FDA clearance to initiate clinical evaluation of its enhanced, personalized, off-the-shelf cellular immunotherapy for breast cancer. Bria-PROS+, Bria-OTS and Bria-BRES+ programs are personalized immunotherapies, based on HLA matching between patients and the respective immunotherapy cell lines.
About briacell therapeutics corp.
BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. 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 FDA clearance of the IND application and the planned initiation of a Phase 1/2a clinical study of Bria‑PROS+, and expectations regarding the potential clinical benefits of the Bria‑OTS+ platform, 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.comÂ
Investor Relations Contact:
investors@briacell.com
