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BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer

Key Takeaway: BriaCell Therapeutics has announced the inclusion of Mayo Clinic as a clinical site in its Phase 3 study for metastatic breast cancer. The study now comprises 69 active sites across 15 states, aiming to evaluate the efficacy of Bria-IMT combined with immune checkpoint inhibitors. Positive interim data from a previous Phase 2 study supports the potential effectiveness of this treatment. The study has received FDA Fast Track designation, highlighting its significance in cancer therapy.

Market Sentiment Analysis

POSITIVE FACTORS

  • Addition of Mayo Clinic enhances the credibility of the study.
  • Bria-IMT has received FDA Fast Track designation.
  • Positive Phase 2 survival data supports the potential of the therapy.
  • Expansion to 69 clinical sites increases patient recruitment opportunities.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+44%
120-day peak, hindsight
Typical move
14.8%
average across 8 past catalysts
Cash runway
~7 mo
Medium dilution risk
Lead asset
SV-BR-1-GM
Phase 3 · Breast Cancer

Full Press Release Details

PHILADELPHIA and VANCOUVER, British Columbia, July 15, 2025 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (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 a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612 ) in metastatic breast cancer.
BriaCell’s Phase 3 study now has 69 active clinical sites across 15 states, including Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and University of Arizona.
“We are very excited to be working with renowned clinical experts at a leading cancer center like Mayo Clinic, who also participated in BriaCell’s Phase 2 study,” stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “We strongly believe that our novel immunotherapy has the potential to transform cancer care for patients and their families.”
BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT™, plus immune check point inhibitor (CPI) versus physician’s choice in a dvanced metastatic b reast c ancer (Bria-ABC).
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. BriaCell recently (ASCO 2025) announced positive Phase 2 survival data in a similar MBC 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 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 beliefs regarding the potential of the Bria-IMT therapy to transform cancer care; the Company’s anticipated timeline for analyzing interim data; the Company’s analysis of interim data 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.
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.
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Frequently Asked Questions

What is the focus of BriaCell's Phase 3 study?

The study focuses on evaluating Bria-IMT combined with immune checkpoint inhibitors in metastatic breast cancer.

How many clinical sites are involved in the study?

The study now includes 69 active clinical sites across 15 states.

What designation has Bria-IMT received from the FDA?

Bria-IMT has received FDA Fast Track designation.

What were the results of the Phase 2 study?

The Phase 2 study reported positive survival data for a similar patient population.

Last updated: Jul 15, 2025