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BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study

Key Takeaway: BriaCell Therapeutics has added UCLA Health Jonsson Comprehensive Cancer Center as a key site for its pivotal Phase 3 study evaluating Bria-IMT in advanced metastatic breast cancer. The study aims to improve survival outcomes and has shown promising results in earlier Phase 2 trials. The FDA has granted Fast Track designation to the Bria-IMT regimen, indicating its potential to address unmet medical needs.

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POSITIVE FACTORS

  • Addition of UCLA Health enhances trial credibility and enrollment potential.
  • Encouraging Phase 2 data supports the efficacy of Bria-IMT combination.
  • FDA Fast Track designation highlights the treatment's potential.

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 31, 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, announces the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT™ in combination with a checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer (MBC).
“The randomized Phase 2 data reported with the Bria-IMT combination regimen are encouraging, and we believe BriaCell’s Phase 3 study represents an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer,” stated Kelly E. McCann, MD, PhD, Breast Medical Oncologist, and Lead Investigator at UCLA Health Jonsson Comprehensive Cancer Center. “We are excited to support this important study and anticipate strong patient enrollment through our large multi-center clinical site.”
“The inclusion of UCLA Health underscores our strategy to partner with top-tier institutions to accelerate trial enrollment and execution,” said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “We remain confident in our timeline for sharing top-line data in 2026.”
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 against physician’s choice in patients with advanced metastatic breast cancer. This design builds upon maturing positive survival data from BriaCell’s Phase 2 study, most recently presented at ASCO 2025, which evaluated the same combination in a similar MBC patient population . Notably, 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 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 BriaCell’s Phase 3 study representing an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer; the Company’s anticipated strong patient enrollment through their large multi-center clinical site; the Company’s anticipated timeline for sharing top-line data; and the Company’s timeline for its 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 evaluates Bria-IMT in combination with a checkpoint inhibitor for advanced metastatic breast cancer.

What institution has joined BriaCell's study?

UCLA Health Jonsson Comprehensive Cancer Center has been added as a key site.

What designation has the Bria-IMT regimen received?

The Bria-IMT regimen has been granted FDA Fast Track designation.

What is the primary endpoint of the Phase 3 study?

Overall survival (OS) is the primary endpoint of the study.

When is BriaCell expected to share top-line data?

BriaCell anticipates sharing top-line data in 2026.

Last updated: Jul 31, 2025