- Biomarkers Identified in the Phase 2 Study Show Similar Trends in the Ongoing Pivotal Phase 3 Bria-IMT™ Study in Metastatic Breast Cancer (MBC)
- Positive delayed-type hypersensitivity (DTH), a potential biomarker predictive of improved clinical outcomes, was significantly associated with longer progression-free survival (PFS) in a blinded phase 3 analysis of all current patients
- No new safety or tolerability issues were identified.
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 13, 2025 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer treatment, will present positive clinical results biomarker data from the ongoing pivotal Phase 3 trial of Bria-IMT plus inhibitor checkpoint immune (CPI) in metastatic breast cancer at a poster presentation at the European Society of Medical Oncology (ESMO) 2025 Congress Annual Meeting, October 17–21 in Berlin, Germany.
Details of the poster presentation are given below.
#3928: Feasibility and Biomarker Validation of the International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Advanced MBC (BRIA-ABC)
Presentation number: 570P
Speaker: Dr. Giuseppe Del Priore
Date and time: October 20, 2025, 12:00 – 13:00 CET.
Presentation location: Messe Berlin, Messedamm 22, 14055 Berlin, Germany, room 25.
Abstract Summary
BriaCell's pivotal Phase 3 trial of Bria-IMT in combination with an immune checkpoint inhibitor (CPI) in metastatic breast cancer randomizes patients 1:1:1 to Bria-IMT + CPI, Physician's Choice, or Bria-IMT monotherapy. At the time of abstract submission, data were available on 68 evaluable patients with an average of 6 prior lines of treatment (2–13). Additional data will be presented at the ESMO conference.
Clinical efficacy data: Subgroups with positive biomarkers, regardless of treatment group, showed a significant improvement in progression-free survival in patients who developed an immune response to Bria-IMT (as measured by delayed-type hypersensitivity) (p = 0.0002).
Tolerance profile: Bria-IMT was well tolerated without treatment discontinuation due to adverse events (AEs). The most common AEs included fatigue 22.8%, anemia 22.8%, and nausea 21.5%.
About BriaCell's pivotal Phase 3 clinical trial of the Bria-IMT combination regimen in patients with MBC
BriaCell's pivotal Phase 3 trial of Bria-IMT in combination with an immune checkpoint inhibitor (CPI) in metastatic breast cancer is ongoing.
Interim data will be analyzed after 144 patient events (deaths) have occurred, comparing overall survival (OS) in patients treated with the Bria-IMT combination regimen with patients treated at physician's choice as the primary endpoint. Positive results from the pivotal phase 3 study could lead to full approval and marketing authorization for Bria-IMT in patients with MBC. BriaCell reported positive phase 2 survival data in a similar population of patients with MBC treated with the same Bria-IMT combination regimen.. The Bria-IMT combination regimen has received FDA Fast Track designation.
For more information about BriaCell's pivotal Phase 3 trial of Bria-IMT and an immune checkpoint inhibitor in metastatic breast cancer, visit ClinicalTrials.gov. NCT06072612.
After the presentations, copies of the presentations will be posted on the website. https://briacell.com/scientific-publications/.
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company developing novel immunotherapies to transform cancer treatment. Additional information can be obtained at https://briacell.com/.
Safe Harbor
This press release contains “forward-looking statements” that involve significant 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 can be identified by the use of words such as “expect”, “believe”, “consider”, “may”, “estimate”, “anticipate”, “intend”, “seek”, “could”, “could”, “plan”, “potential”, “forecast”, “project”, “target”, “target”, “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 that BriaCell will provide clinical data presentations at ESMO 2025; and the content of all such presentations is based on BriaCell's current expectations and is subject to inherent uncertainties, risks and assumptions that are difficult to predict. In addition, some forward-looking statements are based on assumptions about future events that may prove to be inaccurate. These and other risks and uncertainties are described in more detail under the heading “Risks and Uncertainties” in the most recent Management's Discussion and Analysis, under the heading “Risk Factors” in the Company's most recent annual information form, and under the heading “Risks and Uncertainties” in the Company's other filings with the Canadian securities regulators and the U.S. Securities and Exchange Commission, all of which are available under profiles Companies on SEDAR+ at www.sedarplus.ca and about EDGAR in www.sec.gov. The forward-looking statements contained in this announcement are made as of this date and BriaCell Therapeutics Corp. does not undertake any obligation to update such information, except as required by 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 information:
William W. Williams, MD
President and CEO
1-888-485-6340
[email protected]
Investor Relations Contact:
[email protected]
