BriaCell to Present Phase 2 Survival & Phase 3 Clinical Data at SABCS® 2025
Rhea-AI Summary
BriaCell (Nasdaq: BCTX) will present three posters at the San Antonio Breast Cancer Symposium (SABCS) on December 10, 2025, reporting positive Phase 2 survival and Phase 3 biomarker data.
A pooled interim analysis of 116 patients with MHC subtyping in the ongoing pivotal Phase 3 showed an excellent safety profile, improved PFS in HR+/HER2- and HER2-low subtypes, and NLR as a potential biomarker. Phase 1/2 data in 54 metastatic breast cancer patients reported continued overall survival benefit and DTH as a possible predictive biomarker. Cytokine analysis of 30 patients suggests Th1-biased signatures may predict response. An interim Phase 3 analysis is expected in 1H2026.
Positive
- Pooled interim analysis includes 116 patients
- Improved PFS reported in HR+/HER2- and HER2-low subtypes
- Phase 1/2 54-patient cohort shows continued overall survival benefit
- Identification of multiple potential biomarkers: NLR, DTH, Th1 cytokines
- Interim Phase 3 analysis expected in 1H2026
Negative
- Key data are interim or maturing, not final readouts
- Small cohort sizes: 54 and 30 patients limit statistical conclusiveness
- Phase 3 results dependent on ongoing study and future interim analysis timing
Insights
Phase‑2 survival and Phase‑3 biomarker posters suggest favorable signals and an upcoming pivotal interim readout in
BriaCell reports maturing Phase 2 overall‑survival benefit and supportive biomarker signals, plus pooled interim safety and PFS observations from 116 patients with MHC subtyping in the ongoing pivotal Phase 3. The data types — survival, progression‑free survival, safety, and multiple biomarker classes (NLR, DTH, Th1 cytokine signatures) — are the exact endpoints that can influence regulatory and clinical interpretation when supported by formal statistical analysis.
Key dependencies and risks include whether the survival and PFS signals meet prespecified statistical thresholds and whether biomarker subgroups are prospectively validated; interim pooled analyses can show promise but often change with full data. The safety description as "excellent" is clinically relevant but requires full adverse‑event tables to assess grade distribution and treatment attribution.
Concrete near‑term items to watch are the planned interim analysis timing (
- Three poster presentations at the San Antonio Breast Cancer Symposium (SABCS), now available and to be presented on December 10, 2025, highlight robust survival and clinical benefit data in Phase 2, plus positive key biomarker data from the pivotal Phase 3
- The pivotal Phase 3 study of Bria-IMT+CPI in advanced metastatic breast cancer is ongoing with an interim analysis expected in 1H2026
PHILADELPHIA and VANCOUVER, British Columbia, Dec. 02, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, will be presenting positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS®) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.
“Our survival and biomarker data at SABCS is very encouraging because it underscores the potential of our novel immunotherapy and precision medicine to treat cancer patients,” stated William V. Williams, MD, BriaCell’s President & CEO. “We remain committed to improve survival and clinical outcomes in cancer patients whose medical needs remain unmet.”
“We are extremely pleased with biomarker and patient subgroup data suggesting their use for identifying patients who are most likely to benefit from our treatment,” stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer.
The details of the poster presentations are listed below.
Late-Breaking Abstract Number: 3688
Presentation Number: PS1-13-22
Presentation Title: Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM - 2:00 PM
A pooled interim analysis of 116 patients with available MHC subtyping in the ongoing pivotal phase III study demonstrated an excellent safety profile, improved progression-free-survival (PFS) n HR+/HER-2 and HER2- low subtypes and potential use of Neutrophil to Lymphocyte Ratio (NLR) as a biomarker of clinical benefit,
Late-Breaking Abstract Number: 3713
Presentation Number: PS1-13-23
Presentation Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM - 2:00 PM
Maturing data analysis of the of the Phase 1/2 study evaluating the Bria-IMT regimen in combination with an anti–PD-1 checkpoint inhibitor (CPI) in 54 metastatic breast cancer demonstrated continued overall survival benefit with potential use of delayed type hypersensitivity (DTH) as a biomarker predictive of clinical benefit.
Abstract Number: 1614
Presentation Number: PS2-09-03
Presentation Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer.
Poster Presentation Date/Time: Wednesday, December 10, 2025, 5:00 PM - 6:30 PM
Analysis of 35 different blood cytokines/chemokines from 30 patients enrolled in the Phase 1/2 studies of Bria-IMT alone or in combination with an immune checkpoint inhibitor (CPI) suggests that Th1 biased cytokines and chemokines may serve as potential predictive biomarkers of clinical responses to the Bria-IMT regimen in metastatic breast cancer
Copies of the posters will be made available at https://briacell.com/scientific-publications/.
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 presenting three posters at the 2025 SABCS, and the contents of such posters, 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.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
FAQ
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