BriaCell to Highlight Positive Phase 2 & Phase 3 Clinical Data at SABCS® 2025
Rhea-AI Summary
BriaCell (Nasdaq: BCTX) will present three posters at the San Antonio Breast Cancer Symposium on December 10, 2025 highlighting positive Phase 2 safety and efficacy signals, positive biomarker findings, and survival data.
The company said its pivotal Phase 3 Bria-IMT+CPI trial is ongoing with an interim analysis expected in H1 2026. The Bria-IMT regimen has received Fast Track designation from the US FDA. Abstract and poster copies will be available on the company's scientific publications webpage.
Positive
- Three posters scheduled at SABCS on Dec 10, 2025
- Phase 2 safety and efficacy signals described as positive
- Positive biomarker and survival data reported across studies
- Fast Track designation granted by US FDA for Bria-IMT regimen
Negative
- Pivotal Phase 3 trial ongoing; definitive readout not yet available
- Interim analysis only expected in H1 2026; timing and outcome uncertain
- No regulatory approval or commercialization data disclosed
Insights
Three SABCS posters report positive Phase 2 signals, Phase 3 biomarker findings, Fast Track designation, interim analysis due
BriaCell presents positive safety, efficacy and biomarker data from a Phase 2 study and positive biomarker findings from its ongoing pivotal Phase 3 program at SABCS on
The business mechanism is clear: positive Phase 2 signals and supportive biomarkers can strengthen the evidence base for a cell-based immunotherapy and may de-risk regulatory dialogue, especially with an existing Fast Track status. Key dependencies include the robustness and statistical strength of the reported data, the design and timing of the planned interim analysis, and how the biomarker findings correlate with clinical endpoints.
Watch the three poster abstracts for exact endpoints, effect sizes, safety details, and subgroup analyses; the interim analysis timing and readout criteria in
- Three poster presentations at the San Antonio Breast Cancer Symposium (December 10, 2025) will highlight positive Phase 2 safety and efficacy signals and positive biomarker findings in both the Phase 2 and the pivotal Phase 3 studies
- The pivotal Phase 3 study of Bria-IMT+CPI is ongoing with an interim analysis expected in H1-2026
- The Bria-IMT regimen has received Fast Track Designation from US FDA
PHILADELPHIA and VANCOUVER, British Columbia, Nov. 25, 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 present positive biomarker and survival 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.
“Positive clinical data from our Phase 2 study, together with differentiated biomarker findings from our Phase 3 program reinforce our confidence in our pivotal Phase 3 study in metastatic breast cancer,” stated William V. Williams, MD, BriaCell’s President & CEO. “Together with our pipeline of novel off-the-shelf cell-based immunotherapies, we remain committed to advancing breakthroughs in cancer immunotherapy as we work to improve survival and clinical outcomes in cancer patients with unmet medical needs.”
“Our biomarker data provides important insights into the mechanism of action of our novel immunotherapy with the goal of delivering more precisely targeted treatment options for oncologists, physicians, and patients,” commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.
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 CST
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 CST
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 CST
Copies of the abstracts and 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
What data will BriaCell (BCTX) present at SABCS on December 10, 2025?
When is the interim analysis for BriaCell's pivotal Phase 3 (BCTX) expected?
What regulatory status does BriaCell's Bria-IMT regimen (BCTX) have?
Where can investors find BriaCell's SABCS abstracts and posters (BCTX)?
Does BriaCell (BCTX) report a Phase 3 readout date at SABCS 2025?
