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- BriaCell presents positive clinical data in three posters at the San Antonio Breast Cancer Symposium (SABCS ® )
- Phase 3 study of Bria-IMT™ plus immune check point inhibitor (CPI) continues to support biomarkers to identify patients who benefit from treatment with BriaCell's regimen
- Maturing Phase 2 study data continues to support meaningful clinical benefit of the Bria-IMT regimen with outstanding long-term survival
- No toxicity related discontinuations in Phase 3
briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, presents 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.
"We are very excited to see the robust and positive biomarker data, which may enable us to more confidently predict clinical responses in patients treated with the Bria-IMT regimen early in their treatment course," stated Kelly E. McCann, MD, PhD, breast medical oncologist at UCLA Health Jonsson Comprehensive Cancer Center, and lead investigator at UCLA for the Bria-ABC pivotal Phase 3 study. "These biomarkers could serve as highly valuable tools for clinicians, helping them inform treatment decisions for metastatic breast cancer, a complex disease in which many patients have limited or no remaining treatment options."
"BriaCell's data shows the promise of the Bria-IMT regimen to address major unmet needs in the treatment of metastatic breast cancer, including in patients with CNS metastasis who have progressed on several lines of therapy – median 6 prior treatments," stated Chaitali S. Nangia, MD, Partner, Hoag Medical Group and first author of the poster.
"Our findings support further evaluation of cytokine and chemokine biomarkers as potential predictors of survival and clinical benefit with our Bria-IMT regimen, establishing a path towards more personalized therapeutic strategies in metastatic breast cancer patients with limited treatment options," commented Miguel A. Lopez-Lago, PhD, BriaCell's Chief Scientific 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 CST
Summary
In BriaCell's pivotal Phase 3 study in metastatic breast cancer, patients are randomized 1:1:1 to receive Bria-IMT plus an immune check point inhibitor (CPI), Bria-IMT monotherapy or Treatment of Physician's Choice (TPC). A pooled interim analysis of 116 patients with available MHC subtyping and median 6 prior lines of therapy assessed safety, biomarker correlations and progression-free-survival (PFS) per imaging. All data remains blinded to date.
Key Findings
- Favorable safety profile: The Bria-IMT regimen was well tolerated with no treatment-related discontinuations due to adverse events (AEs). The most common AEs were fatigue, anemia, and nausea and were predominantly low grade.
- Early PFS signals by subtype: Median PFS values appeared highest in patients with HR+/HER2- disease (3.7 months) and HER2-Low disease (3.9 months).
- Neutrophil-to-Lymphocyte Ratio (NLR) as a potential predictive biomarker: Consistent with findings from the Phase 2 study , the Neutrophil to Lymphocyte Ratio (NLR) continues to show potential as a biomarker of clinical benefit. Patients with favorable NLR of 0.7 – 2.3 demonstrated longer PFS with a median of 4.4 months vs 2.6 months in those with NLR <0.7 or >2.3.
Conclusion
Biomarkers previously associated with PFS and overall survival (OS) in BriaCell's phase 2 study continue to show a direct relationship with PFS in this ongoing phase 3 study. Further analysis is planned as enrolment progresses, and as OS data mature.
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
The data analysis of Phase 1/2 study evaluating the Bria-IMT regimen in combination with an anti–PD-1 checkpoint inhibitor (CPI) in 54 metastatic breast cancer is presented below. Six patients had Central Nervous System (CNS) metastasis.
Summary
Positive Delayed Type Hypersensitivity (DTH) may be key predictor of clinical benefit as median overall survival (OS) was significantly (P=0.0001) higher in patients who were DTH+ (11.3 months) vs those who were DTH- (4.7 months).
In four evaluable patients with CNS metastasis, best clinical benefit Rate (CBR) including complete response (CR), partial response (PR), or stable disease (SD) in patients was 100% in HER2+ patients, 100% in HR+ patients, 50% in patients with TNBC, and 75% overall.
Conclusion
Maturing positive Phase 2 data continue to support the potentially meaningful clinical benefit of the Bria-IMT regimen and the ongoing pivotal Phase 3 study is further evaluating this immunotherapy and the role of biomarkers in predicting patient response.
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
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).
Summary
- Bria-IMT immunotherapy produced Th1 biased cytokine and chemokine changes consistent with immune activation suggesting their use as potential biomarkers to predict clinical responses of cancer patients to Bria-IMT regimen.
- Patients with Stable Disease (SD) or PR (Partial Response) showed significantly higher levels of immune activating factors including IL-2, IL-15, IL-27, TNF-α, CXCL10, CCL2, CCL13, CCL26, and IL-17Apost-treatment, suggesting enhanced T-cell activation and pro-inflammatory signaling.
- No induction of Th2- or regulatory-associated cytokines was observed suggesting that the Bria-IMT regimen did not suppress immune activation.
- Elevated post-treatment levels of IL-1β, IL-6, IL-8, TNF-α, and MCP-4 were associated with better Overall Survival (OS).
Conclusion
BriaCell's data 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 at the 2025 SABCS ® , the contents of such presentations, and the results and conclusions contained in this press release, 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.
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Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
