BriaCell Presents Phase 3 Clinical Biomarker Data at ESMO 2025
Rhea-AI Summary
BriaCell (Nasdaq: BCTX) presented biomarker data from its ongoing pivotal Phase 3 trial of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer at ESMO 2025 (poster #3928).
Pooled, blinded data from 113 patients (median 6 prior lines) show biomarker trends consistent with Phase 2: neutrophil-to-lymphocyte ratio (NLR) remains a potential predictor of clinical benefit (Phase 2 PFS 4.5 vs 2.5 months; HR 0.5, 95% CI 0.3–0.8, p=0.005). No new safety or tolerability signals were identified and there were no treatment-related discontinuations.
Interim OS analysis is planned at 144 events. Bria-IMT combination has FDA Fast Track designation.
Positive
- Pooled data available for 113 patients (median 6 prior lines)
- NLR biomarker aligns with Phase 2 predictive trends (Phase 2 HR 0.5, p=0.005)
- No new safety signals and no treatment-related discontinuations reported
- FDA Fast Track designation for the Bria-IMT combination regimen
- Interim OS plan triggered at 144 patient events
Negative
- Phase 3 efficacy comparison remains blinded; PFS vs physician’s choice not yet disclosed
- Pooled dataset is limited to 113 patients, below interim OS event threshold
- Patient population is heavily pretreated with median 6 prior lines, which may affect outcomes
- Reported predictive NLR effect is based on prior Phase 2 subgroup data, not mature Phase 3 OS
News Market Reaction
On the day this news was published, BCTX gained 2.45%, reflecting a moderate positive market reaction. Argus tracked a peak move of +15.1% during that session. Our momentum scanner triggered 32 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $661K to the company's valuation, bringing the market cap to $28M at that time. Trading volume was very high at 3.8x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
- Biomarkers identified in BriaCell’s Phase 2 study are showing similar and encouraging trends in the ongoing pivotal Phase 3 study of Bria-IMT™ in metastatic breast cancer (MBC)
- No new safety or tolerability issues identified in pooled analysis of ongoing pivotal Phase 3 study
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 20, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces encouraging clinical biomarker data in its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer. The findings are being presented in BriaCell’s poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting taking place October 17 – 21, 2025 in Berlin, Germany. The Phase 3 data shown is for all patients evaluated regardless of treatment assignment (i.e. is blinded).
“We are encouraged by the early constructive clinical biomarker data which could allow us to predict clinical and survival outcomes in our patients and would help guide treatment decisions for metastatic breast cancer patients with limited options,” stated Dr. William V. Williams, BriaCell’s President and CEO.
Poster #3928: Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Late Stage MBC (BRIA-ABC)
In BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer, patients are randomized 1:1:1 to Bria-IMT + CPI, Treatment of Physician’s Choice, or Bria-IMT monotherapy. As of the time of the poster submission, pooled data was available in 113 patients, with a median of 6 prior lines of treatment (2–13). Evaluable only pertains to imaging. All 113 are evaluated for safety, PFS, etc.
As reported in the Phase 2 study, Neutrophil to Lymphocyte Ratio (NLR) continues to be a potential biomarker of clinical benefit as progression free survival (PFS) was significantly higher in patients with NLR of 0.7 – 2.3 (4.5 months) vs those with NLR < 0.7 or > 2.3 (2.5 months) {(HR) of 0.5 (
In the Phase 3 study, PFS data comparing BriaCell’s Bria-IMT combination regimen versus those treated with physician’s choice remains blinded at this time. Bria-IMT has been well tolerated in the Phase 3 study with no treatment-related discontinuations due to adverse events (AEs). The most common AEs are minor, including fatigue, anemia, and nausea.
About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.
Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell reported positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen. The Bria-IMT combination regimen has received FDA Fast Track designation.
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.
A copy of the poster presentation is posted on 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: BriaCell's plans to present clinical data presentations at the ESMO Congress 2025, and the contents of all such presentations; BriaCell's statements regarding early constructive clinical biomarker data allowing the Company to predict clinical and survival outcomes and guide treatment decisions for metastatic breast cancer patients; and the Company's anticipated timing of 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.
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 biomarker did BriaCell report at ESMO 2025 for BCTX Bria-IMT?
How many patients were included in the pooled Phase 3 BCTX dataset presented at ESMO 2025?
Did BriaCell report new safety issues for Bria-IMT in the Phase 3 update (BCTX)?
When will the pivotal Phase 3 (BCTX) interim overall survival analysis occur?
Does the Phase 3 BCTX presentation include a direct PFS comparison versus physician’s choice?
What regulatory designation does Bria-IMT have relevant to BCTX investors?
