On October 20, 2025 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, reported 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) (Free ESMO Whitepaper) 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).

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"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 (95% CI 0.3–0.8, p=0.005)}.

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 View Source

(Press release, BriaCell Therapeutics, OCT 20, 2025, View Source [SID1234656936])