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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, will be presenting positive clinical biomarker data of its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer at its poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting taking place October 17 – 21 in Berlin, Germany.
The details of the poster presentation is listed below.
#3928: Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Late Stage MBC (BRIA-ABC)
Presentation Number: 570P
Speaker: Dr. Giuseppe Del Priore
Date and Time: Oct 20, 2025, at 12:00 - 1:00 pm CET
Presentation venue: Messe Berlin, Messedamm 22, 14055 Berlin, Germany, Hall 25
Abstract Summary
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, Physician's Choice, or Bria-IMT monotherapy. As of the time of the abstract submission, data in 68 evaluable patients, with a median of 6 prior lines of treatment (2–13), was available. Additional data will be presented at the ESMO conference.
Clinical efficacy data: Treatment arm agnostic biomarker positive subgroups showed significant improvement in progression free survival in patients who developed an immune response to Bria-IMT (as measured by delayed type hypersensitivity) (p=0.0002).
Tolerability profile: Bria-IMT was well tolerated with no treatment-related discontinuations due to adverse events (AEs). Most common AEs include fatigue 22.8%, anemia 22.8%, and nausea 21.5%.
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.
Following the presentations, copies of the presentations will be posted on https://briacell.com/scientific-publications/.
