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BriaCell announces presentation of survival, clinical benefit data at ASCO 2025

BriaCell (BCTX) Therapeutics announces the presentation of positive survival and clinical benefit data in three clinical poster presentations and one publish-only abstract at the upcoming 2025 American Society of Clinical Oncology Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL. Abstract Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer: Preliminary selected clinical and biomarker data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer. Abstract Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer: Phase 2 study of Bria-IMT in combination immunotherapy with an immune checkpoint inhibitor consisted of 54 patients; 11 received pembrolizumab, 44 retifanlimab. Median overall survival, progression-free survival, objective response rate and clinical benefit rate were evaluated against two pivotal Phase 3 studies of FDA approved drugs, ASCENT and TROPiCS-02. Bria-IMT was well-tolerated with no treatment-related discontinuations. 22% of patients are still in active survival follow up. This analysis does not stratify Bria-IMT patients by hormone receptor or HER2 status, and the dataset reflects the information available at the time of abstract submission. Updated data will be shared during the company’s presentation at ASCO 2025. PFS and OS: Patients treated with Bria-IMT’s selected Phase 3 formulation demonstrated significantly improved progression-free survival and overall survival compared to those who received the alternate formulation not advanced to Phase 3. The overall survival observed in the Phase 3 formulation cohort was comparable to that reported in the ASCENT and TROPiCS-02 studies and exceeded survival outcomes in their respective treatment of physician’s choice arms. BriaCell’s Phase 2 study also achieved a Clinical Benefit Rate of 61%, outperforming ASCENT and TROPiCS-02, and an Objective Response Rate of 14%, which matched or exceeded the TPC arms in both studies. Importantly, these outcomes were achieved in a more heavily pretreated patient population than those in the comparator trials-highlighting Bria-IMT’s strong anti-cancer activity. The favorable efficacy profile of the Phase 3 formulation supports its continued evaluation in BriaCell’s ongoing pivotal Phase 3 trial comparing Bria-IMT to treatment of physician’s choice. Abstract Title: Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer:Heavily pre-treated MBC patients were treated in a dose escalation Phase 1/2 study of Bria-OTS monotherapy. The Phase 1 part of the study has enrolled and treated 3 patients. The first patient treated with single agent therapy has confirmed resolution of a breast cancer metastasis in the lung and remains on study.

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