- BriaCell Therapeutics has received its **fourth consecutive positive recommendation** from an independent Data Safety Monitoring Board (DSMB) for its pivotal **Phase 3 study of Bria-IMT™ plus immune checkpoint inhibitor**.  **[1610820_a730f8aa13234263b2a0355cd8d6dafa_0]** **[1610820_a730f8aa13234263b2a0355cd8d6dafa_1]** 
- The DSMB identified **no safety concerns** after reviewing safety data from the study in patients with **metastatic breast cancer**, recommending the **continuation of the study without modifications**.  **[1610820_a730f8aa13234263b2a0355cd8d6dafa_0]** **[1610820_a730f8aa13234263b2a0355cd8d6dafa_1]** 
- The ongoing Phase 3 study is being conducted under **FDA Fast Track Designation**, reflecting the significant unmet medical need in metastatic breast cancer.  **[1610820_a730f8aa13234263b2a0355cd8d6dafa_0]** **[1610820_a730f8aa13234263b2a0355cd8d6dafa_1]**

BriaCell Receives Positive DSMB Recommendation for Phase 3 Study

- BriaCell Therapeutics has added **Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University** to its pivotal Phase 3 clinical study for metastatic breast cancer (MBC).  **[1610820_3f20768d6b1a4007b906fc7fec832cd6_1]** 
- The study, evaluating Bria-IMT plus an immune checkpoint inhibitor, now includes **79 clinical sites** across **23 US states** enrolling patients.  **[1610820_3f20768d6b1a4007b906fc7fec832cd6_0]** **[1610820_3f20768d6b1a4007b906fc7fec832cd6_1]** 
- BriaCell anticipates reporting **top-line data as early as H1-2026**.  **[1610820_3f20768d6b1a4007b906fc7fec832cd6_1]** 
- The Bria-IMT combination regimen has received **FDA Fast Track designation**.  **[1610820_3f20768d6b1a4007b906fc7fec832cd6_1]**

BriaCell Expands Clinical Sites for Phase 3 Metastatic Breast Cancer Study

- **BriaCell Therapeutics Corp. (BCTX)** announced a **collaboration with Memorial Sloan Kettering Cancer Center’s (MSK’s) Therapeutics Accelerator Cohort program** to advance its Bria-OTS+ immunotherapy platform.  **[1610820_b57d27944df74c3c887c97b7db220e96_1]** 
- The collaboration aims to **accelerate the clinical development of Bria-OTS+**, a next-generation personalized off-the-shelf immunotherapy for multiple cancer indications, including **metastatic breast cancer and prostate cancer**.  **[1610820_b57d27944df74c3c887c97b7db220e96_1]** 
- MSK will provide **manufacturing, Investigational New Drug (IND) development, and clinical protocol support** for a Phase 1 clinical trial of Bria-BRES+, a breast cancer immunotherapy within the Bria-OTS+ platform.  **[1610820_b57d27944df74c3c887c97b7db220e96_1]**

BriaCell Therapeutics Announces Collaboration with MSK Accelerator for Bria-OTS+ Development

- BriaCell Therapeutics will present **positive clinical biomarker data** from its ongoing pivotal Phase 3 study of Bria-IMT in metastatic breast cancer at the ESMO Congress 2025 on **October 20, 2025**.  **[1610820_f68c28b967fd4eb7b42304a213862af0_1]** 
- Biomarkers identified in the Phase 2 study show similar trends in the ongoing Phase 3 study, with **positive delayed-type hypersensitivity (DTH)** significantly associated with **longer progression-free survival (PFS)** in current Phase 3 patients.  **[1610820_f68c28b967fd4eb7b42304a213862af0_0]** **[1610820_f68c28b967fd4eb7b42304a213862af0_1]** 
- Bria-IMT demonstrated a **well-tolerated profile** with no treatment-related discontinuations due to adverse events in the Phase 3 study.  **[1610820_f68c28b967fd4eb7b42304a213862af0_1]** 
- The Bria-IMT combination regimen has received **FDA Fast Track designation**, and positive results from the ongoing Phase 3 study could lead to full approval and marketing authorization.  **[1610820_f68c28b967fd4eb7b42304a213862af0_1]**

BriaCell to Present Positive Phase 3 Biomarker Data at ESMO 2025

- BriaCell Therapeutics Corp. (BCTX) has been awarded a **$2,054,651** non-dilutive research grant from the National Cancer Institute (NCI).  **[1610820_69b9d0e4dfb54bfea7c63a0e0728aca6_0]** **[1610820_69b9d0e4dfb54bfea7c63a0e0728aca6_1]** 
- The grant is designated to advance **Bria-PROS+**, BriaCell’s next-generation personalized off-the-shelf immunotherapy for prostate cancer.  **[1610820_69b9d0e4dfb54bfea7c63a0e0728aca6_1]** 
- The funds will be used to complete manufacturing of Bria-PROS+ clinical supply and to support an upcoming Phase 1/2a trial in metastatic prostate cancer.  **[1610820_69b9d0e4dfb54bfea7c63a0e0728aca6_0]** **[1610820_69b9d0e4dfb54bfea7c63a0e0728aca6_1]** 
- Dr. William Oh, MD, Director of Precision Medicine, Yale Cancer Center, is the Principal Investigator for the upcoming clinical study.  **[1610820_69b9d0e4dfb54bfea7c63a0e0728aca6_0]** **[1610820_69b9d0e4dfb54bfea7c63a0e0728aca6_1]**

BriaCell Therapeutics (BCTX)