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BriaCell links circulating biomarker to survival in breast cancer

Dynamic changes in CAML PD-L1 at 3 months associated with improved PFS (HR=2.73) and OS (HR=2.27). Baseline CAML PD-L1 and tumor CPS scores were not significantly associated with survival outcomes. Analysis included 111 heavily pretreated metastatic breast cancer patients across multiple studies. Findings support further evaluation of CAML PD-L1 as a predictive biomarker for immunotherapy response.

BriaCell DSMB Recommends Continuing Phase 3 Metastatic Breast Cancer Study

Independent DSMB recommends continuing pivotal Phase 3 Bria-ABC study without modifications. Board raised no safety or clinical concerns after reviewing clinical data. This is the seventh consecutive positive DSMB recommendation for the trial. Study holds FDA Fast Track designation due to unmet need in metastatic breast cancer.

BriaCell's Bria-MEL+ clears genetic engineering milestone in melanoma program

BriaCell Therapeutics announced Bria-MEL+, its personalized melanoma immunotherapy vaccine candidate, has cleared a key genetic engineering milestone on August 24, 2026. Bria-MEL+ is an off-the-shelf, whole-cell cancer vaccine using patient HLA matching via a saliva test to select from premanufactured cell lines, avoiding individualized manufacturing. The program is derived from BriaCell's Bria-OTS+ platform, which demonstrated activation of innate and adaptive immunity at the 2026 AACR Annual Meeting. BriaCell's pipeline also includes Bria-IMT in a pivotal Phase 3 trial for metastatic breast cancer and Bria-PROS+ which received FDA clearance to initiate clinical evaluation in prostate cancer. The American Cancer Society estimates approximately 112,000 new melanoma cases and 8,510 deaths in the US in 2026, underscoring the unmet medical need.

BriaCell opens first Canadian site for pivotal Phase 3 trial

BriaCell Therapeutics Corp. has expanded its pivotal Phase 3 clinical trial for metastatic breast cancer by opening its first Canadian site at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto, Ontario. The study evaluates Bria-IMT in combination with an immune checkpoint inhibitor and is identified by ClinicalTrials.gov as NCT06072612. The trial has over 80 active clinical sites in the United States across 15 states, including major institutions like Penn Medicine's Abramson Cancer Center and Mayo Clinic.

BriaCell engages CRA and Kaleio for Bria-IMT commercial strategy

BriaCell Therapeutics has engaged Charles River Associates and Kaleio to support commercial strategy and market access evaluation for Bria-IMT. The therapy is currently in a pivotal Phase 3 study for metastatic breast cancer. These engagements are preparatory steps for potential future commercialization, contingent on clinical success and regulatory approvals.

BriaCell partners with Uneedle for scalable Bria-IMT administration

BriaCell Therapeutics Corp. has entered into a Memorandum of Understanding with Uneedle to support the commercial readiness of microneedle technology for Bria-IMT. The collaboration focuses on scaling devices for commercial quantities, contingent on regulatory approval, while currently utilizing the technology in a pivotal Phase 3 study for metastatic breast cancer.