BriaCell Phase 3 Breast Cancer Trial Clears Fifth Straight Safety Review, Study Continues

BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXW, BCTXZ, BCTXL))) (TSX:BCT) ("BriaCell" or the "Company"), clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces that the independent Data Safety Monitoring Board (DSMB) has issued its fifth consecutive positive recommendation following review of safety data from BriaCell's pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).

Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell's ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.

"This marks the fifth consecutive DSMB review supporting the continued conduct of BriaCell's pivotal Phase 3 Bria-ABC study," said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. "We are encouraged by the DSMB's ongoing confirmation of the safety profile of the Bria-IMT regimen and remain focused on advancing this program for patients with limited treatment options. We look forward to providing additional clinical updates as the study progresses."