BriaCell Announces Positive Recommendation from Data Safety Monitoring Board for Pivotal Phase 3 Study in Metastatic Breast Cancer

On June 24, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer ( NCT06072612) (Press release, BriaCell Therapeutics, JUN 24, 2025, View Source [SID1234654343]).

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Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly as per the study protocol, and this marks the third consecutive positive recommendation from the DSMB affirming the favorable safety profile observed to date. Bria Cell’s 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 this patient population.

"The third consecutive DSMB review is a meaningful milestone in our Phase 3 trial, which continues to highlight the excellent safety and tolerability profile of BriaCell’s regimen," commented Dr. William V. Williams, BriaCell’s President & CEO. "This latest positive review further strengthens our confidence in Bria-IMT’s potential as a transformative immunotherapy for patients with metastatic breast cancer."