Announcement • 18h
Briacell Therapeutics Corp. Receives Positive Recommendation from Data Safety Monitoring Board for Phase 3 Study of Bria-Imt Plus Immune Checkpoint Inhibitor in Metastatic Breast Cancer BriaCell Therapeutics Corp. announced that the independent Data Safety Monitoring Board (DSMB) has issued its sixth 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. Announcement • May 16
Briacell Therapeutics Corp. Expands Pipeline to Include Ovarian Cancer Immunotherapy Candidate Bria-Ova+ BriaCell Therapeutics Corp. announced progress in developing Bria-OVA+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for ovarian cancer. Bria-OVA+, BriaCell’s next generation personalized immunotherapy candidate for ovarian cancer, is designed with additional immune-stimulating components to support enhanced anti-tumor activity. BriaCell recently reported preclinical data for Bria-BRES+, its next-generation breast cancer immunotherapy candidate derived from the same Bria-OTS+ platform. In a recent AACR poster presentation, Bria-BRES+ demonstrated activation of both adaptive and innate immunity, including naïve/resting T cells, dendritic cells, and natural killer (NK) cells. BriaCell believes this multipronged immune activation supports the potential of the Bria-OTS+ platform to generate anti-tumor immune responses and may help inform the development of Bria-OVA+ for ovarian cancer. BriaCell has licensed ovarian cancer cell-lines from American Type Culture Collection (ATCC) and has commenced development activities to support production of Bria-OVA+ for potential clinical use. According to National Cancer Institute, an estimated 21,010 women in the U.S. will be diagnosed with ovarian cancer, and approximately 12,450 will die from the disease in 2026. Ovarian cancer remains the deadliest gynecologic cancer. It is inherited or acquired abnormal BRCA gene. Treatments include surgery to remove the tumor/s, platinum-based chemotherapy, ELAHERE, a folate receptor alpha (FRa)-directed antibody and microtubule inhibitor conjugate, and LYNPARZA, a poly (ADP-ribose) polymerase inhibitor, also referred to as a PARP inhibitor. However, many patients do not respond to these treatments and are often associated with harsh side effects. Announcement • May 15
BriaCell Therapeutics Corp. Completes Manufacturing Of Clinical Supplies Of Bria-PROS+ For Prostate Cancer BriaCell Therapeutics Corp. announced that it has completed manufacturing clinical supplies of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy candidate for prostate cancer. In August 2025, BriaCell was awarded a $2 million non-dilutive grant from the US National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+. The design of Bria-PROS+ is intended to support enhanced immune system activation while maintaining a favorable safety profile. As reported in BriaCell’s recent AACR preclinical poster presentation, Bria-PROS+ demonstrated activation of both adaptive and innate immunity including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes these preclinical findings support further clinical evaluation as a potential immunotherapy for prostate cancer. Bria-PROS+ is based on the same Bria-OTS+ platform as Bria-BRES+, BriaCell’s next generation breast cancer immunotherapy candidate, which recently received FDA clearance of its Investigational New Drug (IND) application. Bria-PROS+ builds on Bria-Cell’s Bria-OTS clinical program in breast cancer, where the first patient dosed experienced the sustained complete resolution of a lung metastasis. This 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures achieved complete (100%) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy. The complete response of the lesion, initially observed at 2 months, was subsequently confirmed at 4 months, 6 months, and at 11 months. The patient received 17 cycles of Bria-OTS, completed 12 months of the study, and remains in survival follow-up.