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BriaCell (NASDAQ: BCTX) said an independent Data Safety Monitoring Board issued its fourth consecutive positive recommendation after reviewing safety data from the pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor in metastatic breast cancer (NCT06072612). The DSMB identified no safety concerns and recommended the study continue without modifications. The study is conducted under FDA Fast Track designation. DSMB meetings occur quarterly; this is the fourth positive quarterly review. Management highlighted confidence in the regimen's safety and tolerability and reiterated commitment to advancing the trial for patients with urgent unmet needs.
BriaCell (Nasdaq: BCTX) added Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University to its pivotal Phase 3 metastatic breast cancer study (ClinicalTrials.gov NCT06072612).
The trial now has 79 clinical sites across 23 US states enrolling patients and evaluates Bria-IMT plus an immune checkpoint inhibitor versus physician’s choice. Interim analysis is planned once 144 patient events (deaths) occur, and the company anticipates reporting top-line data as early as H1-2026. The Bria-IMT regimen holds FDA Fast Track designation.
BriaCell (Nasdaq: BCTX) announced a collaboration with Memorial Sloan Kettering Cancer Center's Therapeutics Accelerator to support the development of Bria-OTS+, including Bria-BRES+ for metastatic breast cancer, on October 21, 2025. The agreement covers manufacturing, IND preparation and clinical protocol support aimed at enabling a Phase 1 clinical trial.
The partnership gives BriaCell access to MSK’s institutional expertise in cell therapy manufacturing and clinical development to expedite Bria-OTS+ advancement into the clinic.
BriaCell (Nasdaq: BCTX) presented biomarker data from its ongoing pivotal Phase 3 trial of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer at ESMO 2025 (poster #3928).
Pooled, blinded data from 113 patients (median 6 prior lines) show biomarker trends consistent with Phase 2: neutrophil-to-lymphocyte ratio (NLR) remains a potential predictor of clinical benefit (Phase 2 PFS 4.5 vs 2.5 months; HR 0.5, 95% CI 0.3–0.8, p=0.005). No new safety or tolerability signals were identified and there were no treatment-related discontinuations.
Interim OS analysis is planned at 144 events. Bria-IMT combination has FDA Fast Track designation.
BriaCell (Nasdaq: BCTX) will present positive clinical biomarker data from its ongoing pivotal Phase 3 BRIA-ABC study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer at ESMO 2025 on Oct 20, 2025.
In a blinded analysis of 68 evaluable patients (median 6 prior lines), patients who developed a positive delayed-type hypersensitivity (DTH) response showed a significant improvement in progression-free survival (p=0.0002). No new safety or tolerability issues were identified; common AEs: fatigue 22.8%, anemia 22.8%, nausea 21.5%.
Primary OS interim analysis will occur at 144 patient deaths; Bria-IMT has FDA Fast Track designation.
BriaCell (Nasdaq: BCTX) will present preclinical data for Bria-OTS+ at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, November 7-9, 2025, in National Harbor, MD.
Presentation details: Title "Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance"; Abstract No. 353; Location Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center; Date Friday, Nov. 7, 2025. Poster will be posted after the meeting at https://briacell.com/scientific-publications/.
BriaCell Therapeutics (NASDAQ: BCTX) has published research validating the mechanism of action of its Bria-OTS+™ platform, a personalized, off-the-shelf cellular immunotherapy for cancer treatment. The study, conducted in collaboration with the National Cancer Institute (NCI), appeared in the peer-reviewed journal JCI Insight.
The research demonstrates that semi-allogeneic dendritic-cell vaccines can enhance anti-tumor responses through partial HLA matching and planned mismatching. This mechanism enables effective tumor-antigen presentation while driving robust CD4⁺ helper responses, supporting the clinical results observed in BriaCell's Phase 1/2a study in metastatic breast cancer.
The findings validate BriaCell's approach to developing scalable cancer immunotherapies and provide insights into how Bria-OTS+ may address unmet medical needs in cancer treatment.BriaCell Therapeutics (NASDAQ: BCTX) has secured a $2.05 million non-dilutive grant from the National Cancer Institute (NCI) to advance Bria-PROS+™, its next-generation personalized off-the-shelf immunotherapy for prostate cancer. The funding will support the manufacturing and upcoming Phase 1/2a clinical trial for patients with metastatic prostate cancer.
The study will be led by Dr. William Oh from Yale Cancer Center as Principal Investigator. The Bria-OTS+ platform aims to address the challenges of traditional personalized cancer treatments by offering a more streamlined approach to immunotherapy for patients with advanced prostate cancer.
BriaCell Therapeutics (NASDAQ: BCTX), a clinical-stage biotechnology company, has announced a 1-for-10 share consolidation (reverse stock split) to maintain Nasdaq listing compliance. The consolidation is set to take effect on August 25, 2025.
Under the consolidation terms, shareholders will receive one new share for every ten existing shares. Fractional shares will be handled by rounding up fractions of ½ or greater to one whole share, while smaller fractions will be cancelled. The company's convertible securities will be proportionally adjusted.
Post-consolidation, BriaCell will continue trading under the symbols BCT on TSX and BCTX on Nasdaq. Registered shareholders will receive transmittal letters from Computershare Investor Services with exchange instructions.
BriaCell Therapeutics (NASDAQ: BCTX) has been selected to join Memorial Sloan Kettering Cancer Center's (MSK) Therapeutics Accelerator 2025 Cohort program to advance the development of its Bria-OTS+™ immunotherapy platform. The collaboration aims to accelerate the clinical development of BriaCell's next-generation personalized off-the-shelf immunotherapy for multiple cancer indications, including metastatic breast cancer and prostate cancer.
Through this program, BriaCell will gain access to MSK's extensive expertise and institutional resources, including GMP manufacturing services, IND Application support, and regulatory strategy assistance. MSK, with over 135 years of leadership in cancer care, will provide crucial support to expedite Bria-OTS+ development.
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