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BriaCell (Nasdaq: BCTX) presented Phase 2 survival and Phase 3 biomarker data across three posters at SABCS® 2025 (Dec 9-12, 2025). A pooled interim analysis (116 patients) from the Bria-ABC Phase 3 trial showed a favorable safety profile with no treatment-related discontinuations, early PFS signals by subtype (median PFS: HR+/HER2- 3.7 months; HER2-Low 3.9 months) and a potential predictive Neutrophil-to-Lymphocyte Ratio (NLR) signal (favorable NLR 0.7–2.3: PFS 4.4 vs 2.6 months). Phase 2 data (n=54) reported DTH+ patients with higher median OS (11.3 vs 4.7 months, P=0.0001) and Th1-biased cytokine signatures correlated with clinical benefit in biomarker analyses (n=30). Further analysis planned as enrollment and OS mature.
BriaCell (Nasdaq: BCTX) reported that its pivotal Phase 3 study in metastatic breast cancer has screened >230 patients and enrolled >160, with enrollment exceeding expectations and strong site/patient interest.
The company expects a topline interim data readout as early as 1H2026; the interim analysis will occur once 144 patient events (deaths) are observed and will assess overall survival (OS) versus physician’s choice. The Phase 3 regimen retains FDA Fast Track designation and positive results could support full approval and marketing authorization for Bria-IMT.
BriaCell (Nasdaq: BCTX) will present three posters at the San Antonio Breast Cancer Symposium (SABCS) on December 10, 2025, reporting positive Phase 2 survival and Phase 3 biomarker data.
A pooled interim analysis of 116 patients with MHC subtyping in the ongoing pivotal Phase 3 showed an excellent safety profile, improved PFS in HR+/HER2- and HER2-low subtypes, and NLR as a potential biomarker. Phase 1/2 data in 54 metastatic breast cancer patients reported continued overall survival benefit and DTH as a possible predictive biomarker. Cytokine analysis of 30 patients suggests Th1-biased signatures may predict response. An interim Phase 3 analysis is expected in 1H2026.
BriaCell (Nasdaq: BCTX) will present three posters at the San Antonio Breast Cancer Symposium on December 10, 2025 highlighting positive Phase 2 safety and efficacy signals, positive biomarker findings, and survival data.
The company said its pivotal Phase 3 Bria-IMT+CPI trial is ongoing with an interim analysis expected in H1 2026. The Bria-IMT regimen has received Fast Track designation from the US FDA. Abstract and poster copies will be available on the company's scientific publications webpage.
BriaCell (Nasdaq: BCTX) announced that its subsidiary BriaPro initiated a research collaboration with Receptor.AI on Nov. 20, 2025 to design isoform-selective small-molecule kinase inhibitors for multiple cancer indications.
The partnership will combine Receptor.AI's AI-driven small-molecule discovery platform for target assessment, hit identification, and lead optimization with BriaPro's proprietary technology to expand BriaPro's small-molecule pipeline and aim to accelerate development of kinase inhibitors with improved selectivity, ADMET constraints, and potential to enhance immune-mediated tumor targeting.
BriaCell (Nasdaq: BCTX) will present clinical and preclinical data at the 2025 San Antonio Breast Cancer Symposium (SABCS), Dec 9–12, 2025. The company announced three clinical posters and one preclinical poster, including two late-breaking clinical posters reporting updated biomarker and survival data from its Phase 3 Bria-ABC trial and Phase 2 Bria-IMT study in metastatic breast cancer.
All posters are scheduled for Wednesday, Dec 10, 2025; poster copies will be available at https://briacell.com/scientific-publications/ after presentation.
BriaCell (Nasdaq: BCTX) is presenting preclinical evidence for its next‑generation Bria-OTS+ cancer immunotherapy platform at SITC 2025 (Nov 7–9, National Harbor, MD).
Poster Title: Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance. Presentation times: Nov 7, 12:15–1:45 PM and 5:35–7:00 PM ET (Prince George ABC).
Key preclinical findings show rapid, potent and durable anti‑tumor activity driven by coordinated activation of innate and adaptive immunity; lead candidates Bria-BRES+ (breast) and Bria-PROS+ (prostate) demonstrated increased tumor cell cytotoxicity and broad platform applicability across multiple solid tumor models.
BriaCell (Nasdaq: BCTX) announced a poster at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting on Nov 7, 2025 showing preclinical anti-cancer activity of its next-generation Bria-OTS+ platform. The poster (Abstract 353) will present immune activation and cytotoxicity data for lead candidates Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer).
The company reported completion of GMP manufacturing for planned clinical trials and a $2 million NCI SBIR award to support manufacturing and planned clinical evaluation of Bria-PROS+.
Poster sessions: Prince George ABC, Gaylord National Resort — 12:15–1:45 PM and 5:35–7:00 PM ET on Nov 7, 2025.
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.
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