BriaCell Presents Outstanding Phase 2 Survival & Promising Phase 3 Clinical Data at SABCS® 2025

Core Insights - BriaCell Therapeutics Corp. presented positive Phase 2 survival and Phase 3 biomarker data at the 2025 San Antonio Breast Cancer Symposium, highlighting the potential of its Bria-IMT regimen in treating metastatic breast cancer [1][6]. Group 1: Clinical Data and Findings - The Bria-IMT regimen shows promise in addressing unmet needs in metastatic breast cancer treatment, particularly for patients with CNS metastasis who have undergone a median of 6 prior treatments [2][6]. - The Phase 3 study involves a randomized trial comparing Bria-IMT plus immune checkpoint inhibitors, Bria-IMT monotherapy, and Treatment of Physician's Choice, with a pooled interim analysis of 116 patients [4][6]. - The regimen demonstrated a favorable safety profile with no treatment-related discontinuations due to adverse events, and the most common adverse events were low grade [7]. Group 2: Biomarkers and Predictive Indicators - Biomarkers such as the Neutrophil-to-Lymphocyte Ratio (NLR) have shown potential as predictors of clinical benefit, with favorable NLR values correlating with longer progression-free survival (PFS) [7][8]. - Positive Delayed Type Hypersensitivity (DTH) was identified as a key predictor of clinical benefit, with median overall survival significantly higher in DTH+ patients compared to DTH- patients [10][11]. - Th1-biased cytokines and chemokines may serve as potential predictive biomarkers for clinical responses to the Bria-IMT regimen, indicating enhanced immune activation [14][16]. Group 3: Future Directions - Further evaluation of cytokine and chemokine biomarkers is planned to establish more personalized therapeutic strategies for metastatic breast cancer patients with limited treatment options [3][8]. - Ongoing analysis of the Phase 3 study aims to mature the understanding of overall survival data and the role of biomarkers in predicting patient response [11][12].