BriaCell Presents Outstanding Phase 2 Survival & Promising Phase 3 Clinical Data at SABCS(TM) 2025

Executive Summary

• BriaCell presented positive Phase 2 survival and Phase 3 biomarker data across three posters at the 2025 San Antonio Breast Cancer Symposium.
• Interim analysis of 116 Phase 3 patients showed favorable safety (no treatment‑related discontinuations) and early progression‑free‑survival signals, especially in HR+/HER2‑ and HER2‑Low subgroups.
• Phase 2 data demonstrated that positive delayed‑type hypersensitivity (DTH) and Th1‑biased cytokine signatures correlate with longer overall survival, including notable benefit in patients with CNS metastases.

Key Details

• Poster 1 – Late‑Breaking Abstract 3688 (PS1‑13‑22):
• Pooled interim analysis of 116 Phase 3 patients with MHC subtyping; median 6 prior therapies.
• Safety: No treatment‑related discontinuations; most common AEs were fatigue, anemia, nausea (low grade).
• Median PFS: HR+/HER2‑ disease – 3.7 months; HER2‑Low disease – 3.9 months.

• Neutrophil‑to‑Lymphocyte Ratio (NLR) as predictive biomarker: NLR 0.7–2.3 → median PFS 4.4 months vs 2.6 months for NLR outside range.

• Poster 2 – Late‑Breaking Abstract 3713 (PS1‑13‑23):

• Phase 1/2 study of Bria‑IMT + anti‑PD‑1 CPI in 54 metastatic breast cancer patients (6 with CNS metastasis).
• DTH+ patients: median OS 11.3 months vs DTH‑ patients 4.7 months (p = 0.0001).

• Clinical Benefit Rate (CBR) in CNS cohort: 100% in HER2+, 100% in HR+, 50% in TNBC, overall 75%.

• Poster 3 – Abstract 1614 (PS2‑09‑03):

• Cytokine/chemokine profiling of 30 patients from Phase 1/2 studies.
• Post‑treatment increases in Th1 cytokines (IL‑2, IL‑15, IL‑27, TNF‑α, CXCL10, CCL2, CCL13, CCL26, IL‑17A) associated with SD or PR.
• No rise in Th2/regulatory cytokines, indicating preserved immune activation.

• Elevated IL‑1β, IL‑6, IL‑8, TNF‑α, MCP‑4 linked to improved overall survival.

• Overall Conclusions:

• Biomarker analyses (NLR, DTH status, Th1 cytokine signatures) consistently correlate with better PFS and OS, supporting their use for patient selection in the Bria‑IMT regimen.
• Safety profile remains favorable with no discontinuations due to adverse events.

Notable Quotes

• “We are very excited to see the robust and positive biomarker data, which may enable us to more confidently predict clinical responses… early in their treatment course.” – Kelly E. McCann, MD, PhD, Lead Investigator, UCLA.
• “BriaCell’s data shows the promise of the Bria‑IMT regimen to address major unmet needs… median 6 prior treatments.” – Chaitali S. Nangia, MD, First Author.
• “Our findings support further evaluation of cytokine and chemokine biomarkers as potential predictors of survival and clinical benefit…” – Miguel A. Lopez‑Lago, PhD, Chief Scientific Officer.