BriaCell to Present Phase 2 Survival & Phase 3 Clinical Data at SABCS(TM) 2025

Executive Summary

• BriaCell will present three poster abstracts at the 2025 San Antonio Breast Cancer Symposium (SABCS) highlighting positive Phase 2 survival data and promising biomarker signals from its pivotal Phase 3 trial.
• Interim analysis of 116 patients in the Phase 3 Bria‑IMT + CPI study shows an excellent safety profile, improved progression‑free survival in HR+/HER‑2‑negative and HER2‑low subtypes, and suggests neutrophil‑to‑lymphocyte ratio (NLR) as a predictive biomarker.
• Phase 2 data from 54 metastatic breast‑cancer patients demonstrate continued overall‑survival benefit and identify delayed‑type hypersensitivity (DTH) as a potential efficacy biomarker; cytokine profiling in 30 patients further supports Th1‑biased signatures as predictors of response.

Key Details

• Poster 1 – Abstract 3688
• Title: “Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria‑ABC Phase 3 Trial.”

• Interim analysis of 116 patients with MHC subtyping shows:

  • Excellent safety profile.
  • Improved progression‑free survival (PFS) in HR+/HER‑2‑negative and HER2‑low subtypes.
  • Neutrophil‑to‑lymphocyte ratio (NLR) identified as a potential biomarker of clinical benefit.

• Poster 2 – Abstract 3713

• Title: “Survival Results of Phase II Bria‑IMT Allogenic Whole Cell‑Based Cancer Vaccine.”

• Data from 54 metastatic breast‑cancer patients (Phase 1/2) receiving Bria‑IMT + anti‑PD‑1 CPI show:

  • Continued overall‑survival benefit.
  • Delayed‑type hypersensitivity (DTH) response proposed as a predictive biomarker.

• Poster 3 – Abstract 1614

• Title: “Th1‑biased cytokine signatures as biomarkers of clinical benefit following SV‑BR‑1‑GM cancer vaccination in breast cancer.”

• Analysis of 35 blood cytokines/chemokines from 30 patients (Phase 1/2) receiving Bria‑IMT alone or with CPI indicates:

  • Th1‑biased cytokine and chemokine profiles may serve as predictive biomarkers of clinical response.

• Presentation Schedule

• All three posters will be presented on Wednesday, December 10, 2025:

  • Posters 1 & 2: 12:30 PM – 2:00 PM (Session PS1‑13).
  • Poster 3: 5:00 PM – 6:30 PM (Session PS2‑09).

• Future Outlook

• The pivotal Phase 3 Bria‑IMT + CPI trial continues, with a formal interim analysis planned for the first half of 2026.

Notable Quotes

“Our survival and biomarker data at SABCS is very encouraging because it underscores the potential of our novel immunotherapy and precision medicine to treat cancer patients,” – William V. Williams, MD, President & CEO, BriaCell.

“We are extremely pleased with biomarker and patient subgroup data suggesting their use for identifying patients who are most likely to benefit from our treatment,” – Dr. Giuseppe Del Priore, Chief Medical Officer, BriaCell.