BriaCell to Highlight Positive Phase 2 & Phase 3 Clinical Data at SABCS(TM) 2025
Executive Summary
- BriaCell will present three poster abstracts at the 2025 San Antonio Breast Cancer Symposium highlighting positive Phase 2 safety/efficacy signals and biomarker findings from both its Phase 2 and pivotal Phase 3 studies.
- The pivotal Phase 3 trial of the Bria‑IMT + CPI regimen continues, with an interim analysis slated for the first half of 2026.
- The Bria‑IMT regimen has received Fast Track Designation from the U.S. FDA, accelerating its development pathway.
Key Details
- Poster Sessions (December 10, 2025):
- Abstract 3688 – PS1‑13‑22: “Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria‑ABC Phase 3 Trial.”
- Abstract 3713 – PS1‑13‑23: “Survival Results of Phase II Bria‑IMT Allogenic Whole Cell‑Based Cancer Vaccine.”
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Abstract 1614 – PS2‑09‑03: “Th1‑biased cytokine signatures as biomarkers of clinical benefit following SV‑BR‑1‑GM cancer vaccination in breast cancer.”
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Clinical Highlights:
- Positive safety and efficacy signals reported from Phase 2 study.
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Favorable biomarker data supporting mechanism‑of‑action insights across both Phase 2 and Phase 3 programs.
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Regulatory Milestone:
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Bria‑IMT regimen granted Fast Track Designation by the U.S. FDA, facilitating more frequent interactions with regulators and potential expedited review.
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Future Timeline:
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Interim analysis of the pivotal Phase 3 trial expected in H1‑2026.
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Company Statements:
- CEO William V. Williams emphasized confidence in the pivotal Phase 3 study based on the new data.
- CSO Miguel A. Lopez‑Lago highlighted the importance of biomarker findings for targeted therapy development.
Notable Quotes
“Positive clinical data from our Phase 2 study, together with differentiated biomarker findings from our Phase 3 program reinforce our confidence in our pivotal Phase 3 study in metastatic breast cancer,” – William V. Williams, MD, President & CEO, BriaCell.
“Our biomarker data provides important insights into the mechanism of action of our novel immunotherapy with the goal of delivering more precisely targeted treatment options for oncologists, physicians, and patients,” – Miguel A. Lopez‑Lago, PhD, Chief Scientific Officer, BriaCell.