Briacell Therapeutics adds UCLA to breast cancer study

Executive Summary

• Briacell Therapeutics has added UCLA Health Jonsson Comprehensive Cancer Center as a key site in its pivotal Phase 3 clinical study (Bria-ABC) for Bria-IMT in combination with a checkpoint inhibitor for advanced metastatic breast cancer.
• The Phase 3 study builds on positive Phase 2 data and aims to share top-line data in 2026, with an interim analysis planned after 144 patient events (deaths) occur.
• Bria-IMT holds FDA Fast Track designation, highlighting its potential to address serious unmet medical needs in metastatic breast cancer.

Key Details

• Study Addition: UCLA Health Jonsson Comprehensive Cancer Center added as a key site for the pivotal Phase 3 study (NCT06072612).
• Study Design: Randomized Phase 3 evaluating Bria-IMT in combination with a checkpoint inhibitor versus physician's choice in patients with advanced metastatic breast cancer (MBC).
• Primary Endpoint: Overall survival (OS).
• Interim Analysis Trigger: Conducted after 144 patient events (deaths) have occurred.
• Timeline: Company anticipates sharing top-line data in 2026.
• Prior Data: Builds on maturing positive survival data from the Phase 2 study, recently presented at ASCO 2025.
• Regulatory Status: Bria-IMT combination regimen has been granted "FDA Fast Track" designation.
• Investigator Quote: Kelly E. McCann, MD, PhD, noted encouraging Phase 2 data and expects strong patient enrollment through the large multicenter clinical site.
• Strategic Quote: Dr. Giuseppe Del Priore, Chief Medical Officer, stated that including UCLA Health underscores the strategy to partner with top-tier institutions to accelerate trial enrollment and execution.

Notable Quotes

• "The randomized phase 2 data reported with the Bria-IMT combination regimen are encouraging, and we believe Briacell's phase 3 study represents an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer." — Kelly E. McCann, MD, PhD
• "The inclusion of UCLA Health underscores our strategy to partner with top-tier institutions to accelerate trial enrolment and execution. We remain confident in our timeline for sharing top-line data in 2026." — Dr. Giuseppe Del Priore