Briacell adds three sites to Bria-IMT phase 3 study

Executive Summary

• Briacell Therapeutics has added several key clinical sites to its pivotal Phase 3 study for Bria-IMT in metastatic breast cancer, including major centers like Dartmouth Cancer Center, Cedars-Sinai, and Emory University.
• The company anticipates reporting top-line data from the study as early as the first half of 2026.
• The Phase 3 study is evaluating Bria-IMT plus an immune checkpoint inhibitor versus physician's choice of treatment, with a primary endpoint of overall survival (OS) triggered by 144 patient events.

Key Details

• New Clinical Sites Added: Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University.
• Existing Clinical Sites: Mayo Clinic, Los Angeles Cancer Network, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Blood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center.
• Study Design: Pivotal Phase 3 clinical study (NCT06072612) evaluating Bria-IMT plus an immune checkpoint inhibitor (CPI) versus physician's choice of treatment in advanced metastatic breast cancer (MBC).
• Primary Endpoint: Overall survival (OS), with interim data analysis occurring once 144 patient events (deaths) occur.
• Regulatory Status: Bria-IMT combination regimen has received U.S. FDA fast-track designation.
• Data Timeline: Top-line data expected as early as the first half of 2026.
• Potential Outcome: Positive results could result in full approval and marketing authorization for Bria-IMT in MBC patients.

Notable Quotes

• "We are encouraged by the strong engagement from major academic and leading community cancer centres, which underscores confidence in Briacell's novel technology," stated Dr. William V. Williams, Briacell's president and chief executive officer. "We expect the addition of these clinical sites will further accelerate patient enrolment in Briacell's pivotal phase 3 study of Bria-IMT regimen in MBC and support our mission to bring this therapy to patients with significant unmet medical needs."