BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer

Executive Summary

• Independent Data Safety Monitoring Board (DSMB) issued its fifth consecutive positive recommendation, indicating no safety concerns for BriaCell’s pivotal Phase 3 Bria‑ABC study of Bria‑IMT™ plus a checkpoint inhibitor in metastatic breast cancer.
• The DSMB advised the trial continue without modifications; meetings are held quarterly per protocol.
• The study is conducted under FDA Fast Track designation, underscoring its potential impact on an unmet medical need.

Key Details

• DSMB Recommendation: Fifth consecutive positive safety review; no concerns raised; continuation of study recommended unchanged.
• Study Designation: Phase 3 Bria‑ABC trial (NCT06072612) holds FDA Fast Track status.
• Therapeutic Regimen: Bria‑IMT™ combined with an immune checkpoint inhibitor (CPI).
• Patient Population: Individuals with metastatic breast cancer.
• Quarterly Monitoring: DSMB meetings occur quarterly in accordance with the study protocol.
• CEO Quote: “We are encouraged by the DSMB’s ongoing confirmation of the safety profile of the Bria‑IMT regimen and remain focused on advancing this program for patients with limited treatment options.” – Dr. William V. Williams, President & CEO.

Notable Quotes

“This marks the fifth consecutive DSMB review supporting the continued conduct of BriaCell’s pivotal Phase 3 Bria‑ABC study,” said Dr. William V. Williams, President and Chief Executive Officer of BriaCell.

Materiality Assessment: Material – Positive (the repeated favorable safety endorsement is a material development for a clinical‑stage biotech company).