BriaCell Therapeutics Corp. announced that its registration-enabling pivotal Phase 3 study of its lead clinical candidate, Bria-IMT?, in combination with an immune check point inhibitor, is fully approved by the Institutional Review Board (IRB) and will soon enroll patients with advanced metastatic breast cancer. The study will evaluate the efficacy and safety of the Bria-IMT?

combination regimen in patients who have failed at least two approved therapies for the disease. Bria-IMT? is currently under Fast Track Designation by the U.S. FDA intended to accelerate the review process of novel treatments that address unmet medical needs.

Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT? immune checkpoint inhibitor combination in advanced metastatic breast cancer. FDA has agreed that improvement in overall survival in the Bria-IMT?

combination arm as compared to the physician?s choice of treatment arm will be the primary endpoint of the study. The study will enroll 177 patients in the Bria-IMT? combination therapy arm and 177 patients in the treatment of physician?s choice arm.

To gather additional information on the Bria-IMT? regimen alone, 50 patients will be enrolled in this regimen and will be eligible for combination therapy following their initial post treatment evaluation. Expect frequent and responsive FDA communication under Fast Track status during pivotal Phase 3 study.

The successful completion of the pivotal study would allow BriaCell to subsequently submit a Biologics License Application and accelerate the path to commercialization.