BriaCell Therapeutics Corp. is advancing its Bria-IMT™ targeted immunotherapy in combination with an immune checkpoint inhibitor (Retifanlimab) in a pivotal Phase 3 study for metastatic breast cancer, following promising Phase 2 results. The company's Form 10-K report for the fiscal year ended July 31, 2024, highlights these strategic initiatives and clinical advancements.
Clinical Trial Results and FDA Designation
In its Phase 2 study, BriaCell reported encouraging patient survival and clinical benefit in metastatic breast cancer. Patients treated with Bria-IMT™ showed a median overall survival of 13.4 months, compared to 6.7-9.8 months for similar patients reported in existing literature. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Bria-IMT™, which is intended to expedite the review of novel treatments that address unmet medical needs.
Phase 3 Study and Enrollment
The pivotal Phase 3 study of Bria-IMT™ in combination with an immune checkpoint inhibitor is expected to enroll 177 patients in the Bria-IMT™ combination therapy arm and 177 patients in the treatment of physician’s choice arm. This trial aims to confirm the Phase 2 findings and support a potential Biologics License Application (BLA) submission, which could accelerate commercialization.
Personalized Immunotherapies and Prostate Cancer Development
BriaCell is also developing personalized off-the-shelf immunotherapies, Bria-OTS™ and Bria-OTS+™, which provide a platform technology to develop personalized treatments for various types of cancer. The company announced positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with the FDA for Bria-PROS+™ for prostate cancer, marking an expansion of their therapeutic pipeline.
Financial Overview
For the years ended July 31, 2024, and 2023, BriaCell incurred $26.44 million and $14.26 million, respectively, in net research and development expenses. The company's strategic initiatives are aimed at transforming cancer care by harnessing the body's immune system to recognize and destroy cancer cells. As of July 31, 2024, BriaCell has a negative working capital of ($3.81 million) and an accumulated deficit of $85.44 million. The company intends to raise additional capital through debt or equity financings to achieve its business plan objectives.
