BriaCell Therapeutics Corp.

BriaCell Therapeutics Corp. is a clinical-stage biotechnology company that develops new immunotherapies to treat cancer. The company focuses on harnessing the body's immune system to identify and destroy cancer cells. BriaCell is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune checkpoint inhibitor (Retifanlimab) in a pivotal Phase 3 study for metastatic breast cancer (NCT06072612). Bria-IMT™ has received Fast Track Designation from the U.S. Food and Drug Administration (FDA), which aims to speed up the review of new treatments for unmet medical needs. In its Phase 2 study of Bria-IMT™ combined with retifanlimab, BriaCell reported a median overall survival of 13.4 months in its metastatic breast cancer patients, compared to 6.7-9.8 months reported in the literature for similar patients. Additionally, patients in the Phase 2 Bria-IMT™ study treated with the Phase 3 formulation in combination with an immune checkpoint inhibitor since 2022 (post-COVID) showed a median overall survival of 16.5 months. A completed Phase 1/2 combination study of Bria-IMT™ with retifanlimab (an anti-PD1 antibody from Incyte) confirmed its tolerability and early efficacy (NCT03328026). BriaCell also has an ongoing Phase 1/2 study for Bria-OTS™, its personalized off-the-shelf immunotherapy, also known as Bria-BRES™, for metastatic breast cancer (NCT06471673). In this study, the first patient treated with 4 inoculations of cells (single agent) showed complete resolution of a lung metastasis. BriaCell is developing Bria-OTS™ and its advanced form, Bria-OTS+™, as a platform technology for personalized off-the-shelf immunotherapies for various cancer types. In September 2024, the company announced positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with the FDA for Bria-PROS+™ for prostate cancer.