BCTX Big News Today
FDA Approves BriaCell’s Pivotal Registrational Study Design in Advanced Metastatic Breast Cancer
PHILADELPHIA and VANCOUVER, British Columbia, June 27, 2023 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage immunotherapy company driven to fight cancer and improve patients’ lives, announces that it has received approval from FDA on its pivotal registrational study design for Bria-IMT™ in combination with a checkpoint inhibitor in advanced metastatic breast cancer.
FDA has approved the study design, the primary and secondary endpoints, and patient population in BriaCell’s upcoming pivotal registration clinical study. The study will include advanced metastatic breast cancer patients who have exhausted all other treatment options.
The trial will be a randomized, open-label study comparing the Bria-IMT™ combination regimen with an immune check point inhibitor in one arm with treatment of physicians’ choice in another arm in advanced metastatic breast cancer. A third smaller arm with the Bria-IMT™ regimen alone will be included in the study to address FDA’s combination drug assessment requirements. Upon achieving statistically significant milestones, BriaCell may apply for full approval of the Bria-IMT™ combination regimen following the Biologics Licensing Application (BLA) filing process.
“FDA approval of our study design represents a major milestone towards our goal of making a huge impact in the lives of advanced metastatic breast cancer patients who have failed currently approved therapies,” stated Dr. William V. Williams, BriaCell’s President and CEO.
“We are extremely grateful that the FDA Office of Oncologic Diseases has approved our strategy and has provided us with a route to accelerate the development of our novel immunotherapy in this difficult-to-treat patient population. A successful study may significantly transform the approach to treat advanced breast cancer,” added Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “We are working closely with FDA to further accelerate the development of our lead candidate and eventual market authorization.”
Patient recruitment and dosing will commence in summer 2023.
