FDA approves BriaCell's registrational study design for Bria-IMT combo in advanced breast cancer

BriaCell Therapeutics Corp.

FDA approved primary and secondary endpoints, study design, and patient population for Bria-IMT plus checkpoint inhibitor in advanced metastatic breast cancer.
Trial is randomized, open-label with three arms: Bria-IMT combo, physician's choice, and Bria-IMT alone.
Patients must have exhausted all other treatment options; recruitment and dosing begin summer 2023.
Upon statistically significant milestones, BriaCell may apply for full approval via BLA filing.
CEO notes FDA's route to accelerate development for difficult-to-treat patient population.

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