BriaCell advances preparatory work for new Bria-OTS™ breast cancer clinical trial

• Bria-OTS™ would build on BriaCell’s existing clinical trial data with Bria-IMT™, treating each patient with the optimized pre-manufactured Bria-OTS™ formulation based on HLA-type.
• BriaCell and National Cancer Institute collaborating on Bria-OTS™, BriaCell’s off-the-shelf personalized immunotherapy, as a treatment for cancer.
• BriaCell to present Bria-OTS™ approach at the American Association for Cancer Research (AACR) Annual Meeting 2022.

Excerpt from the Press Release:

PHILADELPHIA and VANCOUVER, British Columbia, April 07, 2022 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, announces that its novel off-the-shelf (OTS) personalized immunotherapy, Bria-OTS™, is currently being manufactured at a cGMP facility and undergoing quality control testing for the potential upcoming clinical trial for patients with advanced breast cancer.

BriaCell is currently conducting extensive testing on the immunotherapy products in compliance with the most recent guidelines of the Center for Biologics Evaluation and Research (CBER) division of the FDA— to ensure patient safety. BriaCell expects Bria-OTS™ to enter an open-label Phase I/IIa clinical trial designed to evaluate its safety and efficacy in patients with advanced breast cancer. The clinical trial will be managed by Cancer Insight, LLC.

BriaCell is collaborating with the National Cancer Institute (NCI, Center for Cancer Research), part of the National Institutes of Health, under a previously-announced Cooperative Research and Development Agreement to conduct pre-clinical studies to develop novel off-the-shelf personalized therapeutics for cancer. BriaCell and NCI are using their combined expertise in tumor immunology, molecular biology and cellular therapies to design preclinical studies which are intended to trigger the immunologic pathways necessary to create potent immune responses against cancer in mouse models. The goal is to develop novel therapeutics for future clinical collaborations, allowing cancer patients to potentially benefit from potent and personalized cancer immunotherapy in the future.

Clinical Trials: Advanced Breast Cancer

BriaCell has two advanced breast cancer immunotherapy programs in different stages of clinical development:

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