Dr. William Williams reports

FDA APPROVES BRIACELL'S PIVOTAL REGISTRATIONAL STUDY DESIGN IN ADVANCED METASTATIC BREAST CANCER

Briacell Therapeutics Corp. has received approval from the FDA (United States Food and Drug Administration) on its pivotal registrational study design for Bria-IMT in combination with a checkpoint inhibitor in advanced metastatic breast cancer.

The FDA has approved the study design, the primary and secondary end points, 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 checkpoint 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 the 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 chief executive officer.

"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.

About Briacell Therapeutics Corp.

Briacell is a clinical-stage immunotherapy company developing novel treatments that boost the ability of the body's own cancer fighting cells to destroy cancer.

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