BriaCell Therapeutics’ Bria-IMT gets FDA fast track status in breast cancer


BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its lead candidate — Bria-IMT for the treatment of metastatic breast cancer.

The US-based clinical-stage biotech company specializes in targeted immunotherapies for cancer.

Bria-IMT is a cell-based immunotherapy, which has been designed to preferentially kill tumor cells without damaging the normal cells.

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Presently, BriaCell Therapeutics is enrolling and dosing patients with advanced breast cancer in its phase I/IIa combination study of Bria-IMT with a checkpoint inhibitor called retifanlimab and an immunomodulator called epacadostat, both owned by Incyte Corporation.

According to BriaCell Therapeutics, initial findings on patient survival in the phase I/IIa study was presented originally at the San Antonio Breast Cancer Symposium in December 2021 and was over 12 months compared with 7-10 months in a study in 3rd line breast cancer patients.

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Commenting on the fast track status of Bria-IMT, Dr. Del Priore — BriaCell Therapeutics Chief Medical Officer said: “We are grateful for the opportunity to accelerate the development of our novel immunotherapy in advanced breast cancer. We continue to move forward with the clinical evaluation of Bria-IMT towards a potential registration study to bring hope to patients living with this deadly disease.”

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