FDA grants fast track status to BriaCell for breast cancer immunotherapy

May 2022 Pharma News Nalinee Pandey

The Food and Drug Administration (FDA) has granted fast track status to Bria-IMTTM for metastatic breast cancer patients.

The BriaCell Therapeutics Corporation is a biotechnology company that specialises in developing immunotherapies for cancers. Their lead candidate is Bria-IMTTM, cell-based immunotherapy that is designed to selectively target cancer cells without causing any harm to normal cells. The mechanism by which Bria-IMT™ destroys tumour cells in patients with advanced breast cancer can be seen at https://briacell.com/moa/.

The data from survival studies with Bria-IMTTM were presented late last year (Dec 2021) at the San Antonio Breast Cancer Symposium.  Here, 26 advanced breast cancer patients received Bria-IMTTM as monotherapy and 12 as a combination, with four patients transitioning from monotherapy to the combination study. All these participants were heavily pre-treated with a median of five or more treatment regimens. The overall survival was over 12 months (average of nine prior regimens) compared to 7-10 months of survival in 3rd line breast cancer patients (2 prior regimens). Patients who match Bria-IMT™ at one or more HLA types and those with grade I (well-differentiated) or grade II also benefited from Bria-IMT™.

The Fast track status approved by FDA will apply to metastatic breast cancer patients. Further, the company is evaluating Bria-IMT™ in combination with other immune checkpoint inhibitors in clinical studies. The details of these studies are listed on ClinicalTrials.gov as NCT03328026. Also, the company is enrolling advanced breast cancer patients for a phase 1/11a study combining  Bria-IMT™ with retifanlimab (Incyte’s checkpoint inhibitor) and its immunomodulator, epacadostat, under corporate collaboration with Incyte.