BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy
BriaCell Therapeutics Corp. recently announced the US FDA has granted Fast Track status to BriaCell’s lead candidate, Bria-IMT, for the treatment of metastatic breast cancer (breast cancer that has spread beyond the breast).
The Fast Track designation will apply to patients with metastatic breast cancer. BriaCell is developing Bria-IMT in combination with immune checkpoint inhibitors in a clinical trial listed in ClinicalTrials.gov as NCT03328026. BriaCell is currently enrolling and dosing advanced breast cancer patients in its Phase 1/2a combination study of Bria-IMT with Incyte’s checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat under corporate collaboration with Incyte.
Initial data on patient survival in this study was first presented at the San Antonio Breast Cancer Symposium in December 2021 and was over 12 months (average of 9 prior regimens) compared with 7-10 months in a study in third-line breast cancer patients (those who failed 2 prior regimens for metastatic breast cancer). Other patient subsets with possible survival benefit included those who match Bria-IMT at 1 or more HLA type and those with grade I (well differentiated) or grade II (moderately differentiated) breast cancer.
“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 toward a potential registration study to bring hope to patients living with this deadly disease,” said Dr. Del Priore, BriaCell’s Chief Medical Officer.
Bria-IMT is a cell-based immunotherapy designed to selectively destroy tumor cells without harming the normal cells. To view the schematic video showing the mechanism by which Bria-IMT destroys tumor cells in patients with advanced breast cancer, visit: https://briacell.com/moa/.
The clinical trial evaluates safety and efficacy of Bria-IMT, in combination with Incyte’s checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat, in patients with advanced breast cancer. The combination study is listed in ClinicalTrials.gov as NCT03328026.
BriaCell is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer. For more information, visit https://briacell.com/.
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