BriaCell Announces Positive End of Phase 2 Meeting With the FDA for Bria-IMT Combination in Advanced Metastatic Breast Cancer
BriaCell Therapeutics Corp. is pleased to announce that it has received agreement and positive feedback from its End of Phase 2 meeting with the FDA regarding BriaCell’s lead clinical candidate, Bria-IMT in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic breast cancer.
BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell’s upcoming pivotal clinical study. This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist.
Registration study success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer.
“The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies,” said Dr. William V. Williams, BriaCell’s President and CEO. “Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options.”
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/.
Total Page Views: 1080