BriaCell Receives FDA Clearance to Initiate Bria-PROS+™ Clinical Study in Prostate Cancer
BriaCell announced that the FDA completed its review of the Investigational New Drug application for Bria-PROS+, issuing a Study May Proceed letter and clearing the way for a Phase 1/2a clinical study in prostate cancer. Bria-PROS+ is the company's next-generation personalized, off-the-shelf, cell-based immunotherapy, which had previously received a $2 million grant from the US National Cancer Institute.
Why it matters — FDA clearance of the IND allows BriaCell to move Bria-PROS+ into clinical evaluation in prostate cancer, a key milestone in advancing its oncology pipeline.