BriaCell announces feedback from pre-IND meeting with FDA for Bria-PROS+

BriaCell Therapeutics has received feedback from its Pre-IND meeting with the U.S. Food and Drug Administration, which is a step forward to opening an IND to conduct a Phase 1/2 study of its personalized off-the-shelf immunotherapy, Bria-PROS+, in advanced prostate cancer. As a result of the Pre-IND meeting, FDA waived the animal toxicology and animal pharmacokinetic studies requirement for opening the IND, greatly simplifying the development pathway for Bria-PROS+. Other areas of discussion included BriaCell’s plan to initiate the Phase 1/2 study pending completion of standard manufacturing and testing requirements. These interactions also inform the further development of the proprietary Bria-OTS+ platform as the company pursues the development of Bria-BRES+, Bria-LUNG+ and Bria-MEL+, for breast cancer, lung cancer and melanoma, respectively. BriaCell is currently evaluating its personalized immunotherapy Bria-BRES in a phase 1/2a study in metastatic breast cancer.