By Chris Wack


BriaCell Therapeutics Corp. said Wednesday it has received agreement and positive feedback from its End of Phase II meeting with the U.S. Food and Drug Administration regarding its lead clinical candidate, Bria-IMT, in combination with a checkpoint inhibitor 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 the upcoming clinical study.

The company said the 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 submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer.

BriaCell shares were up 10% to $7.65 in premarket trading.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

01-18-23 0920ET