- BriaCell has successfully completed its Phase I safety and tolerability evaluation of Bria-IMT™ in combination with Incyte’s retifanlimab in advanced breast cancer.
- The combination treatment showed a favorable safety profile in 12 patients.
- Phase II efficacy portion of the study, under FDA’s fast track designation, now underway with survival data and clinical benefit being compiled.
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 21, 2022 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXW))))) (TSX:BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is pleased to announce the completion of the Phase I part of the clinical trial of its lead candidate, Bria-IMT™, in combination with Incyte’s PD-1 inhibitor, retifanlimab, in advanced breast cancer. The efficacy and survival data of the treated patients is being evaluated in the Phase II part of the study which was recently awarded the FDA’s fast track designation. Under an FDA approved protocol, another arm has recently been added to the Phase II study to evaluate the effects of dosing schedules for patients in the study.
“We are very impressed by the clinical data showing a favorable safety profile for our treatment in advanced breast cancer patients who have failed other therapies,” commented Dr. Del Priore, BriaCell’s Chief Medical Officer. “We look forward to further advancing this program and sharing the data in the coming months.”
The Phase I portion of the trial, with the primary goal of assessing safety and tolerability of the combination, enrolled 12 subjects who had previously failed at least two prior lines of therapy, characterized as a difficult-to-treat patient population. The combination treatment had a favorable safety profile and appeared well-tolerated with no dose-limiting toxicities.
Now progressing through the Phase II part of the clinical trial, a randomized controlled design will be used to allow comparison of the effectiveness of the treatment regimens between the two arms of the study with different dosing schedules.
BriaCell is on schedule to meet with the FDA later this year to discuss the design of a key registration study.
