BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXL) announced it received FDA clearance for an Investigational New Drug application to begin a Phase 1/2a clinical study of Bria-BRES+ in metastatic breast cancer patients.

The FDA clearance allows the Philadelphia and Vancouver-based biotechnology company to commence testing of its cell-based immunotherapy designed for metastatic breast cancer treatment. BriaCell has prepared clinical supplies and plans to initiate the study in the coming months, according to a company statement.

"We are honored to announce FDA clearance of the first IND for our next generation personalized immunotherapy, Bria-BRES+," stated Dr. William V. Williams, BriaCell's President and CEO.

Bria-BRES+ represents an advancement from the company's existing Bria-OTS breast cancer program. In that program, a 78-year-old patient with advanced metastatic breast cancer achieved complete resolution of a lung metastasis after receiving four doses of Bria-OTS therapy. The response was observed at two months and confirmed at four, six, and 11 months following treatment.

According to preclinical data presented at the American Association for Cancer Research conference, Bria-BRES+ demonstrated activation of adaptive and innate immunity, including T-cells, dendritic cells, and natural killer cells.

The patient in the Bria-OTS study had experienced multiple prior treatment failures before receiving the immunotherapy. She completed 17 cycles of treatment over 12 months and remains in survival follow-up.

BriaCell describes itself as a clinical-stage biotechnology company focused on developing immunotherapies for cancer treatment.