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BriaCell Says FDA Clears Way For Bria-BRES+ Phase 1/2a Study

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-- BriaCell Therapeutics (BCT.TO) has received FDA approval to initiate clinical evaluation of its next generation cell-based immunotherapy for metastatic breast cancer, the company said Wednesday.

The company, which is developing new immunotherapies, said FDA clearance of its investigational new drug (IND) application opens the way to begin the phase 1/2a clinical study for Bria-BRES+, which features additional immune activating components designed to boost clinical efficacy.

Bria-BRES+ builds on Bria-OTS breast cancer clinical program, where the first patient dosed experienced the sustained complete resolution of a lung metastasis. The patient received 17 cycles of Bria-OTS, completed 12 months of the study, and remains in survival follow-up, a statement noted.

"We are honored to announce FDA clearance of the first IND for our next generation personalized immunotherapy, Bria-BRES+," said chief executive William Williams. "The unique design of Bria-BRES+ offers the potential for a favorable safety profile and meaningful therapeutic benefit in metastatic breast cancer. We look forward to advancing Bria-BRES+ into the clinic as we seek to bring new hope to these patients who have few to no effective treatment options."

BriaCell shares were last seen down US$0.02, to US$4.05 in New York trading.

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