BriaCell Receives FDA Clearance to Initiate Bria-BRES+™ Clinical Study in Breast Cancer
- FDA clearance of Investigational New Drug (IND) application opens path to commence Phase 1/2a clinical study for Bria-BRES+ in metastatic breast cancer
- Bria-BRES+ is BriaCell’s next generation personalized immunotherapy for breast cancer, and features additional immune activating components designed to enhance clinical efficacy
- BriaCell has prepared clinical supplies of Bria-BRES+ and plans to initiate a Phase 1/2a clinical study in metastatic breast cancer in the coming months
Excerpt from the Press Release:
PHILADELPHIA and VANCOUVER, British Columbia, May 06, 2026 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to report it has received FDA clearance to initiate clinical evaluation of Bria-BRES+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer.
“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 & CEO. “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.”
As reported in BriaCell’s recent AACR preclinical poster presentation, Bria-BRES+ demonstrated activation of both adaptive and innate immunity including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with metastatic breast cancer.
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