PHILADELPHIA and VANCOUVER, British Columbia — May 6, 2026 — Leads & Copy — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) has received FDA clearance for its Investigational New Drug (IND) application for Bria-BRES+, paving the way for a Phase 1/2a clinical study in metastatic breast cancer.
Bria-BRES+ represents BriaCell’s next-generation personalized immunotherapy for breast cancer, enhanced with additional immune-activating components to boost clinical efficacy. The company has prepared clinical supplies and anticipates initiating the study in the coming months.
Dr. William V. Williams, President & CEO of BriaCell, expressed honor in announcing the FDA clearance for Bria-BRES+, the company’s next-generation personalized immunotherapy. He emphasized its unique design, suggesting a favorable safety profile and significant therapeutic potential for metastatic breast cancer patients. BriaCell aims to bring renewed hope to patients with limited effective treatment options.
BriaCell’s recent AACR preclinical poster presentation highlighted Bria-BRES+’s activation of both adaptive and innate immunity, encompassing the activation of naïve (resting) T-cells, dendritic cells, and natural killer (NK) cells. BriaCell anticipates that this comprehensive immune activation will enhance clinical efficacy and prevent immune escape in metastatic breast cancer patients.
Bria-BRES+ builds upon BriaCell’s Bria-OTS™ breast cancer clinical program, where the first patient experienced a sustained and complete resolution of lung metastasis. This 78-year-old woman, with advanced metastatic breast cancer and multiple prior treatment failures, achieved 100% resolution of a lung metastasis after four doses of Bria-OTS single-agent therapy. The complete response was initially observed at 2 months and confirmed at 4, 6, and 11 months. The patient completed 17 cycles of Bria-OTS over 12 months and remains in survival follow-up.
Figure 1: In January 2026, Bria-OTS monotherapy resulted in 100% resolution of a tumor in the right lung of a metastatic breast cancer (MBC) patient following 2 months of therapy and confirmed at 4, 6, and 11 months of therapy1 (axial and coronal views)
BriaCell Therapeutics Corp. focuses on developing targeted and effective approaches for cancer management.
Source: BriaCell Therapeutics Corp.
