PHILADELPHIA and VANCOUVER, British Columbia, May 6, 2026
BriaCell Therapeutics Corp. has received FDA clearance for its Investigational New Drug (IND) application to initiate a Phase 1/2a clinical study evaluating Bria-BRES+™, the company’s next-generation personalized immunotherapy for metastatic breast cancer. The regulatory milestone marks a significant advancement for the clinical-stage biotechnology company as it prepares to expand its immuno-oncology pipeline with a novel off-the-shelf cell-based therapy designed to improve treatment outcomes in patients with advanced breast cancer.
FDA IND Clearance Opens New Clinical Pathway
The FDA’s clearance enables BriaCell to move forward with the planned clinical evaluation of Bria-BRES+™, a therapy engineered with additional immune-activating components intended to strengthen anti-tumor activity. According to the company, the therapy is designed to activate both the adaptive and innate immune systems, potentially improving efficacy against metastatic disease while reducing the risk of immune escape. BriaCell stated that it has already prepared clinical supplies and intends to begin the Phase 1/2a study in the coming months.
The company highlighted that Bria-BRES+ builds upon the earlier success of its Bria-OTS™ breast cancer program, which demonstrated encouraging patient outcomes in advanced metastatic breast cancer. The FDA clearance represents an important regulatory achievement for the company and further strengthens its position within the growing field of personalized cancer immunotherapy.
Immunotherapy Shows Promising Preclinical Activity
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BriaCell recently presented preclinical findings at the American Association for Cancer Research (AACR), where Bria-BRES+ demonstrated activation of multiple immune pathways, including stimulation of naïve T-cells, dendritic cells, and natural killer (NK) cells. The company believes this multi-pronged immune activation strategy could provide enhanced clinical benefit for patients with difficult-to-treat metastatic breast cancer.
Company President and CEO Dr. William V. Williams stated that the next-generation immunotherapy has the potential to deliver a favorable safety profile alongside meaningful therapeutic benefit for patients who currently have limited treatment options. The company emphasized that metastatic breast cancer remains an area of high unmet medical need, creating strong demand for innovative immuno-oncology approaches capable of improving survival and treatment response.
Earlier Clinical Findings Support Program Expansion
BriaCell also referenced previously reported clinical observations from its Bria-OTS™ program involving a 78-year-old metastatic breast cancer patient who experienced a complete resolution of a lung metastasis following treatment. The patient reportedly achieved a sustained 100% tumor resolution after four doses of therapy, with the response confirmed at multiple follow-up intervals including 4, 6, and 11 months.
The company noted that the patient completed 17 treatment cycles and remains in long-term survival follow-up. The earlier clinical outcome has helped strengthen confidence in BriaCell’s immunotherapy platform and supports continued development of next-generation personalized cancer therapies targeting metastatic disease. Images included in the company’s announcement illustrated progressive tumor reduction and confirmed long-term response durability in the treated patient.
BriaCell continues to focus on developing targeted and effective immuno-oncology treatments designed to transform cancer care through innovative personalized therapeutic approaches. The latest FDA clearance is expected to accelerate the company’s clinical development strategy and broaden its presence within the rapidly evolving biopharmaceutical oncology sector.
Source: BriaCell press release
