BriaVax is a genetically engineered cellular vaccine derived from a human breast tumor cell line as a potential treatment for advanced breast cancer. It is being developed by the immuno-oncology biotechnology company BriaCell.
How BriaVax works
BriaVax is derived from a human breast cancer cell line that expresses the protein Her2/neu, which is overexpressed in some epithelial cancers like breast and ovarian cancers. It was designed to produce and secrete granulocyte/macrophage-colony stimulating factor (GM-CSF), a protein that promotes the activation of certain immune system cells called dendritic cells, responsible for presenting antigens to specialized cells of the immune system.
It is thought that BriaVax peptides or protein fragments are displayed on the surface of dendritic cells, changing the tumor’s antigen-presentation system and allowing the tumor cell to be recognized as foreign and eliminated by T-cells.
To amplify the activation of the immune system of the cancer patients, BriaVax can be combined with other immune system activators, including Cytoxan (cyclophosphamide), and the cell signaling molecule interferon-α.
BriaVax in clinical trials
The efficacy of BriaVax in treating metastatic cancer was tested in a Phase 1 trial. The study involved three patients with breast cancer and one with ovarian cancer who had failed to respond to prior treatments. Therapy consisted of the injection of BriaVax in four divided doses to the back and thighs of the patients.
The therapy was well tolerated and no significant treatment-associated adverse events were observed. The median overall survival was 35 months.
A report of the study was published, showing one robust responder with more than 90 percent regression during treatment. When treatment was halted, the cancer came back, but responded well to re-treatment.
Based on these results, BriaCell initiated a Phase 1/2 study (NCT03066947) in metastatic breast cancer patients who failed at least one prior treatment. The trial is currently recruiting patients in Washington, California, and Florida to evaluate the safety and efficacy of BriaVax.
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