Briacell, an immuno-oncology company focused on developing therapeutics to target tumor-specific antigen generation and T-cell response, has successfully initiated a phase 3 clinical trial for its lead candidate – Bria IMT. This pivotal study is enrolling women with metastatic breast cancer, in order to evaluate safety and efficacy of Briacell’s cancer immunotherapy drug regimen. This innovative therapy focuses on stimulating the immune system to attack tumor cells, in order to inhibit cancer growth.
The phase 3 trial, conducted at 30 sites across the US, is a randomized, double-blind, placebo-controlled study of whole-body radiotherapy plus Bria IMT versus whole-body radiotherapy alone. The primary objective is to assess the overall survival rate of patients receiving Bria IMT therapy, compared to those receiving radiotherapy alone. Secondary outcomes include assessment of the response to therapy, and overall progression-free survival.
Subjects will receive up to four doses of Bria IMT on therapy days 1, 14, 21, and 28. Biomarker assessments, including immune monitoring, will be taken at the beginning of the study and periodically throughout the trial. Results of the study will be compared to a controlled group of women who received only whole-body radiotherapy.
Bria IMT is designed to generate a robust presence of antigen-specific T-cells, which are critical for successful cancer immunotherapy. It works by amplifying the patient’s existing immune-cell populations and by also introducing antigen-specific T-cells that have been harvested from healthy donors. Once activated, these cells will then recognize and target tumor cells that possess the specific antigen.
This novel technology has the potential to be a major breakthrough in the fight against metastatic breast cancer, which is currently associated with poor prognosis. To-date, there are limited treatments if disease progression occurs with existing therapies, and radiotherapy plus Bria IMT offers a promising alternative therapeutic path.