Bria-IMT™ Cell Therapy
The pivotal Phase 3 combination study is listed on ClinicalTrials.gov as NCT06072612.
Bria-IMT™ was awarded Fast Track status by the U.S. Food and Drug Administration (FDA).
BriaCell recently announced completion of enrollment of advanced breast cancer patients in its randomized ongoing Phase 2 combination study of Bria-IMT™ with Incyte’s immune checkpoint inhibitor, retifanlimab. This study followed successful completion of a Phase 1 study showing a favorable safety and efficacy profile for the combination regimen.
About Bria-IMT™ (SV-BR-1-GM)
Developed and characterized by a team of dedicated scientists and clinicians, Bria-IMT™ (SV-BR-1-GM) is an off-the-shelf targeted cellular immunotherapy for the treatment of advanced metastatic breast cancer (i.e. breast cancer that has spread from the breast or armpit to other areas of the body including the bones, lungs, liver or sometimes the brain). Bria-IMT™ is a genetically engineered human breast cancer cell line with features of immune cells. It is clinically used as a targeted immunotherapy.
Mechanism of Action of Bria-IMT™: The mechanism of action of Bria-IMT™ is currently under investigation. We hypothesize that Bria-IMT™ both indirectly and directly stimulates the body’s own cancer-fighting cells to attack and destroy breast cancer tumors. INDIRECTLY, Bria-IMT™ produces breast cancer “antigens” (proteins that are expressed in breast cancer cells) that are then recognized by the immune system, which can then recognize those same antigens in a patient’s breast cancer and attack the cancer. In addition, Bria-IMT™ appears to be able to DIRECTLY stimulate these cancer-fighting immune cells markedly, boosting the body’s response.
We believe that Bria-IMT™:
1. Produces antigens (proteins made by breast cancer cells) which are taken up by immune cells.
2. The immune cells present the antigens to CD4+ and CD8+ T-cells, cells known for tumor destruction.
3. Secretes a protein called GM-CSF which further boosts the immune response.
4. Also directly stimulates cancer-fighting T-cells, acting like an immune cell, further boosting the response.
Bria-IMT™ has been dosed in dozens of patients with advanced breast cancer, with remarkable efficacy and safety, leading to the recent initiation of our pivotal phase 3 study.