Phase 3 Combination Study of Bria-IMT™ with an Immune Check Point Inhibitor in Advanced Breast Cancer
Awarded Fast Track status by the U.S. Food and Drug Administration (FDA), BriaCell is conducting a pivotal Phase 3 clinical study of Bria-IMT™, BriaCell’s lead candidate, in combination with an immune checkpoint inhibitor. Additional information on this combination study is available on ClinicalTrials.gov as NCT06072612. Positive results from the pivotal study could allow commercialization of Bria-IMT™.
Phase 1/2 Combination Study of Bria-IMT™ with Retifanlimab (INCMGA00012) in Advanced Breast Cancer (Completed Enrollment)
BriaCell has completed enrollment and continues dosing advanced breast cancer patients in its randomized Phase 2 combination study of Bria-IMT™ with Incyte’s immune checkpoint inhibitor, retifanlimab, under corporate collaboration with Incyte.
Patients with advanced breast cancer are eligible for combination therapy with retifanlimab if they have failed 2 or more prior lines of therapy.
Additional information on the Phase 1/2 combination study of Bria-IMT™ with retifanlimab is available on ClinicalTrials.gov as NCT03328026.
Rationale for the combination study of Bria-IMT™ with an immune check point inhibitor
Immune checkpoint inhibitors such as KEYTRUDA® (pembrolizumab), OPDIVO® (nivolumab), YERVOY® (ipilimumab), ZYNYZ™ (retifanlimab-dlwr) have come to the forefront in the fight against cancer with substantial benefits for some patients. The significance of immune checkpoint inhibitors was recognized by the Nobel committee by awarding Dr. Tasuku Honjo and Dr. James P. Allison with the 2018 Nobel Prize in Physiology or Medicine (Scientists behind game-changing cancer immunotherapies win Nobel medicine prize), validating the Company’s approach to study Bria-IMT™ in combination therapy with the immune checkpoint inhibitors.
Drs. Alison and Honjo independently, using different strategies, showed an effective approach of treating patients by awakening certain cells of the immune system (T cells) to attack tumors. This approach of treating patients with immune checkpoint inhibitors, designed to overcome immune suppression in cancer patients, is revolutionizing the fight against cancer.
Bria-IMT™ uses a breast cancer cell line which produces GM-CSF. Bria-IMT™ has also been shown to indirectly and directly stimulate T cells, and hence boost the immune system. BriaCell has published these findings in a leading immunology journal. It is important to note that pembrolizumab and other similar immunotherapy drugs have not been shown to work on their own in breast cancer.
BriaCell conducted two Proof of Concept trials using Bria-IMT™ in metastatic breast cancer patients who had failed multiple prior treatments. The first trial produced a median overall survival of 35 months and at least one “robust responder with >90% regression during treatment, subsequent relapse (upon halting treatment) responded to re-treatment. These findings were confirmed in another study of 23 patients with advanced breast cancer showing clinical benefit and tumor regressions in predictable subsets of patients. Based on these findings, the combination study with immune check point inhibitors was initiated.