Abivax Includes First Patient in U.S. Phase 1/2 Clinical Trial of ABX196 to Treat Hepatocellular Carcinoma
· First patient dosed with ABX196, an iNKT (invariant Natural Killer T cell) agonist, in combination with nivolumab
· Phase 1/2 study to evaluate safety, tolerability and preliminary efficacy of the combination therapy
· Clinical trial conducted with Scripps MD Anderson Cancer Center in San Diego, California, and the MD Anderson Cancer Center in Houston, Texas
· ABX196 is Abivax’s second compound in clinical development, following its lead candidate ABX464 in inflammatory diseases
PARIS, France & SAN DIEGO, California, February 26, 2020 – 06:00 p.m. (CET) – Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, today announced dosing of the first patient in a U.S. Phase 1/2 clinical trial of ABX196 to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.
In this trial, ABX196, an invariant Natural Killer T cell (iNKT) agonist, is administered together with the checkpoint inhibitor nivolumab (Opdivo®, Bristol Myers Squibb) to evaluate the potential beneficial effects of a combination therapy, with ABX196 boosting the activity of nivolumab in HCC patients.
The study’s objective is to generate initial data about the safety and tolerability of this novel combination treatment as well as data on its preliminary efficacy. Thus far, ABX196, both alone and in combination with a checkpoint inhibitor, showed a statistically highly significant therapeutic effect in reducing tumor growth as measured by MRI and increasing survival in mice with HCC.
Prof. Hartmut J. Ehrlich M.D., CEO of Abivax, said: “The treatment of the first patient with ABX196 is an important step for Abivax and further reinforces the significant potential of our pipeline. With ABX464 in the field of inflammatory diseases and ABX196 in oncology, Abivax is now testing two very promising drug candidates in different major disease areas with high unmet medical need. Together with our partners, we are very much looking forward to exploring the impact of this iNKT agonist in a combination treatment with nivolumab in order to learn more about ABX196’s capacity to broaden and potentiate the efficacy of checkpoint inhibitors.”
The study is conducted at two renowned cancer centers of excellence, the Scripps MD Anderson Cancer Center in San Diego, CA, and the MD Anderson Cancer Center in Houston, TX. Abivax plans to involve additional leading cancer centers in the U.S. in the subsequent expansion phase of the study.
Darren Sigal, M.D., Program Director of GI Oncology at Scripps MD Anderson Cancer Center in San Diego, physician with Scripps Clinic and principal investigator of the study said: “Despite the recent advances in treating hepatocellular carcinoma, most patients will still not respond to checkpoint inhibitor therapy and ultimately die of their disease. ABX196 is the first non-checkpoint inhibitor immune therapy to be evaluated in HCC; it activates the iNKT cell, a key anti-cancer immune cell. We are excited to investigate the potential clinical benefits of combining ABX196 with nivolumab in this Phase 1/2 trial.”
ABX196 is Abivax’s second promising drug candidate progressing through clinical development. It follows ABX464, which is being developed in a Phase 2b trial in ulcerative colitis and a Phase 2a trial in rheumatoid arthritis. A Phase 2b study is also planned in Crohn’s disease for ABX464.