Abivax has doest the first patient with an iNKT agonist, ABX196, in a Phase 1/2 study to evaluate safety, tolerability and preliminary efficacy of the combination therapy. ABX196 is Abivax’s second compound in clinical development, following its lead candidate ABX464 in inflammatory diseases.
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.”
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.”