Glenmark's monoclonal antibody enters human trials stage

Glenmark Pharmaceuticals SA, a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd, has announced that GBR 830, a novel monoclonal antibody is entering human trials. GBR 830 is a pure antagonist of OX40, a co-stimulatory receptor expressed on T cells mediating T cell activation and survival. Glenmark has now completed the phase I enabling preclinical development program for GBR 830 and has filed a phase I clinical trial application with the Netherlands authorities. GBR 830 is the first OX40 antagonistic antibody devoid of agonistic properties to enter clinical studies.
 
OX40 is a very well validated target with the potential to treat a wide array of autoimmune diseases. However, discovering antibodies that inhibit OX40 and do not have agonistic properties, which would lead to unwanted side effects, has proven very difficult and based on Glenmark’s data GBR 830 is devoid of any agonistic properties.
 
GBR 830 targets auto-reactive T cells. This cell type drives the pathology in most autoimmune diseases and including, but not limited to illnesses such as rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and lupus.
 
Preclinical head to head comparison with competitor antibodies in animal and translational models of autoimmune disease confirmed the superiority of GBR 830’s mechanism of action with respect to safety and efficacy and lack of agonism.
 
Dr Michael Buschle, President of Biologics and Chief Scientific Officer, Glenmark Pharmaceuticals Ltd, said, “With GBR 830, Glenmark has succeeded in generating a truly antagonistic OX40 antibody. This was a very difficult program but our persistence ultimately paid off.”