Glenmark Pharmaceuticals announced that it is advancing its novel monoclonal antibody GBR 830 into a Phase I clinical trial in humans.
GBR 830 is a pure antagonist of OX40 being considered as a validated potential target in the treatment of a range of autoimmune diseases. OX40 is a co-stimulatory receptor expressed on T cells that mediates T cell activation and survival. The company said that GBR 830 qualifies as an antibody for OX40 because it does not have agonistic properties that might produce unpleasant side effects. GBR 830 targets auto-reactive T cells that drive the pathology in most autoimmune diseases such as lupus, rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis.
Dr. Michael Buschle, President of Biologics and Chief Scientific Officer of Glenmark Pharmaceutical, 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.”
The company said that, based on data from preclinical comparison with competitor antibodies in animal translational models of autoimmune disease, GBR 830 was safe and effective and lacked agonistic properties.
Glenmark has recently completed the Phase I enabling preclinical development program for the drug candidate and has filed a Phase I trial application with The Netherlands regulatory authorities. The clinical trial will support the company’s plans to file an Investigational New Drug (IND) application for GBR 830.
Aside from GBR 830, Glenmark also has other candidates in development, including GBR 500 which is currently in Phase II trials and licensed to Sanofi. A first-in-class molecule labeled GBR 900 is in Phase I studies.
Last month the company announced the inauguration of its new antibody manufacturing facility in Switzerland. The new facility, which is located at La Chaux-de-Fonds, will develop novel state-of-the-art monoclonal antibodies, including bi-specific antibodies.