Glenmark Pharmaceuticals’ Swiss subsidiary has announced that its new monoclonal antibody GBR 830 is entering human trials for the treatment of autoimmune diseases.
The company said that GBR 830 is the first OX40 antagonistic antibody devoid of agonistic properties to enter clinical studies.
OX40 is a co-stimulatory receptor expressed on T cells mediating T cell activation and survival, as well as has the potential to treat a wide array of autoimmune diseases.
The company has now completed the Phase I enabling preclinical development programme for GBR 830 and has submitted a Phase I clinical trial application with The Netherlands authorities.
However, discovering antibodies that inhibit OX40 and do not have agonistic properties, which would lead to unwanted side- effects, has proven difficult and based on the company’s data GBR 830 is devoid of any agonistic properties.
GBR 830 targets auto-reactive T cells, which drives the pathology in most autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and lupus.
According to the company, preclinical models showed new mechanism of action of GBR 830 leading to superior efficacy when compared with other T cell targeting antibodies, paired with an excellent safety profile.
Preclinical head to head comparison with competitor antibodies confirmed the superiority of GBR 830’s mechanism of action with respect to safety and efficacy and lack of agonism.
Glenmark Pharmaceuticals president of biologics and chief scientific officer Michael Buschle said: "With GBR 830 Glenmark has succeeded in generating a truly antagonistic OX40 antibody. This was a very difficult programme but our persistence ultimately paid off."