Glenmark's Novel Monoclonal Antibody GBR 830 for Treatment of Autoimmune Diseases Entering Human Trials

MUMBAI,India, July 3, 2014 /PRNewswire/ --

• GBR 830 is an antagonistic monoclonal antibody with first in class potential for the treatment of autoimmune diseases targeting OX40, a co-stimulatory receptor on T cells
• The antibody has successfully completed the Phase I enabling preclinical development program and a Phase I clinical trial application has been filed with The Netherlands authorities
• Preclinical models showed unique mechanism of action of GBR 830 leading to superior efficacy when compared to other T cell targeting antibodies, paired with an excellent safety profile
• With this, Glenmark now has three monoclonal antibodies in clinical development

Glenmark Pharmaceuticals S.A., a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd., announced today 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.

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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.

Commenting on the progress with GBR 830, 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."

About Glenmark Pharmaceuticals Ltd

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company and ranked among the top 80 Pharma and Biotech companies of the world in terms of revenues. Glenmark is a leading player in the discovery of new molecules both NCEs and NBEs. Glenmark has several molecules in various stages of clinical development and primarily focused in the areas of Inflammation, Pain and Oncology. The company has significant presence in branded formulations across emerging economies including India. Its subsidiary, Glenmark Generics Limited services the requirements of the US and Western Europe markets.

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SOURCE Glenmark Pharmaceuticals Ltd