Glenmark Pharmaceuticals SA (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announced the discovery and initiation of IND enabling studies of a novel clinical development candidate, GBR 830, an anti-OX40 monoclonal antibody. GBR 830 has been discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland. GBR 830, an anti-OX40 monoclonal antibody is a potential global first-in-class molecule. OX40, also known as CD134, plays a key role in T-cell mediated autoimmune disorders.

OX40 is a well known target and the development of OX40 antagonists has been very challenging. Glenmark has achieved a significant milestone with the successful generation of an antagonistic OX40 monoclonal antibody coupled with generation of data validating the role of OX40 in autoimmune diseases.

GBR 830 shows great promise to emerge as a valuable therapeutic option to treat patients suffering from immune pathologies such as autoimmune diseases like rheumatoid arthritis (RA) and inflammatory bowel disease (IBD).

Commenting on this milestone, Dr Michael Buschle, chief scientific officer and president - Biologics, Glenmark Pharmaceuticals mentioned, “GBR 830 is a tremendous achievement for us. No antagonistic antibodies targeting OX40 are currently in clinical stage of development. We are confident that the antibody expertise and product development capabilities of the Switzerland Biologics Research Centre will continue to enrich the Glenmark discovery pipeline.”

OX40 (CD134) is a member of the TNFR/TNF super family and is mainly expressed on activated CD4 and CD8 T cells as well as a number of other lymphoid and non-lymphoid cells. Costimulatory signals from OX40 to an activated T cell promote division and survival, augmenting the clonal expansion of effector and memory populations. OX40 mediated costimulatory signaling plays a central role in the development of multiple inflammatory and autoimmune diseases. Inhibiting these interactions can be used to treat these conditions. Conversely, agents that activate OX40 are being developed to activate T-cells to target cancer cells. No OX40 antagonistic antibodies are currently in clinical stage of development.