Glenmark initiates IND enabling studies of GBR 401 anti-CD19 monoclonal antibody in B cell lymphomas

Glenmark Pharmaceuticals Ltd.Apr 1 2011

- Glenmark's first novel molecule for an oncology indication - GBR 401 is a monoclonal antibody targeting CD19. The antibody is implicated in treatment of B cell malignancies and inflammatory disorders mediated by B lymphocytes - CD19 is expressed earlier and more broadly in B-cell development than CD20 and represents a promising treatment approach - GBR401 has been developed using an advanced technology platform that greatly enhances the efficacy of the antibody and has been developed completely in-house by Glenmark - Glenmark will file for Phase I trials in Q4 FY 2011-12

Glenmark Pharmaceuticals announces the discovery and initiation of IND enabling studies of a Novel Biological Entity (NBE) lead candidate, GBR 401, an anti-CD19 monoclonal antibody. GBR 401 is developed completely in-house by Glenmark's Biologics Research Centre located in Switzerland.

The disease areas primarily targeted by GBR 401 are lymphomas and leukemia's of B-cell origin. Lymphomas are cancers originating from the lymphatic system. Non-Hodgkin's lymphoma (NHL), a type of B cell lymphoma, is the most common form of blood cancer. Leukemia is a cancer of the white blood cells. In addition the CD19 target holds potential for treatment of inflammatory disorders such as rheumatoid arthritis.

GBR 401 shows great promise to emerge as a valuable therapeutic option to treat patients affected with B-cell malignancies. GBR 401 has demonstrated strong anti-tumour potency and anti-proliferative apoptotic activity in several in-vitro and in-vivo studies. CD19 is known to be expressed earlier and more broadly in B-cell development than CD20, the latter being the target of the worlds second largest selling anti-cancer biotech product rituximab (Rituxan(R) / MabThera(R)) whose annual 2010 sales were in excess of US$6 billion.

Mr. Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticals mentioned "We are excited to announce GBR 401, which has been developed completely in-house leveraging our biologics antibody know-how. 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."

"Targeting CD19 is a promising approach to treat B-cell malignancies. Further, GBR 401 has been developed using a technologically advanced platform that greatly enhances the efficacy of the antibody" said Dr. Michael Buschle, President-Biologics, Glenmark Pharmaceuticals S.A., Switzerland.