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Drug-maker Glenmark Pharmaceuticals Ltd has initiated early studies on a Novel Biological Entity (NBE) primarily targeting lymphomas and leukaemia of B-cell origin.
The lead candidate, GBR 401, is an anti-CD19 monoclonal antibody developed in-house by Glenmark's Biologics Research Centre located in Switzerland, a note from the company said.
Glenmark will file for Phase I clinical trials, where the prospective drug is exposed for the first time to humans, in the fourth quarter of 2011-12, the company said.
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. Leukaemia is a cancer of the white blood cells, the note explained.
Within the seven major markets comprising the US, Europe and Japan, new cases of NHL and leukaemia of B cell origin were estimated at 1.26 lakh and 34,000 respectively, the note added.
The CD19 target holds potential for treatment of inflammatory disorders such as rheumatoid arthritis as well, the company said.
Further, the note added, CD19 is known to be expressed earlier and more broadly in B cell development than CD20, the latter being the target of the world's second largest selling anti-cancer biotech product rituximab whose annual 2010 sales were in excess of $6 billion.
Mr Glenn Saldanha, Chief Executive and Managing Director of Glenmark Pharmaceuticals, said GBR 401 had been developed completely in-house, leveraging Biologics' antibody knowhow that would further continue to fuel Glenmark's pipeline.
Glenmark's NBE basket
With the addition of GBR 401, Glenmark will now have four monoclonal antibodies in the Novel Biologics Entity (NBE) pipeline. The others include GBR 500, a monoclonal antibody for the treatment of inflammatory bowel disease and multiple sclerosis and GBR 600 for the prevention of von Willebrand Factor (vWF) mediated diseases. In Sept 2010, Glenmark received the exclusive license to the monoclonal antibody BXL1H5 or GBR 900, including the exclusive target license to commercialise monoclonal antibodies against TrkA receptor for pain from Lay Line Genomics, an Italy-based company.
Glenmark shares were marginally up at Rs 283 on the BSE on Thursday.
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