Glenmark Pharma enters Oncology with discovery of IND enabling studies of innovative bispecific antibody

Glenmark Pharma enters Oncology with discovery of IND enabling studies of innovative bispecific antibody

Glenmark Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals (GPL) has entered into Oncology with the discovery and initiation of IND enabling studies of a novel clinical development candidate, GBR 1302, a HER2xCD3 bispecific antibody.

GEM 1302 was discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland. GBR 1302 is based on Glenmark's innovative BEAT antibody technology platform which facilitates the efficient development and manufacture of antibodies with dual specificities, so-called bispecific antibodies. GBR 1302 is the first clinical development candidate based on the BEAT technology. Glenmark expects to obtain approval for the Initiation of clinical studies during this financial year.

HER2, also known as HER2/neu, or receptor tyrosine-protein kinase erbB-2, is the target of the antibody cancer drugs trastuzumab, pertuzumab and trastuzumab emtansine and is involved in breast cancer and ovarian cancer.

GBR 1302's mode of action is different from current HER2 targeting antibodies. It redirects cytotoxic T cells through its CD3 binding arm onto HER2 expressing cancer cells and induces the killing of the cancer cells. The killing of cancer cells by GBR 1302 is more rapid, more complete and not subject to the same resistance escape mechanisms as competing therapies.

Glenmark which operates in North America through its subsidiary Glenmark Generics Inc. has a fast growing generics business with a robust portfolio of over 90 products authorized for distribution in the U.S. in niche segments like Dermatology, Hormones, Controlled Substances, Oncology and Modified Release products.