biw-8962

BIW-8962 is a humanized, recombinant, non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody that targets the ganglioside GM2, a tumor-associated antigen overexpressed on the surface of various cancer cells including multiple myeloma and neuroblastoma. The drug was engineered to enhance antibody-dependent cellular cytotoxicity (ADCC) by removing fucose from its carbohydrate structure, which increases its ability to mediate immune cell killing of GM2-expressing tumor cells. Preclinical studies demonstrated antitumor activity in multiple myeloma cell lines and animal models. In clinical trials for multiple myeloma, BIW-8962 showed acceptable safety but did not demonstrate significant clinical efficacy; as a result, further development for this indication was halted. The drug was also investigated preclinically and/or in early-phase trials for other cancers such as small cell lung carcinoma and mesothelioma but did not advance beyond phase 1 for these indications. The precursor mAb KM8969 shares complementarity-determining regions with BIW-8962.

Other names

anti-ganglioside GM2 monoclonal antibody BIW-8962