Novartis' TIM-3 Monoclonal Antibody MBG453 Granted Clinical Trial Approval in China for Higher-Risk MDS and CMML-2

Text | Baihuawen

On July 6, Novartis’ TIM-3 monoclonal antibody MBG453 received clinical trial approval in China for use in combination with azacitidine for the treatment of patients with intermediate-, high-, or very-high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia-2 (CMML-2), as stratified by the Revised International Prognostic Scoring System (IPSS-R).

TIM-3 is a receptor protein of the TIM family, expressed on the surface of T cells, regulatory T (Treg) cells, and innate immune cells (dendritic cells, natural killer cells, and monocytes). MBG453 can inhibit the function of the TIM-3 receptor, thereby simultaneously targeting myeloid leukemia cells and immune cells. This not only kills cancer cells but may also enhance the activity of immune cells.

Novartis’s MBG453 is currently in Phase III clinical trials globally for myelodysplastic syndromes and chronic myeloid leukemia, with additional indications under development including acute myeloid leukemia, myelofibrosis, and solid tumors.

Source: NextPharma

Currently, no TIM3-targeted drugs have been approved for marketing either domestically or internationally. The Chinese companies with the most advanced development of TIM3 monoclonal antibodies include BeiGene (BGB-A425), Hengrui Medicine (SHR-1702), and Kelun Pharmaceutical (KL-A293). Among these, SHR-1702 is currently in Phase I clinical trials for advanced solid tumors.

Source: NextPharma