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Recently, ISM3412, a class 1 new drug developed by InSilico Medicine Cayman TopCo (Insilico Medicine), received implied approval for clinical trials in China. The indication is for advanced/metastatic solid tumors. ISM3412 is a highly selective oral MAT2A inhibitor discovered with the assistance of artificial intelligence. It received FDA approval in April 2024 to conduct clinical trials in the United States for the treatment of MTAP- deficient cancers.
As a strategic partner of Insilico Medicine, Medicilon provided preclinical research services for ISM3412, including pharmacokinetics and safety evaluation tests. This support laid a solid foundation for the rapid approval of the drug.
ISM3412 is a structurally novel and highly selective MAT2A inhibitor, designed with the assistance of Insilico Medicine's generative chemistry engine, Chemistry42, using a ligand-based drug design (LBDD) strategy. In preclinical studies, ISM3412 demonstrated excellent drug-like properties, strong efficacy at low doses, good solubility and permeability, and ideal safety characteristics in animal models. Insilico Medicine presented some of the preclinical data from this project at the 2023 AACR conference. These data support further clinical evaluation of ISM3412 as a potential best-in-class MAT2A inhibitor. In preclinical experiments, ISM3412 demonstrated specific inhibition of MTAP-deleted cancer cells and showed a more favorable safety profile, offering the potential to provide new treatment options for clinical patients. Furthermore, ISM3412 not only demonstrates potent monotherapy efficacy but also exhibits synergistic "synthetic lethality" when used in combination with PRMT5 inhibitors.
The dual approval of ISM3412 in both the United States and China marks another significant milestone for Insilico Medicine in the field of artificial intelligence-driven pharmaceuticals. Since 2021, Insilico Medicine has established over 30 diverse in-house pipeline combinations and nominated 18 preclinical candidate projects from them. Among these, 7 projects have successfully progressed to the clinical trial stage. The achievement fully demonstrates Insilico Medicine's leading position and innovative capabilities in the field of artificial intelligence-driven pharmaceuticals.
The deep integration of AI and pharmaceuticals has enabled Insilico Medicine to achieve the clinical stage entry of 7 projects in just 3 years, providing unprecedented speed and possibilities in drug development. As an avid supporter of AI pharmaceuticals, Medicilon not only provides preclinical research services including efficacy, pharmacokinetics, and safety evaluation for AI drugs but also has established an AI technology service platform. This platform covers advanced technologies such as protein structure prediction and simulation, binding site discovery, information extraction and cleansing, and customized project database construction. It enables deep involvement in critical stages of drug development, such as Target-to-hit, Hit-to-lead, Lead-to-PCC, facilitating efficient advancement of drug development pipelines.
Medicilon congratulates Insilico Medicine on the dual approval of ISM3412 in both the United States and China, and looks forward to the smooth progress of ISM3412 in clinical trials, bringing new treatment options to patients with advanced/metastatic solid tumors at the earliest opportunity. Medicilon will continue to innovate and integrate cutting-edge technologies, accelerating the deep integration of AI and drug development. We are committed to providing our clients with customized solutions for "speeding up, reducing costs, and increasing efficiency". We will collaborate closely with partners like Insilico Medicine to advance the development of the AI+ pharmaceutical field together!
About Insilico Medicine
Insilico Medicine is a clinical-stage biotechnology company driven by generative artificial intelligence. Through next-generation AI systems connecting biology, chemistry, and clinical trial analysis, Insilico Medicine utilizes modern machine learning technologies such as deep generative models, reinforcement learning, and transformer models to build a powerful and efficient AI drug development platform. This platform identifies novel targets and generates candidate drugs with specific molecular structures. Insilico Medicine focuses on areas of unmet medical needs such as cancer, fibrosis, immunology, central nervous system diseases, and age-related diseases, advancing and accelerating the development of innovative drugs.