Core Viewpoint - InnoCare Pharma has received approval from the China National Medical Products Administration for the Investigational New Drug application to conduct clinical trials of ICP-538, marking it as the first VAV1 degrader approved for clinical trials in China and the second globally [1][2]. Group 1: Product Overview - ICP-538 is a novel, potent, and highly selective orally administered molecular glue degrader targeting VAV1, aimed at treating autoimmune diseases such as inflammatory bowel disease, systemic lupus erythematosus, and multiple sclerosis [2][3]. - The drug induces rapid and efficient degradation of VAV1 protein in a dose-dependent manner, facilitating the formation of a ternary complex between the CRBN E3 ubiquitin ligase and the VAV1 protein [2]. Group 2: Mechanism of Action - Degradation of VAV1 effectively inhibits T-cell proliferation, differentiation, activation, and cytokine release, as well as B-cell activation and cytokine release, leading to anti-inflammatory and immunomodulatory effects [3]. - Preclinical studies indicate that ICP-538 results in significant reductions in cytokines associated with immune-mediated diseases, with no detectable effects on other proteins [3]. Group 3: Company Insights - InnoCare is a commercial stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class and/or best-in-class drugs for cancer and autoimmune diseases with unmet medical needs [4]. - The company has branches in major cities including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [4].
InnoCare Announces IND Approval to Initiate Clinical Trial of VAV1 Degrader ICP-538 in China