InnoCare’s ICP-538: China’s First VAV1 Degrader Enters Clinical Trials for Autoimmune Diseases

Beijing, China – In a significant step forward for autoimmune disease treatment, InnoCare Pharma has dosed the first healthy volunteer in a clinical trial in China evaluating ICP-538, an oral therapy targeting multiple sclerosis (MS) and other autoimmune conditions. This milestone marks the first VAV1 degrader to enter clinical trials in China and the second globally, positioning the program at the forefront of targeted protein degradation research in autoimmune disease.

Understanding ICP-538 and VAV1 Degradation

ICP-538 is a novel molecular glue degrader (MGD) designed to selectively degrade the VAV1 protein. VAV1 plays a crucial role in the signaling pathways of T-cells and B-cells, immune cells central to the development of autoimmune diseases. By reducing VAV1 levels, ICP-538 aims to lessen the activity of these immune cells and mitigate inflammatory damage [1].

The therapy functions as a “molecular glue,” connecting the VAV1 protein to the CRBN E3 ubiquitin ligase, a natural protein degradation mechanism within cells. Preclinical studies have demonstrated that ICP-538 induces rapid and dose-dependent degradation of VAV1, significantly reducing the production of pro-inflammatory molecules associated with immune-mediated diseases, without affecting other proteins [2].

Potential Applications and Autoimmune Diseases Targeted

In addition to multiple sclerosis, InnoCare is developing ICP-538 for the treatment of other autoimmune conditions, including inflammatory bowel disease (IBD) and systemic lupus erythematosus (SLE) [2]. Autoimmune diseases occur when the immune system mistakenly attacks the body’s own tissues. In MS, this attack specifically targets the myelin sheath, a protective coating around nerve fibers essential for nerve signal transmission.

InnoCare’s Progress and Future Outlook

The Investigational Latest Drug (IND) application for ICP-538 was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) in February 2026 [2]. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, expressed optimism about the drug’s potential, stating the company believes ICP-538 will become a better treatment option for patients with autoimmune diseases [1].

Another VAV1 degrader, MRT-6160, is also under development for MS and other autoimmune conditions and has undergone a Phase 1 trial in the U.S. Involving healthy volunteers [1].