Hong Kong-based biotech SinoMab BioScience Ltd (HKG: 3681) has announced that the National Medical Products Administration (NMPA) has accepted for review an investigational new drug (IND) filing for SM17, a potential global first-in-class monoclonal antibody. Developed in-house by SinoMab, SM17 is the world’s first humanized IgG4-κ monoclonal antibody targeting IL-17RB, an immunoregulatory protein with potential as a treatment for asthma, atopic dermatitis, idiopathic pulmonary fibrosis, and other immunological disorders.
SM17’s Mechanism of Action and Potential Applications
SM17 is capable of suppressing Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), thereby blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25, a critical cytokine classified as an “alarmin,” has been implicated in the pathogenesis of airway viral responses and allergic diseases, such as asthma.
IND Filing and Clinical Development Progress
The IND filing signifies that SinoMab is set to begin China-based development of SM17, which has already entered a first-in-human Phase I study in the United States in June 2022 for assessment as a treatment for asthma. The China Phase I study will serve as a bridging study to the US trial and provide data specific to the Chinese ethnic group. The progress of the US Phase I study is reportedly strongly positive, with no serious adverse events in patients, and the trial is expected to be completed six months ahead of schedule by the end of 2023.
SinoMab’s Pipeline and Clinical Candidates
SM17 is SinoMab’s third pipeline candidate product to enter the clinic, following lead candidate SM03 (suciraslimab), a CD22-targeted antibody that achieved primary endpoints in a Phase III study for rheumatoid arthritis last month, and SN101, a Bruton’s tyrosine kinase (BTK) inhibitor currently in Phase II trials in China and the US.-Fineline Info & Tech
