SinoMab BioScience Limited (SinoMab or the Company, together with its subsidiaries, the Group, HKG: 3681), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, today announced that the first healthy subject has been dosed in Phase I clinical trial of SM17 in the U.S. SM17 is a First-in-Class (FIC) humanized anti-IL-17RB monoclonal antibody. The subject is currently in a normal condition.
SM17 is the world’s first humanized IgG4-k monoclonal antibody targeting IL-17RB. SM17 is currently under development by SinoMab, and was engineered by LifeArc (a leading medical research charity based in the United Kingdom). SM17 was originally developed by Dr. Andrew McKenzie, FRS, who also serves as a member of the Company’s Scientific Advisory Board, at the MRC Laboratory of Molecular Biology (LMB).
SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as “alarmin”, which has shown to be implicated in the pathogenesis of airway viral responses and allergic diseases, such as uncontrolled severe asthma. Uncontrolled severe asthma is associated with increased mortality/ morbidity, diminished quality of life and increased health expenditures. These patients are at risk of recurrent asthma exacerbations and hospitalizations. The Company expected that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB on ILC2s, will have a broad effect on airway inflammation. The Company believes the huge potential of SM17 could satisfy unmet medical needs in asthma treatment. The Phase I study is a Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) to investigate the safety, tolerability and pharmacokinetics of SM17 in healthy subjects.
SM17 received Investigational New Drug (IND) approval from U.S. Food and Drug Administration (FDA) on 11 March 2022. Despite the pandemic, SinoMab soon initiated the first-in-human dose in Phase I clinical trial. This marks a significant milestone on the collaboration between SinoMab and LifeArc, and demonstrates the efficient implementation of SinoMab’s new drug R&D programs.
Melanie Lee, Chief Executive Officer of LifeArc, said: “We applied our antibody capabilities when working with Dr. Andrew McKenzie at the LMB, to firstly generate and select a clinical candidate antibody targeting IL-17RB, and then humanise it. After evaluating and choosing the lead candidate, it was licensed to SinoMab to take forward into clinical development and towards patients. It’s so rewarding to know that this antibody is going into trials and could eventually make a difference to people with severe asthma.”
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: “SM17’s successful first-in-human dosing in Phase I clinical trial marked another milestone in our pipeline development. Following our flagship product, SM03 and key product, SN1011, we now have another key asset entering the clinical trial stage. This further assures our potential commercialization prospects and proves our capability for progressing multiple assets of R&D concurrently. We are confident of the enormous prospects for SM17’s clinical development as well as our commercialization opportunities in general. Moving forward, we will accelerate the implementation of our projects, adhere to our vision of independent innovation to bring benefits to patients and create value for shareholders.”
LifeArc is a self-financing and leading UK medical research charity. It partners and works with academics, industry, charities and patient groups to unlock the potential of early-stage science. It has an office in London and scientific research facilities in Stevenage and Edinburgh. It also has a specialist science team working at the Francis Crick Institute in London.
About SinoMab BioScience Limited
SinoMab BioScience Limited (HKG: 3681) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.