sutimlimab   Click here for help

GtoPdb Ligand ID: 9807

Synonyms: BIVV009 | Enjaymo® | IPN-009 | IPN009 | sutimlimab-jome | TNT009
Approved drug Immunopharmacology Ligand
sutimlimab is an approved drug (EMA & FDA (2022))
Compound class: Antibody
Comment: Sutimlimab (TNT009) is a humanised, monoclonal antibody that is designed to selectively inhibit the classical complement pathway by targeting C1s [3]; C1s being the serine protease component of the C1-complex in the complement pathway of the immune system. It prevents hemolysis. Sutimlimab is claimed in True North Therapeutics' patent WO2016164358A1 [4] and is likely to be the antibody designated as VH4/VK2 based on peptides matches between those provided in the submission to the WHO for INN sutimlimab and those in the patent application (namely SEQ IDs NOs 42 and 44). The research code TNT009 was changed to BIVV009 when True North Therapeutics were acquired by Bioverativ (a Sanofi company) in 2017, and clinical trials are ongoing using both of these code names.
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Summary of Clinical Use Click here for help
Click here to link to's list of current TNT009 (and BIVV009) trials. In May 2020 the FDA granted priority review of sutimlimab for the treatment of complement C1-activated hemolysis in adult patients with cold agglutinin disease (CAD). In February 2022 the FDA authorised sutimlimab as the first and only approved treatment for the prevention of hemolysis in CAD patients.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT02502903 Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders Phase 1 Interventional Bioverativ Therapeutics Inc.