GtoPdb Ligand ID: 9807

Synonyms: BIVV009 | IPN-009 | IPN009 | TNT009
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. 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.
Immunopharmacology Comments
TNT009 is designed to selectively inhibit disease processes in the classical complement pathway whilst sparing the alternative and lectin complement pathways, which are required to maintain immune surveillance and other functions.
Immunopharmacology Disease
Disease X-Refs Comment References
Cold agglutinin disease Orphanet: ORPHA56425
TNT009 is a first-in-class C1-complex-targeting mAb, that is hoped to provide an effective treatment for CAD and other complement-mediated disorders. It is a Phase 3 clinical candidate for CAD (see NCT03347396) and Phase 1 for other disorders (see NCT02502903 and NCT03275454). TNT009 is an FDA and EMA orphan drug for the treatment of hemolysis in patients with primary CAD.