China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) released the latest data from a Phase I single-dose escalation study for its pipeline drug candidate CAN106, a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The results were unveiled at the European Hematology Association (EHA) congress in Singapore.
Study Results
The study demonstrated for the first time that CAN106 can effectively and rapidly reduce C5 levels and completely block terminal complement activity for up to four weeks. The drug showed good tolerance with no drug-related serious adverse events. Researchers reported a rapid, dose-dependent reduction of free C5 and CH50, with free C5 in the two highest dose groups (8 and 12mg/kg) reduced by >99% and CH50 inhibited by ≥90%. Terminal complement activity was completely and continuously blocked.
Pharmacokinetic Profile
The half-life of circulating CAN106 in healthy subjects was 31 days, comparable to the approved anti-C5 drug ravulizumab, administered every 8 weeks.
Mechanism of Action
CAN106 prevents the formation of the membrane attack complex (MAC) by binding and neutralizing C5, a complement system protein involved in conditions like paroxysmal nocturnal hemoglobinuria (PNH). By blocking the cleavage of C5 into C5a and C5b, CAN106 inhibits MAC activation.
Development and Partnerships
CAN106 exhibits favorable pharmacokinetic/pharmacodynamic (PK/PD) profiles, safety, and tolerability. CANbridge partnered with Wuxi Biologics and Privus Biologics in 2019 and 2020 to develop rare disease drugs, holding global exclusive development and commercialization rights to CAN106. A Phase Ib/II study in PNH in China was initiated in March 2022.-Fineline Info & Tech
