BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–CANbridge Pharmaceuticals Inc. (HKEX:1228) , a China and US-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, announced that results from its CAN106 Phase 1 trial were presented at the 2022 European Hematology Association Congress, in Vienna, Austria, on June 10th. The same data will also be presented at the 14th International Conference on Complement Therapeutics, June 17-22, in Rhodes, Greece.
Researchers reported that the long-acting, humanized, anti-C5 monoclonal antibody, CAN106, was safe and well-tolerated with mostly mild or moderate adverse events and no drug-related serious adverse events in this first-in-human single ascending dose study in healthy subjects. Furthermore, CAN106 led to rapid (within 24 hours), dose-dependent reductions in free C5 and in CH50, a measure of serum hemolytic activity that reflects complement pathway activity. At the two highest doses (8 and 12 mg/kg), CAN106 achieved complete and sustained blockade of terminal complement activity, with all subjects showing a >99% reduction in free C5 and ≥90% inhibition of CH50. In addition, the half-life of circulating CAN106 in healthy volunteers was 31 days, which is similar to that of the approved anti-C5 agent, ravulizumab, which is dosed every eight weeks in patients.
The C5 protein is a component of the complement system, part of the innate immune system. Dysregulation or over-activity of the complement pathway is implicated in various complement-mediated diseases, including paroxysmal nocturnal hemoglobinuria (PNH).
“This is the first time we’ve been able to demonstrate, in humans, that CAN106 is able to achieve potent and rapid reduction of C5 levels and completely block terminal complement activity for up to four weeks, suggesting the possibility of an extended dosing regimen,” said Gerry Cox, MD, Ph.D., Chief Development Strategist and Interim Chief Medical Officer, CANbridge Pharmaceuticals. “With this data in healthy volunteers, we were able to show, via two independent measures, that our antibody suppresses the complement pathway activation implicated in PNH and other complement-mediated diseases. Building upon these encouraging results, we recently initiated a Phase 1b/2 study in PNH in China to identify the optimal dosing regimen of CAN106 in patients. We believe CAN106 will be applicable to other complement-mediated diseases as well.”
“We are pleased that the first data from our CAN106 clinical program was presented to the prestigious European Hematology Association and has been accepted at the International Conference on Complement Therapeutics later this month,” said James Xue, Ph.D., Founder, CEO and Chairman, CANbridge Pharmaceuticals. “This data provides a promising signal of complete and sustained complement inhibition, which we are investigating in our Phase 1b/2 trial in PNH, where we hope to bring new treatment choices to patients in China who currently have no extended-dose options, as well as to other markets globally, where treatment access is limited.”
Title: A Phase 1 Single Ascending Dose Study of CAN106, a Long-Acting Anti-C5 Complement Monoclonal Antibody in Clinical Development for PNH and Other Complement-Mediated Diseases
Abstract code: P822
Poster Session: Friday, June 10, 16:30 – 17:45 CEST
Authors: Chin Meng Khoo, Department of Medicine, National University Hospital, Singapore; Charlene Song, Clinical Development and Medical Affairs, CANbridge Pharmaceuticals, Inc.; Qizhen Wu, Clinical Development and Medical Affairs, CANbridge Pharmaceuticals, Inc., Gerald F. Cox, Clinical Development and Medical Affairs, CANbridge Pharmaceuticals.
Abstract available on the EHA website.
About CANbridge Pharmaceuticals Inc.
CANbridge Pharmaceuticals Inc. (HKEX:1228) is a China and US-based global biopharmaceutical company committed to the research, development and commercialization of transformative therapies for rare disease and rare oncology.
CANbridge has a comprehensive and differentiated pipeline of 13 drug assets with significant market potential, targeting some of the most prevalent rare diseases and rare oncology. These include Hunter syndrome (MPS II) and other lysosomal storage disorders (LSDs), complement mediated disorders, hemophilia A, metabolic disorders, rare cholestatic liver diseases and neuromuscular diseases, as well as glioblastoma multiforme (GBM).
CANbridge strategically combines global collaborations and internal research to build and diversify its drug portfolio and invest in next-generation gene therapy technologies for rare disease treatments. CANbridge global partners include, but are not limited to, Apogenix, GC Pharma, Mirum, Wuxi Biologics, Privus, the University of Massachusetts Medical School (UMass) and LogicBio.
For more on CANbridge Pharmaceuticals Inc., please go to: www.canbridgepharma.com.
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