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▎WuXi AppTec content team editor (the content of this article is from Beihai Kangcheng's press release) Recently, Beihai Kangcheng announced that its long-acting recombinant humanized monoclonal antibody CAN106 targeting complement protein C5, in a single dose escalation (SAD) 1 Positive top-line results in Phase 1 clinical trials
.
Thirty-one healthy volunteers were randomized into six dose groups (0.
25/0.
75/2/4/8 and 12 mg/kg CAN106) and followed for at least 112 days
.
The final results confirmed that CAN106 was safe and well tolerated with no drug-related serious adverse events (SAEs)
.
CAN106 is an innovative long-acting recombinant humanized monoclonal antibody that binds and neutralizes C5, thereby preventing the formation of the membrane attack complex (MAC) that causes cytolysis and other factors associated with paroxysmal nocturnal hemoglobinuria Symptoms associated with PNH
.
When C5 protein is cleaved into C5a and C5b, MAC is activated, and the specific binding of CAN106 to C5 can block this process
.
CAN106 exhibited favorable pharmacokinetic/pharmacodynamic properties, safety and tolerability, suggesting its potential to effectively inhibit certain complement-mediated diseases
.
CAN106 showed good dose-dependent and pharmacokinetic properties with a terminal elimination half-life of approximately 32 days
.
CAN106 resulted in a dose-dependent reduction in free C5, a key protein required for activation of the terminal complement pathway, and potent inhibition of CH50 within 24 hours after administration
.
All subjects in the highest two dose groups (8 and 12 mg/kg) showed >99% reduction in free C5
.
Subjects in both cohorts also had >90% inhibition of CH50, and this inhibition persisted for 2 to 4 weeks
.
Previous studies have shown that a CH50>90% inhibition threshold indicates complete blockade of the classical terminal complement pathway
.
The complement system is a part of the innate immune system, and many rare diseases are related to the dysregulation of the complement system.
C5 is a clinically proven effective target for the treatment of diseases related to the dysregulation of the complement system
.
Image source: 123RF At the same time, Beihai Kangcheng's clinical trial application in China has been approved, and a phase 1b/2 clinical trial for the treatment of paroxysmal nocturnal hemoglobinuria can be conducted in China
.
PNH is a deadly rare disease in which hemolysis occurs due to dysregulation of the complement system, destroying red blood cells
.
In many countries, anti-C5 treatment options are limited, and in China, there is currently no approved long-acting antibody therapy for PNH
.
Xue Qun, Ph.
D.
, founder, chairman and CEO of Beihai Kangcheng, said, "These strong data demonstrate that CAN106 is safe and well-tolerated, reducing C5 levels to over 99% in healthy volunteers, while maintaining Inhibits CH50 by >90%
.
We are very encouraged
.
These results demonstrate complete functional blockade of the C5-mediated complement system by CAN106 and, importantly, provide the first validation of CAN106 as a potential complement-mediated disease Human data on treatments
.
We expect to promote CAN106 as a potential "first-in-class" PNH therapy in China and a potential "best-in-class" PNH therapy in other markets where PNH treatment options are very limited
.
Introduction to Paroxysmal Nocturnal Hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and fatal disorder of the complement system
.
The complement system is part of the immune system that attacks cell membranes to remove microorganisms and damaged cells, but its imbalance in regulation can lead to some diseases
.
PNH is a typical complement-related disease, which can cause severe anemia, thromboembolism, gastrointestinal pain and dysfunction, fatigue, pulmonary hypertension, renal Functional impairment will eventually lead to death
.
Reference: [1] Beihai Kangcheng announced the positive data of the phase I trial of CAN106, and was approved by the NMPA to conduct a phase Ib/II clinical trial for the treatment of PNH
.
Retrieved February 7, 2022, from https:// Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the opinions in this article do not represent WuXi AppTec This position does not mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
.
Thirty-one healthy volunteers were randomized into six dose groups (0.
25/0.
75/2/4/8 and 12 mg/kg CAN106) and followed for at least 112 days
.
The final results confirmed that CAN106 was safe and well tolerated with no drug-related serious adverse events (SAEs)
.
CAN106 is an innovative long-acting recombinant humanized monoclonal antibody that binds and neutralizes C5, thereby preventing the formation of the membrane attack complex (MAC) that causes cytolysis and other factors associated with paroxysmal nocturnal hemoglobinuria Symptoms associated with PNH
.
When C5 protein is cleaved into C5a and C5b, MAC is activated, and the specific binding of CAN106 to C5 can block this process
.
CAN106 exhibited favorable pharmacokinetic/pharmacodynamic properties, safety and tolerability, suggesting its potential to effectively inhibit certain complement-mediated diseases
.
CAN106 showed good dose-dependent and pharmacokinetic properties with a terminal elimination half-life of approximately 32 days
.
CAN106 resulted in a dose-dependent reduction in free C5, a key protein required for activation of the terminal complement pathway, and potent inhibition of CH50 within 24 hours after administration
.
All subjects in the highest two dose groups (8 and 12 mg/kg) showed >99% reduction in free C5
.
Subjects in both cohorts also had >90% inhibition of CH50, and this inhibition persisted for 2 to 4 weeks
.
Previous studies have shown that a CH50>90% inhibition threshold indicates complete blockade of the classical terminal complement pathway
.
The complement system is a part of the innate immune system, and many rare diseases are related to the dysregulation of the complement system.
C5 is a clinically proven effective target for the treatment of diseases related to the dysregulation of the complement system
.
Image source: 123RF At the same time, Beihai Kangcheng's clinical trial application in China has been approved, and a phase 1b/2 clinical trial for the treatment of paroxysmal nocturnal hemoglobinuria can be conducted in China
.
PNH is a deadly rare disease in which hemolysis occurs due to dysregulation of the complement system, destroying red blood cells
.
In many countries, anti-C5 treatment options are limited, and in China, there is currently no approved long-acting antibody therapy for PNH
.
Xue Qun, Ph.
D.
, founder, chairman and CEO of Beihai Kangcheng, said, "These strong data demonstrate that CAN106 is safe and well-tolerated, reducing C5 levels to over 99% in healthy volunteers, while maintaining Inhibits CH50 by >90%
.
We are very encouraged
.
These results demonstrate complete functional blockade of the C5-mediated complement system by CAN106 and, importantly, provide the first validation of CAN106 as a potential complement-mediated disease Human data on treatments
.
We expect to promote CAN106 as a potential "first-in-class" PNH therapy in China and a potential "best-in-class" PNH therapy in other markets where PNH treatment options are very limited
.
Introduction to Paroxysmal Nocturnal Hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and fatal disorder of the complement system
.
The complement system is part of the immune system that attacks cell membranes to remove microorganisms and damaged cells, but its imbalance in regulation can lead to some diseases
.
PNH is a typical complement-related disease, which can cause severe anemia, thromboembolism, gastrointestinal pain and dysfunction, fatigue, pulmonary hypertension, renal Functional impairment will eventually lead to death
.
Reference: [1] Beihai Kangcheng announced the positive data of the phase I trial of CAN106, and was approved by the NMPA to conduct a phase Ib/II clinical trial for the treatment of PNH
.
Retrieved February 7, 2022, from https:// Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the opinions in this article do not represent WuXi AppTec This position does not mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
