17 August 2020 | News
Phase IIa clinical trial is a single dose-escalation study with three subcutaneously administered doses to explore the safety and efficacy of ASC22 in chronic hepatitis B patients.
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China-based Ascletis Pharma Inc. recently announced the dosing of the first HBV patient in Phase IIa clinical trial of ASC22, which is a first-in-class, subcutaneously administered PD-L1 antibody. ASC22(Envafolimab) Phase IIa clinical trial is a single dose-escalation study with three subcutaneously administered doses (0.3, 1.0, and 2.5 mg/kg) to explore the safety and efficacy of ASC22(Envafolimab) in chronic hepatitis B patients.
As T cell exhaustion in chronic HBV infections is an important factor in immune tolerance, blocking the PD-1/PD-L1 pathway could be an effective immunotherapy approach to improve specific T cell function and lead to an effective clinical cure for chronic hepatitis B. There are 257 million people worldwide, including 70 million people in China, infected by HBV.
Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis commented, "We are excited about dosing the first chronic hepatitis B patient with ASC22(Envafolimab). As first-in-class immunotherapy with the potential to clinically cure chronic hepatitis B, ASC22(Envafolimab) offers convenient subcutaneous injections for patients and has potential to be a cornerstone therapy in various treatment regimens, including combinations with our in-house developed drug candidates and potentially with drug candidates from other industry leaders."