(RTTNews) – Ascletis Pharma Inc. (ASCLF.PK) announced dosing of the first HBV patient in Phase IIa clinical trial of ASC22, which is a first-in-class, subcutaneously administered PD-L1 antibody.
The company noted that ASC22 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.
ASC22, also known as KN035 or Envafolimab, licensed from Alphamab by Ascletis for all viral indications, is a PD-L1 single domain antibody Fc fusion and has the advantages of subcutaneous injection and good stability at room temperature.
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