Ascletis Pharma announces 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 (ClinicalTrials.gov Identifier: NCT04465890).

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.

“We are excited about dosing the first chronic hepatitis B patient with ASC22(Envafolimab),” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. “As a 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 industrial leaders.”

“We are expecting the clinical results of the safety and efficacy of Envafolimab in HBV patients,” said Dr. Ting Xu, Chairman of Alphamab. “Due to its unique immune mechanism, Envafolimab is likely to trigger HBV specific immune response, produce seroconversion, and bring hope of cure to patients. And it may also be used in patients with other chronic viral infections. The safety and convenience of subcutaneous administration of Envafolimab have been reflected to the greatest extent in the treatment of chronic diseases.”