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Gale Pharmaceuticals Co.
, Ltd.
announced today that the Phase IIa clinical trial of ASC22 (Envolimab) has achieved good results
.
ASC22 is the world's first (first-in-class) PD-L1 antibody that can be injected subcutaneously for the functional cure of chronic hepatitis B (CHB)
The Phase IIa clinical trial of ASC22 is a single-dose escalation study, using three subcutaneous doses (0.
3, 1.
0 and 2.
5 mg/kg, three patients with each dose injection), and a 12-week follow-up to explore the role of ASC22 in chronic Safety and effectiveness in patients with hepatitis B (ClinicalTrials.
gov registration number: NCT04465890)
.
The primary efficacy endpoint of the trial was the decline of hepatitis B surface antigen during the 12-week follow-up after a single dose
The Phase IIa clinical trial data showed that after a single administration of ASC22 (0.
3, 1.
0, and 2.
5 mg/kg doses, respectively), the hepatitis B surface antigen showed a dose-dependent downward trend
.
Of the nine patients treated with ASC22, eight showed some degree of hepatitis B surface antigen decline at the end of the 12-week follow-up
ASC22 showed good safety and tolerability in different dose groups, and all drug-related adverse reactions were grade 1
.
During the 12-week follow-up, no adverse reactions of grade 2 or above were observed.
On January 12, 2019, Gally and Suzhou Corning Jereh Biotechnology Co.
, Ltd.
reached an exclusive development agreement on the programmed cell death ligand-1 (PD-L1) antibody drug ASC22 (KN035)
.
According to the terms of the agreement, Gale has obtained the exclusive rights to develop and commercialize ASC22 (KN035) in the Greater China region for the treatment of viral diseases, including hepatitis B and AIDS
"It is very exciting that only a single administration of ASC22 can reduce the surface antigen of hepatitis B by more than 1.
0 log," the principal investigator of the ASC22 clinical trial, the vice president of the Infectious Diseases Branch of the Chinese Medical Doctor Association, and the Department of Infectious Diseases, Peking University First Hospital Professor Wang Guiqiang, Director of the Center for Liver Diseases, said, “As an immunotherapy, ASC22 has the potential for functional cure of chronic hepatitis B and the convenience of subcutaneous injection
.
I look forward to the next ASC22 phase IIb hepatitis B trial in more subjects.
Dr.
Wu Jinzi, founder, chairman and chief executive officer of Geli said: "We are very excited about the good results achieved in the phase IIa clinical trial of ASC22.
We believe that as the world's first immunotherapy, ASC22 will demonstrate the functional cure of chronic hepatitis B.
Great potential
.
"
Dr.
Xu Ting, Chairman of Corning Jerry, said: “The results of this single-dose trial are very encouraging
.
Based on its advantages in safety, convenience, and compliance, KN035 (ASC22) is expected to be a good candidate for chronic diseases including hepatitis B and AIDS.
