Ascletis Announces Approval of Phase II Clinical Trial of ASC22 (Envafolimab) by China NMPA for Immune Restoration/Functional Cure of HIV-1 Infected Patients

Ascletis Pharma Inc. (HKEX: 1672) today announces the approval of the Phase II clinical trial of ASC22 (Envafolimab) by China National Medical Products Administration (NMPA) for the proposed new indication of immune restoration/functional cure of human immunodeficiency virus 1 (HIV-1) infected patients.

ASC22 (Envafolimab) is a subcutaneously administered single domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection. Immune restoration/functional cure in HIV-1 infected patients is the second indication of ASC22 developed by Ascletis, in addition to functional cure of chronic hepatitis B (CHB) patients.

HIV is estimated to infect approximately 38 million people globally, with approximately 0.69 million deaths in 2019 and approximately 1.7 million new infections occurring yearly. Combination antiretroviral therapy (cART) may lead to viremia suppression but is not curative, as nearly all HIV infected individuals experience viral rebound within weeks or months of discontinuing antiretroviral therapy.

The Phase II study is a randomized, single-blind, placebo-controlled, multi-center clinical trial in China which evaluates the safety and efficacy of 1 mg/kg or 2.5 mg/kg ASC22 or matching placebo given once every four weeks (Q4W) in combination with cART in HIV-1 infected patients with 12-week treatment and 12-week follow-up.

"PD-1 and PD-L1 expressions are elevated in HIV-1 infected patients compared to healthy subjects. Since we have shown promising results of functional cure in CHB patients through blocking PD-1/PD-L1 pathway by ASC22, we believe it is likely that ASC22 can help restore HIV-1 specific immunity in patients." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, "With the advantage of subcutaneous administration compared to those antibodies through intravenous injection, it will be much more convenient for patients with chronic virus infection as they can inject the drug by themselves and do not need to go to hospital or clinic."

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong, S.A.R., China Stock Exchange (1672.HK), a global platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors) to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 18 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

1. Viral Diseases: (1) Hepatitis B Virus (functional cure): focus on breakthrough therapies for CHB functional cure with a subcutaneously-injected PD-L1 antibody – ASC22 and Pegasys® as cornerstone drugs. (2) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients. (3) Hepatitis C: successfully launched an all-oral regimen of combining ASCLEVIR® and GANOVO® (RDV/DNV regimen). 2. Non-alcoholic Steatohepatitis/Primary Biliary Cholangitis: Gannex, a wholly-owned company of Ascletis, is dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THRβ and FXR, three fixed-dose combinations for NASH and one PBC program targeting FXR. 3. Cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors): a pipeline of oral inhibitors targeting FASN, which plays a key role in cancer lipid metabolism, and a pipeline of oral PD-L1 small molecule next generation immune checkpoint inhibitors. 4. Exploratory Indications: Acne: Following NASH and recurrent GBM, the third indication for ASC40 has been approved to enter Phase 2 clinical trial.

Source: Ascletis Pharma Inc.