Shanghai Public Health Clinical Center Initiated Functional Cure Study of Anti-PD-L1 Antibody ASC22 (Envafolimab) in Combination With Chidamide in HIV-Infected Patients

HANGZHOU,Chinaand SHAOXING,China,Feb. 14,2022 -- Ascletis Pharma Inc. (HKEX: 1672) today announces that Shanghai Public Health Clinical Center initiated functional cure study of anti-PD-L1 antibody ASC22 (Envafolimab) in combination with Chidamide in patients infected by human immunodeficiency virus (HIV) with antiviral suppression.

The objective of this study (ClinicalTrials.gov Identifier: NCT05129189) is to evaluate the effect of ASC22 (Envafolimab) combined with Chidamide on the viral reservoirs of latently infected cells in HIV patients. Ascletis BioScience Co.,Ltd. and Shenzhen Chipscreen Biosciences Co.,Ltd. provide ASC22 and Chidamide,respectively,for the clinical trial.

The study design of this trial is 1 mg/kg ASC22 (Envafolimab) subcutaneous injection once every four weeks (Q4W) in combination with 10 mg Chidamide administered orally twice a week (BIW) with 12-week treatment.

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 such as hepatitis B virus (HBV) and HIV.

Latently infected cells by HIV are a major barrier to curing HIV. Recent data[1] demonstrated that blocking PD-1/PD-L1 pathway resulted in reversing HIV latency in the clinical trial and supported the rationale for combining PD-1/PD-L1 antibody with other drugs to reduce the HIV reservoir of latently infected cells.

[1] Uldrick et al.,Sci. Transl. Med. 14,eabl3836 (2022) 26 January 2022

Jun Chen,MD,Deputy Chief Physician,Infection and Immunity,Shanghai Public Health Clinical Center,stated,"I am very pleased that the study has been successfully initiated! Previous studies have suggested that PD-1/PD-L1 inhibitors may be very promising drugs for achieving a functional cure for HIV,and I am very much looking forward to the results of the study."

Dr. Jinzi J. Wu,Founder,Chairman and CEO of Ascletis,"I am very happy that combination of ASC22 and Chidamide is recognized by experts at Shanghai Public Health Clinical Center as a treatment option for HIV functional cure. PD-1 and PD-L1 expressions are elevated in HIV-1 infected patients compared to healthy subjects. Recent data indicated that blocking PD-1/PD-L1 pathway reversed HIV latency in patients. I expect clinical data from the ASC22 combined with Chidamide trial will be very exciting."

Dr. Lu Xianping,Chairman and General Manager of Chipscreen Biosciences,"The major obstacle that impedes HIV eradication is the persistence of latent reservoir. Chidamide is the first approved subtype of selective histone deacetylase oral inhibitor (HDACi) of the world. Data showed Chidamide safely and vigorously disrupts HIV latency,and therefore it is expected to play a key role in treatment. I expect that the results of Chidamide combined with ASC22 will bring more positive benefits to patients with HIV/AIDS."

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong 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 20 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) COVID-19 pipeline: currently includes (i) ritonavir oral tablet (100 mg),an authorized product,(ii) ASC10,an oral RNA dependent RNA polymerase (RdRp) inhibitor and (iii) ASC11,an oral 3-chymotrypsin like protease (3CLpro) inhibitor. (3) HIV/AIDS: ASC22,an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients. (4) 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. For more information,please visit www.ascletis.com.