Shanghai Public Health Clinical Center has initiated a functional cure study of anti-PD-L1 antibody ASC22 (Envafolimab) in combination with chidamide in HIV-infected patients

HANGZHOUChina and SHAOXING, China, February 14, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672) announces today that the Shanghai Public Health Clinical Center has initiated a functional cure study of anti-PD-L1 antibody ASC22 (Envafolimab) in combination with Chidamide in patients infected with the virus. immunodeficiency (HIV) with antiviral suppression.

The objective of this study ( 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 for this trial is a subcutaneous injection of 1 mg/kg ASC22 (Envafolimab) once every four weeks (Q4W) in combination with 10 mg Chidamide given orally twice weekly ( BIW) with a 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 virus B (HBV) and HIV.

Cells latently infected with HIV are a major obstacle to curing HIV. Recent data[1] demonstrated that blocking the PD-1/PD-L1 pathway resulted in the reversal of HIV latency in the clinical trial and supported the rationale for combining the 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) January 26, 2022

Jun ChenMD, Deputy Chief Physician, Infection and Immunity, Shanghai Public Health Clinical Center, said, “I am very happy that the study has been successfully launched! Previous studies have suggested that PD-1/PD-L1 inhibitors may be very promising drugs for achieving a functional cure for HIV, and I look forward to the results of the study.”

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

Dr. Lu Xianping, Founder, Chairman and CEO of Chipscreen Biosciences, said, “The main obstacle hindering the eradication of HIV is the persistence of the latent reservoir. Chidamide is the world’s first approved oral selective histone deacetylase inhibitor (HDACi) subtype. . Data has shown that chidamide safely and vigorously disrupts HIV latency, and therefore is expected to play a key role in therapy. I expect the results of chidamide combined with ASC22 to provide more positive benefits to HIV/AIDS patients.

About Ascletis

Ascletis is an innovative, R&D-focused biotechnology company listed on the Hong Kong Stock Exchange (1672.HK), a global platform covering the entire value chain, from discovery and development to manufacturing and marketing. Ascletis is committed to developing and commercializing innovative medicines in the areas of viral diseases, NASH/PBC and cancer (oral cancer metabolic and immune checkpoint inhibitors) to address unmet medical needs both in China and globally. Led by a management team with deep expertise and proven track record, Ascletis targets therapeutic areas with unmet medical needs from a global perspective and effectively advances pipeline development with the goal of dominating global competition. . To date, Ascletis has three commercialized products and 20 robust R&D pipelines of globally competitive drug candidates, and is actively exploring new therapeutic areas.

1. Viral Diseases: (1) Hepatitis B Virus (Functional Cure): Focus on Breakthrough Therapies for Hepatitis B Functional Cure with Subcutaneously Injected PD-L1 Antibody – ASC22 and Pegasys ® as basic drugs. (2) COVID-19 pipeline: currently includes (i) ritonavir oral tablet (100mg), an authorized product, (ii) ASC10, an oral RNA-dependent RNA polymerase (RdRp) inhibitor, and ( iii) ASC11, a 3-inhibitor of chymotrypsin like protease (3CLpro). (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to functional cure of HIV-infected patients. (4) Hepatitis C: successful launch of an all-oral regimen combining ASCLEVIR® and GANOVO® (RDV/DNV regimen).

2. Non-alcoholic steatohepatitis/primary biliary cholangitis: Gannex, a 100% Ascletis company, 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 a 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 small molecule PD-L1 next-generation immune checkpoint inhibitors.

4. Exploratory indications: Acne: After NASH and recurrent GBM, the third indication for ASC40 has been approved to enter the phase 2 clinical trial. For more information, visit www.ascletis. com.

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SOURCEAscletis Pharma Inc.

Company Codes: Hong Kong: 1672

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