Clinical Results of ASC22 (Envafolimab) in Combination with Chidamide for Functional Cure of HIV Infection Presented at the 12th IAS Conference on HIV Science

HANGZHOU and SHAOXING,China,July 25,2023 -- Ascletis Pharma Inc. (HKEX: 1672,"Ascletis") today announces that Shanghai Public Health Clinical Center presented clinical results of ASC22 (Envafolimab) in combination with Chidamide for functional cure of human immunodeficiency virus (HIV) infection at the 12th International AIDS Society (IAS) Conference on HIV Science in Brisbane,Australia,and virtually.

Led by Jun Chen,MD,Deputy Chief Physician,Infection and Immunity,Shanghai Public Health Clinical Center,this investigator-initiated Phase II trial (ClinicalTrials.gov Identifier: NCT05129189) enrolled 15 subjects in total living with HIV who had achieved virological suppression to receive a subcutaneous injection of ASC22 (1 mg/kg) once every four weeks (Q4W) in combination with 10 mg Chidamide administered orally twice a week (BIW) during the 12-week treatment while maintaining antiretroviral therapy (ART). Subjects were followed up for 24 weeks and measured the changes in the levels of cell-associated (CA) HIV RNA,plasma HIV RNA,total and integrated HIV DNA and HIV-specific CD8+ T cell function.

The objective of this study is to evaluate the efficacy of ASC22 (Envafolimab) combined with Chidamide on the viral reservoirs of latently infected cells in HIV-infected people. Ascletis BioScience Co.,Ltd.,a wholly-owned subsidiary of Ascletis,provided ASC22 (Envafolimab) for the clinical trial.

This Phase II study showed that combination treatment with ASC22 and Chidamide is well tolerated and effectively activated latent HIV reservoirs. There was a significant increase in CA HIV RNA at week 8 and week 12 compared to the baseline,with an average rise of 4.27-fold and 3.41-fold,respectively (P=0.001,P=0.006) in the subjects. The HIV CA RNA to total DNA ratios also showed the same trend (P=0.038,P=0.017,respectively). Further investigations are warranted.

It was estimated that there were approximately 39 million people living with HIV globally with 0.63 million deaths caused by AIDS-related illnesses and 1.3 million new HIV infections in 2022[1]. Combination ART can suppress the virus in blood,but it is not curative,as nearly all HIV-infected individuals will experience viral rebound within weeks or months when ART is discontinued.

"PD-1 and PD-L1 expressions are elevated in HIV-1 infected patients compared to healthy subjects. Recent studies indicated that blocking PD-1/PD-L1 pathway reversed HIV latency in patients. We are excited that ASC22 in combination of Chidamide effectively activated the latent HIV reservoirs. "Dr. Jinzi J. Wu,Founder,Chairman and CEO of Ascletis.

[1] UNAIDS. Global HIV & AIDS statistics — FACT SHEET. 2022. https://www.unaids.org/en/resources/fact-sheet

About International AIDS Society (IAS) Conference on HIV Science

The International AIDS Society (IAS) Conference on HIV Science is the premier global platform to advance the HIV response. As the world' s largest conference on HIV and AIDS,it sits uniquely at the intersection of science,advocacy and human rights,bringing together scientists,policy makers,healthcare professionals,people living with HIV,funders,media and communities. IAS 2023,the 12th IAS Conference on HIV Science,is scheduled to take place in Brisbane,and virtually from 23 to 26 July 2023.

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK),covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record,Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases,non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution,Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date,Ascletis has 20+ drug candidates in its R&D pipeline. The most advanced drug candidates include ASC10 (RSV infection),ASC22 (CHB functional cure),ASC40 (acne),ASC40 (recurrent glioblastoma),ASC40 (NASH),ASC41 (NASH) and ASC61 (advanced solid tumors).

For more information,please visit www.ascletis.com.