Shanghai Public Health Clinical Center completes first patient dosing in clinical trial of PD-L1 antibody ASC22 in combination with hydamide for functional treatment of HIV infection

HANGZHOU and SHAOXING, China, July 3, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announced that the clinical trial of PD-L1 antibody ASC22 in combination with Chidamide for the functional treatment of human immunodeficiency virus (HIV) infection, which was initiated by the Public Health Clinical Center in Shanghai, completed the first patient dosing recently.

Ascletis previously announced the completion of the first patient dosing in a Phase II clinical trial of ASC22 as an antiretroviral therapy (ART)-based monotherapy for immune restoration/functional cure of human immunodeficiency virus 1 (HIV-1) infection (https :// This investigator-initiated trial, which recently completed first patient dosing, will further explore the potential of ASC22 in combination with Chidamide. Clinical trials of ASC22 both as a monotherapy and in combination are favorable to improving Ascletis’ line of functional HIV treatments.

ASC22 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 HIV cells are a major obstacle to curing HIV infection. Latest data [1] demonstrated that blocking the PD-1/PD-L1 pathway resulted in reversal of HIV latency in a clinical trial and supports the rationale for combining a PD-1/PD-L1 antibody with other drugs to reduce the HIV reservoir of latently infected cells. Chidamide is the first globally approved subtype-selective histone deacetylase inhibitor (HDACi), mainly targeting class I subtype 1, 2, 3 and class IIb histone deacetylase (HDAC) subtype 10, with an anti-epigenetic abnormality mechanism.

“I am very pleased that the study of PD-L1 antibody ASC22 in combination with Chidamide for the functional cure of HIV infection has entered the clinical stage with the first dosed patient.” Previous studies have suggested that PD-1/PD-L1 inhibitors may be very promising drugs to achieve a functional cure of HIV, and I expect the study results to benefit more HIV-infected patients,” said Jun Chen, MD, Deputy Chief Physician, Infection and Immunity, Shanghai Public Health Clinical Center and principal investigator of the study.

“The completion of the first patient dosing marks a new milestone in the study of the PD-L1 antibody ASC22 in combination with Chidamide for the functional cure of HIV infection. Functional cure of HIV/AIDS remains a challenge in China and globally despite improved access to standard ART treatment. The expressions of PD-1 and PD-L1 are increased in HIV-1 infected patients compared to healthy individuals. Recent data show that blocking the PD-1/PD-L1 pathway reverses HIV latency in patients and hopefully clears the HIV reservoir,” said Dr. Jinzi J. Wu, founder, chairman and CEO of Ascletis. .

Dr. Lu Xianping, founder, chairman and general manager of Chipscreen Biosciences, said: “The main obstacle preventing the eradication of HIV is the persistence of a latent reservoir, while current treatments are still ineffective in eliminating the HIV reservoir. Data show that Chidamide safely and vigorously disrupts HIV latency and is therefore expected to play a key role in treatment. I expect that the results of Chidamide combined with ASC22 will bring more positive benefits to HIV/AIDS patients.

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

About ASC22 (KN035)

Ascletis Pharma Inc (1672.HK) retains global and exclusive rights to develop and commercialize ASC22 (KN035) in viral indications. Positive progress has been made from clinical trials of ASC22 (KN035), including:

1) Functional cure of chronic hepatitis B (CHB): interim results of a Phase IIb clinical trial in China showed that 1 mg/kg KN035 (ASC22) plus NA for 24 weeks of treatment was well tolerated by patients with CHB. 42.9% of patients with baseline HBsAg≤100 IU/mL achieved sustained HBsAg loss, indicating the potential for functional cure. Abstract selected for oral presentation at EASL ILC 2022.

2) Functional HIV Cure: A Phase II clinical trial is ongoing with first subject dosing recently completed in China. A phase I/II clinical trial in the US has received IND clearance from the US Food and Drug Administration. A clinical trial of ASC22 (KN035) in combination with Chidamide initiated by the Shanghai Public Health Clinical Center (investigator-initiated trial) has also completed the first patient dosing.

About Ascletis

Ascletis is an innovative R&D-led biotechnology company 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 experience 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 is rapidly advancing its drug pipeline to be a leader in global competition. To date, Ascletis has three marketed products viz. ritonavir tablets, GANOVO® and ASCLEVIR®, and 20 drug candidates in its research and development. The most advanced drug candidates include ASC22 (functional treatment of CHB), ASC10 and ASC11 (oral small molecules for the treatment of COVID-19), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis) and ASC40 (acne).

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SOURCE Ascletis Pharma Inc.

Company codes: Hong Kong: 1672

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