Shanghai Public Health Clinical Center Completed the First Patient Dosing in Clinical Study of PD-L1 Antibody ASC22 in Combination with Chidamide for Functional Cure of HIV Infection

Ascletis Pharma Inc. today announces that the clinical study of PD-L1 antibody ASC22 in combination with Chidamide for functional cure of human immunodeficiency virus (HIV) infection, which was initiated by Shanghai Public Health Clinical Center, has completed the first patient dosing recently. Previously, Ascletis announced the completion of the first patient dosing in the Phase II clinical trial of ASC22 as a monotherapy based on anti-retroviral therapy (ART) for immune restoration/ functional cure of human immunodeficiency virus 1 (HIV-1) infection This investigator-initiated trial, which has completed the first patient dosing recently, will further explore the potential of ASC22 in combination with Chidamide. Clinical trials on ASC22 as both monotherapy and combination are all conducive to enhancing Ascletis' pipeline on HIV functional cure. 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 cells by HIV are a major barrier to curing HIV infection. 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. Chidamide is the global first approved subtype-selective histone deacetylase oral inhibitor (HDACi) mainly targeting the subtype 1, 2, 3 of Class I and subtype 10 of Class IIb histone deacetylase (HDAC), with a mechanism against epigenetic abnormality. "I'm very glad that the study of PD-L1 antibody ASC22 in combination with Chidamide for functional cure of HIV infection entered the clinical stage with the first patient dosed. Previous studies have suggested that PD-1/PD-L1 inhibitors may be very promising drugs for achieving a functional cure for HIV, and I expect the results of the study could benefit more HIV-infected patients." said Jun Chen, MD, Deputy Chief Physician, Infection and Immunity, Shanghai Public Health Clinical Center and the principal investigator of the study. "The completion of the first patient dosing marks a new milestone of the study of PD-L1 antibody ASC22 in combination with Chidamide for functional cure of HIV infection. Functional cure of HIV/AIDS remains a challenge in China and globally despite the improved access of standard ART treatment. 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, and hopefully clear 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, stated, "The major obstacle that impedes HIV eradication is the persistence of latent reservoir, while current treatments are still ineffective in eliminating HIV reservoir. 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." [1] Uldrick et al., Sci. Transl. Med. 14, eabl3836 (2022) 26 January 2022 About ASC22 (KN035) Ascletis Pharma Inc (1672.HK) retains the global and exclusive rights to develop and commercialize ASC22 (KN035) on viral indications. Positive progress has been made from clinical trials of ASC22 (KN035) including: 1) Chronic hepatitis B (CHB) functional cure: interim results from the Phase IIb clinical trial in China showed 1mg/kg of KN035 (ASC22) plus NAs for 24-week treatment were well-tolerated in CHB patients. 42.9% of patients with baseline HBsAg?100 IU/mL obtained sustained HBsAg loss, which indicates the potential of functional cure. The abstract has been selected to oral presentation at EASL ILC 2022. 2) HIV functional cure: Phase II clinical trial is ongoing with first subject dosing completed recently in China. The Phase I/II clinical trial in the U.S. has obtained IND clearance from U.S. Food and Drug Administration. The clinical trial of ASC22 (KN035) in combination with Chidamide, initiated by Shanghai Public Health Clinical Center (investigator initiated trial) also completed first patient dosing.

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