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July 5, 2022

Ascletis Pharma doses first subject in HIV treatment trial

The study will evaluate the potential of PD-L1 antibody ASC22 in combination with Chidamide.

Ascletis Pharma has dosed the first participant in the clinical trial of ASC22 (envafolimab) plus chidamide for functional cure of human immunodeficiency virus (HIV) infection.

ASC22 is a single domain antibody against programmed death-ligand 1 (PD-L1).

It is given subcutaneously and can restore virus-specific immune responses in chronic viral infection patients.

Last month, the company dosed the first participant in the Phase II clinical trial of ASC22 along with anti-retroviral therapy (ART) for immune restoration/ functional cure of HIV-1 infection in China.

The investigator-initiated trial was designed to assess ASC22’s safety and efficacy to treat HIV-1 infection versus placebo, along with ART once every four weeks (Q4W) during 12-week treatment and 12-week follow-up.

Initiated by Shanghai Public Health Clinical Center, the study will further explore the PD-L1 antibody’s potential in combination with Chidamide.

Chidamide mainly targets the subtype 1, 2, 3 of Class I and subtype 10 of Class IIb histone deacetylase (HDAC) and acts against epigenetic abnormality.

It is said to be the first approved subtype-selective histone deacetylase oral inhibitor (HDACi) in the world.

As per the recent data, blocking the PD-1/PD-L1 pathway reversed HIV latency and supported the rationale for combining PD-1/PD-L1 antibody with other drugs for reducing the HIV reservoir of latently infected cells.

Ascletis Pharma chairman, founder, and CEO Dr Jinzi Wu said: “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.”

The company stated that the clinical trials on ASC22 in combination and as monotherapy are conducive to improve its pipeline on HIV functional cure.

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