China-based Ascletis Pharma Inc. (HKG: 1672) announced that the clinical study of PD-L1 antibody ASC22 (envafolimab) in combination with chidamide as a functional cure for human immunodeficiency virus (HIV) infection has completed the enrollment of 15 HIV-infected patients. The study achieved this milestone in just two months since the first patient was dosed in July.
Study Design and Objectives
The study (ClinicalTrials.gov Identifier: NCT05129189) is designed to evaluate the efficacy of envafolimab combined with chidamide in clearing the viral reservoirs of latently infected cells in HIV patients. Ascletis BioScience Co., Ltd and Shenzhen Chipscreen Biosciences Co., Ltd are providing envafolimab and chidamide, respectively, for the clinical trial.
Envafolimab and Chidamide Background
Envafolimab is the world’s first subcutaneously administered single-domain antibody against PD-L1. It is viewed as having the properties necessary to potentially restore virus-specific immune responses in patients with chronic viral infections. The drug was originated by Alphamab Oncology (HKG: 9966) and licensed to Ascletis for viral disease indications in a January 2019 deal, which was expanded to a global scale in November 2021 after initial trial successes against hepatitis B.
Chipscreen’s chidamide is a first-in-class subtype-selective histone deacetylase inhibitor that has been on the market in China since December 2014 as a treatment for peripheral T-cell lymphoma, a rare disease. A second indication approval was awarded in November 2019 for use in combination with hormonal therapy in previously treated ER+/HER2- advanced breast cancer. The drug was out-licensed to Japan’s Meiji Seika Pharma for the territories of Japan, South Korea, Thailand, Malaysia, Indonesia, Philippines, Vietnam, and Singapore in January 2020.-Fineline Info & Tech
