Ascletis Pharma announces that the clinical study of PD-L1 antibody ASC22 (Envafolimab) in combination with Chidamide for functional cure of human immunodeficiency virus (HIV) infection has completed the enrollment of 15 HIV infected patients.

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 patients. Ascletis BioScience and Shenzhen Chipscreen Biosciences provide ASC22 (Envafolimab) and Chidamide, respectively, for the clinical trial.

The study design of this trial is 1 mg/kg ASC22 (Envafolimab) subcutaneous injection once every four weeks (Q4W) in combination with 10 mg Chidamide administered orally twice a week (BIW) with 12-week treatment.

"The clinical study of PD-L1 antibody ASC22 (Envafolimab) in combination with Chidamide for functional cure of HIV infection enrolled the first patient on July 1, 2022. I'm very happy it completed all patient enrollment within less than 3 months. I expect to advance the clinical study to further explore the potential of ASC22 (Envafolimab) in combination with Chidamide as functional cure of HIV Infection." said Jun Chen, MD, Deputy Chief Physician, Infection and Immunity, Shanghai Public Health Clinical Center and the principal investigator of the study.

"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 with healthy subjects. Recent data indicated that blocking PD-1/PD-L1 pathway reversed HIV latency in patients, and hopefully clear the HIV reservoir. 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 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."