China-based Ascletis Pharma Inc. (HKG: 1672) announced the dosing of the first patient in its Phase II clinical trial for ASC22 (envafolimab) in combination with anti-retroviral therapy (ART) for the immune restoration and functional cure of human immunodeficiency virus 1 (HIV-1) infection. This trial marks a significant step forward in exploring potential curative options for HIV-1.
Trial Design
The Phase II study (ClinicalTrials.gov: NCT05330143) is a randomized, single-blind, placebo-controlled, multi-center clinical trial. It will evaluate the safety and efficacy of ASC22 administered at doses of 1 mg/kg or 2.5 mg/kg in combination with ART, compared to placebo plus ART, over 12 treatment weeks with a 12-week follow-up. The primary outcome measures include changes to the CD4/CD8 ratio from baseline at weeks 4, 8, and 12.
Drug Profile and Mechanism
ASC22, a subcutaneously administered single-domain antibody against PD-L1, is the world’s first of its kind. It has the potential to restore virus-specific immune responses in patients with chronic viral infections. This mechanism offers hope for a functional cure in HIV-1 infection, where current combination ARTs suppress viremia but do not provide a cure.
Development Background
Envafolimab was originally developed by Alphamab Oncology (HKG: 9966) under a January 2019 deal focused on viral disease indications. The collaboration expanded globally in November 2021 following promising trial results in hepatitis B. ASC22 received clinical approval in the US for assessment as a functional cure for chronic hepatitis B virus in January 2022, with a subsequent clinical study for HIV functional cure initiated in China the following month.-Fineline Info & Tech
