Hangzhou and Shaoxing, China, May 11, 2022-- Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today the Investigational New Drug (IND) application approval of ASC22 (Envafolimab) by U.S. Food and Drug Administration (FDA) for the indication of immune restoration/functional cure of human immunodeficiency virus 1 (HIV-1) infected patients.
Human immunodeficiency virus (HIV) is estimated to infect approximately 37.7 million people globally, with approximately 0.68 million deaths in 2020 and approximately 1.5 million new infections occurring yearly. In the U.S., there were approximately 1.2 million patients living with HIV at year-end 2019. Combination antiretroviral therapy (cART) may lead to viremia suppression but is not curative, as nearly all HIV infected individuals experience viral rebound within weeks or months after antiretroviral therapy discontinuation.
ASC22 (Envafolimab) 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. Immune restoration/functional cure in HIV-1 infected patients is the second indication of ASC22 that obtained IND approval from U.S. FDA, in addition to the indication of functional cure of chronic hepatitis B (CHB) patients.
The U.S. FDA approved ASC22 trial is a multi-center, randomized, single-blind, placebo-controlled, Phase I/II clinical trial to evaluate the safety, efficacy, and pharmacokinetics characteristics of ASC22 in HIV infected patients on antiretroviral therapy (ART). The objectives of this Phase I/II trial are (1) to evaluate the safety of ASC22 versus placebo in participants on suppressive ART; (2) to determine whether ASC22 1.0 mg/kg, given once every four weeks, can improve HIV-1-specific cellular immune responses; and (3) to evaluate the effects of ASC22 versus placebo on latency reversal of HIV.
Ascletis announced that it had obtained a global and exclusive license as of November 8, 2021 from Suzhou Alphamab Co., Ltd. to develop and commercialize ASC22 for all viral diseases including Hepatitis B and HIV/AIDS. Ascletis books sales globally for ASC22 of all viral diseases.
“U.S. IND approval of ASC22 (Envafolimab) for HIV/AIDS treatment is a major step in our effort to pursue HIV functional cure. Meanwhile, we are looking forward to collaborating with the industrial leaders in the field of HIV/AIDS.” said Jinzi J. Wu, PhD, Founder, Chairman and CEO of Ascletis.
 UNAIDS. Global HIV & AIDS statistics — FACT SHEET. 2021.
 CDC. Estimated HIV incidence and prevalence in the United States, 2015–2019. HIV Surveillance Supplemental Report 2021; 26 (No. 1).
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 20 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne).
For more information, please visit www.ascletis.com.
Ascletis Pharma Inc.