Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, today announced that a Phase I study of the best-in-class anti-CD24 antibody, ATG-031, has been approved by the Institutional Review Board (IRB) of The University of Texas MD Anderson Cancer Center in Houston, Texas, the United States. This clinical study, codenamed the PERFORM trial and led by MD Anderson, will be conducted in patients with advanced solid tumors or B-NHL. 

The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or B-NHL. The study's primary objective is to evaluate the safety and tolerability of ATG-031 as a monotherapy, and determine the appropriate dose for Phase II studies. The secondary objective is to characterize the pharmacology, evaluate the immunogenicity, and assess the preliminary efficacy of ATG-031.

Dr. Amily Zhang, Antengene's Chief Medical Officer said,"We are excited about the progress being made with ATG-031. We look forward to further characterizing the safety, tolerability, and preliminary efficacy of ATG-031. We will begin enrolling patients for the study as soon as possible and plan to release the first batch of preliminary data from the study in 2024."

"Through committed work and unrelenting innovation, our R&D organization successfully advanced the ATG-031 program to the clinical stage in just three years, an achievement that has truly made us proud," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "Based on the robust preclinical data of ATG-031, we are confident that the drug will continue to demonstrate its therapeutic potential in clinical studies. Moving forward, Antengene will press ahead the clinical development of its global rights programs with the aim of serving a broader population of patients."