• Discovered and developed in-house by Antengene's R&D team, ATG-022 is an antibody-drug-conjugate (ADC) targeting the Tumor Associated Antigen (TAA) Claudin 18.2.
• The Phase I CLINCH trial is designed to evaluate the safety, pharmacology, and preliminary efficacy of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. ATG-022 has also received the investigational new drug (IND) approval by the China National Medical Products Administration (NMPA) and is currently recruiting patients with advanced or metastatic solid tumors.

Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that the first patient has been dosed in the Phase I CLINCH trial to evaluate ATG-022 as a monotherapy in patients with advanced or metastatic solid tumors.

The CLINCH trial is a multi-center, open-label Phase I dose-finding study of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-022 and to determine important dosing parameters including maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of ATG-022 monotherapy. The secondary objective is to characterize the pharmacology and evaluate the preliminary efficacy of ATG-022

"The TAA Claudin 18.2 has become an important cancer target, clinically validated by promising data from different agents and modalities. ATG-022 binds to Claudin 18.2 with low nanomolar affinity and demonstrated potent in vitro and in vivo antitumor effects, including in vivo efficacies demonstrated in Claudin 18.2 low expression models. Having the first patient dosed in the Phase I CLINCH study in Australia marks another milestone in the clinical development program for ATG-022. ATG-022's excellent preclinical activity, safety, coupled with its ADC-based format support our view that ATG-022 has the potential to be an effective treatment and address an unmet need in cancer care." said Dr. Amily Zhang, Antengene's Chief Medical Officer. "We will work closely with all the investigators of this study in efforts to soon provide an effective new treatment option to patients around the world."