Antengene Launches Phase II Expansion for ATG-022 ADC in Asia-Pacific

In March 2024, Antengene Corporation Limited, a prominent biopharmaceutical firm known for its innovative and commercial-stage advancements in the hematology and oncology sectors, declared the commencement of a Phase II dose expansion study for ATG-022, a Claudin 18.2 antibody-drug conjugate (ADC). This study, known as CLINCH, is being conducted in China and Australia and follows promising preliminary results that indicated partial and complete responses in clinical trials.

The CLINCH trial is a multi-faceted, open-label Phase I/II study that focuses on the monotherapy application of ATG-022 for patients battling advanced or metastatic solid tumors. The trial is divided into two parts: a dose escalation phase and a dose expansion phase. Its primary goal is to assess the safety and tolerability of ATG-022, and to establish dosing parameters such as the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). A secondary aim is to analyze the pharmacological profile and initial efficacy of the drug.

The expansion phase is set to include individuals with gastric cancer and other solid tumors. Notably, in May 2023, ATG-022 received two Orphan Drug Designations (ODDs) from the U.S. Food and Drug Administration (FDA) for pancreatic cancer and gastric cancer treatments.

Dr. Amily Zhang, Antengene's Chief Medical Officer, expressed enthusiasm for the study's progression, highlighting the strong preclinical data and the early positive findings observed in two patients with metastatic gastric cancer. The company is committed to working closely with regulatory bodies and researchers to explore the full clinical potential of ATG-022.

ATG-022 is an innovative ADC that targets Claudin 18.2, a protein that plays a role in cell adhesion and is often overexpressed in various types of cancer, including gastric, esophageal, cholangiocarcinoma, and pancreatic. Preclinical studies have shown that ATG-022 has a strong affinity for Claudin 18.2 and has displayed significant antitumor effects both in vitro and in vivo, even in models with low Claudin 18.2 expression. These results suggest a broad clinical application for ATG-022 in treating gastric cancer patients with varying levels of Claudin 18.2 expression. The drug has also shown a favorable safety profile in Good Laboratory Practice (GLP) toxicology studies.

Antengene is a global biopharmaceutical company that has been at the forefront of developing first-in-class and best-in-class therapeutics since 2017. The company has a diverse pipeline of nine oncology assets and has secured 29 investigational new drug (IND) approvals and submitted 11 new drug applications (NDAs) across the Asia-Pacific region. Notably, the NDA for XPOVIO® (selinexor) has been approved in several Asia-Pacific markets, including Mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, and Australia. Antengene's mission is to provide innovative treatments for patients globally, transcending geographical boundaries.