• 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.

SHANGHAI and HONG KONG, March 29, 2023 /PRNewswire/ -- 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."

About ATG-022

ATG-022 is an antibody-drug-conjugate targeting Claudin 18.2. Claudins are cell adhesion molecules normally expressed within the tight junctions between cells to form a barrier that regulates cell permeability. In cancer, Claudins are expressed at the cell surface due to changes in cell polarity. The Claudin 18.2 isoform is overexpressed in various primary malignant tumors including gastric, esophageal and pancreatic cancers.

Data from preclinical studies, including results from gastric cancer-patient derived xenograft models presented at the 2022 American Association for Cancer Research (2022 AACR), showed that ATG-022 binds to Claudin 18.2 with low nanomolar affinity and demonstrated potent in vitro and in vivo antitumor effects, including in vivo efficacy demonstrated in Claudin 18.2 low expression models. This could pave the way for broad clinical utility of ATG-022 in gastric cancer patients with a wide range of Claudin 18.2 expression levels. ATG-022 demonstrated an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".

Since 2017, Antengene has built a pipeline of 9 innovative clinical-stage oncology assets, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 28 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 9 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO^® (selinexor) already approved in Mainland of China, Taiwan,China, South Korea, Singapore and Australia.

Forward-looking statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled "Risk Factors" in our periodic reports filed with the Hong Kong Stock Exchange and the other risks and uncertainties described in the Company's Annual Report for year-end December 31, 2021, and subsequent filings with the Hong Kong Stock Exchange.

For more information, please contact:

Investor Contacts: 
Donald Lung
E-mail: Donald.Lung@antengene.com   
Mobile: +86 18420672158

PR Contacts:
Peter Qian
E-mail: Peter.Qian@antengene.com 
Mobile: +86 13062747000