Antengene Enters into a Global Clinical Collaboration with MSD to Evaluate ATG-022 (CLDN18.2 ADC) In Combination with KEYTRUDA® (pembrolizumab)

- ATG-022 is Antengene's CLDN18.2 antibody-drug conjugate; KEYTRUDA^® (pembrolizumab) is MSD's anti-PD-1 therapy.

SHANGHAI and HONG KONG, May 20, 2025 /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 medicines for cancer, today announced it has entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD's anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) in patients with advanced solid tumors.

At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene presented the latest data from its Phase I/II CLINCH study. Results showed an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 95.2% in patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%). Additionally, the study demonstrated an ORR of 30.0% and a DCR of 50.0% in patients with low CLDN18.2 expression (IHC 2+ < 20%). ATG-022 also exhibited a favorable safety profile and extended treatment durations, with no observed cases of ophthalmological or neurological toxicities, nor interstitial lung disease.

ATG-022 is uniquely positioned in the global landscape, with data supporting meaningful efficacy across all levels of Claudin 18.2 expression in gastric cancer, including high, low, and ultra-low expressors. This broad-spectrum activity positions ATG-022 as a promising treatment for a wider patient population compared to other CLDN18.2-targeting therapies.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ATG-022

ATG-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, and pancreatic cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATG-022, for gastric and pancreatic cancers.

Data from the ongoing CLINCH study demonstrated that ATG-022 delivers robust efficacy across all levels of CLDN18.2 expression in gastric cancer patients, including those with high, low, and ultra-low expression. This broad activity positions ATG-022 as a potential market leader, capable of addressing the largest patient population with CLDN18.2-positive tumors. Furthermore, the strong efficacy observed in patients with low CLDN18.2 expression suggests promise for treating other tumor types with similar expression profiles.

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".

Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 11 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia 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, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to 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

source: Antengene Corporation Limited