Antengene's ATG-022 (CLDN18.2 ADC) Granted Breakthrough Therapy Designation for the Treatment of Gastric/Gastroesophageal Junction Adenocarcinoma

In the ongoing CLINCH Phase I/II clinical study, data show that ATG-022 demonstrated significant antitumor activity and a favorable safety profile in patients with gastric or gastroesophageal junction adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels. In the ongoing CLINCH Phase I/II clinical study, data show thatATG-022 demonstrated significant antitumor activity and a favorable safety profile in patients with gastric or gastroesophageal junction adenocarcinoma across...

In the ongoing CLINCH Phase I/II clinical study, data show that ATG-022 demonstrated significant antitumor activity and a favorable safety profile in patients with gastric or gastroesophageal junction adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels.

To date, three patients in the study have achieved CR during treatment, with one case observed in each of the three aforementioned cohorts (i.e., both dose levels in the CLDN18.2 moderate-to-high expressor cohorts and the CLDN18.2 low and ultra-low expressor cohort). This broad-spectrum antitumor activity positions ATG-022 as a potential new treatment option for a wider patient population compared with other CLDN18.2-targeted therapies.

Antengene is currently conducting the Phase II dose-expansion stage of ATG-022 in the Mainland of China and Australia, with the program now entering mid-to-late stage of clinical validation. The company will continue to advance the clinical development of ATG-022 in gastric cancer while exploring its potential in other CLDN18.2-positive tumors. For gastric cancer indications, the development strategy spans first- through third-line treatment:

In addition, the ongoing Phase II study includes a basket trial cohort covering multiple tumor types. In a certain subtype of gynecologic tumor, all 7 patients who had undergone at least one efficacy assessment demonstrated tumor shrinkage, indicating significant clinical potential for ATG-022 in other CLDN18.2-positive tumors. This cohort remains open for enrollment and follow-up, and the continued data generation is expected to further strengthen the robust value proposition of ATG-022 across multiple tumor types.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages and includes several in-house discovered programs, including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 × 4-1BB bispecific antibody), ATG-031 (CD24-targeting macrophage activator), and ATG-042 (oral PRMT5-MTA inhibitor).

Antengene has also developed AnTenGager™, a proprietary T cell engager 2.0 platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies indications.

To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor), is approved in the 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.

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