On January 15, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that it recently presented at the 44th Annual J.P. Morgan Healthcare Conference held in San Francisco. At the conference, Antengene shared the latest data and clinical development plans for its core clinical asset, ATG-022 (a CLDN18.2 antibody-drug conjugate [ADC]), as well as R&D progress on ATG-125 (a B7-H3 x PD-L1 bispecific ADC), its steric hindrance masking AnTenGager T cell engager (TCE) platform, and other key preclinical programs.
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1. Core Clinical Program: ATG-022
Latest data from the Phase I/II CLINCH study: As of December 25, 2025, among patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%) in the 2.4 mg/kg dose cohort, the objective response rate (ORR) was 40% (12/30) and the disease control rate (DCR) was 90% (27/30), with a median progression-free survival (mPFS) of 5.09 months and a median overall survival (mOS) of 14.72 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), the mPFS was 6.97 months, and the mOS has not yet been reached. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%) treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21). In addition, one patient in each of the three dose groups achieved a complete response (CR). These results demonstrated the potent anti-tumor activity of ATG-022 across all levels of CLDN18.2 expression.
Promising frontline combination potential: Compared with the data presented at the Company’s R&D Day in November last year, the 1.8 mg/kg dose group demonstrated a further improvement in ORR and a meaningful prolongation in mPFS, while maintaining a favorable safety profile. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was only 19.4%. This differentiated safety profile positions ATG-022 as a potentially best-in-class ADC in terms of safety, with the potential to be combined with checkpoint inhibitors (CPIs) and chemotherapy to transform the current frontline standard-of-care regimen.
First Disclosure of Positive Clinical Signals of ATG-022 in Non-Gastrointestinal Tumors: As of January 6, 2025, among 9 efficacy evaluable patients, the ORR was 22.2% (2/9), and DCR was 88.9% (8/9). These data suggest that ATG-022 may have the potential to treat CLDN18.2-positive non-gastrointestinal tumors, which could expand the treatable patient population beyond gastrointestinal cancers. The efficacy observed to date also supports further exploration of CLDN18.2 as a pan-tumor therapeutic target.
Advancing clinical development across 1L to 3L gastric cancer: Antengene is currently conducting the Phase I/II CLINCH study and the Phase Ib/II CLINCH-2 study of ATG-022 in Mainland of China and Australia. The Company continues to advance the clinical development of ATG-022 across different lines of gastric cancer treatment, including first-line therapy in combination with checkpoint inhibitors (CPIs) and chemotherapy (CAPOX/FOLFOX); second-line therapy in combination with CPIs; and third-line therapy as monotherapy, covering patients with varying levels of CLDN18.2 expression. In addition, the CLINCH study of ATG-022 includes a basket trial cohort evaluating multiple tumor types, with the majority of patients continuing to receive treatment.
2. Next-Generation ADCs and Proprietary TCEs
ATG-125 (B7-H3 × PD-L1 bispecific ADC): ATG-125 is an "IO+ADC " dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of immuno-oncology (IO) therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target B7-H3-ADC or PD-L1-ADC approaches. The Company plans to submit an IND for ATG-125 in Q1 2027.
TCE platform with steric hindrance masking technology: AnTenGager is Antengene’s proprietary, second-generation T cell engager (TCE) 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 diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has discovered multiple investigational programs:
ATG-201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGager TCE platform for the treatment of B cell related autoimmune diseases. Preclinical data presented at the 2025 American College of Rheumatology (ACR) Annual Meeting showed that in non-human primate (NHP) models, the monkey surrogate of ATG-201 achieved deep and durable depletion of naïve B cells with a favorable safety profile, characterized by only a very mild and transient increase in cytokine levels. The IND-enabling study of ATG-201 has been completed and the IND-submission is under preparation.
ATG-106 (CDH6 x CD3 TCE): A global first-in-class CDH6 x CD3 targeted TCE being developed for the treatment of ovarian cancer and kidney cancer. The Company plans to submit an IND for ATG-106 in the first half of 2027.
ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecologic tumor, non-small cell lung cancer, and pancreatic ductal adenocarcinoma. The Company has nominated a preclinical candidate (PCC) in January 2026.
Additional TCE programs for solid tumors: Antengene plans to submit an IND for ATG-110 (LY6G6D × CD3 TCE) in the first half of 2027 for the treatment of microsatellite-stable colorectal cancer. In addition, ATG-115 (an undisclosed bispecific antibody) and two undisclosed trispecific antibody programs are currently in preclinical development.
3. Innovative Treatment for Autoimmune Diseases: Globally First-in-Class ATG-207
ATG-207 is a globally first-in-class dual-function biologic being developed for the treatment of T cell–mediated autoimmune diseases. The Company plans to present the preclinical data for ATG-207 for the first time at an international scientific conference in 2026.
(Press release, Antengene, JAN 15, 2026, View Source [SID1234662060])