Announcement • Aug 19
Antengene Presents Key R&D Highlights Including Atg-022 Clinical Data, Antengager and Trigager Tce Platforms, and Atg-207 Bifunctional Fusion Protein
Antengene Corporation Limited had been invited to participate in the Evercore 2nd China Biotech Summit, where it presented multiple key R&D highlights during a fireside chat. At the event, the Company presented updated clinical data for ATG–022 (CLDN18.2 antibody–drug conjugate [ADC]). Regarding T–cell engager (TCE) technologies, beyond its previously disclosed proprietary AnTenGager TCE platform, the Company showcased the TriGager TCE platform and multiple TCE functional modules for the first time. The Company also introduced ATG–207, a first–in–class aCD3-TGF-ß bifunctional fusion protein. Latest data from the Phase II CLINCH study: As of June 26, 2026, 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 42.4% (14/33) and the disease control rate (DCR) was 90.9% (30/33), with a median overall survival (mOS) of 12.85 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), and the mOS was not yet reached, with a median follow–up of 14.03 months. One patient in each of the two dose groups achieved a complete response (CR). Compared with the data cutoff of December 25, 2025, the incidence of Grade =3 treatment–related adverse events (TRAEs) in the 1.8 mg/kg dose cohort increased slightly from 19.4% to 21.0%, with only 9.7% of patients experiencing dose reduction due to TRAEs. These data demonstrate that despite more than six months of ongoing treatment follow–up and potential toxin accumulation in vivo, the incidence of Grade =3 TRAEs remained stable in the 1.8 mg/kg dose cohort. This favorable safety profile supports the combination of ATG–022 with chemotherapy and anti-PD-1 antibodies in the first–line setting, enabling the full therapeutic potential of ATG–022. With a median follow–up of 14.03 months, mOS was not yet reached for the 1.8 mg/kg dose cohort, which further validates that ATG–022 can deliver durable long–term survival benefits for patients across all levels of CLDN18.2 expression. Antengene is currently conducting the Phase II CLINCH study, the Ib/II CLINCH–2 study, and the pivotal Phase III CLINCH–3 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 anti-PD-1 antibodies and chemotherapy (CAPOX/FOLFOX); second-line therapy in combination with anti-PD-1 antibodies; and third-line therapy as monotherapy. 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. There is no universal template for designing TCE molecules across diverse targets and indications. Therapeutic potential can only be unlocked by striking a precise balance between efficacy and safety. To this end, the Company has built a comprehensive TCE engineering technology system, including proprietary platforms such as AnTenGager and TriGager, along with multiple functional modules, forming a flexible and customizable technology toolbox. Leveraging this system, the R&D team can perform modular assembly and customized design of molecular structures based on the biological characteristics of different targets. This approach improves development efficiency while providing robust technical support for differentiated clinical strategies. AnTenGager TCE platform: AnTenGager is Antengene's proprietary, second-generation 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 built a pipeline of multiple drug candidates, two of which have been out-licensed under exclusive license agreements: ATG-201 (CD19 x CD3 TCE):A global exclusive license agreement has been entered into with UCB. The Company has received USD 60 million upfront payment from UCB to date and is eligible to receive an additional USD 20 million near–term milestone payment, up to approximately USD 1,100 million in additional milestone payments, as well as tiered royalties on future net sales. ATG-106(CDH6×CD3 TCE):An exclusive license agreement has been entered into with K2 Therapeutics, which was established by MPM BioImpact. Subject to satisfaction of certain near–term conditions, Antengene is entitled to upfront and near-term considerations of approximately USD 20 million, up to USD 960.5 million in additional milestone payments, as well as tiered royalties on future net sales. TriGager TCE platform: TriGager is Antengene's proprietary tri–specific TCE platform with steric hindrance masking technology, enabling the construction of diverse logic–gate molecules including AND–Gate, True AND–Gate and OR–Gate. AND–Gate and True AND–Gate molecules require target cells to co–express two disease–associated antigens before T–cell–mediated cytotoxicity can be triggered. This mechanism improves target specificity, reduces off–target toxicity, and expands the pool of druggable targets for TCE modalities. By contrast, OR–Gate molecules trigger T–cell–mediated killing upon recognition of either one of the disease–associated antigens, better addressing target–expression heterogeneity. Meanwhile, the platform supports incorporation of an engineered CD2 co–stimulatory moiety, which optimizes molecular developability, enhances TCE potency, and mitigates the risk of CRS, balancing efficacy and safety. The Company also presented ATG–207, a globally first-in-class aCD3-TGF-ß bifunctional fusion protein being developed for the treatment of T cell–mediated autoimmune diseases, and first disclosed its preclinical data at the 2026 European Congress of Rheumatology (EULAR 2026).
