ATG-022

Feb. 24, 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 diseases, solid tumors and hematological malignancies, announced that it has entered into a clinical collaboration agreement with Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", SEHK: 1877.HK; SSE: 688180). Under the collaboration, the parties will jointly evaluate the synergistic therapeutic potential of Antengene's ATG-037, an oral small-molecule CD73 inhibitor, in combination with Junshi Biosciences' JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, in patients with solid tumors in Mainland China, with the goal of identifying clinical signals across multiple tumor types. This collaboration builds on the encouraging Phase I proof-of-concept clinical data generated with ATG-037. At a time when resistance to checkpoint inhibitors (CPIs) has become a major clinical challenge, the Phase I study evaluating ATG-037 in combination with CPIs has already demonstrated promising potency into reversing CPI resistance. Beyond validating the synergistic potential of these two innovative drugs, this collaboration aims to advance the efficacy of existing immunotherapies and extend the overall survival (OS) of cancer patients through a "triple-axis" approach that incorporates immune checkpoint signalling, anti-angiogenesis, and the alleviation of adenosine-mediated immunosuppression. ATG-037, Antengene's orally administered small-molecule CD73 inhibitor, offers significant advantages over anti-CD73 monoclonal antibodies. In preclinical studies, ATG-037 demonstrated stronger inhibition of cell-surface CD73 enzymatic activity and overcame the "hook effect" commonly observed with antibody-based approaches. In addition, ATG-037's higher tissue penetration compared with antibodies may facilitate complete CD73 inhibition at the cellular level. ATG-037 has demonstrated encouraging clinical activity in combination with anti–PD-1 therapy in patients with CPI-resistant melanoma and non-small cell lung cancer (NSCLC), based on the latest data presented at Antengene's R&D Day in November 2025. In the ongoing Phase I/Ib STAMINA-01 study, the combination achieved an objective response rate (ORR) of 33.3% with a disease control rate (DCR) of 100% in patients with CPI-resistant melanoma, and an ORR of 21.4% with a DCR of 71.4% in patients with CPI-resistant NSCLC. The dataset was generated in Australia in patients with CPI-refractory solid tumors, with pembrolizumab and/or nivolumab as the predominant prior anti–PD-1 therapies, and more than 70% of melanoma patients were refractory to both anti–PD-1 and anti–CTLA-4 (ipilimumab). These results support ATG-037's clinically meaningful activity across multiple tumor types, particularly in patients with prior immunotherapy resistance. Importantly, ATG-037 has demonstrated a favorable safety and tolerability profile in combination treatment, with no new or unexpected safety signals observed, including in patients receiving long-term therapy.Grade 3 or higher treatment-related adverse events only occurred in 7.9% of patients. Responses have also shown encouraging durability, including a patient who achieved a complete response and has remained on study for over three years and is currently receiving ATG-037 monotherapy for more than a year, as well as multiple patients with durations of response exceeding 12 months. These data support ATG-037's potential role as a backbone agent for next-generation immuno-oncology combination regimens. JS207, Junshi Biosciences' independently developed recombinant humanized anti-PD-1/VEGF bispecific antibody, has demonstrated promising anti-tumor activity and a manageable safety profile in both preclinical and clinical studies. JS207's preclinical studies demonstrated its robust anti-tumor efficacy in multiple tumor models and supported a differentiated mechanism of action, with VEGFA shown to enhance JS207's antigen binding activity, T-cell activation potency and internalization of cell-surface PD-1. In a poster presented at ESMO Asia 2025, JS207 monotherapy showed encouraging efficacy across solid tumors. 62 patients with PD-L1 positive NSCLC received JS207 monotherapy as first-line treatment, and achieved an ORR of 58.1% and a DCR of 87.1%. Clinical activity has also been observed in additional tumor types, including hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC), supporting the potential of PD-1/VEGF dual targeting across multiple tumor settings. To date, JS207 has 11 ongoing phase II clinical studies, exploring its use in combination with chemotherapy, monoclonal antibodies, antibody-drug conjugates (ADCs) and other drugs in NSCLC, colorectal cancer, triple-negative breast cancer, liver cancer and other tumor types, with nearly 500 patients enrolled. Based on the accumulated data from these studies, the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application, allowing Junshi Biosciences to initiate an open-label, two-arm, randomized, active-controlled, Phase II/III clinical study comparing JS207 to nivolumab for the neoadjuvant treatment of patients with stage II/III, resectable, actionable genomic aberration (AGA)-negative NSCLC. The scientific rationale for the collaboration is based on the complementary and potentially synergistic mechanisms of CD73 inhibition and dual PD-1/VEGF targeting. CD73 is recognized as a key regulator of immune suppression and angiogenesis within the tumor microenvironment through the generation of adenosine, which can dampen anti-tumor immune responses. In both clinical and preclinical settings, CD73 inhibitors have demonstrated meaningful synergy with anti–PD-1 monoclonal antibodies. In addition, CD73 activity has been shown to promote angiogenesis, including through upregulation of VEGF signaling, and may contribute to the development of resistance to anti-VEGF therapies. Given the broad relevance of immune suppression, angiogenesis and adenosine signaling across solid tumors, this combination strategy has the potential to be applicable across multiple tumor types. Taken together, these observations suggest that combining CD73 blockade with PD-1/VEGF-directed approaches has the potential to enhance and sustain therapeutic effects. Together, the combination of ATG-037 with JS207 represents a potential "triple-axis" approach that simultaneously modulates immune checkpoint signaling, angiogenesis, and the adenosine pathway. With the potential to deepen responses while maintaining a favorable safety profile, the combination of ATG-037 with JS207 may further improve the durability of benefit and may translate into improved OS. We look forward to working closely with Junshi Biosciences and leveraging our respective expertise in target biology and clinical development to accelerate the evaluation of ATG-037 in combination with JS207 across multiple solid tumor types, with the goal of identifying clinical signals and delivering more innovative treatment options for patients in Mainland China. 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 x 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 32 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 Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). The content above comes from the network. if any infringement, please contact us to modify.