On September 22, 2025 Akeso Inc. (9926.HK) reported that the first patient has been dosed in its registrational Phase II study (AK130-202), evaluating AK130, a fully independently developed TIGIT/TGF-β bifunctional antibody fusion protein, in combination with ivonescimab (PD-1/VEGF bispecific antibody), for treating locally advanced or metastatic pancreatic cancer in patients who have failed up to two prior lines of systemic therapy (Press release, Akeso Biopharma, SEP 22, 2025, View Source;bifunctional-antibody-fusion-protein-ak130-combined-with-ivonescimab-for-advanced-pancreatic-cancer-302562663.html [SID1234656161]).
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AK130 is the world’s first and only TIGIT/TGF-β bifunctional antibody fusion protein in registrational clinical development. The initiation of the AK130-202 study marks a significant milestone in Akeso’s strategy approach of "IO2.0 + IO2.0" combinations. This clinical development strengthens Akeso’s leadership position in the emerging global IO 2.0 cancer therapy landscape.
To date, Akeso has nine self-developed bispecific antibodies or bispecific antibody-drug conjugates (ADCs) in clinical development or received regulatory approval. Leveraging its proprietary bispecific antibody technology platform, Akeso has multiple advanced combination therapy research programs that include commercially approved therapies such as ivonescimab and cadonilimab (PD-1/CTLA-4 bispecific antibody), as well as potentially first -in-class candidates such as AK130 and AK146D1 (Trop2/Nectin4 bispecific ADC).
Preclinical studies indicate that dual blockade of the PD-1/VEGF and TIGIT/TGF-β pathways has synergistic therapeutic potential. This combination could remodel the tumor immune microenvironment and enhance anti-tumor immune responses. Prior clinical data from ivonescimab monotherapy in first-line pancreatic cancer has shown strong efficacy potential. The combination of AK130 and ivonescimab is expected to further improve the therapeutic benefit in this challenging malignancy.
About AK130 (Bifunctional Antibody Fusion Protein)
AK130 is Akeso’s entirely in-house developed bifunctional antibody fusion protein. It combines an anti-TIGIT monoclonal antibody with the extracellular domain of the human TGF-β receptor II. TIGIT is an emerging immune checkpoint, and blocking TIGIT-CD155 interactions can relieve suppression of tumor-infiltrating CD8+ T cells and NK cells, thereby enhancing their anti-tumor activity. TGF-β signaling contributes to immunosuppression, immune evasion, and resistance to checkpoint inhibitors. By blocking both TIGIT and TGF-β, AK130 can activate T-cell responses while reducing the immunosuppressive activity of Tregs, leading to enhanced anti-tumor effects.
As the first and only TIGIT/TGF-β bifunctional antibody fusion protein in registrational clinical development globally, AK130 has now been administered to the first patient in its combination therapy study with ivonescimab for advanced pancreatic cancer. Additional clinical trials are ongoing to evaluate AK130 as a monotherapy for advanced solid tumors and in combination with ivonescimab for advanced hepatocellular carcinoma.