Akeso Inc. has announced 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.

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.