HONG KONG, Sept. 22, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) 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-ß 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-ß 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-ß 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-ß 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-ß signaling contributes to immunosuppression, immune evasion, and resistance to checkpoint inhibitors. By blocking both TIGIT and TGF-ß, 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-ß 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.
Forward-Looking Statement of Akeso, Inc.
This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.
For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.
SOURCE Akeso, Inc.
