Initiation of Various Clinical Trials of PD-1/VEGF Bispecific Antibody (AK112)

On May 12, 2021, Akeso, Inc. (9926.HK) announced that various clinical trials of PD-1/VEGF bi-specific antibody (research and development code: AK112) as monotherapy or in combination treatment, a novel immuno-oncology drug independently developed by the Company, have been initiated after dose escalation and extended phase I clinical trials in the People’s Republic of China, Australia and other countries. The research includes:


1. AK112 as a monotherapy for treatment of advanced non-small cell lung cancer (Center for Drug Evaluation of National Medical Products Administration (“CDE”) registration number: CTR20210807);


2. AK112 as a monotherapy for treatment of recurrent/metastatic gynecological tumors (CDE registration number: CTR20210400);


3. AK112 in combination with chemotherapy for treatment of advanced non-small cell lung cancer (including after treatment failure by first-line PD-1/L1 inhibitor and after treatment failure by tyrosine kinase inhibitor (TKI), CDE registration number: CTR20210201);


4. AK112 in combination with chemotherapy for first-line treatment of extensive stage small cell lung cancer (CDE registration number: CTR20210584);


5. AK112 in combination with Poly ADP-ribose Polymerase (PARP) inhibitor for treatment of wild-type breast cancer gene (BRCA) platinum-sensitive recurrent ovarian cancer (CDE registration number: CTR20210713).


AK112 is another first-in-class bi-specific antibody drug developed by the Company to enter advanced clinical development stage following the registrational phase II clinical trial of the first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody) of the Company in China and the United States.


Dr. Xia Yu, President and CEO of Akeso, Inc. expressed that:

AK112 shows curative features of both immunotherapy drug and anti-angiogenesis drug. Based on the satisfactory results of early clinical trials, several trials of AK112 have entered proof of concept (POC) clinical development stage rapidly. Leveraging its effective clinical operation capabilities, the Company expects to achieve further research results on AK112 in relevant indications in the next 12 months.




AK112 is a first-in-class and the first to enter clinical trial PD-1/VEGF bi-specific antibody independently developed by the Company. Engineered with our unique TETRABODY technology, AK112 blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibody in combination with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma). In the view of the co-expression of VEGF and PD-1 in the tumor micro environment, AK112, as a single agent to block these two targets, may block these two pathways more effectively and enhance the anti-tumor activity, as compared to combination therapy.



The Company is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). The Company’s vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.