Akeso Announces Launch of U.S. Investigator-Initiated Study of Cadonilimab (PD-1/CTLA-4 Bispecific Antibody)

Published: Dec. 6, 2021 at 6:20 PM CST

HONG KONG, Dec. 6, 2021 /PRNewswire/ -- Today, Akeso, Inc. (9926.HK) announced that the company will support an investigator-initiated study (IIS) to evaluate the efficacy and safety of Akeso's novel, first-in-class anti-PD-1/CTLA-4 bispecific antibody, cadonilimab, for the treatment of neuroendocrine cervical carcinoma in the United States.

Following a review of the efficacy data from the Akeso-sponsored Phase 2 clinical trial of Cadonilimab in recurrent or metastatic cervical cancer, this study was initiated and will be led by Michael Frumovitz, M.D., M.P.H., FACOG, Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center.


Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bispecific PD-1/ CTLA-4 immunooncology backbone drug developed by Akeso Biopharma. It is one of Akeso's core assets within the company's broad pipeline of therapeutic monoclonal antibodies. It is being developed for various indications such as lung cancer, gastric cancer, hepatocellular carcinoma, cervical cancer, esophageal squamous carcinoma, and nasopharyngeal carcinoma. Clinical data from ongoing studies demonstrate that Cadonilimab has promising efficacy against a wide variety of tumor types while exhibiting lower toxicity and a more favorable safety profile when compared to the co-administration of anti-PD-1 plus anti-CTLA-4 therapies.


Akeso, Inc. (9926.HK) 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 bispecific 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 bispecific 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.

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