Akeso Appoints Prof. Bradley Monk as Lead Gynecologic Oncology Advisor and Chair of the Steering Committee

-- To develop its registration trial of AK104 (Bi-specific Anti-PD1/CTLA-4 Antibody) in Cervical Cancer

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Jun 24, 2020, 00:44 ET

LOS ANGELES, June 24, 2020 /PRNewswire/ -- Akeso, Inc. ("Akeso", 9926.HK) announced the appointment of Professor Bradley J. Monk, MD, FACOG^[1], FACS^[2] as Lead Gynecologic Oncology Advisor and Chair of the Steering Committee for its global Phase 2, multicentre registration study to evaluate the efficacy and safety of AK104 (bi-specific anti-PD-1/CTLA-4) in patients with recurrent or metastatic cervical cancer.

"It is a delight and honour to formally welcome Prof. Monk to our team as Lead Gynecologic Oncology Advisor. Prof. Monk has an excellent reputation as an international expert in gynecologic cancers," said Dr. Michelle Xia, Chairman and CEO of Akeso, Inc. "His outstanding track record as an investigator, coupled with his vast clinical experience as a gynaecologic oncologist and author of more than 300 peer-reviewed publications, makes him the ideal advisor for the development of our rich pipeline of immuno-oncology assets including two leading first-in-class bi-specific candidates AK104（anti-PD-1/CTLA-4）and AK112（anti-PD-1/VEGF). Prof. Monk's appointment demonstrates his strong commitment to and confidence in the development of our innovative therapeutic antibodies for the benefit of women suffering from gynecologic cancers."

Prof. Monk is currently the Professor of Gynecologic Oncology at the University of Arizona College of Medicine, Phoenix. He is board certified in both Obstetrics & Gynecology and Gynecologic Oncology; and practices at Arizona Oncology (US Oncology Network). He is the Fellow of the American College of Surgeons (ACS) and the American College of Obstetricians and Gynecologists (ACOG). Prof. Monk also serves as a Co-Director for the Gynecologic Oncology Group (GOG) Research Consortium and the Medical Director for the Gynecologic Program of the US Oncology Research Network. Among his many professional contributions, Prof. Monk was the first to report the activity of anti-vascular growth factor (VEGF) therapy in ovarian cancer and his papers in the New England Journal of Medicine led to the global approval of anti-VEGF therapy and PARP inhibitors in recurrent ovarian and cervical cancers in 2014. He was awarded the highly prestigious Ernst Wertheim Award for his research in cervical cancer in 2013.

About AK104

AK104 is a next-generation, first-in-class humanized tetrameric bi-specific antibody drug candidate that is developed in-house by Akeso, Inc. It is designed to achieve preferential binding to tumor infiltrating lymphocytes rather than normal peripheral tissue lymphocytes. Based on Akeso's proprietary TETRABODY technology, AK104 simultaneously targets two immune checkpoints: PD-1 and CTLA-4. AK104 is in a tetrameric form and have so far displayed the efficacy of combination PD-1 and CTLA-4 blockade with lower toxicity. It is currently in Phase Ib/II and Phase II clinical trials in China, North America and Australia for multiple indications.

About AK112

AK112 is a first-in-class humanized tetrameric bi-specific antibody drug candidate that simultaneously blocks the binding of PD-1 and VEGF-A to their respective receptors. It has been developed in-house by Akeso and is based on the company's proprietary TETRABODY technology. Combination therapies with anti-PD-1 antibodies and VEGF blockers have shown high efficacy in a variety of tumor types, such as renal cell carcinoma, non-small cell lung cancer, and hepatocellular carcinoma. Due to VEGF-A and PD-1 co-expression in the tumor microenvironment, AK112 as a single agent that simultaneously blocks these two targets may be more efficacious against tumors than the co-administration of medicines in combination. AK112 has FDA^[3] IND^[4] approval and is currently in a Phase I clinical trial.

About Akeso

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 our establishment, the Company has established an comprehensive in-house drug development platform (ACE Platform), encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, process development, and GMP-compliant commercial scale manufacturing. The Company has also successfully established a bi-specific antibody drug development technology platform (Tetrabody Technology Platform). The Company currently has a pipeline of over 20 innovative investigative drugs for the treatment of major diseases like cancer and autoimmune diseases, 9 of which have entered clinical stage, including two first-in-class bi-specific antibodies (PD-1/CTLA-4 and PD-1/VEGF) and a novel anti-CD47 antibody. The Company's vision is to become a global leading biopharmaceutical company through research and development of break-through new drugs that are first-in-class and best-in-class therapies.

*[1] FACOG: American College of Obstetricians and Gynecologists

* [2] FAGS: American College of Surgeons

*[3] FDA: U.S. Food and Drug Administration

*[4] IND: Investigational New Drug

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SOURCE Akeso, Inc.