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


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 

Media Enquiries: 

Vivien Li 
(86-760)89873998 
pr@akesobio.com 

SOURCE:  Akeso