Country for PR: China
Contributor: PR Newswire Asia (China)
Thursday, August 13 2020 - 23:05
ANTI-PD-1/CTLA-4 Bi-specific Antibody (AK104) of Akeso Granted FDA Fast Track Designation for Recurrent and Metastatic Cervical Cancer
LOS ANGELES, Aug. 13, 2020 /PRNewswire-AsiaNet/ --

Akeso, Inc (9926.HK) - a biopharmaceutical company dedicated to the research, 
development, manufacturing and commercialization of new innovative antibody 
drugs that are affordable to patients worldwide - today announced that the U.S. 
Food and Drug Administration (FDA) has granted Fast Track Designation for 
AK104, a novel anti-PD-1/CTLA-4 bi-specific antibody, as monotherapy for the 
treatment of patients with recurrent or metastatic squamous cervical cancer who 
have disease progression on or after platinum-based chemotherapy.

"The Fast Track Designation of AK104 is another significant milestone in the 
development of this innovative bispecific antibody.  We are encouraged that the 
FDA recognizes the potential of AK104 to address a serious condition and fill 
an unmet medical need in patients whose cancer has unfortunately worsened 
despite standard of care chemotherapy," said Dr Michelle Xia, Chairman and CEO 
of Akeso. "We look forward with much optimism to continue working closely with 
the FDA to bring AK104 to cervical cancer patients earlier."

About Fast Track Designation [1]

Fast track is a process designed to facilitate the development, and expedite 
the review of drugs to treat serious conditions and fill an unmet medical need. 
The purpose is to get important new drugs to the patient earlier. Fast Track 
addresses a broad range of serious conditions.  Once a drug receives Fast Track 
designation, early and frequent communication between the FDA and a drug 
company is encouraged throughout the entire drug development and review 
process. The frequency of communication assures that questions and issues are 
resolved quickly, often leading to earlier drug approval and access by patients.

About AK104

AK104 is a potential next-generation, first-in-class humanized IgG1 tetrameric 
bi-specific antibody drug candidate that is developed in house by Akeso,Inc., 
is designed to achieve preferential binding to tumor infiltrating lymphocytes 
rather than normal peripheral tissue lymphocytes. Based on Akeso's proprietary 
"TETRABODY" technology, AK104 can simultaneously targets two immune checkpoint 
molecules: PD-1 and CTLA-4. AK104 is in a tetrameric form, which is designed to 
bind to PD-1 and CTLA-4 simultaneously and have so far displayed the efficacy 
of PD-1 and CTLA-4 combination blockade with lower toxicity. It is currently in 
Phase Ib/II and Phase II clinical trials in China and Australia for multiple 

Information about Akeso, Inc

The Company is a biopharmaceutical company dedicated to the research, 
development, manufacturing and commercialization of innovative antibody drugs 
that are affordable to patients worldwide. Since the Company's establishment, 
the Company has established an comprehensive end-to-end drug development 
platform (ACE Platform) and system, encompassing fully integrated drug 
discovery and development functions, including target validation, antibody drug 
discovery and development, CMC process development, and GMP-compliant 
commercial scale manufacturing. The Company has also successfully established a 
bi-specific antibody drug development technology (Tetrabody technology). The 
Company currently has a pipeline of over 20 innovative investigative drugs for 
the treatment of major diseases like cancer, autoimmune diseases, inflammation 
and metabolic diseases, 9 of which have entered clinical stage, including two 
novel 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 efficient and break-through research and development in innovating and 
developing new drugs that are first-in-class and best-in-class therapies.


Source: Akeso, Inc.