ASKG712 IND Filing in China

(Camarillo, California and Nanjing, Jiangsu Province, China) Askgene announces the acceptance of IND to initiate a clinical trial of ASKG712 to treat nAMD (neovascular age related macular degeneration) from NMPA (National Medical Products Administration) in China.

AMD is a disease with a progressive loss of central vision involving the retina of the macular region, which can lead to irreversible vision loss in patients. It is one of the leading causes of blindness in adults over 50 years old. Data shows that there are currently over 21.4 million AMD patients in China. With the aging of the population, the incidence rate will increase further. The current standard care treatment utilizes single-target anti-VEGF drugs, which require frequent (monthly) intravitreal injections resulting in poor patient compliance and heavy economic burden.

ASKG712 is an innovative bispecific antibody developed by Askgene that targets both VEGF and ANG-2. ASKG712 inhibits the VEGF/VEGFR signaling pathway and controls the formation of new blood vessels. It can also effectively inhibit ANG-2 signaling to improve vascular stability and reduce retinal inflammation. Faricimab, the world’s first bispecific with the same targets as ASKG712 developed by Roche, has achieved all primary endpoints for its four phase III clinical trials in 2021. About half of the patients can reach dosing once every four months. The preclinical results of ASKG712 show that it is safe and has a stronger binding affinity to VEGF and ANG2, which is expected to achieve better clinical efficacy and reduce the number of intravitreal injections.

With the acceptance of the IND, Askgene will carry out clinical trials of ASKG712 in China in the near future.