AffaMed Announces IND Clearance by the FDA for AM712 for the Treatment of Retinal Vascular Diseases

AffaMed Announces IND Clearance by the FDA for AM712 for the Treatment of Retinal Vascular Diseases

February 16, 2022

AffaMed Therapeutics announced that the FDA has approved its Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712), a novel proprietary bispecific biologic molecule that blocks both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) for the treatment of retinal vascular diseases.

Under this IND, AffaMed will shortly begin a Phase 1 research in the United States to explore the safety, tolerability, pharmacokinetics, and efficacy of AM712 in persons with neovascular AMD.

In addition, AffaMed Therapeutics recently signed a licensing deal with AskGene Pharma Inc. for the exclusive global rights to develop, manufacture, and market AM712 outside of Asia and Japan.

“We are excited to partner with AskGene and receive our first IND clearance from the FDA.” Dr. Dayao Zhao, CEO of AffaMed commented: " As part of our China-for-Global innovation strategy to leverage AffaMed’s strong presence in China and the US to advance differentiated therapeutics for the world markets, this license agreement further strengthens our global ophthalmology pipeline.”

“AskGene is committed to rapidly bringing safe and effective medicines to patients through the use of innovative technologies. We are very pleased to cooperate with AffaMed to develop the promising anti-VEGF/ANG2 bispecific molecule AM712(ASKG712) to benefit patients” said AskGene’s CEO Dr. Jeff Lu.

“The exceptional global expertise by the AffaMed team in the ophthalmology area was an important consideration for our collaboration. Working together, we can accelerate the development of ASKG712 globally.”

Dr Ji Li, President of AffaMed commented: “We believe AM712 has the potential to be a best-in-class anti-VEGF/Ang-2 bispecific biologic molecule to address the high unmet medical needs among patients with retinal vascular diseases. We are thrilled to demonstrate our strong execution capabilities in receiving the US IND clearance within 2 months after completing our licensing agreement with AskGene.”

About AM712 (ASKG712)

AM712 is a novel bispecific biologic molecule specifically designed for ocular use. It provides dual inhibition of two important disease-relevant pathways in retinal diseases, VEGF and Ang-2.

In pre-clinical studies, AM712 demonstrated robust efficacy, adequate ocular pharmacokinetics, and the desired safety profile supporting clinical exploration. AskGene recently also received China CTA clearance for AM712(ASKG712) in January 2022.