AM712 (ASKG712) IND Filing in USA

AffaMed Therapeutics (“AffaMed”), in collaboration with Askgene, announces that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712) for the treatment of retinal vascular diseases.

Below is the press release from Affamed ( AffaMed Therapeutics (“AffaMed”), a global clinical stage biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products, today announced that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712), a novel proprietary bispecific biologic molecule blocking both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) for the treatment of retinal vascular diseases.

Under this IND, AffaMed will soon initiate a Phase 1 study in the United States to investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with neovascular AMD.

AffaMed Therapeutics recently entered into a licensing agreement with AskGene Pharma Inc. (“AskGene”) for the exclusive rights to develop, manufacture and commercialize AM712 in ex-Asia plus Japan territories globally.

“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. I am very pleased to witness our rapid execution of this strategy from licensing to US IND clearance and look forward to our close cooperation with AskGene.”

“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 has recently received China CTA clearance for AM712(ASKG712) in January 2022.