AffaMed Therapeutics obtains IND clearance for novel retinal biologic

15-Feb-2022 - Last updated on 15-Feb-2022 at 13:50 GMT

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AffaMed Therapeutics has announced that the US 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 the IND, Shanghai-headquartered AffaMed will soon initiate a Phase 1 study in the US to investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with neovascular AMD.

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’, according to the company.

Licensing agreement

AffaMed Therapeutics recently entered into a licensing agreement with Los Angeles headquartered AskGene Pharma Inc. 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 said. " 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."

Dr. Jeff Lu, CEO, AskGene, added: "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 AMG712(ASKG712) to benefit patients. Working together, we can accelerate the development of ASKG712 globally."

AskGene recently received China CTA clearance for AM712(ASKG712) in January, 2022.