FDA grants IND clearance for AffaMed's AM712 to treat retinal vascular diseases

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AM712 is a novel bispecific biologic molecule specifically designed for ocular use. In pre-clinical studies, it demonstrated efficacy, ocular pharmacokinetics, and the desired safety profile supporting clinical exploration.

FDA grants IND clearance for AffaMed's AM712 to treat retinal vascular diseases

AffaMed Therapeutics today announced that the 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 initiate a Phase 1 study in the United States to investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients 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 Asia and Japan territories.

According to Dayao Zhao, MD, PhD, the IND clearance from the FDA is a milestone for the company.

“As part of our China-for-Global innovation strategy to leverage AffaMed's strong presence in China and the U.S. to advance differentiated therapeutics for the world markets, this license agreement further strengthens our global ophthalmology pipeline,” Zhao said. “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."

According to Jeff Lu, PhD, CEO of AskGene, the company is committed “to rapidly bringing safe and effective medicines to patients through the use of innovative technologies.”

Lu noted that his company was attracted to working with AffaMed’s team, with its expertise in the ophthalmology area.

“Working together, we can accelerate the development of ASKG712 globally,” Lu added.

Ji Li, PHD, president of AffaMed said the company believes 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 U.S. IND clearance within 2 months after completing our licensing agreement with AskGene,” Li said.

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

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