AffaMed Therapeutics Announces IND Clearance by US FDA for AM712 - a Novel Bispecific Biologic for the Treatment of Retinal Vascular Diseases

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Feb 15, 2022, 02:05 ET

SHANGHAI, Feb. 15, 2022 /PRNewswire/ -- 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 AMG712(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.

About AffaMed Therapeutics

AffaMed Therapeutics is a biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmic, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team of AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality clinical development, regulatory affairs, CMC, business development and commercial operations at leading multi-national pharmaceutical companies in China and globally.

About AskGene Pharma

AskGene (California, USA), founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics. AskGene is a pioneer in the discovery and development of next generation cytokine therapeutics. It has established the cutting edge SmartKine® cytokine prodrug platform. The SmartKine® platform significantly improves the developability of cytokines for oncology and inflammation indications. AskGene is actively moving multiple projects into clinical and preclinical developments.

SOURCE AffaMed Therapeutics