InnoVec Biotherapeutics Receives FDA IND Clearance for IVB103, an Intravitreal AAV Gene Therapy for Neovascular Age-Related Macular Degeneration
Innovecbio
Gene Editing Delivery Technology and Drug Developer
2024On July 26, Innovecbio's IVB103 injection received the new drug clinical trial (IND) approval from the U.S. Food and Drug Administration (FDA) in advance, allowing it to officially enter the clinical trial stage.
IVB103The injectable solution, developed on the basis of Innovecbio's independently researched and developed novel carrier, is a drug for intravitreal administration to treat neovascular age-related macular degeneration (nAMD). Preclinical data shows that IVB103 surpasses other advanced products currently under research internationally, demonstrating "best in class" potential. In the Information Request, the FDA raised only one question regarding IVB103’s CMC, with no issues in the Non-clinical section, indicating that the carrier independently developed by Innovecbio possesses excellent safety and drug-like properties, leading to the early receipt of FDA IND approval.
In addition, on July 18, 2024, the Center for Drug Evaluation (CDE) of China officially accepted the clinical trial application for IVB103.
InnoVec Biotherapeutics Inc. (Innovecbio) is a clinical-stage gene therapy company driven by vector innovation. The company is committed to developing gene therapy delivery tools for human application, addressing the challenges of translating delivery tools from animals to humans. Its goal is to discover gene delivery tools for all tissues and organs, enabling gene therapy to be widely applied to both rare and common diseases. InnoVec Biotherapeutics has highly efficient teams in technology development, pipeline research, process optimization, and clinical operations. It has established a leading technology development platform covering multiple disease areas, including ophthalmology, neurology, and muscular disorders. Several innovative products have entered the IIT and IND stages.
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