InnoVec Biotherapeutics Announces FDA IND Clearance for IVB103, an Intravitreal Gene Therapy for nAMD
Innovecbio
Gene Editing Delivery Technology and Drug Developer
On July 26, 2024, Innovecbio's IVB103 injection received the new drug clinical trial (IND) approval from the U.S. Food and Drug Administration (FDA) ahead of schedule, allowing it to officially enter the clinical trial phase.
IVB103 Injection is a drug developed on the basis of Innovecbio's independently researched and developed novel vector for intravitreal administration to treat neovascular age-related macular degeneration (nAMD). Preclinical data show that IVB103 surpasses advanced international products under research in the same category, 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 vector independently developed by Innovecbio has excellent safety and drug-like properties, allowing it to receive FDA IND approval in advance.
In addition, on July 18, 2024, the Center for Drug Evaluation (CDE) of China officially accepted the clinical trial application for IVB103.
About Innovecbio
DanLuCapital
