NeuroNova Tx
Babies suffering from early life brain injury (hypoxic-ischemic brain injury (HIBI)) are at high-risk of neurological consequences. There are currently no effective therapies for the >12.000 cases annually in the 5 major markets in the EU and US combined.
For the past 15 years, the teams of prof. Cora Nijboer and prof. Manon Benders at UMC Utrecht have laid the foundation of stem cell therapy to repair the consequences of HIBI. Intranasal delivery of allogeneic mesenchymal stem cells (IN-MSCs) is a novel regenerative therapy that is protected by a patent application.
A Phase 1 clinical trial in 10 infants with HIBI due to a perinatal stroke shows this therapy is safe and effective with a reduction from 50% to 20% severe disabilities compared to a historical cohort. A planned phase 2/3 trial is funded. Parallel to the Phase 2/3 trial, NeuroNova Therapeutics will take all the steps needed to bring a high-quality cell therapy to market authorization, including upscaling, manufacturing and regulatory approval.
NeuroNova Therapeutics will be led by Danielle Counotte, a neuroscientist by training and an experienced innovation project lead and life-science business developer. Cora Nijboer and Manon Benders will dedicate themselves part-time to NeuroNova as CSO and CMO while keeping the connection to their academic lab/clinic where this therapy originated. The team will be supported by experienced regulatory and CMC consultants, and will have a tight network of global KOLs to endorse this therapy once efficacy is proven.
