Posted by Michael Wonder on 17 Oct 2024
Valneva and LimmaTech awarded FDA fast track designation for tetravalent Shigella vaccine candidate S4V
16 October 2024 - Valneva and LimmaTech Biologics announced today that the US FDA has granted fast track designation to Shigella4V the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech.
Following positive Phase 1/2 results earlier this year, LimmaTech will conduct a Phase 2 controlled human infection model study in the US and a Phase 2 paediatric study in low and middle income countries, both expected to begin before the end of 2024.
