RVT-802 is an investigational thymic-tissue based regenerative therapy that is designed to reconstitute the immune system for the treatment of primary immune deficiency resulting from congenital athymia associated with complete DiGeorge Anomaly (cDGA), or forkhead box protein N1 (FOXN1) deficiency. This is a fatal disorder with no approved therapies.
RVT-802 is the first program to be granted both Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy by the FDA. Enzyvant has initiated its rolling submission of Biologics License Application (BLA) for RVT-802 to the FDA.
Enzyvant is developing this technology in collaboration with Professor M. Louise Markert, PhD, MD, at the Duke University School of Medicine.