EPI-003T

EPI-003T is an investigational mRNA-based therapeutic vaccine encapsulated in lipid nanoparticles (LNP) for the treatment of chronic hepatitis B (CHB). Developed by Shulan (Hangzhou) Hospital, the therapy is administered via intravenous injection to adults with CHB who are virologically suppressed on stable nucleos(t)ide analogue (NA) therapy. The mRNA is designed to express hepatitis B virus (HBV) antigens within host cells, thereby stimulating a robust T-cell mediated immune response intended to help achieve a functional cure. It is currently being evaluated in a Phase 0 dose-escalation and dose-expansion study in China to assess its safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics.