PVT201

PVT201 is a first-in-class, off-the-shelf nanomedicine designed to treat autoimmune liver diseases. It consists of multiple copies of a peptide-major histocompatibility complex (pMHC) covalently conjugated to an iron-dextran nanoparticle. The drug acts by inducing the in vivo formation and expansion of antigen-specific regulatory T cells (Treg cells), which then traffic to inflamed tissues, suppress local pathogenic immune responses, and restore immunological tolerance. This mechanism offers disease modification and hepatoprotection, as demonstrated in preclinical models for primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and autoimmune hepatitis. Unlike cell therapies that require ex vivo expansion of Treg cells, PVT201 leverages the patient’s own immune system for targeted immunomodulation. The drug has received Orphan Drug designation from the US FDA for PBC and is currently being evaluated in Phase 1 clinical trials[1][2][3][5][6].

Other names

Navacim