AFX-001

AFX-001 is a preclinical cell therapy developed by AffyXell Therapeutics, a joint venture between Daewoong Pharmaceutical and Avacta Group. The therapy consists of human pluripotent stem cell-derived mesenchymal stromal cells (hPSC-MSCs) that are genetically engineered to express and secrete Affimer proteins, specifically an anti-CD40L antagonist. Affimers are non-antibody binding protein scaffolds designed to enhance the immunomodulatory effects of the mesenchymal stem cells. By inhibiting the CD40-CD40L interaction, AFX-001 suppresses T cell-mediated immune responses and B cell activation. It is being developed for the treatment of Graft-versus-Host Disease (GvHD) and the prevention of rejection in solid organ transplantation (SOT), with preclinical studies demonstrating reduced clinical scores and improved immune balance in animal models.