ALG-115

ALG-115 is a preclinical-stage, ex vivo gene therapy designed to prevent donor organ rejection at its source following solid organ transplantation, initially focusing on lung transplantation. Developed by Allogenetics, a spin-off of the Hannover Medical School (MHH), ALG-115 is administered as a one-time treatment to the donor organ during the ex vivo perfusion window between procurement and implantation. The therapy utilizes a lentiviral vector to deliver short hairpin RNAs (shRNAs) that target and knock down the expression of beta-2 microglobulin (B2M) and class II transactivator (CIITA), thereby downregulating cell-surface major histocompatibility complex (MHC) class I and class II antigen presentation. By calibrating antigen presentation to a residual level, ALG-115 renders the graft immunologically "invisible" to the recipient's immune system, preventing rejection and potentially eliminating the need for lifelong systemic immunosuppression while preserving the recipient's overall immune competence.