Definition

A preparation of autologous, epigenetically reprogrammed, polyclonal tumor infiltrating lymphocytes (TILs), with potential immunomodulating and antineoplastic activities. The autologous TILs LYL845 are prepared and expanded ex vivo by co-culturing autologous tumor cells with specific Epi-R cell culture media containing optimized cytokine composition and cell activation which creates TILs enriched with CD8-positive T cells with diverse tumor-reactive clones and an enhanced proportion of stem-like T cells. Upon administration, the autologous TILs LYL845 may target and kill tumor cells and secrete pro-inflammatory cytokines. LYL845 shows increased durability of expanded TILs, enhanced polyclonality and increased tumor-reactive cytolytic T cells compared to TILs derived from the standard process.