Intratumoral administration of lefitolimod resulted in a beneficial modulation of the tumor micro-environment (TME) characterized by increased infiltration of activated CD8+ T cells, which showed an up-regulation of Granzyme B. Notably, an increase of IFN-gamma secreting CD8+ T cells within the spleen was detected after re- stimulation with the tumor-specific AH1 peptide antigen or CT26 tumor cells. This evidence concerns the gene GZMB and neoplasm.