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MRx0518 + pembrolizumab is a combination therapy consisting of a novel gut microbiome-derived live biotherapeutic product (MRx0518) and an anti-PD-1 immune checkpoint inhibitor (pembrolizumab). MRx0518 is designed to induce broad immunostimulatory activity to re-engage PD-1 inhibitor activity in patients who have progressed on prior immune checkpoint inhibitors. Preclinical studies showed that MRx0518 increases CD4+ and CD8+ T cell and NK cell infiltration into tumors while decreasing Tregs. The bacterial flagellin moiety activates tumor TLR5, inducing NFκB, cytokine responses, and IFNγ+ CD4+ and CD8+ T cells.
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