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MB097 + Keytruda is an investigational combination immunotherapy regimen consisting of MB097, an orally administered live biotherapeutic product (LBP) developed by Microbiotica, and Keytruda (pembrolizumab), an anti-PD-1 monoclonal antibody developed by Merck & Co. MB097 is a defined consortium of nine commensal bacterial strains identified from the microbiomes of melanoma patients who responded to immune checkpoint inhibitors. It is designed to modulate the gut microbiome and stimulate the immune system—specifically by activating dendritic cells to produce IL-12, which in turn stimulates cytotoxic T lymphocytes and natural killer (NK) cells—to overcome resistance to immune checkpoint inhibitors. Keytruda is an established checkpoint inhibitor targeting programmed cell death protein 1 (PD-1). The combination is being evaluated in the Phase 1b MELODY-1 trial for the treatment of patients with advanced (metastatic) cutaneous melanoma who have failed to respond to prior anti-PD-1 therapy.
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