MB097

MB097 is an oral, live biotherapeutic product (LBP) in clinical development by Microbiotica. [3] It consists of a defined consortium of nine commensal bacterial strains, designed to enhance the efficacy of immune checkpoint inhibitors (ICIs) like pembrolizumab (KEYTRUDA®). [3, 7] The drug was discovered through analysis of the gut microbiome in melanoma patients who responded to ICI therapy, in a collaboration involving Microbiotica, Cancer Research UK, and Cambridge University Hospitals. [7] MB097 aims to modulate the gut microbiome to stimulate an anti-tumor immune response, potentially overcoming primary resistance to anti-PD-1 therapies. [3, 5] Preclinical data suggest its mechanisms include direct interaction with dendritic cells to activate cytotoxic T lymphocytes (CTLs), production of metabolites that enhance tumor-cell killing, and reversal of the inhibitory effects of tumor-associated macrophages. [3] A Phase 1b clinical trial (MELODY-1) is evaluating MB097 in combination with pembrolizumab in patients with advanced melanoma. [2, 4]