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VE800 + nivolumab is an investigational combination therapy consisting of a live biotherapeutic product (VE800) and the immune checkpoint inhibitor monoclonal antibody nivolumab. - **VE800** is a rationally-defined human bacterial consortium composed of 11 distinct nonpathogenic, nontoxigenic commensal bacterial strains derived from healthy donor stool. It is formulated as an oral enteric capsule and designed to modulate the gut microbiome to enhance anti-tumor immune responses by inducing cytotoxic CD8+ T cells and potentiating the effects of immunotherapy[4][5]. - **Nivolumab** is a fully human IgG4 monoclonal antibody that targets programmed death-1 (PD-1), blocking its interaction with PD-L1/PD-L2, thereby enhancing T-cell mediated anti-tumor activity. Nivolumab is FDA-approved for several cancers but not specifically for all indications in this combination[3][4]. The combination aims to improve outcomes in patients with advanced or metastatic cancers by leveraging both microbiome modulation (via VE800) and immune checkpoint inhibition (via nivolumab)[4][6].
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