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XBI-302 + nivolumab is an investigational combination therapy consisting of orally administered fecal microbiota transplantation (FMT) capsules (XBI-302) and the immune checkpoint inhibitor monoclonal antibody, nivolumab. The combination is being studied primarily for its potential to overcome resistance to anti-PD-(L)1 therapies in cancer, particularly in patients with refractory or resistant solid tumors such as gastric cancer. XBI-302 is a gut microbial capsule developed by Shenzhen Xbiome Biotechnology and functions as a microbiome modulator, aiming to restore or alter the gut microbial composition to enhance immune responses. Nivolumab is a programmed death 1 (PD‑1) receptor-blocking antibody that enhances T-cell mediated antitumor activity by inhibiting PD‑1-mediated immune suppression. The rationale for combining these agents lies in evidence that modulation of the gut microbiota can improve response rates and efficacy of immunotherapies like anti-PD‑1 antibodies.
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