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Methods for Enhancing Immune Checkpoint Blockade Therapy by Modulating the Microbiome

Summary of Invention

PICI investigator Jennifer Wargo, MD, MMSc, and researchers at MD Anderson Cancer Center discovered that patients with metastatic melanoma who have a specific profile of microbial strains in their gut, known as the gut microbiome, benefit more from treatment with checkpoint inhibitors than patients with different profiles. In addition, the researchers discovered that transfer of stool collected from cancer patients with the favorable microbiome profile by fecal microbiota transplant (FMT) to mice having cancer improved antitumor activity by checkpoint inhibitor treatment in the mouse tumors. Interestingly, mouse tumor model experiments using FMT from patients with an unfavorable microbiome combined with checkpoint inhibitor treatment did not have antitumor activity. Based on these findings, PICI, MD Anderson and Seres Therapeutics have joined forces to develop and test microbiome administration using a pill made up of a mixture of bacterial strains associated with increased antitumor response to checkpoint inhibitor therapy. The pill aims to alter a patient’s microbiome to improve their response to checkpoint inhibitor therapy.

Potential Impact

Altering a patient’s microbiome with a pill could come with many benefits, including increasing the number of patients who benefit from checkpoint inhibitor therapy and potentially overcoming checkpoint inhibitor resistance.


PICI, Seres and MD Anderson are collaborating on a clinical trial to produce and test microbiome administration using pills. The trial opened in January 2019 at MD Anderson and the Angeles Clinic in California and is actively enrolling patients. Seres received an exclusive option, with pre-defined financial terms, to license intellectual property rights from MD Anderson related to the use of the pill composed of defined microbial strains to improve patient response to treatment with checkpoint inhibitors. Learn more about the clinical trial.

International Publication Number

WO 2018/064165 A2 (.pdf)

International Application Filing Date