Seres Therapeutics’ approach identifies key alterations in the microbiome associated with disease and designs tailored oral therapeutic microbial candidates that aim to improve patient outcomes by establishing a healthy microbiome.
Our SER-287 development candidate is a donor-derived microbiome therapy designed to modulate the gastrointestinal microbiome and improve the signs and symptoms associated with Ulcerative Colitis (UC). Our ongoing Phase 2b trial, ECO-RESET, is evaluating SER-287 as an induction therapy in patients with active mild-to-moderate UC who are failing current therapies. A positive prior Phase 1b study demonstrated clinical improvement and robust engraftment of SER-287-derived bacteria that both correlated with broader changes in the microbiome and metabolic changes in subjects. Based on feedback from the U.S. Food and Drug Administration (FDA), this Phase 2b study, if positive, could serve as one of two studies to support product registration.
Our SER-109 donor-derived development candidate is an oral therapeutic candidate designed to compete with and eradicate Clostridium difficile infection (CDI) in adults with recurrent CDI. Our ongoing trial, ECOSPOR III, is evaluating the safety and efficacy of SER-109 for the prevention of CDI in adults with recurrent CDI. SER-109 has obtained both Breakthrough Therapy Designation and Orphan Drug Designation from the U.S. FDA.
SER-401 is a donor-derived microbiome therapeutic candidate that incorporates the bacterial signature found in melanoma patients who have a robust response to immunotherapy. SER-401 is designed to modify patients’ immunological activity and meaningfully improve patients’ response to checkpoint inhibitor therapy. We are evaluating SER-401’s ability to augment checkpoint immunotherapy in a randomized, placebo-controlled Phase 1b study in patients with metastatic melanoma. The Phase 1b study is being conducted in collaboration with the Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center.
We are also working to advance SER-301, a rationally designed, fermented microbiome candidate for ulcerative colitis, incorporating findings from the SER-287 program and other research.
Through a collaboration with AstraZeneca, we are further investigating uses of microbiome therapeutics to augment oncology approaches.
2. Collaboration with University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy, announced Nov. 14, 2017, regarding evaluation of microbiome therapies to improve the outcomes of cancer patients treated with immunotherapy.
3. Collaboration with AstraZeneca, announced Mar. 11, 2019, regarding advancing mechanistic understanding of the microbiome in augmenting the efficacy of cancer immunotherapy, including potential synergy with AstraZeneca compounds.