Recent Developments in Microbiome Therapeutics Recent-Developments-in-Microbiome-Therapeutics-Nov | Page 13

Finally, the largest company in the field is Seres Therapeutics 61 . Seres’ lead candidate, SER-109, is an oral microbiome
therapeutic for the prevention of Clostridium difficile infection (CDI) in adults with recurrent CDI. The drug has
been designated Breakthrough Therapy and an Orphan Drug by the US FDA and is currently undergoing Phase 3
clinical trial. The company’s other candidate, SER-262 for primary CDI, is undergoing Phase 1b clinical trials. Seres’
candidate for Ulcerative colitis, SER-287, finished its Phase 1b trial in October 2017, with positive topline results. In
January 2016, Seres entered a commercialization agreement with Nestlé for the development and commercialization,
outside of the United States and Canada, for its product candidates SER-109 and SER-262 for CDI, and SER-287
and SER-301 for IBD. In exchange for commercial rights, Seres will be provided an upfront payment of $120 million
in cash, followed by a series of milestone payments and tiered royalties on sales. In 2016, Seres also participated in
several other industry and academic collaborations to further their work:
• Collaboration with Emulate 62 , a company that develops micro-engineered, living-tissue-based systems called
Organs-on-Chips. Seres will use Emulate’s intestine-chip platform to identify novel bacteria compositions with
therapeutic potential.
• Collaboration with Massachusetts General Hospital. Seres will sponsor a placebo-controlled, proof-of-concept
clinical study at the hospital to evaluate the impact of Fecal Microbiota Transplantation (FMT) on adults
suffering from obesity and other metabolic disorders.
• Collaboration with Mayo Clinic. Scientists from the two organizations will collaborate on several preclinical and
clinical studies to identify novel therapeutics for Primary Sclerosing Cholangitis, Non-Alcoholic Steatohepatitis
(NASH) and other liver diseases.
• Collaboration with University of Pennsylvania. Researchers from the two organizations will collaborate on a
clinical study to evaluate the role of the microbiome in certain rare genetic metabolic diseases.
• Multi-year research collaboration with Memorial Sloan Kettering Cancer Center, for the discovery and
development of microbiome therapeutics in the field of immuno-oncology.
• Academic collaborations with researchers at the Research Institute of St. Joseph’s Hamilton and the Medical
University of Graz, for therapeutics for Inflammatory Bowel Disease.
61 
http://www.serestherapeutics.com/
62 https://emulatebio.com/
13
Recent Developments in Microbiome Therapeutics