Vedanta Biosciences Announces Initiation of Phase 1 Clinical Study with Janssen of Microbiome-Derived Product Candidate for Inflammatory Bowel Disease
First clinical study of a rationally-defined bacterial consortium for an immune-mediated disease
Milestone triggers $12 million in payments from Janssen
CAMBRIDGE, Mass., Nov. 27, 2018—Vedanta Biosciences, a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, today announced the initiation of a Phase 1 clinical study in healthy volunteers of VE202, the Company’s orally-administered, live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD). The study is being conducted by Janssen Research & Development, LLC. In conjunction with the initiation of this study, Vedanta Biosciences will receive $12 million from Janssen in milestone payments as part of an ongoing collaboration that has development and commercialization milestone payments of up to a total of $339 million in addition to royalty payments.
“There is significant evidence highlighting the role of the microbiome in the pathogenesis of IBD. Current treatments effectively block mediators of inflammation, but they do not address the underlying alterations in the gut microbiota that may be driving the inflammation in the first place, leaving a need for safe approaches that address this aspect of the disease,” said Bernat Olle, Ph.D., Co-founder and Chief Executive Officer of Vedanta Biosciences. “To our knowledge, VE202 is the first drug candidate based on a rationally-defined bacterial consortium to enter the clinic for an autoimmune disease. We are pleased to collaborate with Janssen’s team, which has produced several important drugs for people living with IBD.”
VE202 is based on the work of Vedanta Biosciences co-founder Kenya Honda, Ph.D., of Keio University, who in 2011 published in Science foundational research demonstrating that members of the gut microbiota could impact the number and activity of regulatory T cells in the gut mucosa. In two further publications in Nature, in collaboration with Vedanta Biosciences, Honda’s group identified cellular mechanisms driving these and other immune-microbiota interactions and demonstrated their potential utility in disease models. Informed by this work, Vedanta Biosciences advanced VE202, a drug candidate consisting of a rationally-defined consortium of regulatory T cell – inducing bacteria.
“Randomized clinical trials of fecal microbiota transplants (FMT) have provided strong evidence for the microbiome’s involvement in inflammatory bowel diseases albeit with varying clinical success depending on the donor used and the frequency of instillations. The inconsistent composition of fecal donor material and the need for chronic administration make FMT a challenging modality for treating IBD,” said Balfour Sartor, M.D., Midget Distinguished Professor of Medicine, Microbiology & Immunology and Co-Director of the UNC Multidisciplinary IBD Center at the University of North Carolina at Chapel Hill. “I believe that a better, more consistent therapeutic approach is to use a well-characterized, rationally-defined, and orally-delivered LBP using bacterial species normally found in the intestine of healthy subjects. I am encouraged by the work Vedanta Biosciences is conducting, and I look forward to the results of this latest clinical study.”
Vedanta Biosciences controls an extensive foundational patent estate in the United States, Europe and Japan broadly covering pharmaceutical compositions including Clostridium bacterial strains and methods of use for therapeutic products, including both consortia of bacterial strains and spore-forming fractions based on beneficial bacteria. The intellectual property estate covers several of Vedanta Biosciences’ therapeutic candidates in development. The company has also been issued patents specifically around the composition and use of VE202 in IBD.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is estimated to affect over one million people in the United States, with as many as 70,000 new cases of the disease diagnosed each year. IBD is believed to result from interactions between genetic factors and environmental triggers, such as commensal bacteria with pathogenic potential. It is associated with chronic inflammation in the gastrointestinal (GI) tract, impairing the ability of affected GI organs to function properly. Symptoms can vary but include diarrhea, abdominal pain, cramping, rectal bleeding, and fatigue. Currently available medications alleviate inflammation and reduce symptoms, but do not provide a cure or prevent long-term complications.
Janssen Biotech, Inc. licensed VE202 from Vedanta Biosciences in 2015. VE202 is an orally-administered investigational live biotherapeutic product (LBP). It is produced from pure, clonal cell banks, which yield a standardized drug product in powder form and bypass the need to rely on direct sourcing of fecal donor material of inconsistent composition. VE202 consists of a defined consortium of live bacteria designed to modulate the activity of regulatory T cells and thereby potentially treat inflammatory bowel disease (IBD).
About Vedanta Biosciences
Vedanta Biosciences is a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria. Vedanta Biosciences is a leader in the microbiome field with capabilities and deep expertise to discover, develop, and manufacture live bacteria drugs. These include what is believed to be the largest collection of human microbiome-associated bacterial strains, a suite of proprietary assays to select pharmacologically potent strains, vast proprietary datasets from human interventional studies, and facilities for cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form. Vedanta Biosciences' pioneering work, in collaboration with its scientific co-founders, has led to the identification of human commensal bacteria that induce a range of immune responses – including induction of regulatory T cells, CD8+ T cells, and Th17 cells, among others. These advances have been published in leading peer-reviewed journals, including Science (multiple), Nature (multiple), Cell, and Nature Immunology. Vedanta Biosciences has harnessed these biological insights and its capabilities to generate a pipeline of programs in infectious disease, autoimmune disease, allergy, and immuno-oncology.
Vedanta Biosciences was founded by PureTech Health (PRTC.L). Its scientific co-founders are world-renowned experts in immunology and microbiology who have pioneered the fields of innate immunity, Th17 and regulatory T cell biology, and include Ruslan Medzhitov, Ph.D., (Yale and Howard Hughes Medical Institute (HHMI)), Brett Finlay, Ph.D., (University of British Columbia and HHMI), Kenya Honda, Ph.D., (inventor of Vedanta Biosciences' lead product candidate; Keio University and RIKEN), Dan Littman, Ph.D., (New York University and HHMI), Alexander Rudensky, Ph.D., (Sloan Kettering and HHMI), and Jeremiah Faith, Ph.D., (Mount Sinai School of Medicine).
Forward Looking Statement
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Allison Mead Talbot
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