Therapy Areas: AIDS & HIV
Vedanta Biosciences Initiates Phase 1 Clinical Study with Janssen of Microbiome-Derived Product Candidate for Inflammatory Bowel Disease
28 November 2018 - - US-based clinical-stage company Vedanta Biosciences has initiated a Phase 1 clinical study in healthy volunteers of VE202, the company's orally-administered, live biotherapeutic product candidate for inflammatory bowel disease, the company said.

The study is being conducted by Janssen Research and Development, LLC.

In conjunction with the initiation of this study, Vedanta Biosciences will receive USD 12m from Janssen in milestone payments as part of an ongoing collaboration that has development and commercialisation milestone payments of up to a total of USD 339m in addition to royalty payments.

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.

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.

Inflammatory bowel disease is estimated to affect over one m 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 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.

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.

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 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), 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).