Puretech Ownership
Product Candidate
Initial Indication(s)
Stage of Development
50.4% Equity

High-risk Clostridioides difficile

Phase 2

Food allergy

Phase 1/2

Inflammatory bowel disease

Phase 1

Solid tumors

Phase 1
Developing a new class of drugs to modulate the human microbiome 

Founded by PureTech, Vedanta Biosciences is developing a new category of therapies for immune-mediated diseases based on a 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 a leading IP position in the field, 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 current good manufacturing practice (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 investigational live biotherapeutic products (LBPs) in infectious disease, autoimmune disease, allergy and immuno-oncology.

In 2017, we initiated a Phase 1a/1b clinical trial of VE303, our lead product candidate for the treatment of recurrent C. difficile infection. We also continued to expand our internal, state-of-the-art cGMP-compliant manufacturing capabilities, giving us a distinct competitive advantage in the microbiome field. A Phase 2 study of VE303 is on track to begin in the second half of 2018. Three additional product candidates are also expected to enter clinical development in 2018, with Phase 1 trial initiations planned in inflammatory bowel disease (IBD) and food allergy, and the submission of an investigational new drug application (IND) for an immuno-oncology product candidate.

  • Program Discovery Process by the PureTech Team
    • PureTech was interested in translating the crosstalk between the immune system and commensal microbes that live in our bodies into therapeutics to modulate a range of immunological processes. PureTech engaged with leading world-renowned experts in immunology, including Ruslan Medzhitov, PhD, professor of immunobiology at Yale, Alexander Rudensky, PhD, a tri-institutional Professor at the Memorial Sloan-Kettering Institute, the Rockefeller University, and Cornell University, Dan Littman, MD, PhD, professor of molecular immunology at NYU, Brett Finlay, PhD, professor at the University of British Columbia, and Kenya Honda, MD, PhD, professor at the School of Medicine, Keio University.
    • Drs. Honda and Rudensky demonstrated the role of the microbiota in inducing regulatory T cells and uncovered some of the molecular mediators, known as short chain fatty acids. PureTech identified and in-licensed intellectual property from Dr. Honda when he was at Tokyo University in November 2011 before his seminal work was published in the journals Science and Nature. Based on Dr. Honda’s work, PureTech pioneered the concept of defined consortia of microbes to modulate the immune system or treat bacterial infections. PureTech played a critical role in the initial product development, initial experiments and planning of key clinical studies, business development and fundraising, and a core PureTech team member who helped lead the identification and platform development is now the chief executive officer of Vedanta.
  • Patient Need & Market Potential
    • Clostridioides Difficile (C. difficile) Infection:
      • The Center for Disease Control and Prevention (CDC) considers C. difficile infections one of the most urgent bacterial threats. C. difficile infections account for approximately 12,800 deaths each year in the United States alone and there are approximately 500,000 cases annually, of which 100,000 to 120,000 patients experience recurrence.
      • Existing interventions include antibiotics such as vancomycin or metronidazole, which have the undesirable side effect of damaging the gut microbiome and leaving patients vulnerable to re-infection. An alternative intervention, fecal transplantation, is an experimental procedure which is exceedingly difficult to standardize and scale and is fraught with potential safety issues.
    • Inflammatory Bowel Disease (IBD):
      • IBD is estimated to affect approximately three million people in the United States, and other autoimmune diseases affect over 20 million people in the United States.
      • Many of the existing interventions are limited by toxicities and systemic immune suppression.
    •  Allergies:
      • Food allergies are a growing public health concern in the United States and have an estimated annual economic cost near $25 billion.
      • Peanut allergies specifically affect an estimated 2.5 million people in the United States.
      • Current treatment options primarily center around allergen avoidance. Desensitization regimens in development have limited efficacy, are risky, require treatment for life and may not be cost-effective.
      • Vedanta’s product candidate, VE416, is being developed to safely induce permanent tolerance to food allergens including peanut allergy.
    • Immuno-oncology:
      • Despite profound survival improvements in some patients, checkpoint inhibitors, such as PD-1, PDL-1 and CTLA-4, are only effective in 20 to 30 percent of patients.
      • Common tumor types where checkpoint inhibitors are utilized include lung, bladder, skin and renal cancers.
      • Vedanta’s immuno-oncology product candidate, VE800, is designed to act in combination with approved checkpoint inhibitors and potentially other immuno-therapies to safely improve their efficacy.
      • Initial proposed indications include advanced and metastatic microsatellite-stable colorectal cancers, affecting more than 46,000 patients in the United States per year, gastric cancers, affecting more than 11,000 patients in the United States per year and melanoma, affecting more than 9,000 patients in the United States per year.
  • Innovative Approach to Solving the Problem
    • As a leader in the microbiome field, Vedanta is developing a new category of therapies for immune-mediated diseases based on a rationally-defined consortia of human microbiome-derived bacteria. Vedanta has helped move the microbiome field beyond correlation to causation, and beyond fecal transplants or fractions to defined, characterized biologic drugs.
    • Unlike fecal transplants, which require use of donors and are untargeted, inherently variable procedures, Vedanta’s approach is based on bacterial consortia therapeutics, which are defined drug compositions produced from clonally isolated bacteria that can trigger targeted immune responses. Unlike single strain probiotics, defined consortia can robustly shift the composition of the gut microbiota and provide colonization resistance against a range of intestinal infectious pathogens.
    • Vedanta’s novel product candidates are administered as a philosophized powder in a capsule dosage form, designed to have specific effects on the immune system, including restoring the balance of the microbiome in the gut to treat immune and infectious diseases and immunopotentiating responses to treat cancer.
  • Milestones Achieved
    • VE303, Vedanta’s product candidate for the treatment of high-risk C. difficile infection (CDI) is being studied in a Phase 2 clinical trial in patients at high risk of CDI. The trial was initiated in December 2018, and dose selection was based on the results from the Phase 1a/1b clinical trial in healthy volunteers, which showed that VE303 treatment resulted in rapid, durable, dose-dependent colonization and accelerated gut microbiota restoration after antibiotics.
    • VE202, Vedanta’s product candidate for the treatment of IBD, was shown to be generally safe and well-tolerated, with durable and dose-dependent colonization in two Phase 1 studies in healthy volunteers. The results of the studies will be used to inform the Phase 2 dose regimen in IBD patients. 
    • VE416, Vedanta’s product candidate in food allergy, is being evaluated in a Phase 1/2 investigator sponsored trial at MassGeneral Hospital for Children for patients 12 years of age or older with a history of peanut allergy. The first patient was enrolled in July 2019 and will explore VE416 both as a monotherapy and in combination with an oral peanut immuno-therapy over the course of several months.
    • VE800, Vedanta’s immuno-oncology product candidate, is being evaluated in a first-in-patient clinical trial with Bristol-Myers Squibb’s, or BMS, checkpoint inhibitor OPDIVO® (nivolumab) in patients with selected types of advanced or metastatic cancer. The trial was initiated in December 2019. As part of the agreement with BMS, Vedanta will conduct the clinical trial and BMS will supply nivolumab.
    • Vedanta also has ongoing discovery efforts to expands its pipeline, including VE707. VE707 is Vedanta’s preclinical discovery program for the prevention of infection and reoccurrence of several multi-drug resistant organisms (MDROs) including carbapenem-resistant Enterobacteriaceae (CRE), extended-spectrum beta lactamase producers (ESBL), and vancomycin-resistant Enterococci (VRE), which are some of the most common hospital-acquired infections.

  • Expected Milestones
    • Topline results for the Phase 2 clinical trial of VE303 are anticipated in 2021.
    • A Phase 2 study of VE202 is expected to begin in 2021.
    • Topline data from the Phase 1/2 clinical trial of VE416 in food allergy are expected in 2021.
    • Topline results from the first-in-patient clinical trial of VE800 are anticipated in 2021.

Unlike fecal transplants or single strain approaches to microbiome modulation, Vedanta Biosciences uses pure, clonal cell banks to produced defined collections, or consortia, of bacterial strains designed to effect durable therapeutic changes in a patient’s gut microbiota. This bypasses the need to rely on direct sourcing of fecal donor material of inconsistent composition.

Rationally defined bacterial consortia

Fecal transplant procedures

Can shift ecosystem, untargeted, variable procedure, non-reproducible input

Defined bacterial consortia drugs

Shifts ecosystem with targeted immune responses

Single strains or small molecules

Overly reductionist, fail to capture pleiotropic MoAs and bacteria-bacteria interactions

Vedanta's in-house, state-of-the-art GMP manufacturing plant

Press Releases

PureTech Founded Entity Vedanta Biosciences Announces Additional Pharmacokinetics Data from Phase 1 Study of VE202 for Inflammatory Bowel Disease to be Presented at United European Gastroenterology Week 2020

October 12, 2020 

PureTech Founded Entity Vedanta Biosciences Awarded Up to $76.9 Million Including $7.4 Million Upfront from BARDA to Advance the Development of VE303

September 30, 2020 

PureTech Founded Entity Vedanta Biosciences Announces the Appointment of Jeffrey Silber, MD, as Chief Medical Officer

September 16, 2020

PureTech Founded Entity Vedanta Biosciences Announces Positive Topline Data from Two Phase 1 Studies for IBD Candidate VE202

June 9, 2020

PureTech Affiliate Vedanta Biosciences Announces Initiation of First-in-Patient Study of Immuno-Oncology Candidate VE800 In Combination with Bristol-Myers Squibb's Opdivo® (Nivolumab)

December 11, 2019

PureTech Affiliate Vedanta Biosciences Awarded $5.8 Million CARB-X Grant to Accelerate Development of VE707 for Multi-Drug Resistant Infections

December 6, 2019

PureTech Affiliate Vedanta Biosciences Raises Additional $16.6 Million of Series C Financing, Bringing Total Capital Raised to $62.1 million

September 23, 2019

PureTech Health Affiliate Vedanta Biosciences Announces First Patient Enrolled in VE416 Phase 1b/2 Food Allergy Clinical Study

July 1, 2019

PureTech Health Affiliate Vedanta Biosciences Announces Expanded Data from Successful Phase 1a/1b Study of VE303 at Digestive Disease Week

May 21, 2019

PureTech Health Affiliate Vedanta Biosciences Closes Extended $45.5 Million Series C Financing

May 13, 2019

PureTech’s Vedanta Biosciences Announces Favourable Decision for Key Microbiome Patent

May 5, 2019

PureTech’s Vedanta Biosciences Publishes Seminal Research in Leading Scientific Journal for its Immuno-oncology Candidate, VE800

January 23, 2019