Puretech Ownership1
Therapeutic Candidate2
Initial Indication(s)
Stage of Development
40.5% Equity
VE303

Clostridioides difficile

Phase 3 Ready
VE202

Inflammatory bowel disease

Phase 2 Ready
VE416

Food allergy

Phase 1/2
VE800

Solid tumors

Phase 1
VE707
Gram-negative infections
Preclinical

1 As of June 30, 2022, PureTech’s percentage ownership of Vedanta Biosciences was approximately 40.5% on a diluted basis. This calculation includes outstanding shares, options, and warrants, but excludes unallocated shares authorized to be issued pursuant to equity incentive plans.
2 Therapeutic candidates are investigational and have not been cleared by the FDA for use in the U.S.

Pioneering a new category of oral therapies for immune-mediated diseases

Vedanta is developing a new category of oral therapies based on defined consortia of bacteria isolated from the human microbiome and grown from pure clonal banks. The human microbiome is increasingly implicated in various immune-mediated diseases. Vedanta is a leader in the field with capabilities and deep expertise to discover, develop and manufacture live bacteria drugs. These include what is believed to be a leading intellectual property position with 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, or CGMP, compliant manufacturing of rationally defined bacterial consortia in powder form. All of this work has helped move the microbiome field beyond correlation to causation, and beyond fecal transplants or fractions to defined, characterized biologic drugs.


  • Program Discovery Process by the PureTech Team
    • We were 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. We engaged with leading world-renowned experts in immunology, including Dr. Ruslan Medzhitov, Professor of Immunobiology at Yale; Dr. Alexander Rudensky, a tri-institutional Professor at the Memorial Sloan-Kettering Institute, the Rockefeller University, and Cornell University; Dr. Dan Littman, Professor of Molecular Immunology at NYU; Dr. Brett Finlay, Professor at the University of British Columbia; and Dr. Kenya Honda, 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.
    • We 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, we pioneered the concept of defined consortia of microbes to modulate the immune system or treat bacterial infections. We 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 infection (CDI): The Centers for Disease Control and Prevention considers CDI one of the most urgent bacterial threats. C. difficile infections account for approximately 12,800 deaths each year in the U.S. alone and there are approximately 500,000 cases annually, of which approximately 100,000 patients experience recurrence. Existing interventions include antibiotics such as vancomycin, fidaxomicin, or metronidazole, which have the undesirable side effect of damaging the gut microbiome and leaving patients vulnerable to re-infection. An alternative intervention, fecal microbiota transplantation (FMT), is an experimental procedure that is exceedingly difficult to standardize and scale and is fraught with potential safety issues.
    • Inflammatory Bowel Disease (IBD): Ulcerative colitis and Crohn’s disease, the most common types of IBD, affect about one million adults in the U.S. and about seven million globally and the prevalence of IBD is expected to continue to grow. Many of the existing interventions are limited by toxicities and systemic immune suppression.
    • Allergies: Food allergies are a growing U.S. public health concern and have an estimated annual economic cost near $25 billion. Peanut allergies specifically affect an estimated 4.6 million adults in the U.S. 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 therapeutic candidate, VE416, is being developed to safely induce permanent tolerance to food allergens
      including peanuts. 
    • Immuno-Oncology: Despite profound survival improvements in some patients, immune checkpoint inhibitors targeting PD-1, PDL-1 and CTLA-4 are only effective in 20-30% of patients. Common tumor types for which checkpoint inhibitors are utilized include lung, bladder, skin and renal cancers. Vedanta’s immuno-oncology therapeutic candidate, VE800, is designed to act in combination with approved checkpoint inhibitors and potentially other immunotherapies to safely improve their efficacy.
    • The Microbiome Field: Moving Beyond FMTs and Fractions
      • Unlike FMTs, which require the 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 therapeutic candidates are administered as a lyophilized 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 & Developmental Status
    • In October 2021, Vedanta announced that its Phase 2 clinical trial of VE303, an orally administered investigational live biotherapeutic product (LBP) in development for the prevention of recurrent CDI in high-risk patients, met its primary endpoint of preventing disease recurrence through Week 8. VE303 achieved a 31.7% absolute risk reduction in rate of recurrence when compared with placebo, representing a greater than 80% reduction in the odds of a recurrence. This is believed to be the most advanced clinical trial of an investigational drug based on a rationally defined bacterial consortium, a microbiome-based therapeutic approach that delivers orally administered candidates of precisely known composition that can be manufactured with pharmaceutical-grade consistency. Based on the Phase 2 data, the Biomedical Advanced Research and Development Authority (BARDA) exercised its first contract option for additional funding of $23.8 million, pursuant to its existing 2020 contract with Vedanta, to support a planned Phase 3 clinical trial of VE303.
    • In June 2022, Vedanta announced the opening of a new facility designed to manufacture clinical and commercial supply for its therapeutic portfolio, including for the planned Phase 3 study and potential commercial launch of its lead candidate, VE303, in CDI. Vedanta believes it was the first company to manufacture CGMP-grade defined bacterial consortia in powdered form, which enables stable, consistent oral formulations.
    • In April 2022, results from a Phase 1a/1b study evaluating the safety, tolerability, and colonization dynamics of VE303 in healthy adults were published in the journal Cell Host & Microbe. VE303 was observed to be generally well-tolerated at all doses tested and to colonize optimally if dosed over multiple days after vancomycin pretreatment. The work illuminates some fundamental features of the colonization dynamics of a live biotherapeutic product (LBP) that may be generalizable. Specifically, it shows that the proportion of LBP strains that colonize, as well as the abundance and durability of colonization, can be significantly improved by the use of a higher dose, longer duration of dosing, and pretreatment with a short course of antibiotics to create an ecological niche for engraftment. VE303 colonization was associated with earlier and increased concentrations of secondary bile acids and short-chain fatty acids, and promoted the establishment of a microbiota community known to resist enteric pathogen colonization.
    • In May 2022, Vedanta announced presentations of research informed by multiple clinical studies at Digestive Disease Week (DDW). The analyses cover several defined bacterial consortia candidates developed by Vedanta, and include assessments of safety, tolerability, efficacy, and the relationships between dosing regimen, consortium strain colonization, and restoration of a patient's resident microbial community. These analyses further deepen Vedanta's understanding of the clinical pharmacology and potential benefits of defined bacterial consortia and help inform future clinical research. This body of data builds on published analyses from earlier clinical work that identified key factors that drive colonization of Vedanta's candidates.
    • In January 2021, Vedanta announced a $25 million investment from Pfizer, as part of the Pfizer Breakthrough Growth Initiative. Vedanta will retain control of all of its programs and has granted Pfizer a right of first negotiation on VE202. As part of the investment, Michael Vincent, M.D., Ph.D., Senior Vice President and Chief Scientific Officer, Inflammation & Immunology Research Unit at Pfizer, joined Vedanta’s Scientific Advisory Board.
    • In July 2021, Vedanta closed a $68 million financing, which included the $25 million investment from Pfizer announced in January 2021.
    • In late 2021, Vedanta completed the build-out of its Phase 3 and commercial launch CGMP manufacturing facility for supply of VE303.
    • A Phase 1/2, investigator-sponsored clinical study exploring use of VE416 in combination with an oral peanut immunotherapy is underway at Massachusetts General Hospital. VE416 consists of seven bacterial strains of the Clostridia class, which were selected based on their ability to induce immune tolerance in the gut.
    • In 2021, a Phase 2 investigator-sponsored trial evaluating VE303 in patients with hepatic encephalopathy (HE) was initiated by the University of Michigan Hospitals-Michigan Medicine. This randomized, double-blind, placebo-controlled trial is planned to enroll up to 18 adult patients with a confirmed diagnosis of cirrhosis and history of at least one episode of overt HE.
    • In July 2021, Vedanta announced results from the Phase 1 study evaluating the safety and initial clinical activity of VE800, and immuno-oncology therapeutic candidate, in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) in 54 patients across select types of advanced or metastatic cancers. VE800 demonstrated an acceptable safety and tolerability profile, although the observed response rates did not meet the prespecified criteria to expand into the next stage of the study. Vedanta is analyzing blood, stool, and tumor samples from patients in whom response or disease control was observed in order to profile patient subtypes that might benefit from microbiome manipulation. Vedanta plans to present the results at a future medical conference and will continue work to identify cancer settings and patient populations that might benefit from microbiome manipulation with its defined bacterial consortia.
    • In February 2021, Vedanta announced the appointment of Mark Mullikin as Chief Financial Officer. Mr. Mullikin brings 25 years of experience raising and deploying capital for life sciences companies, and most recently held leadership roles in finance and investor relations at publicly traded Editas Medicine and Novartis.
    • In October 2021, Vedanta announced the appointment of Simona Levi as Chief Legal Officer and Corporate Secretary. Dr. Levi brings over 25 years of U.S. and international legal experience with private and public companies across the life sciences industry, focusing on complex transactions, intellectual property law and litigation and corporate governance.
    • Vedanta also has ongoing discovery efforts to expand its pipeline, including VE707. VE707 is Vedanta’s preclinical discovery program for the prevention of infection and recurrence of colonization with several multidrug-resistant organisms, including carbapenem-resistant Enterobacteriaceae and extended-spectrum beta lactamase producers, which are leading causes of the most common
      hospital-acquired infections.
    • In June 2021, Vedanta announced additional results from a Phase 1 study in healthy volunteers of VE202, Vedanta's 16-strain LBP candidate for IBD. The results further support the benign safety profile of VE202 and identify an optimal dosing regimen for Phase 2 studies. This followed topline data from two Phase 1 studies exploring 11- and 16-strain VE202 consortia announced in June 2020, which showed that VE202 was generally well-tolerated at all doses and demonstrated durable and dose-dependent colonization. The trial was conducted by Janssen Research & Development, LLC, and a more complete study dataset and analyses will be submitted to a peer-reviewed journal. Vedanta has regained full rights to the program and will owe Janssen single-digit royalty payments on net sales of a commercialized product.

  • Expected Milestones
    • Vedanta plans to initiate a Phase 3 clinical trial of VE303 in patients at high risk for recurrent Clostridioides difficile infection (CDI) in the first half of 2023.
    • Vedanta expects topline data from the Phase 1/2 clinical trial of VE416, Vedanta’s therapeutic candidate for food allergy, in 2023, subject to investigator timelines.

Note: Active INDs or the foreign regulatory equivalent are on file for VE202, VE303, VE416 and VE800. Our board designees represent a majority of the members of the board of directors of Vedanta, but Vedanta has its own independent management team. Our role in the development of Vedanta’s therapeutic candidates is through our representation on its board of directors and our role as a substantial shareholder. Vedanta intellectual property portfolio is believed to provide a dominant position for the development and commercialization of microbiome medicines based on defined consortia of gut bacteria. Vedanta was incorporated in December 2010.

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.


5 Nearly 100,000 isolates obtained from >275 healthy donors from 4 continents, >3,000 WGS, extensively phenotyped.


Press Releases

PureTech Founded Entity Vedanta Biosciences Unveils State-of-the-Art Manufacturing Facility to Provide Clinical and Commercial Supply of Oral Therapies Based on Defined Bacterial Consortia

June 28, 2022


PureTech Founded Entity Vedanta Biosciences Presents Data from Multiple Studies at Digestive Disease Week 2022 Annual Meeting

May 24, 2022


PureTech Founded Entity Vedanta Biosciences Publishes Phase 1a/1b Results for Lead Program VE303 in Cell Host & Microbe and Highlights Planned Presentations of Phase 2 VE303 Results

April 13, 2022


PureTech Founded Entity Vedanta Biosciences Appoints Simona Levi as Chief Legal Officer and Corporate Secretary

October 14, 2021


PureTech Founded Entity Vedanta Announces Positive Topline Phase 2 Data for VE303 in High-Risk C. difficile Infection and Exercise of $23.8 Million Option by BARDA

October 5, 2021


PureTech Founded Entity Vedanta Biosciences Completes $68 Million Series D Financing

July 21, 2021


PureTech Founded Entity Vedanta Biosciences Appoints Mark Mullikin as Chief Financial Officer

February 8, 2021


PureTech Founded Entity Vedanta Biosciences Announces $25 Million Investment from Pfizer Inc.

January 12, 2021


PureTech Founded Entity Vedanta Biosciences Appoints Troy Ignelzi, Chief Financial Officer at Karuna Therapeutics, to its Board of Directors

November 24, 2020 


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