Puretech Ownership1
Therapeutic Candidate2
Initial Indication(s)
Stage of Development
41.4% Equity
VE303

High-risk Clostridioides difficile

Phase 2
VE416

Food allergy

Phase 1/2
VE202

Inflammatory bowel disease

Phase 2 Ready
VE800

Solid tumors

Phase 1

1 As of July 16, 2021, PureTech’s percentage ownership of Vedanta Biosciences was approximately 41.4 percent on a diluted basis. This calculation includes issued and 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 United States.

Pioneering a new category of therapies for immune-mediated diseases

Vedanta is developing a potential new category of therapies for immune-mediated diseases based on a rationally-defined consortia of human microbiome-derived bacteria. 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 (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: 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 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 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 U.S. public health concern 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. 
    • Immuno-Oncology: Despite profound survival improvements in some patients, checkpoint inhibitors targeting 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.Initial proposed indications include advanced and metastatic microsatellite stable (MSS) colorectal cancers, which cause more than 46,000 deaths per year in the U.S., gastric cancers, which causes more than 11,000 deaths per year in the U.S., and melanoma, which causes more than 9,000 deaths per year in the U.S.
    • The Microbiome Field: Moving Beyond Fecal Transplants and Fractions
      • 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 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 June 2021, Vedanta announced additional results from a Phase 1 study in healthy volunteers of VE202, Vedanta's 16-strain live biotherapeutic product (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.
    • VE303, Vedanta’s therapeutic candidate for the treatment of high-risk CDI, is being studied in a Phase 2 clinical trial in patients at high risk of rCDI. 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.
    • A new Phase 2 investigator-sponsored trial evaluating VE303 in patients with hepatic encephalopathy (HE) was recently initiated by the University of Michigan Hospitals-Michigan Medicine. The 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 January 2021, Vedanta announced a $25 million investment from Pfizer, as part of the Pfizer Breakthrough Growth Initiative. The proceeds will fund the Phase 2 clinical trial of VE202 in IBD. Vedanta will retain control of all 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.
    • VE416, Vedanta’s therapeutic candidate for food allergy, is being evaluated in a Phase 1/2 investigator sponsored trial at Mass General Hospital for patients 12 years of age or older with a history of peanut allergy. The first patient was enrolled in July 2019 and the trial will explore VE416 both as a monotherapy and in combination with an oral peanut immunotherapy over the course of several months.
    • Vedanta is nearing the completion of Stage 1 of an open-label Phase 1 study to evaluate the safety and initial clinical activity of VE800, Vedanta’s immuno-oncology therapeutic candidate, in combination with Bristol Myers Squibb's Opdivo® (nivolumab) in 54 patients across select types of advanced or metastatic cancers. This trial is being done under a collaboration and supply agreement with Bristol Myers Squibb. To date, VE800 has demonstrated an acceptable safety and tolerability profile, though 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, to profile patient subtypes that might benefit from microbiome manipulation.
    • Vedanta also has ongoing discovery efforts to expands its pipeline, including VE707. VE707 is Vedanta’s preclinical program for the prevention of infection by several problematic Gram-negative Enterobacteriaceae, which are some of the most common hospital-acquired pathogens.

  • Expected Milestones
    • Topline results for the Phase 2 clinical trial of VE303 are anticipated in the third quarter of 2021.
    • Initiation of a Phase 3 trial for VE303 is expected in mid-2022.
    • Vedanta expects to complete the build-out of its Phase 3 and commercial launch cGMP manufacturing facility for supply of VE303 by the end of 2021.
    • Initiation of a Phase 2 clinical trial of VE202 in mild to moderate ulcerative colitis patients is expected in the second half of 2021.
    • Topline data from the Phase 1/2 clinical trial of VE416 for food allergy are expected in 2022, subject to investigator timelines.

Active INDs or the foreign regulatory equivalent 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 majority shareholder. Vedanta is well-protected with a robust intellectual property portfolio. 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 >80,000 isolates obtained from >275 healthy donors from 4 continents, >3,000 WGS, extensively phenotyped.


Press Releases

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