CARB-X portfolio has 23 early development projects with multiple innovative approaches to tackle the most difficult resistant infections

(BOSTON: November 2, 2017) – CARB-X announced today that it has awarded Vedanta Biosciences of Cambridge, MA (an affiliate of PureTech Health, LSE: PRTC) up to $5.4M to support the development of a novel, human microbiome-derived treatment for the prevention of bacterial infections caused by C. difficile. Antibiotic use can disrupt the gut microbiota and render patients vulnerable to infection with C. difficile. Vedanta’s oral product candidate, VE303, is a rationally defined live bacterial consortia designed to safely reconstitute a healthy gut microbiota and protect against C. difficile infection. Although C. difficile infections are not yet significantly resistant to the drugs used to treat them, most are directly related to antibiotic use.

“The Vedanta VE303 microbiome-based anti-infective project is an exciting addition to the CARB-X pipeline. It is CARB-X’s first award announced for a microbiome project and also the first for a project targeting C. difficile, bringing a novel approach that could potentially protect patients from bacterial infections and save lives,” said Kevin Outterson, Executive Director of CARB-X, the world’s leading non-profit partnership dedicated to accelerating the development of antibiotics, diagnostics and other products to treat deadly infections. “The projects in the Powered by CARB-X portfolio are in the early stages of research, and there is always a high risk of failure. But if successful, these projects hold exciting potential in the fight against the deadliest bacteria.”

“Microbiome-based therapies are a much-needed alternative to antibiotics,” said Bernat Olle, PhD, Vedanta Biosciences CEO. “It is urgent to look for new ways to treat infection that are less prone to eliciting resistance and that do not damage the microbiota and thus render the host vulnerable to re-infection. VE303 has the potential of addressing both of these issues at once.”

The Centers for Disease Control and Prevention (CDC) considers Clostridium difficile (C. difficile) infections one of the most urgent bacterial threats. C. difficile infections account for 15,000 deaths each year in the US alone, and many more die from conditions complicated by C. difficile infections. Global estimates are not available. Current treatments for C. difficile infections include antibiotics, which can further damage the gut microbiome – the community of good bacteria that live in the body – and leave patients vulnerable to serious re-infection. The Vedanta VE303 project aims to rebuild the damaged gut microbiome, and protect against C. difficile

Vedanta plans to initiate Phase 1 clinical trials with its lead product candidate VE303 in 2017, supported by funding from CARB-X.

The CARB-X portfolio is the world’s largest and most scientifically diverse portfolio of early development projects to treat serious drug-resistant bacterial infections and other difficult-to-treat infections. CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, currently funds projects in 6 countries and is working to expand its pipeline with the best science from around the world.

CARB-X is a partnership between the UK charity Wellcome Trust and the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). CARB-X is actively seeking global support from other governments, industry and civil society to expand its ability to fund the best science around the world to get the new life-saving treatments so urgently needed.

BARDA’s Director Rick Bright, PH.D., said: “The support announced today aims to speed development of a potential new antibacterial product to treat patients with life-threatening infections and enhance national security and global health preparedness. At BARDA, we are committed to revitalizing the antibacterial pipeline through a combination of incentives. Today’s announcement is another example of our commitment to promote and accelerate medical countermeasure innovation through novel public-private partnerships like CARB-X.”

Tim Jinks, Head of Drug-Resistant Infections at Wellcome Trust, said: “Wellcome is committed to addressing this urgent global health threat. With drug-resistant infections spreading rapidly it’s vital we speed discovery of new and innovative treatments. The addition of this exciting project to the CARB-X portfolio is another important step in achieving this. Drug discovery must also go hand-in-hand with concerted action to ensure responsible use of antibiotics and availability of existing and new treatments for patients in all countries.”

CARB-X funding is part of an overall commitment of up to US$455m by the US government and Wellcome Trust over a five-year period from 2016-2021. So far this year, including the Vedanta award, CARB-X has announced $57.5 million to help fund 23 projects plus an additional $72.15 million if project milestones are met. These funds are in addition to investments by the companies. Responsible use of existing antibiotics and equitable access, particularly in low-income countries where need is greatest, is also vital to address the global health problem. Both are a condition of CARB-X funding.

CARB-X’s role is to identify and fund promising early research in antibiotics, vaccines and rapid diagnostics to treat the most serious bacterial infections. The goal is to support projects through the early phases so that they will attract additional private or public support for clinical development

CARB-X expects to make further funding announcements later this year.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administrated by CARB-X. The contents are solely the responsibility of the authors and do not necessarily represent the official views of CARB-X, the HHS Administration for Strategic Preparedness and Response, the National Institutes of Health or Wellcome Trust.

Contacts:

CARB-X: Jennifer Robinson
+1-514-914-8974
carb-x@bu.edu
jcrobinson119@icloud.com

Wellcome Trust: Maggie Stratton
+44 (0) 207 611 8609
m.stratton@wellcome.ac.uk

Vedanta Biosciences: Allison Mead Talbot
+1-617-651-3156
amt@puretechhealth.com

About CARB-X
CARB-X is the world’s largest public-private partnership devoted to early stage antibacterial R&D. Funded by BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X will spend up to $455 million from 2016-2021 to support innovative products from ‘hit-to-lead’ stage through to Phase 1 clinical trials. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is led by Boston University. Other partners include the Broad Institute of Harvard and MIT, MassBio, the California Life Sciences Institute and RTI International. For more information, please visit www.carb-x.org.

About Vedanta Biosciences
Vedanta Biosciences is pioneering development of a novel class of therapies for immune and infectious diseases based on rationally designed consortia of bacteria derived from the human microbiome, with clinical trials expected to begin in the second half of 2017. An affiliate of PureTech Health (PureTech Health plc, PRTC.L), Vedanta’s founding team includes a group of world-renowned experts in immunology and microbiology. Vedanta Biosciences is a leader in the microbiome field with capabilities and deep expertise to discover, develop and manufacture drugs based on live bacterial consortia. Leveraging its proprietary technology platform and the expertise of its team of scientific co-founders, Vedanta Biosciences has isolated and maintains what we believe to be the largest collection of human microbiome-associated bacterial strains and has characterized, in collaborations with leading experts, how the immune system recognizes and responds to these microbes. This pioneering work 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 – as well as the characterization of novel molecular mechanisms of microbial-host communication. These advances have been published in leading peer-reviewed journals including Science, Nature (multiple), Cell and Nature Immunology. Vedanta Biosciences has harnessed these biological insights, its proprietary library of microbiome-derived bacterial strains, as well as data from clinical translational collaborations, to generate a pipeline of programs addressing infectious diseases, autoimmune diseases, inflammation and immune-oncology indications.

About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK)

About HHS, ASPR and NIH
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

ASPR leads HHS’s efforts to prepare the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threat agents, pandemic influenza, and emerging infectious diseases.

NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. For more information about NIH and its programs, visit www.nih.gov. News releases, fact sheets and other NIAID-related materials are available on the NIAID website: https://www.niaid.nih.gov.

About Boston University
A leading research university with over 33,000 undergraduate and graduate students from more than 130 countries, nearly 10,000 faculty and staff, 17 schools and colleges, and 250 fields of study. Boston University is consistently ranked among the world’s best research universities and is a member of the American Association of Universities. For further information, see www.bu.edu or contact Ann Comer-Woods anncomer@bu.edu

About the Broad Institute of MIT and Harvard
Broad Institute of MIT and Harvard was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods, and data openly to the entire scientific community. Founded by MIT, Harvard, Harvard-affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff, and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, go to http://www.broadinstitute.org. In support of CARB-X, the Broad Institute created the Collaborative Hub for Early Antibiotic Discovery (CHEAD), which serves an interdisciplinary center that partners with academic investigators engaged in antibiotic development and/or resistance research to accelerate their early-stage, small molecule therapeutics toward Investigational New Drug (IND) application. For further information about CHEAD, go to https://www.broadinstitute.org/infectious-disease-and-microbiome/carb-x-collaborative-hub-early-antibiotic-discovery.

About MassBio
MassBio is a not-for-profit organization founded in 1985 that represents and provides services and support for the world’s leading life sciences supercluster.

MassBio is committed to advancing Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives.

Representing 1000+ biotechnology companies, academic institutions, disease foundations and other organizations involved in life sciences and healthcare, MassBio leverages its unparalleled network of innovative companies and industry thought leaders to advance policy and promote education, while providing member programs, events, industry information, and services.

About the California Life Sciences Institute (CLSI)
The California Life Sciences Institute (CLSI) supports the foundations of innovation that have made California home to the world’s most prominent life sciences ecosystem. With a focus on the San Francisco Bay Area, CLSI’s mission is to maintain California’s leadership in life sciences innovation through support of entrepreneurship, education and career development. CLSI is a member of the CARB-X consortium, serving as an accelerator. CLSI is an affiliate of the California Life Sciences Association (CLSA), which represents California’s leading life sciences organizations. The California Life Sciences Institute is a non-profit 501(c)(3), and was established in 1990 as the BayBio Institute. Learn more at http://califesciencesinstitute.org.

About RTI International
RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.

Media Contacts:

CARB-X: Jennifer Robinson
Jcrobinson119@icloud.com
+1-514-914-8974

Vedanta: Allison Mead Talbot
amt@puretechhealth.com
+1-617-651-3156