Vedanta’s VE707 microbiome program is designed to restore healthy microbiota and prevent infection and colonization recurrence by multi-drug-resistant superbugs
(BOSTON: December 5, 2019) – CARB-X is awarding Vedanta Biosciences, of Cambridge, MA, USA, up to $5.8 million in non-dilutive funding, with the possibility of $3.5 million more if certain project milestones are met, to develop a new category of oral therapeutics designed to restore a patient’s healthy microbiota so that it can fight multi-drug-resistant bacteria.
The funding will support the development of VE707, Vedanta’s preclinical human microbiome program. VE707 is designed to restore a healthy microbiota as well as prevent infection and colonization recurrence of several multi-drug resistant organisms (MDRO) which are responsible for hundreds of thousands of hospital-acquired infections each year in the United States and Europe. This is the second Vedanta project that has been selected by CARB-X for funding and support.
“The addition of Vedanta’s VE707 program to the CARB-X portfolio expands the rich diversity of our pipeline and reflects a novel approach against drug-resistant bacteria,” said Kevin Outterson, Executive Director of CARB-X, which is based at the Boston University School of Law. “Innovations such as VE707, if successful and approved for use in patients, could offer physicians broader treatment options that would strengthen a patient’s ability to fight serious infections and limit the spread of drug-resistant bacteria.” CARB-X is a consortium led by Boston University and funded by a global partnership.
“We are very pleased to partner with CARB-X for a second time and look forward to working with the CARB-X team to develop an alternative to antibiotics to help address the burden of MDRO infections,” said Bernat Olle, PhD, chief executive officer of Vedanta Biosciences. “If we could get rid of intestinal carriage of these MDROs in high risk patients, we could not only prevent infections, but also curb the transmission of these organisms and enable physicians to avoid using antibiotics that select for ever-more resistant bacterial strains.”
Vedanta Biosciences received its first grant from CARB-X for $5.4 million in 2017 to support clinical testing of Vedanta’s oral product candidate, VE303, for the potential treatment of recurrent Clostridioides difficile infection (rCDI). VE303 graduated from the CARB-X portfolio in 2018 and is currently being evaluated in a Phase 2 clinical trial in patients at high risk of rCDI.
VE707 is Vedanta’s preclinical program for the prevention of infection and colonization recurrence of several MDROs. VE707 is designed to be administered orally and consists of a defined consortium of commensal bacteria. It is produced from pure, clonal bacterial cell banks, which yield a product of uniform composition and free of any pathogenic strains, bypassing the need to rely on fecal donor material with inconsistent composition. VE707 is designed to decolonize gut-dwelling multi-drug resistant organisms in patients at high risk for developing infections. Specifically, VE707 is being developed to eliminate intestinal carriage of carbapenem-resistant Enterobacteriaceae (CRE), extended-spectrum beta lactamase producers (ESBL), and vancomycin-resistant Enterococci (VRE) to restore a healthy microbiota as well as prevent infection and colonization recurrence. CRE, ESBL, and VRE infections are some of the most common hospital-acquired infections and are estimated to affect over 500,000 intensive care unit, dialysis, solid organ transplant, and hematopoietic stem cell transplant patients each year in the US and Europe. Infections with these organisms can result in life-threatening treatment delays or death and result in approximately $2 billion healthcare-associated costs due to patient isolation practices alone.
Supporting innovation to address the global rise of drug resistance
CARB-X is investing up to $500 million in antibacterial R&D between 2016-2021. The goal is to support projects through the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients.
The CARB-X portfolio is the world’s largest antibacterial development portfolio with 33 projects in five countries. Since its inception in 2016, CARB-X has announced 52 awards exceeding $160.6 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.
The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (CDC)’s 2013 Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the World Health Organization (WHO) in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
According to the WHO, an estimated 700,000 people die each year worldwide from bacterial infections.
This research is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust and the Bill & Melinda Gates Foundation. The contents of this news release are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.
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Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services , the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). CARB-X is investing up to $500 million from 2016-2021 to support the development of innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics . CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. https://carb-x.org/. Follow us on Twitter @CARB_X.
About Vedanta Biosciences
Vedanta Biosciences is a clinical-stage microbiome leader developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived non-pathogenic bacteria. Vedanta’s proprietary capabilities include what is believed to be the largest collection of human-gut associated bacteria, assays and bioinformatics techniques for consortia design and optimization, vast 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 (2013, 2019), 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. This pipeline includes three clinical-stage product candidates currently being evaluated for the treatment of recurrent C. difficile infection and inflammatory bowel disease (in collaboration with Janssen Biotech, Inc.), and food allergy, as well as a fourth product candidate expected to enter the clinic in 2019 in patients with advanced or metastatic cancers (in combination with Bristol-Myers Squibb’s checkpoint inhibitor OPDIVO®).
Vedanta’s IP portfolio contains over 30 issued patents with coverage through at least 2031. Vedanta Biosciences was founded by PureTech Health (LSE:PRTC). 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.
About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US 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.
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)
Education and research are the foundations for our future. The promotion of education, science and research by the Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields.
About the Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Sue Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at firstname.lastname@example.org. www.bu.edu.