(BOSTON, MA) – CARB-X is backing Seres Therapeutics Inc. (NASDAQ:MCRB) of Cambridge, MA, in the development of a promising pre-clinical microbiome therapeutic to prevent serious bacterial infections and graft versus host disease in patients following solid organ and allogeneic stem cell transplantation. The initial award provides Seres up to $2.5 million with the possibility of up to $3.1 million more if certain project milestones are achieved.
“The Seres SER-155 microbiome-based project is an innovative 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 early 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, including SER-155, hold exciting potential in the fight against the deadliest bacteria.”
“We are delighted to have obtained the support of CARB-X, which is a further testament to the potential of microbiome therapeutics in diverse areas of medicine. The spread of drug-resistant bacterial infections is an urgent public health concern and new approaches are desperately needed,” said David Cook, Ph.D., Chief Scientific Officer and Executive Vice President of Research at Seres. “Published clinical data by our collaborators, Dr. Eric Pamer and Dr. Marcel van den Brink at Memorial Sloan Kettering, demonstrate that the risk of both infection, and graft versus host disease, is linked to the health of the gastrointestinal microbiome. We believe these data provide a strong rationale to further develop SER-155 for these seriously ill patients, and we look forward to advancing the program into clinical development.”
The human microbiome – the network of trillions of bacteria that live in healthy bodies – plays a vital role in keeping us healthy, including providing resistance to pathogens, regulation of immune function and contributing to energy metabolism. When a healthy microbiome is disrupted or damaged by antibiotic use, inflammation or other forces, individuals become more vulnerable to disease and re-infection, including serious life-threatening drug-resistant infections. The SER-155 project is under pre-clinical investigation to determine if it can rebuild the damaged gut microbiome, restoring its resistance to drug-resistant bacteria and improving patient outcomes.
World’s largest and most scientifically diverse portfolio
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 Office of the Assistant Secretary for 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. The World Health Organization estimates that 700,000 people die each year as a result of drug-resistant bacterial infections.
BARDA’s Director Rick Bright, Ph.D., said: “The support announced today will help speed development of a new antibacterial product with the potential to treat patients with life-threatening infections. Antibiotic resistant infections not only pose a day-to-day public health concern but also complicate our response to national security threats, which is why at BARDA we working to revitalize the antibacterial pipeline. 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. The rapid spread of drug-resistant infections threatens to undermine modern medicine. Effective treatments against infections are a vital part of many routine and complex, life-saving operations, such as transplants. It’s vital we speed discovery of new and innovative treatments so doctors can continue to safely carry out these procedures. The addition of this exciting project to the CARB-X portfolio is the first step in achieving this. Incentives to promote new product development must go hand-in-hand with concerted action to ensure responsible use of antibiotics and availability of new healthcare tools for patients in all countries.”
Additionally, the CARB-X partnership leverages NIAID’s long-standing preclinical services program established to facilitate product development for new drugs, vaccines and diagnostics. This particular project is representative of the innovative new types of strategies encouraged by NIAID in recent years.
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 Seres award, CARB-X has announced 24 grants totaling $60.0 million to help fund projects, plus an additional $75.25 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 Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health or Wellcome Trust.
Seres Therapeutics: Carlo Tanzi, PhD
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 Seres Therapeutics
Seres Therapeutics, Inc., is a leading microbiome therapeutics platform Company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ lead program, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration and is in Phase 3 development for multiply recurrent C. difficile infection. Seres’ clinical candidate SER-287 has successfully completed a Phase 1b study in patients with mild-to-moderate Ulcerative Colitis. Seres is also developing SER-262, the first ever synthetic microbiome therapeutic candidate, in a Phase 1b study in patients with primary C. difficile infection. http://www.serestherapeutics.com/
SER-155 is a preclinical stage Ecobiotic® synthetic microbiome therapeutic candidate. The development of SER-155 is supported by clinical data, including data published by Seres’ collaborators at Memorial Sloan Kettering Cancer Center which demonstrates that patients undergoing Hematopoietic Stem Cell Transplantation (HSCT) who have higher microbiome diversity have improved survival, and lower rates of infection and graft versus host disease.
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 firstname.lastname@example.org
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.
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.