CARB-X accelerates a diverse portfolio of innovative antibacterial products towards clinical development and regulatory approval with funding and expertise
BOSTON – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership led by Boston University, is celebrating five years of progress in funding and supporting the development of innovative products targeting antibiotic-resistant bacteria. Since it was founded in July 2016, CARB-X has invested $361 million in non-dilutive funding to develop innovative therapeutics including new classes of antibiotics and non-traditional agents, vaccines and other preventatives such as CRISPR-phage, microbiome-modifying agents and antibodies, and rapid diagnostics.
“The CARB-X portfolio is distinct; no other in the world encompasses therapeutics, diagnostics and preventatives from early preclinical through Phase 1 development,” said Kevin Outterson, Executive Director of CARB-X. “In just five years, CARB-X has steadily built the world’s largest and most scientifically diverse antibacterial R&D portfolio focused on the most dangerous antibiotic-resistant bacteria.”
Antibiotic-resistant bacterial infections kill an estimated 700,000 people around the world each year and represent one of the world’s greatest public health and health-security threats. CARB-X funds projects that primarily target bacterial pathogens classified as Serious/Urgent by the Centers for Disease Control and Prevention (CDC) or Critical/High by the World Health Organization (WHO). These bacteria can cause a broad range of infections and conditions including pneumonia, urinary tract infections, and bloodstream infections that can be difficult to treat and fatal because of emerging resistance.
CARB-X currently supports 60 innovative projects in its portfolio. Additionally, nine projects have successfully graduated from the portfolio: two (T2 Biosystems and Specific Diagnostics) have secured regulatory approval, a third (Iterum Therapeutics) has filed a New Drug Application (NDA) with the FDA, a fourth (Vedanta Biosciences) is conducting a Phase 2 program for recurrent C. difficile. This last is also receiving ARD funding with the U.S. Biomedical Advanced Research and Development Authority (BARDA), the largest funder of CARB-X and advanced clinical development of antibacterial candidates in the U.S. Furthermore, Seres Therapeutics has achieved IND-effective for SER-155, the product CARB-X supported from early development to this milestone, and Entasis Therapeutics recently completed a first-in-human program.
There is a high risk of failure for antibacterial product development. Since its launch, CARB-X has funded a total of 92 projects in 12 countries. These were selected from 1,163 applications for funding from product developers in 39 countries. Applications were received in eight separate CARB-X funding rounds, each strategically focused on areas of critical medical and scientific need identified by CARB-X funders.
“This international partnership has exceeded the U.S. five-year goals, has served to revitalize the pipeline for antibacterial products, and has demonstrated how much can be accomplished when government, international partners, and the private sector work toward a common goal,” said BARDA Director Gary Disbrow, Ph.D. “Through this partnership, new and innovative products are entering clinical development with the potential to save lives and turn the tide on antibiotic-resistant infections.”
The U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) called for a CARB product accelerator, which BARDA co-founded with the Wellcome Trust and the U.S. National Institutes of Health. The partners set a goal of funding 20 programs through the accelerator by the end of five years; CARB-X funded 92. The plan also called for advancing at least two antibacterial drug candidates from preclinical testing to submission of an FDA Investigational New Drug (IND) application to begin clinical trials; CARB-X has advanced 10 projects into Phase 1, including eight first-in-human, supporting nine IND applications or IND-equivalent applications.
CARB-X has transformed and strengthened the global early development antibacterial pipeline
CARB-X has been a driving force in solidifying and enabling the global antimicrobial resistance (AMR) community. In addition to funding product development worldwide, CARB-X has created a network of expertise and support to help product developers and their projects succeed. This comprehensive support is a distinct strength of the CARB-X accelerator model. CARB-X’s Research & Development Team works closely with more than 120 subject matter experts from around the world, and the CARB-X Global Accelerator Network consisting of seven accelerators, to provide scientific, technical and business support tailored to the needs of each project and product developer.
Additionally, CARB-X and its funders have been world leaders in stewardship and access initiatives. Each CARB-X-funded project is governed by antibiotic stewardship and access policies to ensure that these products are used responsibly and made accessible to patients worldwide. Many of these projects target pathogens that cause the greatest health challenges in low- and middle-income countries.
“The U.K. invests Official Development Assistance into CARB-X. By supporting developers to plan for appropriate stewardship of and access to their products, the CARB-X model is upskilling a whole generation of scientists to build these essential criteria into their projects from the beginning,” said Dame Sally Davies, U.K. Special Envoy on Antimicrobial Resistance. “Sustained global action is necessary to prevent catastrophic impact from AMR. CARB-X is a key global mechanism to restock the beginning of the pipeline for antibiotics and antibacterials.”
CARB-X is funded through 2022 by BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, the Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), the U.K. Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).
Asked why Wellcome Trust, a global U.K.-based charity, funds the accelerator, Dr. Tim Jinks, Head of the Drug-resistant Infections Programme, said, “Drug-resistance is shaking the very foundations of modern medicine. To get ahead of this crisis, we need rapid innovation. CARB-X has been incredibly successful in fostering innovation in the early stages of antibiotic development. This is a vital step forward in tackling drug-resistant infections. To complement this success, governments must match this bold, ambitious action and put in place long-term market solutions for a sustainable antibiotic pipeline. This will help ensure promising products can make it to the patients who need them.”
With 30 product developers supported in North America, 21 in Europe and five in Asia and Australia, CARB-X continues to accelerate innovative projects and actively pursue new funding opportunities with current and potential funders around the globe. “Boston University is proud of all that CARB-X has accomplished. CARB-X’s mission and pathbreaking model for entrepreneurial engagement serve as exemplars of Boston University’s commitment to creative leadership to address the world’s biggest challenges,” said Dr. Robert A. Brown, President of Boston University.
The contents of this news release are solely the responsibility of the author and do not necessarily represent the official views of the CARB-X funders.
CARB-X: Genevieve Holmes
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 U.S. Department of Health and Human Services, the Wellcome Trust, a global charity based in the U.K. working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the U.K. Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). CARB-X is investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical and early stage development products against antibiotic resistant infections. CARB-X is headquartered at Boston University School of Law. For more information on CARB-X’s first five years, visit this fact sheet. Follow us at carb-x.org and on Twitter @CARB_X.
About BARDA and NIAID
The U.S. 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 U.S. 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, U.K.)
About the German Federal Ministry of Education and Research (BMBF)
Education and research are the foundations for our future. The promotion of education, science and research by the 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 Global AMR Innovation Fund (GAMRIF)
The Department for Health and Social Care (DHSC) is the U.K. Government department which is responsible for helping people to live more independent, healthier lives for longer. GAMRIF was established to provide seed funding for innovative research and development, specifically in neglected and underinvested areas, in the field of antimicrobial resistance (AMR). GAMRIF is a c.£50m U.K. aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs). The Fund takes a ‘One Health’ approach, seeking to invest in potential solutions to reduce the threat of AMR in humans, animals, fish and the environment. The Fund seeks to leverage additional global funding through interaction with international government bodies, public-private partnerships, product development partnerships, global funding mechanisms and global fora.
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 email@example.com. www.bu.edu.