The conjugated, peptide-based vaccine aims to deliver robust and long-lasting immunity
(BOSTON: February 25, 2025) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award US$2 million to Immunethep to develop a conjugated peptide-based vaccine to prevent infections from all invasive serotypes of Escherichia coli.
Immunethep will further work on its platform technology to develop an optimized formulation that is able to induce a robust and long-lasting immunity to E. coli. If successful, the vaccine would have broad spectrum capabilities in also preventing infections caused by Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus agalactiae and Streptococcus pneumoniae.
There is no vaccine available for E. coli. Invasive E. coli infections pose a significant public health threat, as certain strains can spread beyond the gastrointestinal tract into the bloodstream, urinary system, and other organs, leading to serious and life-threatening conditions, including sepsis, meningitis, pneumonia, and intra-abdominal infections. E. coli is one of the leading causes of bloodstream infections globally, particularly in healthcare settings. Vulnerable populations, such as the elderly, immunocompromised individuals, and those with chronic health conditions, are at greater risk for severe outcomes. The increasing prevalence of antibiotic-resistant E. coli further reduces treatment options, highlighting the urgent need for effective preventative measures and improved diagnostics to avert and manage these potentially deadly infections.
“Immunethep’s conjugated peptide-based vaccine for invasive E. coli infections represents a promising and innovative approach to address the growing challenge of antimicrobial resistance,” said Erin Duffy, PhD, R&D Chief of CARB-X. “This technology leverages a novel platform to induce robust, long-lasting immunity against E. coli and other dangerous pathogens, which could have broad implications for preventing serious infections in vulnerable populations. By supporting the development of this vaccine, we are advancing a potential solution that could help combat infections that are increasingly difficult to treat with antibiotics.”
“We are honoured to join the CARB-X portfolio and receive support for our mission to combat antimicrobial resistance through the development of next generation vaccines to prevent bacterial infections,” said Bruno Santos, CEO of Immunethep.
In March 2024, CARB-X launched a new funding solicitation to fill major R&D gaps in the global antibiotic development pipeline. More than 300 Expressions of Interest were accepted in four distinct product themes: therapeutics for infections caused by Gram-negative pathogens, prevention of invasive disease, diagnostics for neonatal sepsis, and proof-of-concept for novel sample types for diagnosing lower-respiratory tract infections. Additional projects are under review, and new awards will be announced later this year. Register for the CARB-X newsletter to learn about upcoming funding calls that will be announced in 2025.
New estimates published in September 2024 reveal that 39 million deaths directly attributable to bacterial antimicrobial resistance (AMR) will occur between 2025-2050. This is equal to three deaths every minute. Under an alternative scenario where urgent action is taken to replenish a Gram-negative drug pipeline to prevent AMR deaths, more than 11 million deaths could be averted in the same timeframe. This is part of the mission of CARB-X, which is accelerating the development of high-value, innovative products to prevent, diagnose and treat the most dangerous bacterial infections that have become resistant to antibiotics. CARB-X emphasizes performance characteristics that patients need against infections driving the greatest global morbidity and mortality.
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since its inception, CARB-X has supported 113 R&D projects in 14 countries, and CARB-X product developers have made significant progress: 19 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least 9 product developers with active R&D projects have already secured advanced development partnerships to support their clinical development after leaving the CARB-X portfolio. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their product, outlining strategies to ensure responsible stewardship and appropriate access in low- and middle-income countries.
CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), the Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.
CARB-X Contact: Marissa Novel, carbxpr@bu.edu
Immunethep Contact: info@immunethep.com
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. https://carb-x.org/ | X (formerly Twitter) @CARB_X
About Immunethep
Immunethep’s vision is to offer anti-infective immunotherapies that restore the natural ability of our immune system to control the proliferation of pathogenic bacteria. Immunethep is developing preventative and therapeutic broad-coverage anti-bacterial immunotherapies based on the discovery of a novel mechanism different pathogenic bacteria use to suppress host immune response. Committed to improving global health, Immunethep is dedicated to creating breakthrough therapies that tackle the urgent challenges of infectious diseases and AMR. https://www.immunethep.com
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. The Administration for Strategic Preparedness and Response (ASPR) leads the nation’s medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) invests in innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats. BARDA is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics worldwide, having invested more than $2.4 billion in antimicrobial products since 2010. This investment has supported the development of over 160 antimicrobial products and led to the U.S. Food and Drug Administration (FDA) approval of four new antibiotics and FDA 510(k) clearance of eight diagnostics.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
About the German Federal Ministry of Education and Research (BMBF)
Education and research are crucial foundations for our future. Thus, the promotion of education, science and research is a policy priority of the German Federal Government. The German Federal Ministry of Education and Research (BMBF) strengthens education at all stages of life and provides support for scientific research and innovation.
About the Global AMR Innovation Fund (GAMRIF)
The Global AMR Innovation Fund (GAMRIF) is a One Health aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors.
About the Public Health Agency of Canada
The Public Health Agency of Canada (PHAC), established in 2004, is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Its mission is to improve the health of all people and communities in Canada by addressing public health priorities through science, innovation, service delivery, and collaborative action. The Agency collaborates closely with all levels of government, non-government organizations, and international partners to build an effective public health system. PHAC has a strong history of addressing health threats, including collaboration on a One Health approach to antimicrobial resistance (AMR). As part of the recently launched Pan-Canadian Action Plan on AMR 2023-2027, PHAC is piloting an economic pull-incentive project to increase access to essential antimicrobial drugs not yet authorized in Canada to address priority unmet public health needs.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is one of the largest private residential universities in the United States. BU consists of 17 schools and colleges, along with the Faculty of Computing & Data Sciences and 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 leading research universities in the United States
and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu