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CARB-X is funding Syntiron to develop a maternal vaccine to prevent neonatal sepsis

CARB-X is funding Syntiron to develop a maternal vaccine to prevent neonatal sepsis

Syntiron aims to save newborns–too young to be vaccinated–by targeting bacteria that cause common urinary tract infections in pregnant mothers

(BOSTON: January 18, 2024) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is awarding Syntiron US$1.7 million to develop a maternal vaccine that targets Escherichia coli and Klebsiella pneumoniae, two bacterial species that cause a large portion of neonatal sepsis infections. Founded in 2004, Syntiron is a biotechnology company based in Saint Paul, Minnesota, USA, and has several vaccines in development that target bacterial infections.

Neonatal sepsis is a life-threatening response to bloodstream infections that occur in newborns fewer than 28 days old. Due to their immature immune systems, newborns are particularly susceptible to infections. The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the greatest burden in low- and middle-income countries. Since neonatal sepsis progresses rapidly, it requires immediate treatment with IV fluids and antibiotics. The risk of death from neonatal sepsis increases 7.6% every hour a treatment is delayed.

“CARB-X is excited to support the development of Syntiron’s maternal vaccine to help prevent neonatal sepsis, the leading cause of death among infants, especially those located in low- and middle-income countries,” said Erin Duffy, PhD, R&D Chief of CARB-X. “Because newborns at risk for neonatal sepsis are too young to be immunized, the vaccine would be administered to expectant mothers and target bacteria that cause neonatal bloodstream infections in babies and urinary tract infections (UTIs) in mothers. The vaccinated mothers would pass antibodies on to their babies in utero and through breastmilk after birth to strengthen their newborns’ immune systems, helping them ward off infections.”

The CARB-X award supports the development of Syntiron’s Alloy-EK vaccine, which leverages iron receptor proteins (IRPs) as vaccine targets. IRPs are highly genetically conserved, which means they are less likely to change since they perform essential functions. This makes them reliable targets. Syntiron developed the Alloy Platform to safely manufacture and formulate IRP vaccines that maintain robust immunity and cover a broad range of bacterial strains.

“The bacteria targeted by this vaccine are a tremendous burden on public health for babies, children and adults worldwide,” said Lisa Herron-Olson, PhD, Managing Director of Syntiron. “Pregnant women are at particularly high risk of infection by these same bacteria that can cause neonatal sepsis in newborn babies. Preventing these infections by vaccination offers substantial potential health benefit to mothers and babies, while reducing the spread of antimicrobial resistance. The Syntiron team appreciates the support of CARB-X as we bring this vaccine platform forward to improve maternal and infant health throughout the world.”

An estimated 1.27 million people died due to drug-resistant bacterial infections in 2019, a death toll that exceeded HIV/AIDS (864,000) and malaria (643,000) in that same year. CARB-X is building a pipeline of high-value 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. In its first seven years, CARB-X supported 94 R&D projects in 13 countries, and CARB-X product developers have made tremendous progress: 18 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 which can help support their clinical development after leaving the CARB-X portfolio.

Last year, CARB-X launched new funding rounds to support R&D projects and fill critical gaps in the antibacterial pipeline. These include oral therapeutics to replace the workhorse antibiotics that are failing; vaccines for neonatal sepsis; and oral therapeutics, vaccines and rapid diagnostics for gonorrhea, given that resistant strains of gonorrhea have evaded all but one existing antibiotic. Syntiron is the third project and second vaccine to receive a CARB-X award as part of the 2022-2023 funding call. Additional projects are under review, and new product developers will be announced this year. Register for the CARB-X newsletter to learn more about upcoming funding calls that will be announced.

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 under agreement number 75A50122C00028. CARB-X is also funded by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC), the Bill & Melinda 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: Genevieve Holmes, carbxpr@bu.edu

Syntiron Contact: Lisa Herron-Olson, Lisa.Herron-Olson@syntiron.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 Syntiron

Syntiron is a biotechnology company developing a portfolio of vaccines to prevent bacterial infections in humans, especially those caused by antimicrobial-resistant (AMR) bacteria. Syntiron’s Alloy Vaccine Platform leverages bacterial iron receptor proteins as a blueprint for engineering highly immunogenic and broadly protective vaccines in the form of simple proteins. Iron receptor proteins are critical to bacterial survival, and these proteins are highly conserved among different strains and species of pathogenic bacteria. Alloy Vaccines are engineered for simple production and can achieve superior breadth of coverage relative to traditional vaccines targeting more variable components. The indication for Syntiron’s lead Alloy Vaccine is for urinary tract infection, especially among women and older adults.

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 and is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics.

As part of HHS, 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. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

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 UK 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 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.

www.novonordiskfonden.dk/en

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 the third-largest independent university in the United States. BU consists of 17 schools and colleges and the interdisciplinary Faculty of Computing & Data Sciences, 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 65 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu