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CARB-X funds GlyProVac to develop a novel vaccine to prevent sepsis in newborns

CARB-X funds GlyProVac to develop a novel vaccine to prevent sepsis in newborns

GlyProVac aims to target the bacterium Escherichia coli in pregnant women

(BOSTON: February 29, 2024) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is awarding GlyProVac US$467k to develop a maternal vaccine that targets Escherichia coli (E. coli), a bacterial species that causes a large portion of neonatal sepsis infections. GlyProVac is a research and development company spun out of the University of Southern Denmark in Odense and is committed to reducing bacterial infections and antimicrobial resistance worldwide.

The CARB-X award supports the development of GlyProVac’s maternal vaccine, GPV02, which uses a selected bacterial protein, naturally decorated with small sugar molecules, to trigger an immune response for protection. This approach differs from previous attempts to develop protein-based bacterial vaccines since it involves specific natural sugar modifications previously undiscovered. GlyProVac uses BEMAP technology to ensure that GPV02 correctly imitates E. coli, thus preparing the immune system to recognize the bacterium when an infection occurs.

“GlyProVac’s maternal vaccine could 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. 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.”

Neonatal sepsis is a life-threatening response to bloodstream infections that occurs 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.

E. coli can cause a range of infections in humans, including urinary tract infections and neonatal sepsis in newborns, and poses a major challenge for public healthcare systems. We are grateful for the invaluable support, network, and resources provided by CARB-X, which will give us the opportunity to expand the potential of our E. coli vaccine to accelerate the fight against neonatal sepsis,” said Anders Boysen, PhD, CEO and Co-founder of GlyProVac and Co-Inventor of BEMAP. “We see this award as a strengthening of our scientific approach, strong team and commitment to tackle the AMR crisis affecting patients globally.”

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 98 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. GlyProVac is the seventh project and fourth 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 Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), 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

GlyProVac Contact: Ann Zahle Andersen, zahle@glyprovac.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 GlyProVac

GlyProVac is a research and development company pioneering novel protein vaccines. Our team is committed to substantially reduce bacterial infections and antibiotic microbial resistance worldwide. Using our proprietary analytical platform, BEMAP, we revealed the pivotal role of immunogenic O-linked glycosylation in bacterial proteins. We uncover, and then accurately mimic, the natural composition and topology of bacterial antigens. From there, we develop protective and safe vaccines. For more information, please visit www.glyprovac.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 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 Public Health Agency of Canada

The Public Health Agency of Canada is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Created in 2004 with a mission to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health, the Agency’s activities focus on preventing disease and injuries, responding to public health threats, promoting good physical and mental health, and providing information to support informed decision making. The Agency has a long history of working with domestic and international partners on combatting health threats, including AMR. Most recently, the Agency released the Pan-Canadian Action Plan on AMR, a multijurisdictional effort that emphasizes One Health collaboration to make progress on AMR.

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 71 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu