Only one antibiotic remains effective for treating drug-resistant bacterial Neisseria gonorrhoeae strains

(BOSTON: January 16, 2024) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is awarding US$633k to Intravacc to develop a vaccine that prevents Neisseria gonorrhoeae bacterial infections. Intravacc is a global contract development and manufacturing organization located at the Utrecht Science Park Bilthoven in the Netherlands. Intravacc is developing vaccines that target a range of diseases, from COVID-19 to meningitis B and sexually transmitted infections (STIs).

Neisseria gonorrhoeae causes gonorrhea, the second-most reported bacterial STI. Approximately 82 million adults were infected globally in 2020. Untreated gonorrhea can cause serious complications, including pelvic inflammatory disease, ectopic pregnancy, scrotal swelling, urethral stricture, and infertility. It can also lead to an increased risk of contracting HIV. In newborns, untreated gonococcal conjunctivitis – gonorrhea in the eye – can lead to blindness. Since people with gonorrhea do not always exhibit symptoms, reported cases may only capture a fraction of the true health burden.

“Drug-resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone),” said Erin Duffy, PhD, R&D Chief of CARB-X. “Vaccines are powerful tools in the prevention of bacterial infections. With an appropriate vaccination strategy, Intravacc’s vaccine project, if successful, could prevent the disease, and significantly curb the spread of resistant bacteria across the globe.”

The CARB-X award supports the development of Intravacc’s meningococcal outer membrane vesicle (OMV) vaccine that carries several important gonococcal antigens aimed to prevent infections by Neisseria gonorrhoeae (gonococci). Through the tailored gonococcal antigens on the surface of the meningococcal OMV, Intravacc anticipates a significant enhancement in the vaccine candidate’s efficacy against gonorrhea.

“This CARB-X project allows us to combine our science and OMV expertise for the development of a vaccine for gonorrhea infections,” said Jan Groen, PhD, CEO of Intravacc. “We believe the outcome of this vaccine project could be an important contribution to the antimicrobial resistance epidemic.”

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 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 then, CARB-X has supported 93 R&D projects in 12 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.

In 2022, 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, which kills 2.5 million infants annually; and oral therapeutics, vaccines and rapid diagnostics for gonorrhea. Intravacc’s vaccine is the second project to receive a CARB-X grant as part of the 2022-2023 funding call. New product developers will be announced this year. Register for the CARB-X newsletter to learn about upcoming funding calls that will be announced in 2024.

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 as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF), 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

Intravacc Contact: Sander Hagemans, press.office@intravacc.nl

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 Intravacc:

Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization (CDMO) for infectious diseases and therapeutic vaccines. As an established independent CDMO with many years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology world-wide for many vaccines including polio, measles, DPT, Hib and influenza. Intravacc offers a wide range of expertise for independent vaccine development, from concept to Phase I/II clinical studies for partners around the world, including universities, biotech and pharmaceutical companies, governmental agencies and NGOs. With its innovative vaccine platforms OMV-VaccT, Cell-VaccT, Con-VaccT, E.co-VaccT and good manufacturing procedures (GMP) facilities the company is well positioned to address the unmet needs in the vaccine and immune therapy market. For more information, please visit www.intravacc.nl.

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