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CARB-X is funding university of Oxford’s Jenner Institute to develop a new vaccine to prevent gonorrhea

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Vaccine aims to curb the global spread of this devastating disease and strains of ‘super gonorrhea’ antibiotic-resistant bacteria

Arcile published on the CARB-X website

(BOSTON) – CARB-X is awarding up to US$2 million to the Jenner Institute, part of the University of Oxford, UK, to develop a novel vaccine to prevent gonorrhea, a common sexually-transmitted bacterial infection that has developed resistance to most antibiotics. Under the award, the Institute would be eligible for up to $5.3 million more if the project progresses through certain project milestones, subject to available funding.

Their findings to date suggest the vaccine would prevent infections from different strains of gonococcal bacteria, including the most powerful multidrug-resistant strains that are spreading globally at an alarming pace.

“Because of antibiotic resistance, treating gonorrhea is challenging and in some cases not possible because of a lack of antibiotics that are effective,” said Erin Duffy, Chief of Research and Development of CARB-X, a global non-profit partnership led by Boston University and dedicated to funding and supporting the development of innovative products to address antibiotic-resistant bacterial infections. “Vaccines are powerful tools in the prevention of bacterial infections. Jenner’s vaccine project is an exciting approach which, if successful, could prevent the disease, and significantly curb the spread of resistant bacteria across the globe.”

“The Jenner Institute at Oxford University is delighted to be partnering with CARB-X in the development of a new vaccine against gonorrhea, which will be an important weapon in the battle against antibiotic-resistant bacteria,“ said Professor Adrian Hill, Director of the  Jenner Institute.  The Jenner Institute is well known for its recent success in leading the development of the Oxford/AstraZeneca Covid-19 vaccine.

“This is an exciting investment in cutting-edge UK research at the University of Oxford to find new vaccines to tackle the threat of antimicrobial resistance,” Lord Bethell, the UK Minister for Innovation, said about the CARB-X award, which is funded in part by the UK government along with other partners. “AMR has the potential to affect all countries, and all our lives so this global challenge needs a global solution. That’s why the UK is providing funding (via CARB-X) to develop a vaccine which could bring a new solution to this dangerous problem.”

Innovative science

Jenner‘s gonorrhea vaccine, dmGC_0817560 NOMV, consists of blebs, or fluid-filled blisters, from the outer surface of gonococcus, called Native Outer Membrane Vesicles (NOMV). Working alongside the Oxford Vaccine Group, researchers aim to produce an affordable vaccine for global use. The intent is that the vaccine will induce protective immunity against gonorrhea that will prevent individuals from developing the disease and also interrupt the spread of antibiotic resistance found in gonococcal bacteria.  The project is currently in Lead Optimization, a crucial early development phase in which the most promising preclinical vaccine candidate is identified. The CARB-X award is supporting optimization work and scale-up, followed by production of vaccine in the University’s Clinical Biomanufacturing Facility for a first-in-human study

Drug-resistant Neisseria gonorrhoea is identified by the World Health Organization (WHO) as a ‘priority’ pathogen, and classified by the US Centers for Disease Control and Prevention (CDC) as an ‘urgent’ public health threat that requires aggressive action.

Gonorrhea is on the rise

Gonorrhea has developed resistance to most antibiotics, with only one class remaining effective in the treatment of the disease. Gonorrhea spreads easily as many of those infected do not have symptoms and may not know they are infected. Gonorrhea can cause pelvic inflammatory disease and infertility in women and sterility in men. Infection increases a person’s risk of contracting HIV. Babies born to an infected woman can develop blindness.

The WHO estimates that about 78 million people a year are infected with gonorrhea; roughly a half million of those infections occur in the UK, and 1.14 million occur in the US, of which an estimated 550,000 involve drug-resistant bacteria. However, at the global level, gonorrhea is principally a disease of low- and middle-income countries (LMICs), and also disproportionately affects women. While the WHO estimated global prevalence of urogenital gonorrhea in 2016 is 0.9% in women and 0.7% in men, in the African Region prevalence rises to 1.9% in women and 1.6% in men. Since healthcare facilities in LMICs are often sparse and ill-equipped, particularly in the poorest countries of sub-Saharan Africa, the vast majority of infections go untreated. This vaccine is produced using simple and easily transferrable technologies that could allow the vaccine to be produced by manufacturers in LMIC settings.

Supporting global antibacterial innovation to address drug resistance

A non-profit partnership, CARB-X receives its funding from the US Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF), Germany’s Federal Ministry of Education and Research (BMBF), and the Bill & Melinda Gates Foundation. The funding contributions from GAMRIF are earmarked by CARB-X to fund projects that focus on specific antibacterial priorities, and the Jenner project is one such project. GAMRIF funding allocated to CARB-X is focused on innovative research and development in the field of AMR, specifically in neglected and underinvested areas for low- and middle-income countries (LMICs), where the burden of AMR is greatest.

The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 56 active projects focused exclusively on drug-resistant bacteria, including 8 vaccines. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics and other therapeutics, vaccines and other preventatives, rapid diagnostics. The goal is to support therapeutic and preventative projects through the early phases of development including Phase 1 so that they will attract additional private or public support for further clinical development and regulatory approval for use in patients.

Since its launch in 2016, CARB-X has announced 82 awards and has committed more than $305.2 million, with the potential of additional funds if project milestones are met and subject to available funding. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.

The WHO estimates that 700,000 people die each year from drug-resistant infections, including 35,000 in the US and 33,000 in Europe. 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 ranked Critical or High on the WHO list.

Research reported in this news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from the Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), and the UK Global AMR Innovation Fund (GAMRIF). The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.

Contacts:

CARB-X:
Jennifer Robinson
carbxpr@bu.edu

Oxford University Jenner Institute:
Steve Pritchard
steve.pritchard@admin.ox.ac.uk

About CARB-X
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 funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services (HHS), the Wellcome Trust, a global charity based in the UK working to improve health globally, 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 Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US 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 other prevention approaches, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/.  Follow us on Twitter @CARB_X.

Oxford University
Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the fifth year running, and at the heart of this success is our ground-breaking research and innovation.

Oxford is world-famous for research excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research sparks imaginative and inventive insights and solutions.

Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years.

Jenner Institute
The Jenner Institute brings together investigators who are designing and developing numerous vaccines to generate an exceptional breadth of scientific know-how and critical mass, whilst still allowing the individual investigators to remain independent and accountable to their funders and stakeholders. The Jenner Institute is supported by the Jenner Vaccine Foundation, a UK registered charity and is advised by the Jenner Institute Scientific Advisory Board. https://www.jenner.ac.uk/

Oxford Vaccine Group
The Oxford Vaccine Group (OVG) conducts studies of new and improved vaccines for children and adults and is based in the Department of Paediatrics at the University of Oxford. OVG is a UKCRC registered clinical trials unit working in collaboration with the Primary Care Trials Unit at the University (registration number: 52). For more information see: http://www.ukcrc-ctu.org.uk/

About BARDA and NIAID
The US 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 US 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, UK).

About BMBF
Education and research are the foundations for our future. The promotion of education, science and research by the German Federal Ministry of Education and Research (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 UK Government department which is responsible for helping people to live more independent, healthier lives for longer.

This research is co-funded by DHSC’s Global AMR Innovation Fund (GAMRIF). 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 UK 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 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 jeremy22@bu.edu. www.bu.edu.