GSK vaccines in pre-clinical development for the prevention of bacterial infections caused by Group A Streptococcus and Salmonella enterica
(BOSTON) – CARB-X is funding the GSK Biologicals and its affiliate GSK Vaccines Institute for Global Health (GVGH), based in Siena, Italy, to develop new vaccines to prevent serious infections caused by two different pathogens. Together, the two awards could be worth potentially more than $18 million if project milestones are met, subject to available funding.
GSK’s two vaccine projects target the prevention of
- Group A Streptococcus (Strep A) infections, commonly known as Strep Throat, a major reason for antibiotic prescriptions and cause of immune-mediated diseases. The CARB-X award is worth up to $8.2 million, plus up to an additional $4.2 million if the project meets certain milestones.
- Infections caused by Salmonella enterica, which cause Invasive nontyphoidal salmonellosis (iNTS) disease and typhoid fever, are major causes of death among children and significant health challenges primarily in sub-Saharan African countries. Salmonella enterica is listed by the World Health Organization (WHO) as among those bacteria that pose the greatest threat to human health. The CARB-X award is for $2.2 million to support the development of this new vaccine. If project milestones are met, the project could be eligible for up to $4.0 million in additional funding.
There are currently no vaccines available against Group A Streptococcus or iNTS, both of which are rapidly developing resistance to existing antibiotics. Both projects are in the preclinical phase of development.
“Vaccines are powerful weapons in the global fight against antibiotic-resistant bacteria. Vaccines not only prevent infections, they also reduce the need for antibiotics, helping to curb the spread of drug resistance,” said Erin Duffy, R&D Chief of CARB-X, a non-profit global partnership led by Boston University and dedicated to supporting the development of innovative therapeutics, preventatives and diagnostics to address antibiotic-resistant bacterial infections.
“As part of GSK’s overall Global Health approach, GVGH is dedicated to working with partners to develop effective and affordable vaccines that protect vulnerable communities against some of the most prevalent diseases causing high morbidity and mortality in developing countries, said Francesco Berlanda Scorza, GVGH Director. “Thanks to CARB-X support, we have the opportunity to study and advance innovative vaccines against Salmonellosis and Group A Streptococcus, and contribute to the fight against antimicrobial resistance (AMR).”
Group A Streptococcus a major global threat
Most healthy people who become infected with Strep A bacteria develop nothing more than Strep Throat (pharyngitis), an infection and inflammation of the pharynx, the membrane-lined cavity at the back of the throat. Yet Strep A can pose a more serious health threat, particularly to people with weakened immune systems, when the bacteria invade the bloodstream or deeper tissues to produce severe infections, such as sepsis, necrotizing fasciitis (flesh-eating disease), and toxic shock syndrome. Strep A also can trigger post-infectious immune-mediated rheumatic heart disease (RHD), a leading cause of death in the developing world. The Centers for Disease Control and Prevention (CDC) reports that in the United States, up to 20,000 cases of invasive Strep A disease occur each year, from which between 1,250 and 1,900 people die. Globally, Strep A has been reported to cause more than 500,000 annual deaths, of which 319,000 are due to RHD, mostly in populations from low- and middle-income countries (LMICs).
The GSK vaccine aims to reduce the incidence and severity of Strep A infections and in doing so, reduce the global burden of associated autoimmune sequelae and RHD, as well as associated antibiotic prescriptions, which contribute to increased resistance.
S. enterica a deadly challenge in low- and middle-income countries (LMIC)
Invasive nontyphoidal salmonellosis (iNTS) is a highly invasive disease caused mainly by S. enterica serovars Enteritidis and Typhimurium and is found almost exclusively in resource-limited communities of sub-Saharan Africa. In this region, there are more than 480,000 cases of iNTS disease annually with an estimated 70,000 deaths, many of them in young children, while the burden of another strain of this pathogen, Salmonella enterica serovar Typhi, which causes Typhoid Fever, is 1.3 million cases and 20,000 deaths each year. In recent years, the development of multi-drug resistance has been associated with increased numbers of deaths.
GSK’s vaccine approach uses a recently licensed Typhoid Conjugate Vaccine combined with key antigens of other Salmonella strains causing invasive nontyphoidal salmonellosis delivered using the GMMA-technology. The goal is to produce an effective, affordable and sustainable Salmonella vaccine for sub-Saharan Africa that could prevent death and contribute to reduced antibiotic consumption.
Supporting global antibacterial innovation to address drug resistance
The WHO estimates that 700,000 people die each year from antibiotic-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 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.
The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 54 active projects focused exclusively on drug-resistant bacteria. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics, vaccines, rapid diagnostics and other life-saving products. The goal is to support projects through the early phases of development through Phase 1 (or equivalent for diagnostics) 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 80 awards worth more than $299.8 million, with the potential of additional funds if project milestones are met. 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 research projects in this news release are 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), the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF) and the Bill & Melinda Gates Foundation. 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.
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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 funding is provided 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, 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 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.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.
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).
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 supports 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 the Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
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 firstname.lastname@example.org. www.bu.edu.