CARB-X, a global partnership led by Boston University, is awarding SutroVax of Foster City, California, USA, up to $1.64 million in non-dilutive funding with the possibility of $13.4 million more if certain project milestones are met, to develop an innovative vaccine to prevent Group A Streptococcus (GAS) infections in developing countries and in the developed world.
Currently, no vaccine exists for Group A Streptococcus (GAS) bacteria, the causative pathogen in pharyngitis (‘Strep Throat’), which can range from minor illness to very serious and deadly disease. GAS also can cause post-infectious immune-mediated rheumatic heart disease (RHD), a leading cause of mortality in the developing world.
“Vaccines are powerful weapons in the global fight against drug-resistant bacteria. Vaccines prevent infections and reduce the need for antibiotics, helping to curb the spread of drug resistance,” said Kevin Outterson, executive director of CARB-X and professor of law at Boston University. “The SutroVax project is in the early stages of development but if successful and approved for use in patients, it could save lives, improve public health and strengthen health security world-wide.”
“This funding will support our collaborative efforts to develop a safe, effective Group A Strep vaccine to prevent a highly prevalent disease with wide-spread morbidity and mortality, particularly in the developing world” said Grant Pickering, CEO and cofounder of SutroVax. “We are grateful for this support from CARB-X to accelerate the development of this promising vaccine.”
Urgent need to prevent Group A Strep infections
The SutroVax vaccine is currently in the lead optimization phase of development. The vaccine is composed of Group A Strep carbohydrate antigen coupled to an immunogenic protein carrier using SutroVax’ site-specific conjugation technology. The vaccine has been modified to avoid triggering an immune response that can adversely affect human cardiac or brain tissue, which had been seen with earlier vaccines. The discovery of the GAS antigen was made at the University of California at San Diego, and SutroVax has a license to the technology.
Pharyngitis is prevalent in school-age children with an estimated 600 million cases of pharyngitis annually worldwide and, as a result, GAS-related infections are a major source of antibiotic prescriptions. Most of these infections are mild and treatable however increasing numbers of cases are associated with severe invasive infections, including sepsis, necrotizing fasciitis (flesh-eating disease) and toxic shock syndrome. Global mortality figures are not available. The Centers for Disease Control and Prevention (CDC) reports that in the United States alone, approximately 11,000 to 13,000 cases of invasive GAS disease (cellulitis with blood infection, necrotizing fasciitis, pneumonia, and toxic shock syndrome) occur each year, from which, between 1,100 and 1,600 people die. It is estimated that in low- and middle-income countries, up to 180,000 people die from RHD each year.
Driving innovation to address the growing global superbug crisis
The CARB-X portfolio is the world’s largest development portfolio of new antibiotics, diagnostics, vaccines and other life-saving products. It currently has 30 active projects in five countries, and is expected to grow significantly this year.
Since its launch in 2016, CARB-X has announced 47 awards exceeding $137.2 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will evolve continuously, as projects progress and graduate from CARB-X and others fail for a variety of reasons.
Partnership driving antibacterial innovation
CARB-X is investing up to $500 million in antibacterial R&D between 2016 and 2021. The goal is to support projects in the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients. CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centres for Disease Control and Prevention (CDC)’s 2013 Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
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 headquartered in the Boston University School of Law.
Part of CARB-X’s award for SutroVax will come from funds provided by the UK Government’s Global AMR Innovation Fund (GAMRIF). GAMRIF is an Official Development Assistance (ODA) fund which allocates support for projects that promote the welfare and economic development of low- and middle-income countries (LMICs).
A vaccine to prevent infections caused by Group A Streptococcus (GAS) could protect the lives of hundreds of thousands in the developing world, including vulnerable populations – pregnant women, newborn babies and the elderly – who are particularly susceptible to invasive GAS infections. It may also reduce the overuse of antibiotics in LMICs, helping to slow the emergence and spread of antimicrobial resistance.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and awards from Wellcome Trust, the UK Government and the German Federal Ministry of Education and Research, as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders, or CARB-X.