Vaxdyn’s new vaccine against Gram-negative pathogens, if approved, would help curb the rising threat of drug resistant bacteria

(BOSTON) – CARB-X is awarding Vaxdyn, based in Seville, Spain, up to US$892,000, plus an additional $6.36 million if certain project milestones are met, to develop a new vaccine to prevent life-threatening drug-resistant infections, including pneumonia. Vaxdyn is the first Spanish biotech to be funded by CARB-X, a non-profit partnership investing $500 million in the development of innovative vaccines, antibiotics and rapid diagnostics to fight drug-resistant bacteria around the world. 

“The threat of drug-resistance underscores the importance of vaccines as powerful weapons to prevent disease as well as the spread of deadly bacteria,” said Erin Duffy, Chief of Research and Development of CARB-X, which is based at Boston University School of Law. “The Vaxdyn project is in the early phases of development, but if successful and approved for use in patients, it could prevent drug-resistant pneumonia in patients with elevated risk, for example those with chronic lung disease or diabetes, or patients undergoing cancer treatment. This vaccine would also have the potential to prevent infections in newborns by stimulating maternal immunity in pregnant women, an issue of critical importance particularly in low-to-middle income countries around the world.”

Vaxdyn is using its proprietary technology to develop multi-antigen vaccines based on detoxified bacterial cells that present key antigens in their native conformation. KapaVax, the Vaxdyn project funded by CARB-X, is under development as a prophylactic vaccine for the prevention of infections caused by drug-resistant Gram-negative pathogens including Acinetobacter baumannii, Klebsiella pneumoniae and Pseudomonas aeruginosa in multiple at-risk populations. These three bacterial pathogens are deemed serious public health threats. Vaxdyn is working with its key partners, the National Center of Microbiology of the Spanish Institute of Health Carlos III and Laboratorios Reig Jofré.

Vaxdyn’s CEO, Juan J. Infante, said: “In this project, we are determined to develop a vaccine that will prevent life-threatening infections caused by drug-resistant bacteria, providing safe and effective immunity to patients at risk and populations around the world.”

An estimated 700,000 people die each year from drug-resistant bacterial infections, and the death toll is expected to rise unless new preventatives and treatments are found. Pneumonia can be caused by many types of bacteria, including drug-resistant bacteria. Pneumonia is one of the world’s leading cause of death which disproportionately affects the young, the elderly, and the immunocompromised. There were an estimated 880,000 deaths from pneumonia in children under the age of five in 2016. Most were less than 2 years of age. Many of these lives could be saved with vaccines.

New drugs urgently needed to address the global superbug crisis

CARB-X is a consortium led by Boston University and funded by a global partnership. Funding for the Vaxdyn project is provided by the Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), the UK Government’s Global AMR Innovation Fund (GAMRIF), and the Bill & Melinda Gates Foundation.

Bill & Melinda Gates Foundation funds are allocated to the development of vaccines and novel biologics to avert drug-resistant diseases and protect the lives of children and infants, especially in low- and middle-incomes countries (LMICs). GAMRIF funding focuses on innovative research and development in the field of AMR, specifically in neglected and underinvested areas for LMICs. 

There is a high prevalence of multidrug-resistant Gram-negative infections, particularly those caused by A. baumanni, P. aeruginosa, and K. pneumoniae in LMICs. Vaxdyn plans to test whether the vaccine is able to confer protection against strains of these bacteria isolated from LMICs.  In later stages of development, Vaxdyn also intends to test efficacy and safety for specific needs in LMICs, including its potential to protect the health of newborns by vaccinating pregnant mothers.

The CARB-X portfolio is the world’s largest and most diverse antibacterial development portfolio with 44 active projects – antibiotics, vaccines, rapid diagnostics and other life-saving products – in six countries focused on addressing the global rise of drug-resistant bacteria.  With the Vaxdyn project, the CARB-X portfolio now has four vaccines. The goal is to support projects through the early phases of development – through Phase 1 for therapeutics – so that they will attract additional private or public support for further clinical development and approval for use in patients.

Since its launch in 2016, CARB-X has announced 66 awards exceeding $240 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 continuously evolve, as projects progress and others fail for a variety of reasons.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from 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.

Media Contacts:

CARB-X:

Jennifer Robinson carbxpr@bu.edu

Vaxdyn:

Juan J. Infante, CEO

Juanjo.infante@vaxdyn.com

Tel: 0034 606660701

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 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 $500 million from 2016-2021 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.

About Vaxdyn

Vaxdyn is dedicated to improving quality of life in populations affected by infections globally. Headquartered in Seville, Spain, and born from decades of research on infectious diseases and antibiotic resistance, Vaxdyn’s vision is to create specific immunity in high-risk populations against the most antibiotic resistant bacterial pathogens. Vaxdyn works with an international network of collaborators in the development of multi-valent vaccines for preventing infections in individuals affected by chronic diseases of the lungs, liver, kidney, immunocompromised by several co-morbidities such as diabetes or cancer, and populations associated with nursing homes and hospital settings. Vaxdyn is strongly committed to implementing its technology for combating infections in the most vulnerable regions of the world. http://www.vaxdyn.com/ Twitter: @vaxdyn

About the National Center of Microbiology of Spain

The Institute of Health Carlos III (ISCIII) is the national and international reference in biomedical research and public health in Spain. It is the Public Research Organization (OPI) of the Government responsible for funding and executing national biomedical research. It depends on the Ministry of Science, Innovation and Universities (MCIU), although it is also attached to the Ministry of Health, Consumption and Social Welfare (MSCBS). ISCIII was born in 1986 with the General Health Law and, in addition to promoting and coordinating biomedical research, it offers scientific and health technical services to the National Health System (SNS), and has training programs in public health, health management and scientific management. The mission of the National Center of Microbiology of the ISCIII is to support the healthcare systems of Spain with the reference laboratories for control and diagnosis of infectious diseases by execution of several programs, including applied and basic research on infectious diseases. https://eng.isciii.es.

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 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 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 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.

The partnership with CARB-X is part of DHSC’s Global Antimicrobial Resistance 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 AMR. GAMRIF is a £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