EveliQure's diarrhoea vaccine to advance towards clinical trials supported by a significant Horizon2020 award

EveliQure Biotechnologies announces today the award of a grant from Horizon2020 - the European Union´s Research and Innovation programme - that supports first-in-man studies of its proprietary ShigETEC vaccine. The €8.6M grant has been awarded to the SHIGETECVAX project, an international consortium of world-leading vaccine organizations - The European Vaccine Initiative (consortium leader), EveliQure Biotechnologies, University of Gothenburg, International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b) and PATH. The project will run for 5 years and will cover the manufacture and formulation of clinical trial material and Phase 1 safety and immunogenicity studies in two different populations, adults in Europe and children in Bangladesh.

EveliQure’s orally administered ShigETEC vaccine is based on a live attenuated Shigella strain and, unlike previous approaches, induces broad protection against Shigella in a serotype-independent fashion and also against ETEC, two major pathogens responsible for diarrhoeal diseases. Based on extensive preclinical data generated by EveliQure over the last 5 years, it has the potential to be a first-in-class diarrhoea vaccine that targets both travelers and populations in low- and middle-income countries. The first Phase 1 study is expected to start in Europe during the first half of 2020. This latest grant builds on EveliQure’s previous success in securing significant funding from public sources (Austria Wirschaftsservice and Austrian Research Promotion Agency, FFG) and private investors.

“We are thrilled that EveliQure has secured further significant funding to help make the world safe from diarrhoea with a ground-breaking vaccine. Receiving this Horizon2020 award shows the confidence placed in our team, science and business approach. We have a unique technology and a professional team to develop a product that has a great business potential and an exceptional social impact.” – said Gábor Somogyi, MD, MBA, Chief Executive Officer of EveliQure.

“It's exciting to see our unique Shigella-ETEC combination vaccine take this critically important step and move into the first clinical trials with our innovative approach and breakthrough platform. This funding allows us to collaborate with world-leading organizations in the fight against diarrhoeal disease. We believe it has the potential to provide enormous medical, economic and social benefit for travelers and those living in endemic countries.” - commented Frank Malinoski MD, PhD, Chief Medical Officer of EveliQure.

According to the World Health Organization, diarrheal disease kills over 2000 children every day – more than AIDS, malaria, and measles combined. In addition, 30-50% of travelers visiting developing countries suffer from diarrhoea. Out of the most prevalent enteric pathogens causing diarrhoea, effective prophylactic vaccines exist only for cholera, typhoid and rotavirus. To date, no effective vaccine is available for diarrhoeal disease caused Shigella and ETEC.

ABOUT EVELIQURE

EveliQure Biotechnologies (http://www.eveliqure.com/) is an Austrian based biotech company that is a game-changer amongst vaccine companies, championing novel technologies to make the world safe from diarrhoea.

EveliQure is passionate about improving the quality of life for both the poor and the privileged by providing innovative medical solutions that fight diseases of all walks of life.

SHIGIETECVAX Consortium members:

The European Vaccine Initiative (EVI) (http://www.euvaccine.eu/), established in 1998, is a leading non-profit organisation supporting the development of effective, accessible, and affordable vaccines for global health. Through promoting innovative solutions for disease control involving their global partner network of partners, EVI is striving for a world free of the intolerable burden of diseases of poverty within the coming decades. Since its inception in 1998 EVI has contributed to the development and clinical assessment of nearly 40 different vaccine preparations. EVI operates with support from the European Commission, the European & Developing Countries Clinical Trials Partnership (EDCTP), the Innovative Medicines Initiative (IMI), the Global Health Innovative Technology Fund (GHIT), the Coalition for Epidemic Preparedness Innovations (CEPI) and others. EVI is hosted by Heidelberg University in Germany.

icddr,b (https://www.icddrb.org/) has the world’s most experienced clinical research team for evaluating diarrhoeal vaccines in LMICs and characterization of immune responses to ETEC and Shigella in endemic region.

University of Gothenburg (https://www.gu.se/english) and the team of Dr Ali Harandi (UGOT) who is a renowned expert in mucosal vaccines and vaccineinduced response evaluation with his experience in academic and translational immunology research to mucosal pathogens, as well as his involvement in multidisciplinary international research and development programs strengthen our consortium.

PATH (https://www.path.org/) PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. PATH will be involved in oral vaccine formulation studies, will perform the oral formulation development and will lead the development of a target product profile.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 815568.