Project description DEENESFRITPL The first oral vaccine against enterotoxigenic E.coli Enterotoxigenic Escherichia coli bacteria (ETEC) are the cause of travellers’ diarrhoea (TD), which particularly affects people in developing countries. ETEC is transmitted via contaminated food or water and currently, there is no approved vaccine for its prevention. Biopharma in Sweden is developing an oral vaccine against TD associated with ETEC. The company is collaborating with the world’s prominent experts in ETEC vaccine research. The EU-funded ETVAX project will conduct a phase II vaccine study to allow Biopharma to take the necessary steps towards commercialisation. The successful introduction of the vaccine will reduce the number of TD cases among affected travellers and patients with irritable bowel syndrome or other chronic diseases associated with TD. Show the project objective Hide the project objective Objective This project will perform a Phase II study of ETVAX – an oral vaccine against traveller’s diarrhoea (TD) caused by enterotoxigenic E. coli bacteria (ETEC). ETVAX has a strong potential to be the first vaccine with a full ETEC indication. TD caused by enterotoxigenic E. coli bacteria is the most common illness that affects travellers traveling in the developingregions. Currently, there is no approved method for preventing TD.Travellers are recommended to use off-label antibiotics such as Rifaximin or the cholera vaccine Dukoral to prevent TD. In business terms, there exists a strong business opportunity in developing and commercializing an effective and safe ETEC vaccine. Scandinavian Biopharma is the first SME positioned to capture this opportunity. The envisaged Phase II study willallow Scandinavian Biopharma take the key step towards the commercialization of ETVAX.The targeted users of are travellers visiting tropical and subtropical countries. Their number is forecasted to reach 190 million by 2020. Their key need is to prevent TD which can ruin a significant part of a vacation or a business trip. ETVAX will meet this needs by being safe, efficient and easy to use.The project delivers an ultimate EU added value by offering the first ETEC vaccine with proven immunogenicity, safety and efficacy. From the scientific perspective, this means that the project fills the gap in the vaccine research on the EU and global level as no other efficient methods for prevention of TD have been proposed on the market to date. The introduction of ETVAX will ultimately decrease number of TD cases among travellers, decrease number of patients with irritable bowel syndrome or other chronic diseases connected to TD, as well as decrease healthcare costs and productivity losses on the EU level.If successfully validated and accepted by regulatory bodies, ETVAX will take Scandinavian Biopharma to a new level ofcompetitiveness and growth. Fields of science medical and health scienceshealth sciencesinfectious diseasessocial scienceseconomics and businessmedical and health sciencesbasic medicineimmunologymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines Keywords oral vaccine traveller’s diarrhoea enterotoxigenic E. coli bacteria (ETEC) Phase II Study prevention Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SMEInst-05-2016-2017 - Supporting innovative SMEs in the healthcare biotechnology sector Call for proposal H2020-SMEInst-2016-2017 See other projects for this call Sub call H2020-SMEINST-2-2016-2017 Funding Scheme SME-2 - SME instrument phase 2 Coordinator SCANDINAVIAN BIOPHARMA HOLDING AB Net EU contribution € 2 992 750,00 Address INDUSTRIVAGEN 1 171 48 Solna Sweden See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Östra Sverige Stockholm Stockholms län Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 2 992 750,00
