drugset

Drugs / ShigETEC

Follow last change Dec 2025 re-read 3 minutes ago

ShigETEC

also known as ShigETEC vaccine

Developed for: diarrheal disease · shigellosis
Investigated by: Eveliqure Biotechnologies GmbH

Trials 3

today NCT07049159 · Ph 2 NCT05987488 · Ph 1 NCT05409196 · Ph 1

2021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 12 trials
Phase 1	NCT05987488	Nov 2023 → Dec 2025	—	Eveliqure Biotechnologies GmbH	Completed	No outcome recorded
Phase 1	NCT05409196	Sep 2020 → Jun 2021	diarrheal disease, reactive arthritis	Eveliqure Biotechnologies GmbH	Completed	No outcome recorded
Phase 21 trial
Phase 2	NCT07049159	Jun 2025 → May 2027 expected	shigellosis	Eveliqure Biotechnologies GmbH	Recruiting	No outcome recorded

News releases announcing trial results or a regulatory action · 3

Date	Issuer	Release
2022-02-23	Eveliqure Biotechnologies GmbH	Results Eveliqure announces the publication of positive Phase I clinical data for its vaccine candidate against Shigellosis and ETEC eveliqure.com ↗
2020-11-19	Eveliqure Biotechnologies GmbH	Results Eveliqure announces the publica tion of key preclinical data for its clinical stage vaccine candidate against Shigellosis and ETEC eveliqure.com ↗
2020-06-02	Eveliqure Biotechnologies GmbH	Regulatory Eveliqure announces regulatory approval to commence first clinical studies with its combined Shigella and ETEC vaccine eveliqure.com ↗ Eveliqure Biotechnologies today announces that the Hungarian regulatory agency OGYÈI has approved the clinical trial for its vaccine program to prevent diarrhoeal diseases caused by Shigella and Enterotoxigenic E. coli (ETEC).

All press releases naming this drug 6 releases

Date	Issuer	Release
2025-07-23	Eveliqure Biotechnologies GmbH	Eveliqure Announces Dosing of First Participants in a Phase 2b study of the ShigETEC Vaccine in Shigellosis eveliqure.com ↗
2022-02-23	Eveliqure Biotechnologies GmbH	Eveliqure announces the publication of positive Phase I clinical data for its vaccine candidate against Shigellosis and ETEC eveliqure.com ↗
2020-11-19	Eveliqure Biotechnologies GmbH	Eveliqure announces the publica tion of key preclinical data for its clinical stage vaccine candidate against Shigellosis and ETEC eveliqure.com ↗
2020-09-24	Eveliqure Biotechnologies GmbH	Eveliqure announces the initiation of a Phase 1 clinical stud y of its combined Shigella and ETEC vaccine candidate Vienna, 24. September 2020 Eveliqure Biotechnologies GmbH, a n Austrian biotechnology company, today announces the initiation of clinical testing for its ShigETEC vaccine candidate, with the dosing of the first subject in a Phase 1 safety and immunogenicity study in Europe. ShigETEC is an orally administered vaccine candidate targeting Shigella and Enterotoxigenic E. coli (ETEC), two of the major pathogens responsible for diarrhoeal diseases in travelers to endemic countries, as well as a major threat to children living in low- and middle- income countries. Currently no effective vaccines against these two pathogens exist and previous attempts to develop vaccines against Shigella and ETEC have failed. Eveliqure has employed a radically innovative approach based on a live attenuated Shigella vaccine strain rationally designed to provide broad, serotype independent protection against both Shigella and ETEC, and is developing the vaccine for both travelers to endemic countries and for children living in resource-poor countries. Following this initial Phase 1 study run in Hungary, further clinical development of ShigETEC will include Phase 1 testing in non -endemic adults, immune characterization of vaccine responses, vaccine formulation studies and clinical testing of ShigETEC in the pediatric population in resource poor -countries. These activities are supported by the EU-funded SHIGETECVAX international consortium of world -leading vaccine organizations - the European Vaccine Initiative, Eveliqure Biotechnologies, University of Gothenburg, icddr,b and PATH. “Entering clinical development with ShigETEC marks a major milestone for Eveliqure, culminating from our extensive preclinical work performed over the past five years” - commented Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure. “We believe that ShigETEC has the potential to reduce the burden of diarrhoeal diseases for travellers, while also saving hundreds of thousands of children in endemic areas of the world”. “Initiating the Phase 1 study for ShigETEC in adult volunteers is a crucial step towards establishing safety and immunogenicity of our vaccine candidate, and will help us define a well-tolerated, and effective schedule of dosing for our planned Phase 2 human challenge studies ”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure. Compared to single pathogen approaches, ShigETEC has the potential to have a major impact on diarrheal diseases, protecting both travelers to the developing world and children in endemic populations. * * * ABOUT EVELIQURE Eveliqure is an Austrian biotechnology company in Vienna that has developed a proprietary vaccine technology platform aiming at improving the quality of life for both the poor and the privileged by providing innovative medical solutions to fight diarrhoeal diseases. Eveliqure is resident at CEBINA, the C entral European Biotech Incubator and Accelerator (www.cebina.eu). www.eveliqure.com CONTACTS Sophie Zettl, PhD Head of Business Development Eveliqure Biotechnologies GmbH + 43 676 3731595 [email protected] The SHIGETECVAX project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 815568. This project has also received funding from the Wellcome Trust under award number 212399/C/18/Z. eveliqure.com ↗
2020-06-02	Eveliqure Biotechnologies GmbH	Eveliqure announces regulatory approval to commence first clinical studies with its combined Shigella and ETEC vaccine eveliqure.com ↗
2019-09-10	Eveliqure Biotechnologies GmbH	EveliQure's diarrhoea vaccine to advance towards clinical trials supported by a significant Horizon2020 award Vienna, September 2019 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 SHIG ETECVAX 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 pas sionate 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. CONTACTS Ákos Heiszler +36 30 747 05 77 [email protected] 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 o f 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 P reparedness 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 diar rhoeal 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 vaccine -induced response evaluation with his experience in academic and translational immunology research to mucosal pathogens, as well as his involvement in multi -disciplinary 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 en terprises, 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, diagn ostics, 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. eveliqure.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

Field	Value	Cited text
Known as	ShigETEC	ClinicalTrials.gov intervention name — accepted as the source's own label NCT07049159 ↗ 2 NCT05987488 ↗ NCT05409196 ↗
Known as	ShigETEC vaccine	“The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults” NCT05987488 ↗
Modality	Vaccine	“a live, attenuated Shigella/ETEC combination vaccine” NCT05409196 ↗
Route	Oral	“given orally” NCT05409196 ↗