americanpharmaceuticalreviewSeptember 14, 2020
Tag: Eveliqure , ETEC , NIAID , ShigETEC
Eveliqure Biotechnologies GmbH announced the award of a US government contract from the National Institute of Allergy and Infectious Diseases (NIAID), contract #75N93020C00048 with the intent to fund the development of its vaccine candidate, ShigETEC, through Phase 2 clinical testing. NIAID has made a base award of $215,093 with a total contract value of $20.6 million if all contract options are exercised. The contract options are staged along milestones, covering IND filing at FDA, manufacture of clinical trial material and several human challenge studies to prove the efficacy of the vaccine.
ShigETEC is an orally administered vaccine candidate that induces broad protection against Shigella and Enterotoxigenic E. coli (ETEC), two major pathogens of diarrhoeal diseases among children under the age of five living in low- and middle-income countries, and affecting up to half of travellers to the developing world. Diarrhoeal diseases are also the top infectious-disease threats to military personnel deployed in endemic countries. ShigETEC is based on a live attenuated Shigella vaccine strain rationally designed to address the shortcomings of previous vaccine attempts and protects against both Shigella and ETEC.
"The NIAID contract provides substantial support to our vaccine development efforts and will help us pursue our ultimate goal of preventing Shigella and ETEC diarrhoeal diseases, a global problem affecting millions of people. We highly value NIAID's commitment to our project and are looking forward to working with NIAID to advance ShigETEC," said Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure.
"The Phase 2 human challenge studies supported by this award will allow time- and cost-efficient testing of ShigETEC with the additional benefit of extended research to understand protective immune responses induced by our vaccine and will aid the design of Phase 3 field studies," commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure and Principal Investigator of the award.
"Following the previous public funding from the European Union's Research and Innovation program Horizon2020, the Wellcome Trust and the Austrian Research Promotion Agency (FFG), this NIAID support reflects the health and social impact a successful combined Shigella-ETEC vaccine can make in diverse populations affected by diarrhoeal diseases," commented Eszter Nagy MD, PhD, Co-founder and President of Eveliqure.
There are currently no vaccines available to protect people against Shigella and ETEC infections. ShigETEC is currently entering Phase 1 clinical testing.
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