ACE BioSciences Enters Research Collaboration with PATH to Develop Temperature Stable, Oral ETEC

ACE BioSciences, the Danish biotechnology company focused on vaccines for infectious diseases, has entered into a research collaboration with PATH, an international, non-profit, non-governmental organisation, to develop temperature stable ETEC (Enterotoxigenic E.coli) vaccine formulations.

Under the terms of the agreement, funded under PATH's Enteric Vaccine Initiative (EVI), ACE BioSciences will collaborate with PATH's Vaccine Stabilization Project team to develop dry and temperature stable ETEC vaccine candidates. The pilot studies will utilise ACE527, ACE BioSciences' live, whole-cell oral vaccine candidate which comprises three attenuated ETEC strains and represents the culmination of a development programme which has already demonstrated safety and immunogenicity in five clinical trials. The aim of the programme is to develop temperature stable formulations, such as spray or freeze dried vaccines, which would not require refrigerated storage. Such easily stored, orally administered vaccines would support the routine, widespread vaccination of children in developing countries. In addition to providing its ETEC strains, ACE BioSciences will contribute its proprietary knowledge on optimised growth and freeze drying methods and analytical assays for the ETEC strains and give technical support. All parties will share the results of the work.

Enterotoxigenic E coli strains are the most common causes of bacterial diarrhoea, being responsible for an estimated 840 million gastrointestinal infections and about 380,000 deaths worldwide each year. ETEC infection leads to profuse, watery diarrhoea and is primarily spread through food or water contaminated with human waste. Poor drinking water quality and lack of adequate sanitation increase the risk of contracting the disease and as a result, the incidence of ETEC is highest in the developing world. Here it contributes to significant disability and mortality, particularly in the young, elderly and immunocompromised. Combating infection is difficult, since access to appropriate medical care is limited in these areas and antimicrobial resistance to antibiotics is common and increasing.

‘I am delighted that ACE BioSciences can make a positive contribution to this important and pioneering work' commented Ingelise Saunders, ACE BioSciences' CEO. ‘We believe that ACE527, which we are developing to combat travellers' diarrhoea, will be the first oral ETEC vaccine. From an ethical standpoint, this collaboration will help to ensure that all mankind can benefit from our work. From a commercial perspective, we will continue to move forward our in-house development programmes to enhance our portfolio of travellers' diarrhoea vaccines which, in addition to ETEC, includes the first commercial vaccine to combat the bacterium Campylobacter.'

'Diarrheoa is the second leading cause of death in children under the age of five and ETEC is responsible for a significant portion of these fatalities. Prevention through vaccination is a critical part of the strategy to reduce the incidence of life-threatening ETEC illness, as well as other infections, in this young and vulnerable, developing world population,' commented Dr Richard Walker, Director of EVI. 'ACE BioSciences has developed three attenuated strains of enterotoxigenic Escherichia coli that currently represent one of the most complete ETEC vaccines ready for human clinical trials. This work could help improve the practicality of using ETEC vaccines in the developing world and, in so doing, improve their potential value as public health tools.'


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ACE BioSciences
ACE BioSciences was founded in 2001 from Odense University's Centre of Excellence in protein analysis. It has particular expertise in the extraction and analysis of the cell surface proteins used by bacteria, fungi and viruses to infect human cells and thereby cause diseases.

Today, ACE BioSciences is a product based company with a focus on vaccines to protect against infectious diseases caused by bacteria. The company's vaccines are developed in house through pre-clinical and clinical tests. The aim is to develop a portfolio of vaccines against travellers' diarrhoea and other serious infectious diseases. The company's lead product is ACE393, the world's first commercial travellers' diarrhoea vaccine to address Campylobacter and this is about to enter Phase IIb trials. ACE BioSciences recently raised 11.9 million Euros to develop its diarrhoea vaccine portfolio and in the long term the company aims to develop a combination vaccine to address Campylobacter and ETEC.

ACE BioSciences currently employs 20 staff members. www.acebiosciences.com


PATH
PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH's work improves global health and well-being. PATH's Vaccine Stabilization Project is working to improve the effectiveness and efficiency of developing country immunization programs through the development of thermostable vaccines. PATH's Enteric Vaccine Initiative is working with public- and private-sector partners to advance the development of safe, effective, and affordable vaccines against Shigella and ETEC. For more information, please visit www.path.org

Ingelise Saunders, CEO, ACE Biosciences, +45 20 20 36 87

Nicki Brimicombe - NB PR for ACE BioSciences + 44 (0) 1883 732353

Allison Clifford - PATH - 001 202 822 0033