Press release, 25 Jaurary 2010
TD VACCINES A/S Announces Promising Phase I results for ACE527,
a Novel, Three-Strain, Oral ETEC Vaccine to combat Bacterial Diarrhoea
TD Vaccines A/S, the newly created Danish vaccine company announces promising preliminary Phase I trial results for ACE527, a live, 3-strain, oral ETEC (Enterotoxigenic E Coli) vaccine to combat a leading cause of bacterial diarrhoea that afflicts millions of international travellers as well as children in the developing world.
In the Phase I trial, involving 36 adult volunteers (12 placebo; 12 on low dose and 12 on high dose vaccine), ACE527 was very well tolerated, demonstrated a strong safety profile and showed promising initial immunological data. The project will now proceed to a Phase II challenge study with Clinical Proof of Concept anticipated by the year end.
ACE527 is a live, whole-cell ETEC vaccine which is novel because it comprises three attenuated ETEC strains and induces both colonisation factor and toxin specific immune responses. The Phase I study showed a mucosal immune response to colonisation factors on all three strains and confirmed that the vaccine generates a strong mucosal and systemic anti-toxin response as well. The trial was conducted at the Center for Immunization Research at Johns Hopkins University, Baltimore, Maryland, US, where the Phase II trial will also take place.
'These are really strong results and it is exciting that our unique vaccine approach is showing so much promise' commented Ingelise Saunders, TD Vaccines CEO. ‘TD Vaccines’ main focus is to take ACE527 to Proof of Concept by the end of 2010 and then to find a partner that can take the vaccine through to the market. ACE527 is an attractive commercial opportunity since there is no ETEC vaccine currently available to protect travellers and market potential is valued at €900 million. The project is fully funded by PATH, an international nonprofit global health organization, to the conclusion of Proof of Concept and I am delighted by their ongoing commitment to this work.’
Enterotoxigenic E coli strains are one of the most common causes of bacterial diarrhoea. A great many people travelling from developed to developing countries for business or holidays succumb to infection which results in reduced productivity, ruined vacations and considerable personal discomfort. ETEC is responsible for an estimated 840 million gastrointestinal infections and about 380,000 deaths worldwide each year. Moreover, in the developing world 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.
’These results of the ACE527 Phase 1 trial are encouraging,’ commented Dr Richard Walker, Director of PATH’s enteric vaccine initiative. ’Prevention through vaccination is a critical part of our strategy to reduce the incidence of life-threatening ETEC illness, as well as other infections, in the young and vulnerable developing world population.’
The Phase II trial aims to recruit 72 subjects (36 will receive vaccine and 36 placebo) of whom 56 will be challenged with a virulent strain of ETEC (28 subjects each having received vaccine or placebo). The trial is scheduled to start in the second quarter of 2010.
For further information please contact:
Ingelise Saunders, CEO, TD Vaccines, + 45 20 20 3687
Nicki Brimicombe, NB PR for TD Vaccines + 44 (0) 1883 732353
About TD Vaccines A/S
TD Vaccines A/S is a Danish biotechnology company established in November 2009. The company is focused on the development of vaccines to protect against travellers’ diarrhoea (TD). Every year, millions of tourist and business travellers visit destinations in Asia, Africa and Latin America and around half of these succumb to TD.
TD Vaccines’ lead programme is ACE527, an oral ETEC vaccine to protect against ETEC (Enterotoxigenic E Coli). ACE527 is in Phase I trials in the US. Earlier in development, at a preclinical stage, is an oral combination vaccine, ACE920, designed to protect against ETEC and Campylobacter infections.
TD Vaccines is backed by the Danish venture capital investors Sunstone Capital and LD Equity and headed up by Ms Ingelise Saunders, formerly CEO of ACE BioSciences. The new TD Vaccines web site can be found at www.tdvaccines.com.
