ACE BioSciences and PATH announce new collaboration to develop a vaccine against diarrheal disease

June 19, 2008 by PATH

Infectious diseases Vaccines
Partnership will accelerate development of the ACE527 vaccine against enterotoxigenic Escherichia coli (ETEC)

Contact:
Ingelise Saunders, CEO of ACE BioSciences, +45 20.20.36.87, saunders@acebiosciences.com
Allison Clifford of PATH, +1 202.454.5054, aclifford@path.org

Copenhagen, Denmark and Seattle, WA, June 19, 2008—ACE BioSciences and PATH have announced a new partnership to advance the development of a promising vaccine against one of the leading bacterial causes of diarrheal disease, enterotoxigenic E.coli (ETEC). PATH will fund ACE BioSciences to complete Phase 1 and Phase 2 clinical trials up to proof of concept of its ACE527 vaccine. ACE527 offers the broadest coverage among currently available ETEC vaccine formulations, and the vaccine’s components have already been tested in more than 100 subjects.

Diarrhea is the second leading cause of death in children under the age of five, killing more than 1.8 million children each year. ETEC is responsible for up to 840 million infections and approximately 400,000 deaths worldwide each year, mostly in children in developing countries. ETEC may be the first enteric illness encountered by many infants, and it is also the most common cause of diarrhea among travelers and the military when visiting high-risk regions like Asia and Africa.

"This collaboration represents PATH’s first partnership to develop an ETEC vaccine, and we are delighted to work with ACE BioSciences on this promising candidate," commented Dr. Richard Walker, director of PATH’s Enteric Vaccine Initiative. "The ACE527 vaccine is designed to provide particularly broad coverage against ETEC, and this partnership will provide critical evidence to advance PATH’s work in developing vaccines to prevent enteric infections among children in the developing world."

"The ACE527 vaccine is part of our pipeline of travelers’ diarrhea vaccines, and the collaboration with PATH helps ensure we develop a safe and effective vaccine for use in travelers worldwide who visit developing countries where the risk of exposure to ETEC is high. At the same time, we are excited about playing a part in the development of a vaccine to help PATH reach its goals," commented Ingelise Saunders, CEO of ACE BioSciences.

Each year, millions of tourists and business people succumb to travelers' diarrhea when visiting high-risk regions, and ETEC can cause up to an estimated 50 percent of these cases. Another 25 percent is caused by the bacterium Campylobacter. The lead project in ACE BioSciences’ portfolio is a Campylobacter vaccine that has the potential to be the world’s first vaccine against this illness. Together, the two vaccines could cover 75 percent of the bacterial causes of travelers’ diarrhea.

Unsafe water sources and lack of adequate sanitation increase the risk of contracting ETEC, which is primarily spread through food or water contaminated by human waste. As a result, the incidence of ETEC is highest in the developing world. Because access to appropriate medical care is limited in these areas and antimicrobial resistance to antibiotics is common and increasing, prevention through vaccination is a critical strategy to reducing ETEC illness.

There are currently no licensed vaccines against ETEC available. ACE527 is a live, whole cell, oral vaccine, which comprises three attenuated ETEC strains. This agreement will bring the vaccine through to clinical proof of concept, including a Phase 1 dose finding safety and immunogenicity study and a Phase 2 challenge trial, with the goal of developing the first oral vaccine to prevent moderate or severe diarrhea caused by ETEC. The vaccine is expected to reach the travelers’ diarrhea market in 2013.

Earlier this year, ACE BioSciences and PATH entered into a separate research collaboration to develop temperature-stable ETEC vaccine formulations. This research will support and complement the clinical development activities ACE BioSciences will conduct under the new agreement.

About ACE BioSciences
ACE BioSciences was founded in 2001 from Odense University’s Centre of Excellence in protein analysis. The technology platform is to extract and analyze the cell surface proteins used by bacteria and virus to infect human cells and thereby cause diseases.

Today, ACE BioSciences is a product-based company with a focus on novel vaccines to fight serious bacterial infections. The company’s vaccines are developed in-house through preclinical and clinical tests. The aim is to develop a portfolio of vaccines against travelers’ diarrhea and other serious infectious diseases. The company’s lead products are ACE393, the world’s first commercial travelers’ diarrhea vaccine to address Campylobacter, and ACE527, the first orally administered vaccine against ETEC. In the long term, the company aims to develop a combination vaccine to addressCampylobacter and ETEC. In addition, ACE BioSciences recognizes the need to improve existing vaccines and are currently working to develop a new vaccine against Streptococcus pneumoniae. ACE BioSciences currently employs 20 staff members. For more information, visitwww.acebiosciences.com.

About 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.