Challenge. Every year between 15 and 20 million travelers to ETEC endemic regions suffer from episodes of diarrhea, among them, 10 million people contract diarrhea due to Enterotoxigenic Escherichia coli (ETEC). Traveler’s diarrhea also represents one of the top infectious disease threats to military personnel (about 9 million people). ETEC is considered to be the most common cause of traveler’s diarrhea. ETEC producing the heat-stable toxin (ST) was recently shown to be among the top four pathogens causing moderate-to-severe diarrhea. No broadly effective vaccines are available to protect humans against ETEC diarrhea. Heat-stable toxin (ST) is highly conserved and a hence very attractive alternative vaccine target with the potential for broad protection. However, ST must be coupled to a carrier to become immunogenic and must be engineered to remove toxicity and the potential to elicit an immune response that cross-react with the human endogenous peptides guanylin and uroguanylin.
Technology. A screen of all possible single-amino-acid mutants of heat-stable toxin (ST) has identified a panel of non-toxic ST variants. Mapping of epitopes for neutralizing antibodies have identified both safe epitopes but also cross-reacting epitopes. This information feeds into the rational design of an ST-based vaccine component:
- Chemical synthesis of non-toxic variants of ST
- Genetic fusion exploration.
Commercial opportunity. The potential market revenue (traveler and military personnel) is estimated to be between 155 and 464 million US$. The annual sales projections are 6 million doses for the travelers’ market and 0.5 million doses for military purposes a year (PATH, 2011). Commercialization is possible for the industrialized countries and China, but some restrictions exist in Asia (India) due to funding schemes.
Children until the age of 5 years in ETEC -endemic regions are especially vulnerable to this disease leading to several hundred thousand deaths annually. Thus, our vaccine would be of great value for these patients.
Development status. The single and double mutant vaccine candidates are identified.
IP. Patent I. Priority date: 20 February 2013. Patent granted in the US (US10166279B2) and pending grant in Europe (EP2958935A2). Ongoing proceedings in China.
The project is looking for R&D collaboration partners or licensing partners.
For any inquiries, please contact the project manager at VIS: Malgorzata Barczyk (firstname.lastname@example.org; +47 480 82 052)