The $2 million grant is distributed over three years and supports the development of a dry formulation of the vaccine, including clinical manufacturing of both the vaccine active ingredient and a novel recombinant vaccine adjuvant. An adjuvant is a substance that enhances the immune-stimulating properties of a drug.
H. pylori is a bacterium that lives in the stomach and duodenum and causes gastritis, gastric ulcers and gastric cancer, the second leading cause of cancer death worldwide according to the World Health Organization. Up to 50 percent of the world's population is thought to be infected with this bacterium, and at present, there is no known means of preventing infection.
Antex Biologics' vaccine candidate could be used to prevent infection, as well as be used alone or in conjunction with antibiotics to treat existing infections. The company is developing an orally-delivered, inactivated, whole cell vaccine candidate which has previously been evaluated in two Phase 1 clinical trials. Data from the previous trials have shown that the vaccine is safe, and that it stimulated mucosal and systemic immune responses in both uninfected and colonized (infected) subjects.
"The NIAID grant will allow vital studies on H. pylori to continue," said Gary Nabors, Ph.D., Director of Immunology for Antex Biologics and principal investigator for the project. "We are pleased to further develop this candidate that has the potential for worldwide disease prevention."
Over the past two years, the companies of Emergent BioSolutions have attracted nearly $7.5 million in Research and Development funding in the forms of grants and contracts from various government agencies to further develop its vaccine pipeline.
Emergent BioSolutions is a company dedicated to preserving life, protecting health and preventing disease. BioPort Corporation, the world's only manufacturer of the FDA-licensed anthrax vaccine, BioThrax(TM), and Antex Biologics, a research and development company, are wholly-owned subsidiaries of Emergent BioSolutions.