Integrated BioTherapeutics Awarded NIAID Contract For Up to $65 Million for Development of a Vaccine against Ebola and Marburg Viruses
Vaccine Has Potential to Save Millions of Lives
GERMANTOWN, Md., Oct. 7 /PRNewswire/ -- Integrated BioTherapeutics Inc. (IBT), a biotechnology company focused on development of medical countermeasures for biodefense and emerging infectious diseases, announced they have been awarded a multiyear contract for advanced development of a vaccine to protect against Ebola and Marburg viruses from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The contract is valued at approximately $22 million, which, if options are exercised, could total up to $65 million.
Considered a significant bioterrorist threat, Ebola and Marburg lead to death 30-90 percent of the time they are contracted, and there are currently no vaccines or therapeutics available for treatment of humans infected with either virus. Ebola and Marburg virus outbreaks typically occur in resource poor areas in Sub-Saharan Africa, although rare cases have occurred in the United States, Europe and the Philippines. Filoviruses are also a source of concern as potential bioterror agents.
"We are very pleased that NIAID has awarded such a significant contract to fund the advanced development activities for our virus-like particle vaccine against Ebola and Marburg viruses. This is a significant step forward in our mission to improving public health and developing medical countermeasures for biodefense. This contract will fund a major portion of the preclinical and clinical activities required to confirm and refine the activity in animals and verify the activity in humans," commented Dr. Javad Aman, IBT President and Chief Scientific Officer.
IBT is collaborating with colleagues at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) to develop a subunit vaccine, based on the virus-like particles, with broad-spectrum activity toward different strains of Ebola and Marburg viruses. Other collaborating organizations include Protein Sciences Corporation, Meriden, Conn.; Aridis Pharmaceuticals, San Jose, Calif.; Baylor College of Medicine, Houston, Tex.; and AMAR International, Fairfax, Va.
The ultimate objective of the government's program is to develop a safe and effective vaccine to protect against the Zaire, Sudan and Cote d'Ivoire strains of Ebola virus as well as multiple isolates of Marburg virus. The vaccine, to be developed by IBT, provides broad protection in nonhuman primates. The virus-like particle vaccines are strikingly similar to the authentic virus and were originally developed by IBT's founders and their colleagues at USAMRIID.
Initially, IBT will receive approximately $22 million to conduct preclinical activities, including preclinical efficacy animal studies, development and qualification of assays, formulation studies and process development for manufacturing activities. After preclinical studies, NIAID may exercise options to the contract that include cGMP manufacturing, Phase 1 clinical trial, scale-up of cGMP manufacturing, lyophylized formulation and a Phase 2 clinical trial The potential value of the entire contract if all the options are exercised by the government, is $65.2 million.
About Integrated BioTherapeutics Inc.:
Integrated BioTherapeutics Inc. (IBT) is an emerging research-based company dedicated to development of vaccines, immunotherapeutics, and discovery of small molecules targeting emerging infectious agents. IBT is located in Germantown, Maryland. IBT has a portfolio of proprietary recombinant technologies for development of vaccines and immunotherapeutics against major biodefense and emerging infectious agents, with an emphasis on staphylococcal, and streptococcal infections, as well as viral hemorrhagic fevers. IBT has experience and a close working arrangement with many of the United States government agencies including the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), National Cancer Institute (NCI), National Institute of Health (NIH), and the Department of Defense (DOD). Furthermore, IBT has established cooperative working relationships with several universities, as well as pharmaceutical and biotechnology companies for development of joint products for prevention and treatment of staphylococcal infections and viral hemorrhagic fevers.