Date: Jan 15, 2010 Source: ARMY SBIR Success Stories (
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The U.S. government has identified smallpox as one of the highest priority biological threats. Although a World Health Organization global campaign eradicated naturally occurring smallpox by the late 1970's, there remains concern that clandestine stores of smallpox virus could be used as a biological weapon.
Historically, smallpox killed 30% of those infected, and the hemorrhagic and flat (confluent) forms of smallpox were nearly 100% lethal. Presently, there is no effective treatment for smallpox. BioFactura is developing a drug composed of human-like versions of anti-pox antibodies that were originally discovered at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the National Institutes of Health (NIH).
These antibodies have been shown to protect and treat animals exposed to lethal doses of pox viruses. The objective of this program is to provide a medical countermeasure for a smallpox biological attack and, in parallel, develop a medical treatment for adverse reactions to the smallpox vaccine. BioFactura anticipates that a combination of these antibodies will provide superior performance over the legacy human blood-derived treatment for adverse smallpox vaccination events.
Under its Army SBIR contract, BioFactura is developing and integrating novel biopharmaceutical discovery, development, and manufacturing technologies to rapidly accelerate this and other critical products to market.
Phase III Impacts
BioFactura has been awarded over $3 million in DoD funding including an Army SBIR Phase II Enhancement, and Congressional Special Project awards to develop and advance the technology towards the key milestone of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). A successful IND will allow the company to initiate the human clinical trials required for drug approval and sales.
BioFactura's Smallpox Biodefense Therapeutic will be procured through the Joint Program Executive Office-Chemical Biological Defense (JPEO-CBD) to meet a critical DoD requirement and medical need of the warfighter. Additionally, the drug may be procured for civilian biodefense by the Biomedical Advanced Research and Development Authority (BARDA). Furthermore, the discovery and manufacturing platforms developed by BioFactura have broad applications in commercial biopharmaceutical markets.
