With a mortality rate of over 30%, smallpox is one of the most dangerous biological threats. It is person-to-person airborne communicable, highly contagious, exhibits a long pre-symptomatic phase (12-14 days) allowing undetectable spread worldwide, and has no effective treatment. In the event of a smallpox bioterror attack, the US Department of Health and Human Services has developed a Smallpox Response Plan that relies on targeted and mass vaccination strategies to control an outbreak. The US Department of Defense also relies on mandatory smallpox vaccination of deployed soldiers. ACAM 2000 (Acambis) is an effective vaccine against smallpox and is currently procured by the US for the civilian Strategic National Stockpile (SNS) and the Military Vaccine Agency (MILVAX). However, there are risks of serious, life-threatening infections with the smallpox vaccine.
According to a study by the American College of Physicians-ASIM, over 50 million Americans are vulnerable to the serious side effects of the smallpox vaccine, and adverse events regularly occur in the US military vaccine program. These infections are currently treated by administration of Vaccinia Immune Globulin-Intravenous (VIGIV), a human blood-derived product. However, recent and historic adverse event case reports for VIGIV have shown little or no efficacy. In addition, there are significant supply limitations of this critical smallpox defense system element. An improved therapeutic for treating smallpox vaccine related adverse events is essential.
BioFactura is collaborating with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) to develop and commercialize a Smallpox Biodefense Therapeutic. Recent prophylactic and therapeutic lethal vaccinia challenge studies conducted by BioFactura have demonstrated that its monoclonal antibody combination therapeutic provides superior efficacy compared to VIGIV. In addition, the Company’s therapeutic also has been shown to neutralize variola virus (smallpox) and monkeypox virus which may enable the drug to broadly treat smallpox and monkeypox infections (cross-reactive).