05Nov
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 and exhibits a long pre-symptomatic phase (12-14 days) allowing undetectable spread worldwide. While smallpox was declared eradicated in 1980 by the World Health Organization after an extensive vaccination campaign, the threat of bioterrorism and/or inadvertent release remains. Although TPOXX (Tecovirimat, SIGA Technologies, Inc.) received FDA approval for smallpox treatment in 2018, orthopoxviurses, like Variola Virus (VARV), the causative agent of smallpox, can become resistant to treatment suggesting that the best medical countermeasure approach would utilize complementary therapeutics.
Administration of therapeutic antibodies represents a relevant strategy for treatment and/or prophylaxis of individuals exposed to or infected by viral disease agents of significance to the military and anti-bioterrorism efforts. Early studies in collaboration with Dr. Jay Hooper at USAMRIID generated a potent mAb-based therapeutic for infections caused by pathogenic orthopoxviruses (e.g., VARV). To achieve optimal success, the murine monoclonal antibodies at USAMRIID and chimpanzee Fabs discovered at NIH/NIAID have been humanized, extensively developed and analyzed in vivo using both rodent and non-human primate animal models.
In order to fill the need for additional treatment options, BioFactura is advancing the development of a Smallpox Biodefense Therapeutic (SBT) as an antibody-based countermeasure for the treatment of smallpox in humans using a stepwise approach that builds upon years of early product research and development and strong foundation of cell line, process analytical and manufacturing development experience. BioFactura will, under BARDA contract 75A50119C00054 pursue a development program that establishes a controlled manufacturing process of the SBT, a pharmacology, safety and efficacy profile in nonclinical animal models, and safety in a phase 1 clinical trial in healthy, human volunteers. Ultimately, BioFactura intends to seek FDA approval for the SBT as a treatment of smallpox disease.