BioFactura, Inc. today announced a contract option activation of over $13 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, as part of BioFactura’s prime contract valued at up to $67.4 million for the advanced development of a smallpox biodefense therapeutic.
This option activation will continue to support ongoing product development beyond the base period of performance to include process optimization and assay qualification. The contract for the development of the smallpox biodefense therapeutic consists of a previously funded base phase, valued at approximately $9.5 million, and multiple option phases over a total of five years.
This first option award continues BARDA’s financial and programmatic support as BioFactura has successfully met all base milestones including demonstration of humanized product efficacy and commencement of formal interactions with the FDA. Further options that may be activated will support clinical manufacturing, additional non-clinical development studies to support an Investigational New Drug filing, and a first-in-humans Phase 1 clinical study.
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, Variola Virus (VARV), the causative agent for smallpox infections in humans, can become resistant to treatment suggesting that the best medical countermeasure approach would utilize complementary therapeutics that mitigate resistance such as BioFactura’s monoclonal antibody-based Smallpox Biodefense Therapeutic.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00054.
