Dr. Darryl Sampey, President and CEO of BioFactura, stated, “Funding of our first option confirms the commitment of BARDA to support development of this important product. We look forward to continuing our close collaboration with BARDA as we move into the pathway to FDA approval."
FREDERICK, Md. (PRWEB) February 19, 2021
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 product has the potential to fulfill an unmet need in preparedness, augment current medical countermeasures and guard against potential resistance.
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.
Dr. Darryl Sampey, President and CEO of BioFactura, stated, “Funding of our first option confirms the commitment of BARDA to support development of this important product. We look forward to continuing our close collaboration with BARDA’s program and technical groups as we move into manufacturing and the regulatory pathway to FDA approval.”
Dr. Jeffrey Hausfeld, BioFactura’s Chairman of the Board and Chief Medical Officer, stated, “Forecasting potential threats to our citizenry, and the proper planning and mitigation of associated risks are examples of lessons learned and amplified as a result of the COVID pandemic. BioFactura is proud to be part of this collaborative partnership with BARDA in order to further align the mission and goals of governmental agencies and private biotechnology firms for the benefit, welfare, and security of our population.”
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.
About BioFactura, Inc.
BioFactura, Inc. (Frederick MD) develops and commercializes high-value biodefense medical countermeasures and biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal system for bringing these drugs to market with faster, lower cost, superior-quality manufacture. For over 15 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases. http://www.biofactura.com