FITCI Grad BioFactura’s monoclonal antibody-based product has the potential to fulfill an unmet need.
BioFactura, Inc. today announced a contract option activation of over $16 million by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as part of its prime contract valued at over $77 million for the advanced development of its Smallpox Biodefense Therapeutic. This option will continue to support ongoing product development to include clinical manufacturing of the therapeutic for an upcoming first-in-human Phase 1 trial, which may be funded in a future contract option.
BioFactura’s monoclonal antibody-based product has the potential to fulfill an unmet need in preparedness, augment current medical countermeasures and guard against potential resistance. 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 persists.
Dr. Darryl Sampey, President and CEO of BioFactura, stated, “Funding of this option moves the program into cGMP manufacturing to support clinical development. BioFactura is proud to partner with BARDA in providing advanced therapeutics that will protect US citizens.”
Jeffrey Hausfeld, M.D., M.B.A., BioFactura’s Chairman of the Board and Chief Medical Officer, stated, “We are taking lessons learned from the COVID pandemic to ensure preparedness and foresight when dealing with potentially lethal viral pathogens.”
Dr. Kimberly Clark, BioFactura’s Program Manager, added, “BARDA continues to be an excellent partner in this program. We have maintained a collaborative and scientific working relationship that has sustained the accelerated progress of the program towards the Investigational New Drug Application (IND) stage.”
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 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. www.biofactura.com