FREDERICK, MARYLAND, JULY 27, 2020: BioFactura, Inc. today announced a $1 million Small Business Innovation Research (SBIR) Phase II contract awarded by the Joint Science & Technology Office—Chemical and Biological Defense (JSTO-CBD) of the Department of Defense (DoD). The goal of this project is to develop, optimize, and scale-up a highly efficient mammalian cell culture-based bioprocess suitable to meet surge requirement needs for rapid manufacture of a monoclonal antibody (mAb) therapeutic against the Marburg virus (MARV) biothreat.

MARV is a member of the same family as Ebola virus, causes lethal viral hemorrhagic fever, and is classified as a Category A priority pathogen by the NIH, due to high case fatality rates and suspected weaponization. There are currently no MARV vaccines or therapeutics approved for human use. With so much focus on Ebolavirus over the last few years, MARV antibody development efforts have lagged considerably and few MARV-specific mAbs have been described. This problem leaves the U.S. in a vulnerable situation to treat and manage a MARV outbreak. Under the contract, BioFactura will use its proprietary StableFastTM Biomanufacturing Platform to to develop a process for this crucial therapy against MARV that is easily scalable for production at large manufacturing cGMP (current Good Manufacturing Practices) facilities.

Dr. Darryl Sampey, President and CEO of BioFactura, stated, “This Chem-Bio Defense Phase II award builds upon our successful early development of a highly productive StableFast cell line during the SBIR Phase I contract. We look forward to working with our partners at the DoD to develop the drug manufacturing process for advanced testing and clinical readiness to meet threats to the warfighter.” “This government contract for the development of a novel Marburg virus therapeutic countermeasure is the result of continued efforts to create highly effective therapeutics that can be deployed in the event of a biological threat. The current COVID pandemic has taught us a valuable lesson: Strategic preparedness in conjunction with an organized effort at containment and treatment, can mitigate the effects of these deadly pathogens. We applaud the JSTO-CBD and DoD for their foresight,” said Jeffrey Hausfeld MD. MBA., Chairman and Chief Medical Officer of BioFactura, Inc.

This project is supported by the Defense Threat Reduction Agency under Contract No. HDTRA1-20-C-0033. Any opinions, findings and conclusions or recommendations expressed in this press release are those of the authors and do not necessarily reflect the views of Defense Threat Reduction Agency.

 

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