BioFactura advances its critical Smallpox countermeasure in preparation for a first-in-human Phase 1 clinical trial
FREDERICK, Md., Nov. 5, 2024 /PRNewswire-PRWeb/ -- BioFactura, Inc. recently announced contract option activations totaling $7.8 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, as part of BioFactura’s prime contract valued at up to $78 million for the advanced development of a Smallpox Biodefense Therapeutic. This monoclonal antibody cocktail therapeutic has the potential to augment current medical countermeasures, guard against potential resistance of the Smallpox virus, and fulfill an unmet need in our nation’s biothreat preparedness.
In current year of this contract, completed activities included non-clinical efficacy studies (NHP-Mpox challenge and PK studies), tissue cross-reactivity and viral clearance studies, engineering/toxicology manufacturing and an IND-enabling GLP non-clinical toxicology study. After a successful on-site pre-GMP audit of BioFactura’s facilities and Quality Management System by BARBARDA, the first Drug Substance batch for an upcoming first-in-human Phase 1 clinical trial was initiated.
New options that were funded support a non-clinical dose de-escalation Mpox challenge study in a preclinical model, which will inform the appropriate dose levels for the Phase 1 clinical trial as well as process optimization to improve manufacturability of the product, further improve yield and reduce cost of goods. Further options under this contract that may be activated would support first-in-humans Phase 1 clinical safety study, scheduled to begin in H2 2025.
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, “Continued funding and support of this program highlights the need for therapies against smallpox. We look forward to collaborating 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, “The results of our pre-clinical program as outlined above has bolstered our confidence that this medical countermeasure will provide US citizens with a safe and effective product in the event of a biothreat incident to our population. It has also provided the data to explore widening the indications of this therapeutic to include the treatment of Mpox infections now affecting patients in many parts of the world.”
This project has been funded in whole or in part with federal funds from the 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 develops and manufactures high-value biosimilars (i.e., follow-on biologics or generic biopharmaceuticals), biodefense medical countermeasures, and first-in-class novel drugs leveraging both its patented StableFastTM-NS0 Biomanufacturing Platform and globally-proven commercial CHO expression systems to bring these drugs to market with faster, lower cost, superior-quality manufacture. For over 20 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug and vaccine 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
Media Contact
Jeffrey N. Hausfeld M.D., M.B.A., F.A.C.S., BioFactura, Inc, 301-792-8601, [email protected], www.biofactura.com
SOURCE BioFactura, Inc
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