FREDERICK, Md., Nov. 5, 2024
BioFactura advances its critical Smallpox countermeasure in preparation for a first-in-human Phase 1 clinical trial
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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.
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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 BAR
Media Contact
Jeffrey N. Hausfeld M.D., M.B.A., F.A.C.S., BioFactura, Inc, 301-792-8601, [email protected], www.biofactura.com
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SOURCE BioFactura, Inc
