Grifols subsidiary GigaGen, a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint-resistant cancers, has been awarded a contract 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. The award, valued at up to $135.2M, is to develop a recombinant polyclonal antibody therapy for botulinum neurotoxins and a second biothreat of interest to the agency that will be determined at a later time. The BARDA project builds upon GigaGen’s contract awarded by the U.S. DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in 2022. The BARDA project will support the manufacturing and initial clinical development of a drug product that targets all seven BoNT variants. BoNT, one of the most toxic biological substances, is produced by the bacterium Clostridium botulinum and can cause progressive muscle paralysis from the head to the rest of the body, which can be fatal if left untreated. GigaGen recently received clearance from the FDA for its IND application to initiate a Phase 1 clinical trial of GIGA-2339, the company’s candidate for the treatment of HBV infection. The company anticipates initiating the trial in Q4.
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