GigaGen Inc., a biotechnology firm specializing in innovative antibody treatments for immunodeficiencies, infectious diseases, and cancers resistant to checkpoint inhibitors, has announced a new contract awarded by the Biomedical Advanced Research and Development Authority (BARDA). BARDA, part of the U.S. Department of Health and Human Services (HHS) under the Administration for Strategic Preparedness and Response (ASPR), awarded the contract, valued at up to $135.2 million, to support the development of a recombinant polyclonal antibody therapy for botulinum neurotoxins (BoNT) and another yet-to-be-determined biothreat.
“We are excited to receive this BARDA contract and to further our partnership with the U.S. government in advancing novel therapies to counter natural and intentional biological threats,” said Carter Keller, Senior Vice President of Grifols and Head of GigaGen. “Our goal at GigaGen is to revolutionize the treatment of infectious diseases through the world’s first recombinant polyclonal antibody therapeutic platform. This new project, building on our work with the Department of Defense, showcases the adaptability of our platform, making it ideal for rapid responses to emerging biological threats.”
This BARDA project follows GigaGen’s previous contract with the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), awarded in 2022. That project demonstrated the effectiveness of GigaGen’s recombinant human polyclonal antibody platform against two BoNT variants. Having successfully neutralized these variants in vivo, the new BARDA project will focus on manufacturing and early-stage clinical development of a drug targeting all seven known BoNT variants. BoNT, produced by the bacterium Clostridium botulinum, is one of the most toxic substances and can cause life-threatening progressive muscle paralysis.
In addition to its work on BoNT therapies, GigaGen recently received approval from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial for its first recombinant polyclonal antibody treatment targeting hepatitis B virus (HBV), known as GIGA-2339. The company plans to initiate the trial in the fourth quarter of 2024.
