GigaGen Inc., a subsidiary of Spanish biopharma Grifols, has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
The contract will provide an initial commitment of $19.6 million and up to $135.2 million over a six-year period, supporting drug manufacturing and phase 1 trials for the two programs: for botulinum neurotoxins (BoNT) and a second biothreat of interest to the agency that will be determined at a later time.
GigaGen’s next-generation recombinant polyclonal platform offers a novel way to develop synthetic polyclonal antibody therapeutics in the laboratory, which are potentially more powerful than what a natural immune response can provide. The protein engineering technology creates cell lines that express recombinant human antibodies against a diversity of infectious disease antigens. The polyclonal cell bank can then be used to continuously manufacture recombinant polyclonal products against the pathogen of interest at existing manufacturing facilities.
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 (JPEO-CBRND) in 2022. The DOD project demonstrated the utility of GigaGen’s first-in-class recombinant human polyclonal antibody discovery platform against biological threats, focusing on two BoNT variants.
Following success in this program that included in vivo neutralization of the two botulinum neurotoxins, 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 aims to change the way infectious diseases are treated with the world’s only recombinant polyclonal antibody therapeutic platform,” said Carter Keller, senior vice president of Grifols and head of GigaGen in a 3 Oct press release. “Building on our successful collaboration with the Department of Defense (DOD), this project demonstrates the versatility of our recombinant polyclonal antibody platform, which is ideally suited for rapid responses to imminent biological threats.”
GigaGen recently received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial to evaluate the company’s first recombinant polyclonal antibody therapeutic for the treatment of hepatitis B virus (HBV) infection, GIGA-2339. The company anticipates initiating the trial in Q4 2024.
Source: GigaGen
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