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GigaGen, a subsidiary of Grifols, recently introduced that the U.S. FDA has approved the company's new drug clinical trial application (IND) for GIGA-2339, a recombinant polyclonal therapy for the treatment of chronic hepatitis B virus infection, and plans to initiate a Phase I clinical trial in the fourth quarter of this year.

GIGA-2339, a new hepatitis B drug under development, is expected to start phase 1 trials in the fourth quarter of this year

The drug candidate was developed based on GigaGen's next-generation hyperimmune platform. The platform provides a new way to develop recombinant polyclonal antibody therapeutics in the laboratory that may be more powerful than the natural immune response. Using high-throughput, single-cell genomic and protein engineering technologies, GigaGen has created cell lines that express recombinant human antibodies against a variety of infectious disease antigens, including HBV. The polyclonal cell bank can then be used to continuously produce hyperimmune products against relevant pathogens in existing production facilities.

Carter Keller, Senior Vice President and Head of GigaGen, commented: "The FDA's approval of our IND application marks an important milestone in Grifols' commitment to developing transformative antibody drugs for infectious diseases. Chronic hepatitis B virus infection has persistent complications, often developing hepatocellular carcinoma and cirrhosis."