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Grifols' GigaGen Receives FDA Clearance Of IND Application For Phase 1 Trial Of Recombinant Polyclonal For HBV Treatment, GIGA-2339

Benzinga ·  Jul 31 08:10

GIGA-2339 is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic hepatitis B virus (HBV) infection; trial initiation expected in Q4 2024

Containing more than 1,000 fully human recombinant anti-HBV antibodies, GIGA-2339 reproduces the human body's natural immune response

GigaGen's recombinant polyclonals are part of Grifols' robust innovation strategy and commitment to delivering the next generation of antibody drugs for patients and healthcare professionals

SAN CARLOS, Calif. , July 31, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company's first recombinant polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339.

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