GigaGen, a subsidiary of Grifols, has announced the initiation of a Phase I clinical trial for GIGA-2339, a recombinant polyclonal antibody drug candidate targeting chronic hepatitis B virus (HBV) infection. The first patient has been dosed in the dose-escalation trial, which aims to assess the safety and tolerability of the drug in individuals with confirmed chronic HBV. This development marks a significant step forward in the search for more effective HBV treatments, potentially offering a functional cure for millions affected by this chronic disease.
GIGA-2339: Mimicking Natural Immunity
GIGA-2339 is composed of over 1,000 anti-HBV antibodies, engineered to mimic the natural antibody response of donors vaccinated against HBV. According to GigaGen, the drug's potency is more than 2,000 times greater than that of plasma-derived HBV treatments and encompasses a broad spectrum of HBV variants. Preclinical studies in mouse models have demonstrated that GIGA-2339 can neutralize and eliminate HBV's viral antigens and deoxyribonucleic acid (DNA).
Potential to Clear Viral Particles and Stimulate the Immune System
The distinct mechanism of GIGA-2339 could potentially clear viral particles and stimulate the immune system, offering a functional cure for individuals living with HBV. This approach differs from existing therapies that primarily suppress the virus without fully eliminating it.
Management Commentary
GigaGen head and Grifols senior vice-president Carter Keller stated, "The initiation of this Phase I trial with GIGA-2339 represents a milestone in our mission to develop the next generation of antibody drugs for addressing infectious disease treatment. By harnessing the precision of these antibodies, it targets the large diversity of circulating HBV variants, offering a more targeted and effective solution with potential to bring new hope to millions affected by this chronic disease."
Grifols' Commitment to Innovation
The development of GIGA-2339 aligns with Grifols’ commitment to innovation and the development of advanced antibody medications. GIGA-2339 has been created using GigaGen’s advanced platform, showcasing the potential of recombinant polyclonal antibodies in treating infectious diseases.
