GigaGen Gets FDA Clearance for Phase 1 Trial of HBV Treatment GIGA-2339

GigaGen Inc., a biotechnology firm focused on innovative antibody drugs for various medical conditions, has announced a pivotal advancement. The company, a subsidiary of Grifols, revealed that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application. This approval paves the way for a Phase 1 clinical trial of GIGA-2339, a recombinant polyclonal drug aimed at treating chronic hepatitis B virus (HBV) infection. This trial is scheduled to commence in the fourth quarter of 2024.

GIGA-2339 is a groundbreaking therapy, being the first of its kind to strive for a functional cure of chronic HBV. The drug comprises over 1,000 fully human recombinant antibodies, mimicking the body's natural immune response to HBV. Despite current treatments and vaccines, HBV continues to affect approximately 296 million people globally, leading to over 800,000 deaths annually. Current therapies can inhibit viral replication but have limited success in significantly reducing viral protein levels in the body.

Developed through GigaGen’s advanced platform, GIGA-2339 harnesses the natural antibody response from vaccinated donors. This innovative process results in a drug that is more than 2,000 times as potent as existing plasma-derived HBV treatments and is capable of addressing the wide variety of HBV strains. In preclinical studies involving mouse models, GIGA-2339 successfully neutralized and eliminated HBV's viral DNA and antigens, showcasing its potential to activate the immune response and clear viral particles effectively.

Carter Keller, Senior Vice President of Grifols and head of GigaGen, emphasized the significance of the FDA's clearance. He noted that this milestone aligns with Grifols' dedication to developing transformative antibody drugs for infectious diseases. Keller pointed out that patients with chronic HBV often face severe complications, including progression to hepatocellular carcinoma and cirrhosis. He expressed optimism about the upcoming trial and the potential of GIGA-2339 to demonstrate the clinical viability of GigaGen's recombinant polyclonal antibody platform.

The upcoming Phase 1 clinical trial will focus on evaluating the safety and tolerability of GIGA-2339 in patients diagnosed with HBV. This trial represents a critical step toward potentially providing a functional cure for those suffering from chronic HBV infection.

GigaGen's platform signifies a novel approach to developing polyclonal antibody therapeutics in the lab, which could outperform the natural immune response. Utilizing high-throughput, single-cell genomic, and protein engineering technologies, GigaGen creates cell lines that express recombinant human antibodies targeting various infectious diseases, including HBV. The resulting polyclonal cell bank allows for the continuous production of hyperimmune products in existing manufacturing facilities.

Grifols, GigaGen’s parent company, is a global healthcare firm with a long-standing commitment to enhancing health and well-being. Founded in Barcelona in 1909, Grifols specializes in plasma-derived medicines and transfusion medicine, serving more than 110 countries worldwide. The company's innovation spans multiple therapeutic areas, including immunology, hepatology, pulmonology, hematology, neurology, and infectious diseases.

With over 24,000 employees across more than 30 countries, Grifols strives for sustainable business practices that prioritize continuous innovation, quality, safety, and ethical leadership. The company’s extensive network of plasma donation centers, advanced diagnostic technologies, and comprehensive healthcare solutions underscore its dedication to improving patient outcomes globally.

GigaGen continues to leverage its industry-leading technologies to advance transformative antibody therapies for immunodeficiencies, infectious diseases, and checkpoint-resistant cancers. Its unique platforms enable the creation of functional antibody libraries, pushing the boundaries of what is possible in the treatment of complex diseases.

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