GigaGen Wins BARDA Contract for Botulinum Antibody Therapies

GigaGen Inc., a biotechnology firm focused on advancing innovative antibody drugs for numerous medical conditions, has secured a significant contract from the Biomedical Advanced Research and Development Authority (BARDA). This contract, which is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is valued at up to $135.2 million. It aims to support the development of a recombinant polyclonal antibody therapy for botulinum neurotoxins (BoNT) and another biothreat to be identified later.

"We are excited to have been awarded this BARDA contract and to continue our partnership with the U.S. government in developing novel therapies for both naturally occurring and intentional biological threats," said Carter Keller, senior vice president of Grifols and head of GigaGen. "GigaGen intends to revolutionize the treatment of infectious diseases through our unique recombinant polyclonal antibody therapeutic platform. This project builds on our previous collaboration with the Department of Defense (DOD), showcasing the adaptability of our platform for rapid responses to imminent biological threats."

The BARDA project builds upon GigaGen’s earlier contract with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) awarded in 2022. This previous project demonstrated the effectiveness of GigaGen’s recombinant human polyclonal antibody discovery platform against biological threats, specifically targeting two BoNT variants. Following the success of in vivo neutralization of these toxins, the BARDA project will now focus on manufacturing and initial clinical development of a drug targeting all seven BoNT variants. BoNT, produced by the bacterium Clostridium botulinum, is one of the most toxic biological substances and can lead to progressive muscle paralysis, which could be fatal without treatment.

In recent developments, GigaGen 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 for GIGA-2339, a recombinant polyclonal antibody therapeutic for treating hepatitis B virus (HBV) infection. The trial is expected to begin in the fourth quarter of 2024.

The project is funded entirely or in part by federal funds from the Department of Health and Human Services, ASPR, and BARDA under contract number 75A50124C00049.

GigaGen’s platform represents a next-generation approach to developing synthetic polyclonal antibody therapeutics in the laboratory, with the potential to surpass natural immune responses. By leveraging high-throughput, single-cell genomic and protein engineering technologies, GigaGen creates cell lines that express recombinant human antibodies against various infectious disease antigens. The polyclonal cell bank can be utilized to continuously manufacture these recombinant polyclonal products at existing facilities. GigaGen's products have demonstrated significantly higher potency compared to plasma-derived antibody therapies, offering a diverse array of antibodies that can address the wide range of pathogen variants in circulation.

Grifols, the parent company of GigaGen, is a global healthcare firm established in Barcelona in 1909. It specializes in plasma-derived medicines and transfusion medicine, offering innovative healthcare services and solutions in over 110 countries. Driven by patient needs and an extensive understanding of numerous chronic, rare, and life-threatening conditions, Grifols focuses on developing treatments across a range of therapeutic areas, including immunology, hepatology, pulmonology, hematology, neurology, and infectious diseases.

Grifols continues to expand its network of plasma donation centers, which is the largest in the world with over 390 centers across North America, Europe, Africa, the Middle East, and China. As a leader in transfusion medicine, the company provides a comprehensive range of solutions to enhance safety from donation to transfusion, alongside clinical diagnostic technologies. Grifols also supplies high-quality biological materials for life-science research, clinical trials, and pharmaceutical and diagnostic product manufacturing.

Employing over 24,000 individuals in more than 30 countries, Grifols is dedicated to a sustainable business model that emphasizes continuous innovation, quality, safety, and ethical leadership. The company’s Class A shares are listed on the Spanish Stock Exchange as part of the Ibex-35, and its Class B shares are available on the Mercado Continuo and the U.S. NASDAQ through ADRs.