Advancing the Next Generation of Antibody Drugs

We develop novel recombinant monoclonal and polyclonal antibody therapeutics with unique mechanisms of action derived from GigaGen’s transformative drug discovery platform.

Our Company

GigaGen, a subsidiary of Grifols, is Grifols drug discovery engine for recombinant therapeutics. Headquartered in San Carlos, California, GigaGen delivers the speed and innovation of a start-up backed by the resources and reach of a large pharmaceutical company.

GigaGen has created the first recombinant polyclonal antibody drugs using our drug discovery platform that copies, recreates, and enhances the diverse antibody responses of the human body. These precisely engineered therapies are more potent than natural immune system responses.

GigaGen also discovers monoclonal antibodies with unique mechanisms of action for treatment of cancer and autoimmune disease.

Backed by Grifols decades of leadership in plasma therapeutics, these new recombinant therapeutics expand beyond plasma and adhere to the highest scientific, ethical, and quality standards to help improve people’s lives.

GigaGen scientist in a lab coat and cryogenic gloves removing a sample rack from a liquid nitrogen storage tank

Team

Our Science

GigaGen’s drug discovery platform accelerates drug discovery, quickly filling a growing pipeline of transformative recombinant monoclonal and polyclonal antibody drugs.

GigaGen team members gathered around a conference table reviewing a printed report

Transformative Drugs, Faster

GigaGen’s drug discovery platform delivers rapid drug development from discovery to clinic by capturing and recreating the wide range of antibodies found naturally in the human body after an immune response. Our platform uses a combination of advanced methods including:

  • Single-cell emulsion droplet microfluidics
  • Genomics
  • AI/machine learning
  • Protein-library engineering

GigaGen’s approach enables the discovery of a wide spectrum of drug candidates, including rare monoclonal antibodies with unique profiles and recombinant polyclonal antibody drug candidates that mimic the body’s natural immune repertoires.

Platform

GigaGen platform diagram: the human immune repertoire is captured and re-created to produce monoclonal antibodies (mAb) and recombinant polyclonal antibodies (pAb)

Pipeline

GigaGen’s pre-clinical and early-stage clinical pipeline treats a broad range of life-threatening diseases.

GigaGen pipeline chart. Phase I: GIGA-2339, a recombinant polyclonal for Hepatitis B, and GIGA-564, a Treg depleter for oncology. Earlier-stage infectious disease and autoimmune recombinant polyclonal and monoclonal programs are in discovery and lead identification.
GigaGen pipeline chart. Phase I: GIGA-2339, a recombinant polyclonal for Hepatitis B, and GIGA-564, a Treg depleter for oncology. Earlier-stage infectious disease and autoimmune recombinant polyclonal and monoclonal programs are in discovery and lead identification.

Monoclonal Antibodies with Novel Mechanisms of Action

Modulating the Tumor Microenvironment

Our drug discovery platform provides a better understanding of tumor immune response, enabling discovery of antibody drug candidates with unique profiles against several relevant, clinically validated oncology targets.

  • GIGA-564: Differentiated Treg Depleter

Our lead monoclonal drug candidate, GIGA-564, is a non-blocking, anti-CTLA-4 monoclonal antibody designed to target CTLA-4 in a different manner than traditional CTLA-4 blocking antibodies. GIGA-564 is a strong Treg depleter with a unique MoA and improved efficacy and safety profile. GIGA-564 is being evaluated in a Phase 1 trial for the treatment of individuals with advanced solid tumors, and has exhibited a positive safety and tolerability profile while demonstrating early signs of single agent anti-tumor activity in patients with metastatic or locally advanced solid tumors. The trial is being conducted by the U.S. National Cancer Institute (NCI) researchers in close partnership with the GigaGen team, as part of a Cooperative Research and Development Agreement.

Disrupting Autoimmune Disease

GigaGen is developing two monoclonal antibody drug candidates based on insights derived from our drug discovery platform that allow us to better understand underlying causes of autoimmune disease. These drug candidates specifically target immune cell functions to disrupt the autoimmune disease process and rebalance normal immune function.

GigaGen scientist presenting antibody sequence-similarity cluster plots for PD-1 and LAG-3 binders

Recombinant Polyclonal Drugs

The World’s First Recombinant Polyclonal Drugs

GigaGen is advancing the first recombinant polyclonal antibody therapies for infectious disease and disorders of immune regulation. Recombinant polyclonals have the potential to transform the way diseases are treated and cured through:

  • Simultaneous targeting of multiple pathogens, and multiple targets per pathogen
  • Low toxicity due to natural immune system function
  • High potency through selection of the best antibodies from the best immune responses

Polyclonal antibody therapies contain a diverse array of antibodies in a single product. They are an ideal modality for diseases that comprise many targets, such as viruses that are best neutralized by antibodies binding to multiple epitopes, and disorders of immune regulation.

Our drug discovery platform copies and recreates the best immune responses from human donors who are either vaccinated or convalescent for a particular disease. This approach ensures that the diversity of antibodies in our drug candidates closely mimics that of a natural immune response. 

Recombinant polyclonal antibodies are made in the laboratory versus being extracted from plasma. As such, they can be enriched or modified to create therapeutics that are more potent than what the natural immune response can provide. Produced from a single Master Cell Bank, GigaGen’s recombinant polyclonal antibodies are cost efficient and provide a streamlined regulatory process compared to a monoclonal cocktail.

  • GIGA-2339: Hepatitis B Virus (HBV) Recombinant Polyclonal Antibody Therapeutic

GigaGen is developing a recombinant polyclonal therapeutic (GIGA-2339) to treat and potentially cure chronic HBV infection. GIGA-2339 is made in the laboratory and is over 2,000 times more potent than current plasma-derived anti-HBV hyperimmune drugs. It is composed of over 1,000 antibodies against HBV surface antigens, providing better viral antigen coverage that may potentially lead to improved clearance of the virus by the body’s natural immune cells.

  • High Titer Recombinant Anti-Pathogen Polyclonal

GigaGen’s high titer polyclonal targets multiple specific pathogens, mirroring the antibody diversity found in healthy vaccinated or convalescent donors against specific common diseases. It has been engineered to have significantly higher potency than plasma-derived products that are currently used to treat patients with immunodeficiencies.

  • Anti-Botulinum Neurotoxin Recombinant Polyclonal

GigaGen was awarded a contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA), valued at up to $135.2 million, to develop a high-potency recombinant polyclonal antibody drug designed to neutralize all seven botulinum neurotoxin (BoNT) variants and a second biothreat of interest to the agency. This work builds upon a previous contract awarded by the Department of Defense for BoNT. 

GigaGen’s collaboration with BARDA demonstrates how our platform can support rapid responses to biothreats and future pandemics. 

  • Recombinant Human ATG Polyclonal

Anti-thymocyte globulin (ATG) is used with other medications to treat transplant rejection and other inflammatory diseases. GigaGen is developing a recombinant human ATG that is less immunogenic than animal plasma-derived ATG and more consistent from batch to batch. It has the potential to provide improved efficacy with a less frequent dosing regimen.

  • Anti-Rabies Recombinant Polyclonal

GigaGen is developing a high-potency recombinant polyclonal anti-rabies product, which consists of thousands of antibodies against rabies.

Careers

GigaGen is a fast-growing biopharmaceutical company with a mission to make a difference in the way life-changing medicines are discovered and developed. We’re die-hard innovators who aren’t afraid to shake things up in the name of progress. The strength and diversity of our team is paramount to our continued success. Please contact us if you’re ready to make an impact.

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