Advancing the Next Generation of Antibody Drugs

Our single-cell antibody discovery and development platforms recreate complete immune repertoires and find exceptional antibodies with unique properties, enabling us to advance novel mono- and polyclonal antibody drugs for a wide range of diseases.

Our Company

Headquartered in San Carlos, California, GigaGen, a subsidiary of Grifols, is advancing transformative antibody drugs for immunodeficiencies, infectious diseases, and checkpoint resistant cancers by leveraging industry-leading single-cell technologies.

GigaGen’s novel technology platforms uniquely copy and recreate the naturally diverse immune antibody responses of the human body. Our advanced science has enabled us to pioneer the creation of the first recombinant polyclonal antibody drugs to treat infectious diseases. These precisely engineered therapies are developed from human donors who show the strongest antibody response to a particular disease, making them even more potent than the typical human immune-system response.

GigaGen’s innovative technologies are also used for the discovery of novel monoclonal antibodies. Its lead oncology asset, GIGA-564, is a monoclonal antibody that targets CTLA-4, which has demonstrated improved anti-tumor efficacy and reduced toxicity in preclinical models through a unique mechanism of action.

GigaGen is leveraging its proprietary technology platforms for the continued discovery of novel recombinant polyclonal drugs and monoclonal antibodies to treat life-threatening diseases.

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Team

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Our Science

Everyone is made up of trillions of single cells, which all have unique properties. Understanding this extraordinary diversity is instrumental in identifying potential disease indicators and formulating effective treatments.

GigaGen’s platform technologies significantly increase the productivity and speed of drug discovery, quickly filling a growing pipeline of transformative antibody drugs.

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Transformative Drugs, Faster

GigaGen’s single-cell discovery and development platforms capture and recreate the wide range of antibodies found naturally in the human body after an immune response. By using a combination of advanced methods, including single-cell emulsion droplet microfluidics, genomics, and protein-library engineering, our platform enables the creation of recombinant polyclonal antibody drug candidates that mimic the body’s natural immune repertoires, as well as the most potent monoclonal antibodies the immune system has to offer. GigaGen’s singular approach also replaces conventional antibody drug discovery technologies such as hybridomas and phage display, enabling the discovery of a wide spectrum of drug candidates, including rare antibodies with potentially unique profiles.

GigaGen’s technology platforms are recognized by more than 50 patents issued in the United States and worldwide, more than 15 grants from the National Institutes of Health and the National Science Foundation, and more than 10 peer-reviewed journal articles.

Pipeline

GigaGen is using novel single-cell technologies to discover and develop antibody therapies to treat life-threatening diseases.

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Modulating the Tumor Microenvironment

Antibodies with Differentiated Anti-Tumor Mechanisms

Our single-cell technologies have enabled us to better understand immune response to tumors and discover antibody drug candidates with unique profiles against several relevant, clinically validated oncology targets.

Our lead monoclonal drug candidate, GIGA-564, binds the key oncology protein CTLA-4. Unlike most currently available anti-CTLA-4 drugs that block CTLA-4 checkpoint activity, GIGA-564 operates via a unique mechanism of action. It specifically depletes T regulatory cells within the tumor microenvironment, which has been shown to enhance the immune system’s ability to fight cancer. This mechanism has demonstrated increased anti-tumor efficacy while limiting drug toxicities in preclinical models.

GIGA-564 is being evaluated in a Phase 1 trial for the treatment of individuals with 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.

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Recombinant Polyclonal Drugs

The World’s First Recombinant Polyclonal Drugs

GigaGen is advancing the first recombinant polyclonal antibody therapies for immunodeficiencies, infectious diseases and transplant rejection, disorders that are currently treated with polyclonal antibody therapies derived from human or animal plasma. Polyclonal antibody therapies contain a diverse array of antibodies. As such, they are ideal for diseases that comprise many targets, such as viruses that are best neutralized by antibodies binding to multiple epitopes.

Our technology 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 hyperimmunes 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.

  • Anti-Hepatitis B Virus Recombinant Hyperimmune (GIGA-2339):

Hepatitis B virus (HBV) is an infection that affects more than 1 million people in the U.S. and over 350 million people worldwide. It can cause liver damage, cirrhosis and hepatocellular carcinoma (cancer of the liver). In many cases, initial HBV infection (called acute infection) resolves itself without treatment. However, in some cases the disease progresses to chronic infection. Although there is currently no cure for chronic infection, anti-HBV drugs can halt viral replication or delay progression to liver damage and cancer. Yet, these must be taken daily for life and have side effects. Even with viral suppressive treatment, the disease progresses into hepatocellular carcinoma in 20% of cases.

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.

  • IVIG + High Titer Recombinant Anti-Pathogen Hyperimmune:

Immunodeficiencies are characterized by the body’s inability to properly make antibodies, which are required to fight infections. People without a fully functioning immune system are susceptible to recurrent and severe infections caused by viruses and bacteria that healthy people would normally – and naturally – fight off. Patients with immunodeficiencies are treated with intravenous immunoglobulin (IVIG), an antibody product derived from the plasma of thousands of human donors.

GigaGen’s recombinant IVIG mirrors the antibody diversity found in healthy vaccinated or convalescent donors against specific common diseases, though it has been engineered to have significantly higher potency than plasma-derived products.

  • Recombinant Human ATG:

Anti-thymocyte globulin (ATG) is used with other medications to treat transplant rejection and other inflammatory diseases. ATG is a polyclonal antibody typically obtained from plasma of rabbits or horses immunized with human lymphocytes. Since this drug is derived from animals, it can induce anti-drug antibody responses limiting its effectiveness, and it has the potential to cause allergic reactions.

GigaGen is developing a recombinant human ATG that is less immunogenic than animal-derived ATG and more consistent from batch to batch. It has the potential to provide improved efficacy with a less frequent dosing regimen for some indications.

  • Anti-Rabies Recombinant Hyperimmune:

Rabies is a deadly virus transmitted to people from the bite of an infected animal. Disease can be prevented by immediate post exposure prophylaxis (PEP), which consists of rabies vaccination and treatment with plasma-derived human rabies immunoglobulin (HRIg).

Rabies is a worldwide health problem. Every year, more than 29 million people receive rabies PEP. Unfortunately, there are still tens of thousands of deaths annually from those who don’t receive the treatment. For this reason, rabies is considered a Neglected Tropical Disease and an active area of focus for the World Health Organization.

Currently, HRIg is manufactured from human plasma. GigaGen is developing a high-potency recombinant anti-rabies hyperimmune, which consists of thousands of antibodies against rabies.

  • An Example for Rapid Response to Emerging Pathogens – Anti-Botulinum Toxin Recombinant Polyclonal Hyperimmune:

Botulism is a rare bacterial infection that can be fatal in babies. The disease has historically been treated with a human plasma-based hyperimmune. However, manufacturing this drug is challenging, resulting in limited production.

GigaGen was awarded a contract from the U.S. Department of Defense to develop a high-potency recombinant polyclonal antibody drug designed to neutralize botulinum neurotoxins A and B. This work is as an example of GigaGen’s potential platform applicability for the rapid development of recombinant polyclonal antibody drugs against high-priority emerging pathogens and toxins.

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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