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.
Team
Our Science
GigaGen’s drug discovery platform accelerates drug discovery, quickly filling a growing pipeline of transformative antibody drugs.
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
Pipeline
GigaGen’s pre-clinical and early-stage clinical pipeline treats a broad range of life-threatening diseases.
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.
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 by depleting T regulatory cells within the tumor microenvironment. 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.
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. As such, they are ideal 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.
- Anti-Hepatitis B Virus Recombinant Polyclonal (GIGA-2339):
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.
News
Press Releases
In the News
Health and Pharma: The Recombinant Polyclonal Drug Candidate GIGA-2339 for Hepatitis B Treatment
Contagion Live: GigaGen Doses First Patient in Phase 1 Trial of GIGA-2339, a Potential Functional Cure for Chronic Hepatitis B
Clinical Trials Vanguard: Innovating Biothreat Therapies: An Interview with Head of GigaGen
Contagion Live: GigaGen’s New Contract with BARDA for Polyclonal Antibody Development
San Francisco Business Times: Peninsula biotech reels in potential $135 million contract to be first line of treatment against bioterrorism
Fierce Biotech: Grifols’ GigaGen garners up to $135M from BARDA to tackle botulinum biothreat
Clinical Trial Vanguard: Exploring The Future of HBV Treatment with GigaGen GIGA-2339
Contagion Live: HBV Antibody GIGA-2339 Cleared for Clinical Trials to Address Hepatitis B Cure Gap
Drug Target Review: Unleashing the potential of lab-grown recombinant polyclonal antibodie
Drug Discovery World: Where is the opportunity in the therapeutic antibody market?
Drug Discovery News: Recombinant polyclonal antibodies for viral diseases.
Nature Biotechnology: Can gene editing drive out HIV and hepatitis viruses from inside cells?
Contagion Live: Harnessing Recombinant Human Polyclonal Antibodies for Potential HBV Treatment, Cure.
Targeted Oncology: Novel CTLA-4 Agents Build on Immunotherapy Foundation, Aim to Improve Efficacy/Safety
BioSpace: An In-Depth Look at Innovation on Cancer Research Day
GEN: Drug Targets Identified More Discerningly
Biocentury: GigaGen aims to overcome supply limits, boost potency with recombinant convalescent sera substitute
For media inquiries, please contact us.
Publications, Scientific Posters & Presentations
Publications
Antiviral Research: Recombinant polyclonal antibody GIGA-2339 potently and pan-genotypically neutralizes hepatitis B virus
Cell Reports Methods: High-throughput specificity profiling of antibody libraries using ribosome display and microfluidics
Antiviral Research: New technologies in therapeutic antibody development: The next frontier for treating infectious diseases
The Journal of Infectious Diseases: A Potent Recombinant Polyclonal Antibody Therapeutic for Protection Against New Severe Acute Respiratory Syndrome Coronavirus 2 Variants of Concern
Journal of Clinical Immunology: Sequencing the B Cell Receptor Repertoires of Antibody-Deficient Individuals With and Without Infection Susceptibility
mAbs: Predicting antibody binders and generating synthetic antibodies using deep learning
BioRxiv: Lack of blocking activity in anti-CTLA-4 antibodies reduces toxicity, but not anti-tumor efficacy
BMC Biology: Single-cell transcriptomics reveals the effect of PD-L1/TGF-β blockade on the tumor microenvironment
Nature Biotechnology: Generation of recombinant hyperimmune globulins from diverse B-cell repertoires
mAbs: Affinity maturation of antibodies by combinatorial codon mutagenesis versus error-prone PCR
Posters & Presentations
Preliminary phase 1a/1b results of GIGA-564, a novel intratumoral Treg-depleting anti-CTLA-4 antibody, in advanced or metastatic solid tumors
American Association for Cancer Research (AACR)
San Diego, California
April 20, 2026
High-throughput antigen-by-antibody interaction screening using single-cell methods
Keystone Symposia – Antibodies as Drugs: The Art in Antibody Engineering
Breckenridge, Colorado
May 6, 2024
A Cation Exchange-High Performance Liquid Chromatography (CEX-HPLC) Method with a pH Gradient as a Fingerprint Type Identity Assay for Recombinant Polyclonal Antibody Therapeutics
Gordon Research Conference – Biopharmaceutics and Vaccine Development
Galveston, Texas
March 20, 2024
Non-clinical results and design of First-in-Human study for GIGA-564, a third-generation anti-CTLA-4 monoclonal antibody
Society for Immunotherapy of Cancer (SITC)
San Diego, California
November 6, 2023
GIGA-564, a third generation anti-CTLA-4 with minimal ability to block CTLA-4 binding to B7 ligands, has enhanced efficacy but reduced toxicity compared to ipilumumab in pre-clinical models
Society for Immunotherapy of Cancer (SITC)
Boston, Massachusetts
November 10, 2022
A recombinant, fully human ATG polyclonal antibody drug drives immune cell depletion in a model of graft-versus-host disease
International Transplantation Science Meeting
Clearwater, Florida
November 12, 2019
Accelerating Cancer Drug R&D Through Single Cell ‘Omics
Oncology Strategy Meeting West Coast USA
San Francisco, California
May 20, 2019
Recombinant Hyperimmunes for Infectious Disease
10th Annual PEGS Summit Europe
Lisbon, Portugal
November 13, 2018
Building a Deep Immuno-Oncology Portfolio in Less Than a Year
14th Annual PEGS Summit
Boston, Massachusetts
May 2, 2018
Rapid Discovery of High-Affinity, Human Antibodies Against 17 Immuno-Oncology Targets Using Molecular Genomic Screening Methods
Keystone Symposia Conference
Whistler, British Columbia
Feb. 26, 2018
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.