GigaGen Awarded Contract by U.S. Department of Defense to Discover Synthetic Human Antibody Treatments for High-Priority Toxins and Pathogens

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GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today it has entered into a contract with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to demonstrate the utility of its first-in-class recombinant human polyclonal antibody discovery platform against biological threats of interest to the DOD.

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GigaGen Publishes Research Showcasing First-Ever Clinical GMP Manufacturing and IND-Enabling Studies for its New Class of Drugs, Recombinant Polyclonal Antibodies

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GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today the publication of a research article titled, “GMP manufacturing and IND-enabling studies of a recombinant hyperimmune globulin targeting SARS-CoV-2,” in the international, peer-reviewed journal Pathogens. This work showcases for the first time the GMP (good manufacturing practice) manufacturing and IND (Investigational New Drug)-enabling studies of its new class of drugs, recombinant polyclonal antibodies, describing the company’s recombinant polyclonal product that targets SARS-CoV-2, GIGA-2050.

GIGA-2050 is comprised of more than 12,000 antibodies but produced from a single master cell bank (MCB). Prior to GIGA-2050, manufacturing methods for much smaller mixtures of recombinant antibodies often involved the creation of separate MCBs for each monoclonal antibody, followed by mixing the MCBs prior to manufacturing. GIGA-2050 material produced at scales ranging from 3L to 250L had high product quality and consistent yield and potency. Through in vivo studies, GIGA-2050 was shown to be safe and protective against SARS-CoV-2 infection.

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GigaGen Publishes Research Demonstrating the Potential of its Machine Learning Platform to Improve Antibody Drug Discovery and Development

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GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today the publication of a research article titled, “Predicting antibody binders and generating synthetic antibodies using deep learning,” in the peer-reviewed journal mAbs.

The article demonstrates the potential of GigaGen’s machine learning platform to improve the discovery and development of therapeutic antibodies. GigaGen’s machine learning models predict and generate sequences of antibodies that best bind to specific targets and can be used to later generate novel recombinant antibodies against those targets for potential therapeutic application.

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GigaGen Licenses ProteoNic’s 2G UNic Technology Platform for High Yield Production of GigaGen’s Mono- and Polyclonal Antibody Drug Candidates

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GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, and a subsidiary of Grifols, announced today that it has signed a license agreement with Dutch biotech ProteoNic B.V. for the use of its premium 2G UnicTM technology platform to enable high-yield production of GigaGen’s mono- and polyclonal antibody drug candidates.

 

Under the agreement, GigaGen gains non-exclusive, worldwide commercial rights for application of ProteoNic’s technology platform for the development and manufacturing of GigaGen’s recombinant antibody drugs.

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BioSpace: An In-Depth Look at Innovation on Cancer Research Day

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September 24 is World Cancer Research Day, a time for patients, caregivers and companies on the forefront of cancer R&D to look back and look ahead. From cancer immunotherapy to precision medicine and the discovery of novel targets and mutations, there is much hope on the horizon, and BioSpace spoke with a few of the people leading this innovative research.

GigaGen

Entrenched in sunny Biotech Bay, GigaGen is leveraging its single-cell technology, Surge, to capture and recreate complete antibody repertoires to discover new targets and novel, rare monoclonal antibodies with unique anti-cancer profiles.

“The method that we have allows us to go really deep into discovery of novel antibodies,” said GigaGen Co-founder and Chief Executive Officer Dr. David S. Johnson.

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GigaGen Doses First Patient in Phase 1 Trial of Recombinant Hyperimmune Polyclonal Antibody GIGA-2050 for COVID-19

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SOUTH SAN FRANCISCO, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) — GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, and a subsidiary of Grifols, announced today the first patient has been dosed in its Phase 1 clinical trial of GIGA-2050, the company’s recombinant hyperimmune polyclonal antibody drug designed to provide passive immunity to COVID-19 patients.

GIGA-2050 is comprised of more than 12,000 antibodies demonstrating strong neutralizing activity against natural SARS CoV-2 variants in laboratory studies, including the delta variant and other variants that have emerged globally since the beginning of the pandemic. GIGA-2050 encompasses the full diversity of anti-coronavirus antibodies captured from the convalescent serum of 16 exceptional responders to COVID-19.

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GigaGen Publishes Research Describing Novel Mechanism of Action and Therapeutic Potential of its anti-CTLA-4 Drug Candidate, GIGA-564

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SOUTH SAN FRANCISCO, Calif., July 14, 2021 (GLOBE NEWSWIRE) — GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, and a subsidiary of Grifols, announced today publication of research in bioRxiv entitled, “Lack of blocking activity in anti-CTLA-4 antibodies reduces toxicity, but not anti-tumor efficacy.” The publication describes the novel mechanism of action of its anti-CTLA-4 drug candidate, GIGA-564, selected due to its reduced checkpoint inhibition, which resulted in superior anti-tumor activity and lower toxicity in murine models compared to commercially available anti-CTLA-4 drugs.

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GigaGen Publishes Research Describing Potential New Avenues to Overcome Resistance to anti-PD-L1 Therapies

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SOUTH SAN FRANCISCO, May 25, 2021 (GLOBE NEWSWIRE) — GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, and a subsidiary of Grifols, announced today publication of research, titled, “Single cell transcriptomics reveals the effect of PD-L1/TGF-β blockade on the tumor microenvironment,” in the peer-reviewed journal BMC Biology. The preclinical data describes potential new avenues to overcome resistance to anti-PD-L1 therapies.

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GigaGen Publishes Research on Company’s Recombinant Hyperimmunes in Nature Biotechnology

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SOUTH SAN FRANCISCO, Calif., April 15, 2021 (GLOBE NEWSWIRE) — GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, and a subsidiary of Grifols, announced today publication of research, titled, “Generation of recombinant hyperimmune globulins from diverse B cell repertoires,” in the peer-reviewed journal Nature Biotechnology. The data describes GigaGen’s proprietary technology for the production of a new class of antibody drug, “recombinant hyperimmune globulins,” which include its novel COVID-19 therapy, GIGA-2050. This program recently received an Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial. A previous version of the data was made available through bioRxiv.

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