GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, announced today publication of a peer-reviewed article titled, “Affinity maturation of antibodies by combinatorial codon mutagenesis versus error-prone PCR,” in the peer-reviewed journal mAbs. The publication is available online here.

 

GigaGen’s newly published data details the technical foundation of its approach for the affinity maturation of monoclonal antibodies discovered via its leading single-cell microfluidic technology platform, Surge. Affinity maturation is commonly used for antibody optimization when developing new drugs. The company is leveraging this technology platform for the development of monoclonal antibodies with unique binding and affinity profiles against selected oncology targets.

 

David Johnson, Ph.D., MBA, co-founder and chief executive officer of GigaGen, commented, “Often, antibodies need to be further engineered through ‘affinity maturation’ to achieve the appropriate affinities and kinetics that translate into in vivo efficacy. While this process can be important for antibody drug development, there are no universally accepted protocols for efficient and high-performance antibody affinity maturation. Our study is one of the most thorough evaluations of affinity maturation methods ever published. We have used knowledge from our work to develop novel antibody therapeutics with unique profiles against selected oncology targets, such as CTLA-4, with the potential to result in enhanced efficacy and safety profiles versus current antibody drug alternatives.”

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SOUTH SAN FRANCISCO, Calif., Sept. 09, 2020 (GLOBE NEWSWIRE) — GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, announced today the company has initiated large-scale manufacturing of its first-in-class recombinant hyperimmune drug for COVID-19, GIGA-2050, in collaboration with two partners for Good Manufacturing Practice (GMP), Waisman Biomanufacturing and Goodwin Biotechnology, Inc.

Large scale production of GIGA-2050 will support an Investigational New Drug application (IND) and Phase 1 studies in COVID-19 patients. The GMP product will be subjected to nonclinical GLP toxicology and pharmacokinetics studies in fall 2020 and the company expects to reach the clinic in early 2021.

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Convalescent therapy has been touted as a fast, effective response to COVID-19, but a new therapy by GigaGen Inc. could be even more promising. GIGA-2050, a new class of drug called a recombinant hyperimmune, offers 100-fold higher potency than convalescent serum therapy.

“GIGA-2050 is a mix of 12,500 different antibody sequences selected from 16 exceptional responders to COVID-19. There’s never been anything like that before,” GigaGen CEO and co-founder David Johnson, Ph.D., told BioSpace. “We’re establishing a completely new type of drug.”

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Blood collected from survivors of COVID-19 has been used to identify antibodies against the disease, which have been turned into experimental drugs to fight it. But it’s not an easy process. So back in March, San Francisco startup GigaGen decided to test a technology it developed to rapidly identify disease-fighting antibodies against SARS-CoV-2, the virus at the heart of the pandemic, and turn them into a drug to fight the disease.

Now the company says it has early evidence that the approach has yielded a promising drug candidate, GIGA-2050. When tested against the SARS-CoV-2 live virus, GIGA-2050 was 100 times more protective than plasma from survivors, they reported on the journal preprint site bioRxiv.

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“One of the reasons we perform single-cell approaches is they allow us to pick up subtle differences that would be missed with more conventional tools,” says David S. Johnson, PhD, CEO and co-founder of GigaGen, a company that specializes in microfluidics and molecular genomics. Two GigaGen platforms, Surge and Magnify, can facilitate the development of polyclonal antibody therapies for transplant rejection, infectious diseases, and immunodeficiency disorders. The platforms can also help identify monoclonal antibody leads for checkpoint-resistant cancers.

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GigaGen is developing polyclonal antibodies for COVID-19 and other infectious diseases that could be more potent and easier to supply than convalescent plasma.

GigaGen Inc. plans to submit an IND for its COVID-19 treatment, GIGA-2050, by year-end.

It calls GIGA-2050 a recombinant hyperimmune product, and said it is akin to recombinant convalescent sera.

GigaGen showed Monday in a bioRxiv publication that GIGA-2050 was 100 times more potent than convalescent sera. The company made the comparison using a microneutralization assay that measured the minimum antibody concentrations needed to prevent cytopathic effects induced by live SARS-CoV-2.

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A South San Francisco biotech firm has come up with a way to make a COVID-19 therapy without relying on repeat antibody donors using a new class of drugs called “recombinant hyperimmunes.” Ken Bastida reports. (8-10-20)

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SOUTH SAN FRANCISCO, Calif., July 29, 2020 (GLOBE NEWSWIRE) — GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, today announced that it will participate in the LifeSci Partners Private Company Virtual Summer Symposium, taking place on August 4-5, 2020.

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SOUTH SAN FRANCISCO, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) — GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, announced today a new submission to bioRxiv, titled, “Capturing and Recreating Diverse Antibody Repertoires as Multivalent Recombinant Polyclonal Antibody Drugs.” In this study, GigaGen presents a novel technology for producing a new class of drug, which it calls “recombinant hyperimmunes.”

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Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

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