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.
In March, the GigaGen team took blood from 50 people in Louisiana who had either tested positive for COVID-19 or shown symptoms of the disease. They selected 16 samples with high levels of disease-fighting antibodies, and from there built 8 libraries, each of which contained between 54,986 and 156,592 different antibodies, according to the study (PDF).
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After screening the libraries, the researchers created GIGA-2050, which GigaGen refers to as a recombinant anti-coronavirus 19 hyperimmune gammaglobulin (rCIG). The drug candidate comprises 12,500 of the most potent COVID-19 antibodies. In addition to showing activity against SARS-CoV-2, the compound also bound to variants of the coronavirus, including SARS-CoV, which caused an outbreak in the early 2000s, GigaGen reported.
“We completed this entire process, from delivery of the first donor sample to lab-scale generation of the rCIG protein product, in less than three months,” the researchers wrote in the study.
GigaGen expects to start clinical trials of GIGA-2050 in COVID-19 patients early next year.
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GigaGen was founded in 2010 and is developing antibody treatments for cancer, primary immune deficiency and other diseases. It has a partnership with Spain-based Grifols to discover new treatments for infectious diseases. In July, Grifols invested $35 million for a 44% stake in GigaGen, plus $15 million for a licensing deal (PDF).
GigaGen will have plenty of competition in the COVID-19 antibody race, most notably from Regeneron, which is already in human trials of a cocktail of anti-COVID antibodies for both treating and preventing the disease. Other companies in the antibody race include Amgen, AstraZeneca, GlaxoSmithKline and Eli Lilly.
GigaGen CEO David Johnson, Ph.D., said in March he believed the company’s approach would prove to be highly scalable and would yield polyclonal therapies that “are consistent from batch to batch, enabling a controlled dosing protocol.”
That said, GigaGen’s scientists are concerned that the public health system is unprepared to support the advanced technologies that have been born during this pandemic. “Though we demonstrated that our technology could be used to generate a pandemic response very quickly, there needs to be further investment by public health authorities to build out emergency GMP production facilities to quickly generate clinical material during a pandemic,” the authors wrote.