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Trial Set for Covid-19 Antibodies in Long-Term Care

Mobile lab team

Mobile lab team with its converted RV-research unit (Eli Lilly and Co.)

3 Aug. 2020. Two companies and NIH are beginning a clinical trial of synthetic antibodies to both treat and prevent Covid-19 infections among people in long-term care. A team from Eli Lilly and Company in Indianapolis and AbCellera Biologics Inc. in Vancouver, British Columbia, with National Institute of Allergy and Infectious Diseases or NIAID, part of National Institutes of Health, plan to use mobile research units to conduct the trial on site at skilled nursing and assisted-living homes.

The trial aims to test Eli Lilly’s and AbCellera’s experimental synthetic antibody code-named LY-CoV555 in a population particularly hard hit by the Covid-19 pandemic. According to Centers for Medicare and Medicaid Services, 40,273 deaths from Covid-19 occurred at nursing homes in the U.S. as of 19 July, about 30 percent of the nearly 133,000 deaths tabulated by Covid Tracking Project by that date.

AbCellera uses what it calls deep mining of B-cells from the immune system to discover antibodies for preventing and treating diseases caused by a range of viruses and bacteria. B-cells are white blood cells in the immune system that produce antibodies, proteins that directly attack invading pathogens, such as bacteria and parasites. The company’s antibody discovery process combines a number of technologies, beginning with single-cell screening with microfluidics, or lab-on-a-chip devices. AbCellera also uses advanced bioinformatics for further analysis and high-throughput characterization to express hundreds of even rare antibodies.

In March, Lilly and AbCellera agreed to co-develop synthetic antibodies that neutralize the proteins on the SARS-CoV-2 coronavirus spike that enter cells and begin the infection process. For the collaboration, AbCellera adapted its discovery process from a project begun in 2018 for U.S. Defense Advanced Research Projects Agency, or DARPA, to devise a rapid system for countermeasures against medical emergencies, including pandemics. AbCellera says it so far screened nearly 62 million patient samples that yielded some 2,000 unique antibodies that bind to SARS-CoV-2 viruses.

“Six months ago, the world knew very little about this virus,” says Ester Falconer, who heads R&D at AbCellera in a company statement. “The data we are continually generating will be absolutely critical to bringing solutions to the pandemic.”

As reported by Science & Enterprise in June, the two companies and Vaccine Research Center at NIAID, tested LY-CoV555 among hospitalized Covid-19 patients in an early-stage clinical trial, and since then began a mid-stage trial testing LY-CoV555 against a placebo with 400 Covid-19 patients having mild to moderate symptoms. The new late-stage trial is enrolling 2,400 participants among residents and staff at late-term care facilities, evaluating LY-CoV555 as a treatment for Covid-19 infections, but also a preventive drug. The study team aims to test participants for infections four weeks after a single dose of LY-CoV555, then four weeks later for symptoms and complications.

To reduce burdens on participating long-term care facilities, Lilly is turning recreational vehicles into mobile research labs. The custom-modified mobile units will serve as infusion clinics for clinical trial participants, as well as self-contained materials storage and preparation labs. The company says it plans deploy a fleet of these mobile labs for the trial.

“While it’s not easy to conduct clinical trials in this setting,” says Daniel Skovronsky, Lilly’s chief scientist in a company statement, “we’re taking on the challenge in an effort to help those who need us the most.”

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