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Covid-19 Antibody Therapy Trial Underway

SARS-Cov-2 viruses

Scanning electron microscope image showing SARS-CoV-2 viruses, in yellow. (NIAID, NIH)

1 June 2020. A clinical trial of neutralizing antibodies to treat Covid-19 infections began testing the therapy with hospitalized patients in New York and Los Angeles. The study is an early-stage test of an antibody therapy for Covid-19 developed by drug maker Eli Lilly and Company in Indianapolis and AbCellera Biologics Inc., a biotechnology company in Vancouver, British Columbia, Canada.

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.

As reported in Science & Enterprise in March, AbCellera says it screened more than 5 million immune-system cells against a blood sample from one of the first people in the U.S. infected with the novel coronavirus, as it was called at the time. From this screening, the company says it identified some 500 unique human antibody sequences that respond to the SARS-CoV-2 virus responsible for Covid-19 infections. Lilly and AbCellera partnered with the Vaccine Research Center at National Institute of of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health, to identify the best-performing candidates.

The experimental treatment, code-named LY-CoV555, is an immunoglobulin G antibody designed to block the SARS-CoV-2 spike protein that penetrates and infects cells. Lilly says it’s enrolling patients hospitalized with Covid-19 infections in the U.S., with the first doses given to participants at New York University and Cedars-Sinai medical center in Los Angeles. Participants are being randomly assigned to receive a single dose of LY-CoV555 or a placebo, with the study team evaluating the therapy’s safety, tolerability, and chemical actions in the body. The number of patients to be enrolled is not disclosed, and the trial does not appear to be registered yet at ClinicalTrials.gov.

Lilly says LY-CoV555 is the first of other neutralizing antibodies it plans to test against SARS-CoV-2 over the next several months, both on their own and in combinations. If the first LY-CoV555 trial is successful, says the company, it will next test the treatment among non-hospitalized patients. In addition, the company plans to assess LY-CoV555’s value as a vaccine.

“Antibody therapies such as LY-CoV555 may have potential for both prevention and treatment of COVID-19 and may be particularly important for groups hardest hit by the disease such as the elderly and those with compromised immune systems,” says Daniel Skovronsky, Lilly’s chief scientist in a company statement. “Later this month, we will review the results of this first human study and intend to initiate broader efficacy trials. At the same time as we are investigating safety and efficacy, we also are starting large-scale manufacturing of this potential therapy.”

Skovronsky adds that Lilly aims “having several hundred thousand doses available by the end of the year,” if LY-CoV555 shows promise as a Covid-19 treatment.

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