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Biotech Innovations
July 14, 2020

COVID-19 Antibody Trials Have Begun

JAMA. 2020;324(2):128. doi:10.1001/jama.2020.11582

Potential antibody treatments for coronavirus disease 2019 (COVID-19) are being tested in early trials, companies recently announced.

Pharmaceutical giant Lilly, in collaboration with Vancouver-based AbCellera Biologics, disclosed on June 1 that the first patients had been dosed in a phase 1 trial. A week later, Lilly and Chinese partner Junshi Biosciences announced a phase 1 study of another investigational antibody treatment, JS016. Regeneron’s dual-antibody cocktail, REGN-COV2, entered trials during the second week of June.

Lilly’s first investigational drug, LY-CoV555, is an intravenously administered neutralizing IgG monoclonal antibody directed against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. Researchers at AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases identified the antibody produced by immune cells in a blood sample taken from an early patient who recovered from COVID-19.

The double-blind trial will test safety and tolerability over 2 months. An estimated 40 adult patients diagnosed with COVID-19 within the previous 3 days who do not require mechanical ventilation will be randomized to receive LY-CoV555 or a placebo. The first patients were dosed at the New York University Grossman School of Medicine and Cedars-Sinai in Los Angeles.

If the experimental treatment is found to be safe, a phase 2 trial will test it among nonhospitalized patients. Lilly also expects to study the antibody as a preventive approach for people who cannot receive vaccines. It’s already being manufactured at large scale, “with the goal of having several hundred thousand doses available by the end of the year,” Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer, said in a statement.