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Trial Testing Multi-Company Covid-19 Therapy

SARS-Cov-2 virus

Scanning electron microscope image of SARS-Cov-2 virus, in orange, emerging from cells (NIAID, Flickr)

27 Jan. 2021. A clinical trial already underway is expanding to test a combination of two synthetic antibodies from different companies as a treatment for Covid-19 infections. The trial is now testing two antibodies from drug maker Eli Lilly and Co. in Indianapolis, but adding a section to test the Eli Lilly’s antibody bamlanivimab combined with a synthetic antibody code-named VIR-7831 made by Vir Biotechnology in San Francisco and drug maker GlaxoSmithKline in London.

Bamlanivimab was initially developed by biotechnology company AbCellera Biologics in Vancouver as an immunoglobulin G antibody designed to block the SARS-CoV-2 spike protein that penetrates and infects cells, and licensed by Eli Lilly in March 2020. In November 2020, the Food and Drug Administration authorized bamlanivimab for emergency use to treat out-patients testing positive for the SARS-CoV-2 virus with mild to moderate Covid-19 symptoms, but at high risk of more serious infections.

The mid-stage clinical trial was originally designed to test bamlanivimab among individuals testing positive for the SARS-CoV-2 virus responsible for Covid-19 infections, but with only mild to moderate symptoms and not hospitalized. In the trial bamlanivimab is being assessed on its own, and with a companion synthetic antibody etesevimab, against a placebo.

That study is expanding to include a test of VIR-7831 from Vir Biotechnology and GSK with bamlanivimab. Vir develops treatments for infectious diseases with a series of platforms, including synthetic antibodies that work like natural, but often rare, antibodies produced by people who recover form these conditions. The company’s antibodies are designed to neutralize pathogens or stimulate the immune system, in some cases both.

Targeting multiple regions of the spike protein

Vir says VIR-7831 is designed to both block viral entry into healthy cells and clear infected cells, and binds to a different component in the SARS-CoV-2 spike protein than bamlanivimab. In addition, says the company, VIR-7831 neutralizes SARS-CoV-2 viruses by fixing to a common antigen binding site shared with the SARS-CoV-1 virus responsible for the SARS pandemic in 2003, thus making it difficult for viral mutations to escape.

“With a virus like SARS-CoV-2,” says Daniel Skovronsky, Eli Lilly’s chief scientist in a statement, “it’s expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of Covid-19 until vaccines are widely available and utilized.”

The trial is enrolling 700 out-patient participants with mild to moderate Covid-19 symptoms at 107 sites in the U.S. The study team is looking primarily in changes in viral load of participants after seven days, as well as changes in symptoms, need for hospitalization, and chemical actions of the treatments in the body. The companies say the first dose was given today to a participant in the new section of the trial.

“As the virus continues to evolve,” adds Vir Biotechnology’s CEO George Scangos, “we, along with Lilly and GSK, share the view that we should pursue all possibilities to help end the pandemic and maximize the number of lives that can be saved.”

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