Originally established to study influenza, a partnership between the National Institute of Allergy and Infectious Diseases (NIAID) and biotechnology company AbCellera quickly pivoted to become a major player in the development of antibody-based COVID-19 therapies.
One of those therapies, bamlanivimab, has been authorized to treat patients with mild to moderate COVID-19 symptoms who are at risk for more severe disease, when combined with another antibody.
NIAID and AbCellera first joined forces in 2018, through a Research Collaboration Agreement (RCA) negotiated by NIAID’s Technology Transfer and Intellectual Property Office (TTIPO) aimed at identifying and characterizing antibodies against the influenza virus. The relationship evolved to encompass methods for studying coronavirus antibodies, as well as developing coronavirus monoclonal antibodies that could be used for prevention or treatment.
This partnership, along with the coronavirus research it supported, paid huge dividends when the COVID-19 pandemic emerged just a few years later.
Like other coronaviruses, SARS-CoV-2, which causes COVID-19, is spherical and has proteins called spikes protruding from its surface. These spike proteins latch onto human cells and undergo a structural change that allows the viral membrane to fuse with the cell membrane. The resulting viral infection ultimately leads to COVID-19.
The pivotal collaboration used an engineered version of the SARS-CoV-2 spike protein as “bait” to search for antibody-producing cells (B-cells) that target this viral protein. This step was crucial, because live SARS-CoV-2 or isolated “natural” SARS-CoV-2 spike protein cannot be used effectively to identify and isolate neutralizing antibodies.
Work done by NIAID and partners, beginning in January 2020, contributed to a February 2021 Emergency Use Authorization for bamlanivimab in combination with another antibody to treat mild to moderate COVID-19.
NIAID scientists engineered the spike protein based on their previous work with other types of coronaviruses. AbCellera then used its proprietary high-throughput, machine-based process — developed as part of the Defense Advanced Research Projects Agency’s Pandemic Prevention Platform — to find the most potent antibodies among millions of antibody-producing cells from a patient who had recovered from COVID-19 infection.
NIAID exclusively licensed the intellectual property covering these antibodies to AbCellera to expedite development of antibodies for treatment and prevention. AbCellera further partnered with Eli Lilly, which had the capacity and resources to develop a therapeutic antibody to SARS-CoV-2.
One such antibody, bamlanivimab, was developed by NIAID and collaborators on an accelerated timetable beginning in January 2020, including a “first in human” trial initiated in June 2020. Preliminary clinical evidence led the Food and Drug Administration (FDA) to grant an Emergency Use Authorization (EUA) in February 2021 for bamlanivimab in combination with another antibody to treat mild to moderate COVID-19 symptoms in patients at risk of developing severe symptoms or death.
It remains unclear if significant vaccine hesitancy will persist in the population, which could lead to many more COVID-19 cases. For many patients, monoclonal antibodies like bamlanivimab offer one of the best therapeutic options to keep mild or moderate COVID-19 from becoming severe.
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