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Wednesday, August 12, 2020

Aug. 10 Press Release, National Institute of Allergy and Infectious Diseases

On Monday, August 10, the NIH announced that they are looking for volunteers to test two monoclonal antibodies that are about to enter phase-three clinical trials for COVID-19 prevention. (1) With this new application so close, it’s a good time to take a look at the history of monoclonal antibodies and how they might be used in the management of COVID-19.

Earlier, I described antibodies as a type of protein called an immunoglobulin produced by B cells, a component of the immune system (https://historysedge.wordpress.com/2020/05/15/pandemic-journal-day-65/). Antibodies are configured to bind a specific antigen, usually a protein. Currently, convalescent plasma containing antibodies against the virus, donated by people who have had COVID-19, is used to treat patients under the FDA COVID-19 Expanded Access Program.(2)

Nobel laureates, 1984

While donated plasma varies naturally in composition and concentration of antibodies, cloned antibodies, produced in a lab, can be used to make standardized doses of a particular antibody for use in treatment. The technology itself has seen many refinements since 1975 when Cesar Milstein and Georges J. F. Kohler first figured out how to make cells produce identical antibodies in the Laboratory of Molecular Biology in England. Ten years later they shared the 1984 Nobel Prize in Physiology or Medicine with Niels K. Jerne “for theories concerning the specificity in development and control of the immune system and the discovery of the principle for production of monoclonal antibodies.” (3)

At first monoclonal antibodies or mAbs were used to detect proteins in diagnostic testing, such as in those home pregnancy tests that change color when a specific antibody binds to the hormone human chorionic gonadotrophin (hCG), indicating pregnancy. By 1986 the FDA had approved the first mAb therapeutic drug to help protect kidney transplant patients from rejection. (4)

Today FDA-approved specific monoclonal antibodies are used for a variety of therapeutic applications in areas such as cancer, chronic inflammatory diseases, and cardiovascular diseases. Some of them are being tested for related use in COVID-19, such as Tocilizumab, an anti-inflammatory drug used in rheumatoid arthritis. (For international standardization, the pharmaceutical names of monoclonal antibodies end in -mab.) (5)

Both new and existing monoclonal antibodies are currently under development or in trials for treatment or prevention of COVID-19. Here are a few ways they might be used, as shown by a quick online survey of pharmaceutical companies.

  1. Short-term (a month or two) prevention of COVID in people at risk or exposed.
  2. Direct treatment of patients with COVID.
  3. Reducing the cytokine storm and organ damage.

This week the NIH announced that they are testing two mAbs in cooperation with Regeneron and Eli Lily. The upcoming phase-three clinical trials will test the ability of monoclonal antibodies to protect people who are in close contact with COVID patients, such as professional caregivers or people living in the same household. One test is for efficacy over a 4-week period and the other is for an 8-week period.

According to NIAID Director Dr. Anthony Fauci, we may have results by early fall. (6)

Related Headlines

(6) “Fauci expects results from clinical trial for COVID treatment by fall,” Los Angeles Times, July 17, 2020. https://www.latimes.com/world-nation/story/2020-07-17/fauci-expects-results-from-clinical-trial-for-covid-treatment-by-fall

“Companies test antibody drugs to treat, prevent COVID-19,” by Marilynn Marchione, AP, August 11, 2020. https://apnews.com/c37c678dbe18cd500e4cae916b44205a

“Rheumatoid arthritis drug tied to fewer deaths in COVID patients,” CIDRAP, July 13, 2020. https://www.cidrap.umn.edu/news-perspective/2020/07/rheumatoid-arthritis-drug-tied-fewer-deaths-covid-patients

“COVID-19 treatment: What are monoclonal antibodies and how do they work against novel coronavirus?” Times Now News, August 10, 2020. https://www.timesnownews.com/health/article/covid-19-treatment-what-are-monoclonal-antibodies-and-how-do-they-work-against-novel-coronavirus/634406

Sources for Today’s Topic

(1) “Clinical Trials of Monoclonal Antibodies to Prevent COVID-19 Now Enrolling,” NIH, August 10, 2020. https://www.niaid.nih.gov/news-events/clinical-trials-monoclonal-antibodies-prevent-covid-19-now-enrolling

(2) “COVID-19 expanded access program: Plasma donors needed for treatment protocol,” FDA, August 7, 2020. https://www.uscovidplasma.org/#why

(3) “The Nobel Prize in Physiology or Medicine 1984,” https://www.nobelprize.org/prizes/medicine/1984/summary/

(4) “The Antibody Initiative: monoclonal antibodies, National Museum of American History, Smithsonian,” https://americanhistory.si.edu/collections/object-groups/antibody-initiative/monoclonal

(5)”Revised monoclonal antibody (mAb) nomenclature scheme,” WHO, Geneva, May 26, 2020. https://www.who.int/medicines/services/inn/Revised_mAb_nomenclature_scheme.pdf?ua

“The history of monoclonal antibody development – Progress, remaining challenges and future innovations,” Justin K. H. Liu Ann Med Surg (Lond). 2014 Dec; 3(4): 113–116. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4284445/

Why am I doing this?

The coronavirus pandemic will be indelibly written on our memories just as the Great Depression or the Battle of Britain left their mark on past generations. It is my intention to journal the events of these days from three perspectives: as a retired medical technologist, a historian (Ph.D., 2014), and an ordinary person living through an extraordinary crisis.

You are on History’s Edge.

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