On Saturday, November 21, two experimental therapies for the treatment of “mild to moderate” cases of Covid-19 was authorized by the US’ Food and Drug Administration. For use at the present only as investigational therapies, they are to be used in tandem and only in certain emergency situations.
However, the move is another positive one, coming on the heels of the recent announcements of highly-successful coronavirus vaccines developed by Pfizer/BioNTech, Moderna and Oxford University/AstraZeneca.
Another Greek at the Helm
And again, as with these other vaccines, a Greek is helping to create the treatments which may help save the world from the modern-day scourge f the coronavirus.
George Yancopoulos is the founding scientist and Chief Scientific Officer of Regeneron Pharmaceuticals, working alongside Founder and Chief Executive Officer Leonard Schleifer, M.D. In 2016, Yancopoulos was also named President of Regeneron.
Born in 1959 to Greek immigrants, he grew up in Woodside, New York.
Yancopoulos is the holder of more than one hundred patents and is a principal inventor and developer of Regeneron’s six FDA-approved medicines. Forbes magazine states that Yancopoulos’ financial stake in Regeneron has made him a billionaire. He is the first research and development chief in the pharmaceutical industry to become a billionaire.
In October, President Trump received a cocktail of these treatments during his brief hospitalization for Covid-19.
What Are These Revolutionary New Regeneron Treatments?
Casirivimab and imdemivab are the names for the investigational therapies developed by the firm. Although not yet officially established as treatments for Covid-19, the use of such unapproved products has been justified by the Secretary of the Department of Health and Human Services on the grounds of the existence of a public health emergency.
The two treatments are now allowed to be used exclusively in adults and pediatric patients (12 years of age and older weighing at least 40 kg) and who are at high risk for progressing to severe COVID-19 and/or hospitalization. In these cases, the FDA has issued an Emergency Use Authorization (EUA) for casirivimab and imdevimab in the treatment of Covid-19, according to a letter sent by the FDA to Regeneron on Saturday.
In a statement on the Regeneron Pharmaceuticals website, CEO Schliefer explained that
earlier this past summer, the firm had moved most of its regular commercial medicine manufacturing to their Irish facility in order to produce as much casirivimab and imdevimab as possible at the New York site.
“Even so,” he stated, “given the complexity of antibody manufacturing, the initial supply of our antibody cocktail is limited, and we expect to have only enough to treat approximately 300,000 patients within the next few months.
“The U.S. government has committed to making these doses available for free to the American people and will be responsible for allocation. They must ensure this limited supply is provided fairly to the patients who need it most,” he cautioned.
How Do They Work?
Casirivimab and imdevimab are recombinant neutralizing human IgG1 monoclonal antibodies which target the receptors of the spike protein of SARS-CoV-2. Casirivimab and imdevimab are each supplied in individual single use vials. No information is available on any special conditions, such as ultra cold storage, that are needed by the treatments — which is the case with both the Pfizer/BioNTech and Moderna vaccines.
The FDA cautioned that, when used under the conditions described in this authorization, the known and potential benefits of casirivimab and imdevimab, administered together, must outweigh what they termed “the known and potential risks of such product.”
The FDA noted that as of now, “there is no adequate, approved, and available alternative to the emergency use of casirivimab and imdevimab, administered together, for the treatment of mild to moderate COVID-19 in such patients.
The authorities also stated that the distribution of casirivimab and imdevimab will be controlled by the US Government for use consistent with the terms and conditions of this EUA.
Regeneron will supply the treatments to authorized distributors, who will distribute to healthcare facilities or healthcare providers as required.
The FDA cautioned that the two new treatments are not to be used for all Covid-19 patients, however.
Their use is contraindicated in adults or pediatric patients who are hospitalized due to COVID-19, and adults or pediatric patients who require oxygen therapy — or even adults or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 in those who are on chronic oxygen therapy due to underlying non-COVID-19-related conditions.
Additionally, the Regeneron treatments may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis.
“The Lives We Were Hoping To Save Might Be Our Own”
In his emotional letter, published on Saturday on the Regeneron website, Dr. Schliefer relates the harrowing details of the past year, as the enormous scope of the pandemic began to be realized.
“Throughout the month of February, we continued our preclinical research with urgency,” he stated, “growing increasingly concerned by the reports out of China and Europe. Our scientists would hear the latest from physicians in Italy and leave conference calls in tears. ‘We have to help these people,’ was a common refrain.
“One of the first major US outbreaks was in a Westchester County town not far from our R & D and corporate headquarters. Even before the NY State mandate from Governor Cuomo, we sent all our office-based employees home,” Schliefer recalls.
“And we considered a grave conundrum,” he continued. “We had to keep our R&D programs going, especially the COVID-19 program, while ensuring the safety of our on-site laboratory and manufacturing teams. I couldn’t bear the thought that some of the very people working to address this terrible virus could be struck by it. We quickly set ground rules that included social distancing and mandatory masks, as well as daily temperature checks and staggered work schedules.”
Who is the Greek-American Behind These Revolutionary Therapies?
After graduating as valedictorian of both the Bronx High School of Science and Columbia College, Yancopoulos received his MD and PhD degrees in 1987 from Columbia University’s College of Physicians & Surgeons. He then worked in the field of molecular immunology at Columbia University with Dr. Fred Alt, for which he received the Lucille P. Markey Scholar Award.
Yanopoulos was elected to both the National Academy of Sciences and the American Academy of Arts and Sciences in 2004. According to a study by the Institute for Scientific Information, he was the eleventh most-highly cited scientist in the world during the 1990s, and the only scientist from the biotechnology industry on the list.
Yancopoulos has cloned novel families of growth factors, including ephrins/Ephs and angiopoietins, and elucidated the basis of how many receptors work. His work has included study of how nerves regenerate and how muscles connect to nerves.
Back in 1985, along with his mentor Dr. Fred Alt, he was the first to propose making mouse models with genetically human immune systems (“Human mice”). This groundbreaking research led to Yancopoulos developing “the most valuable mouse ever made,” bred to have immune systems that respond just as a human’s would, so that it can be used for testing how the human body might react to various pharmaceuticals and other substances.
In 1989 Yancopoulos become the founding scientist and Chief Scientific Officer of Regeneron Pharmaceuticals with Founder and Chief Executive Officer Leonard Schleifer, M.D.
The Greek-American researcher plays an active role in Regeneron’s STEM (Science, Technology, Engineering and Math) Education commitments, including the Regeneron Science Talent Search, the nation’s oldest high school science and math competition.
In 2014, he led the launch of the Regeneron Genetics Center, a major initiative in human genetic research that has sequenced exomes from over 1,000,000 people as of February 2020.
Yancopoulos has been awarded Columbia University’s Stevens Triennial Prize for Research and its University Medal of Excellence for Distinguished Achievement.
In 2016, Leonard Schleifer and George Yancopoulos were named the Ernst & Young Entrepreneurs of the Year 2016 National Award Winners in life sciences.
The “George D. Yancopoulos Young Scientist Award” is given at the Westchester Science & Engineering Fair.
The FDA has issued an Emergency Use Authorization for our investigational antibody cocktail to treat mild to moderate #COVID19 in certain high-risk patients 12 years and older. Learn more: https://t.co/yNfOFPyLI0 pic.twitter.com/0QGBnddiVC
— Regeneron (@Regeneron) November 22, 2020