Is this why President Trump Recovered so Quickly?
In 1900, Nobel Laureate Emil von Behring demonstrated antibodies in blood plasma, or serum, could be transferred from one person or animal to another person, conferring immunity against an infectious agent-as illustrated in his work with horses to cure and prevent diphtheria. (1)
With advances in technology, medicine has transitioned from using convalescent serum to fully human recombinant antibodies. (2) Such technologies are now capable of creating animal models of human disease, using genetically modified, or “humanized”, mice that produce fully-human antibodies—as in the case of the proprietary VelociSuite® technologies by Regeneron Pharmaceuticals (3). Regeneron Pharmaceuticals, a leading biotechnology company, is accelerating and improving traditional drug development processes through such technologies, as evidenced by their latest artificial “antibody cocktail” treatment for COVID-19—REGN-COV2.
REGN-COV2’s development is a testament to Regeneron’s expeditious drug discovery model, having started research efforts in the beginning of February and moving into production at the start of June. Regeneron’s antibody “cocktail” was developed using parallel efforts: deriving antibodies from both genetically humanized mice as well as B cells sourced from convalescent patients.
This methodology enabled researchers to collect a swath of fully human antibodies with diverse sequences, binding properties, and antiviral activities (2).
Recombinant fully human antibodies were then surveyed for high degrees of potency and cross-referenced against similarly performing antibodies from human COVID-19 survivors (4). Researchers then aimed to select a set of antibodies that bound to discrete, non-overlapping portions of the Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein—a selection process that protects against a virus’ proclivity for mutational escape (4). This tactic was successfully employed during the development of treatments for Ebola, so it had promising applications for the SARS-CoV-2 pandemic (2).
On September 29th, 2020 Regeneron announced its first data from a descriptive analysis from a concurrent Phase 1/2/3 clinical trial that showed a reduction in viral loads, time to alleviate symptoms (non-hospitalized), and medical visits (6).
On October 1st, 2020, President Donald J. Trump contracted COVID-19, and that same day received a single 8 gram dose of the REGN-COV2 under the FDA’s Expanded Access, or “Compassionate Use”, authorization. This is a pathway for a patient to receive an investigational medical product outside of clinical trials when no satisfactory alternatives are available (7). In addition to the Regeneron Antibodies, President Trump also received doses of zinc, vitamin D, famotidine, dexamethazone, Remdesivir, melatonin and a daily aspirin tablet.
President Trump’s expeditious recovery has largely in part been attributed to REGN-COV2, which the President has routinely touted as an “unbelievable” drug and a “cure” (8). Under the Trump administration’s Operation Warp Speed, Regeneron was awarded $450 million in federal funding to accelerate the manufacturing and distribution of REGN-COV2. Following President Trump’s illness, Regeneron submitted an Emergency Use Authorization application to the FDA to accelerate its availability. If approved, the Trump Administration has agreed to make the therapeutic available to the American people at no cost and be responsible for its distribution (4).
Clinical data is continuing to be released as part of its ongoing investigational study. Read the latest efficacy study here: https://investor.regeneron.com/news-releases/news-release-details/regenerons-covid-19-outpatient-trial-prospectively-demonstrates
Regeneron’s method of drug development is so well established, that it reflects in their mission statement: “To use the power of science to bring new medicines to patients … over and over again.”
HOW ANTIBODIES WORK AGAINST SARS-COV-2