Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today confirmed that, as announced by the White House Press Secretary, Regeneron provided a single 8 gram dose of REGNCOV2, a cocktail of two monoclonal antibodies, for use by President Trump. REGN-COV2 is an investigational COVID-19 therapy, which was provided in response to an Individual Patient Investigational New Drug (IND) application (commonly known as ‘compassionate use’ request) from the President’s physicians.
Regeneron has a compassionate use program with certain established criteria and review committee. As a matter of policy, the company does not disclose whether any individual has or has not submitted a request for compassionate use without their consent or prior disclosure.
The company’s current priority is to maintain a sufficient supply of REGN-COV2 in order to conduct rigorous clinical trials that fully evaluate its safety and efficacy. In addition to the clinical trial supply and product being manufactured under an agreement with the U.S. government, there is limited product available for compassionate use requests that have been approved under rare, exceptional circumstances on a case-by-case basis. Requests for compassionate use must be initiated by a treating physician.
REGN-COV2 is being evaluated for both the treatment and prevention of COVID-19. Clinical trials are actively enrolling hospitalized and non-hospitalized patients, as well as people at risk of infection who have had close household exposure to a COVID-19 patient. Earlier this week, Regeneron announced early data showing a reduction in viral levels and improved symptoms with REGN-COV2 treatment in non-hospitalized COVID-19 patients.
Individuals interested in participating in one of Regeneron’s COVID-19 clinical trials may complete a brief online screener at ClinLife.com/COVID to see if they qualify. More than 2,000 people have been enrolled across the overall REGN-COV2 development program to date, and no unexpected safety findings have been reported by the Independent Data Monitoring Committee.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in 2/3 Science. Preclinical studies have shown that REGN-COV2 reduced the amount of virus and associated damage in the lungs of non-human primates.
REGN-COV2's development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C. Regeneron has recently partnered with Roche to increase the global supply of REGN-COV2. If REGNCOV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents lifetransforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune®, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.