Regeneron is applying our 30 years of scientific and technology expertise to combat the COVID-19 pandemic. We feel uniquely positioned to meet this public health threat using our proprietary VelociSuite? technologies and our track record for rapid response against infectious diseases, such as Ebola.
EVALUATING ONE OF OUR EXISTING MEDICINES FOR COVID-19
Based on early clinical data from China with another IL-6 inhibitor, we are evaluating if there is a potential role for Kevzara? (sarilumab) in the treatment of hospitalized patients with COVID-19. Together with our collaborators at Sanofi, we are conducting controlled clinical trials to study Kevzara in this setting. The use of Kevzara to treat people with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.
- On April 27, we provided an update on the status of the ongoing Phase 2/3 clinical trial in the United States, as well as preliminary Phase 2 data. Click here for more information.
A Novel Anti-Viral Antibody Cocktail
We are using our end-to-end antibody technologies to develop REGN-COV2, our novel anti-viral antibody cocktail that is being studied for its potential both to prevent infection and treat people already infected with SARS-CoV-2.
Clinical trials of REGN-COV2 began in mid-June. The clinical program consists of four separate study populations: two for treatment and two for prevention of COVID-19. The first studies are evaluating safety and efficacy in hospitalized and non-hospitalized patients with COVID-19.
Clinical investigators, hospitals or clinical sites interested in joining the REGN-COV2 clinical trials should email COVID19SiteInterest@regeneron.com.
Our COVID-19-related discovery efforts started in early 2020, when we produced hundreds of virus-neutralizing antibodies in our genetically-engineered mice and isolated similarly-performing antibodies from human COVID-19 survivors. In mid-April, we moved the most potent antibodies into pre-clinical and clinical-scale cell production lines. We are scaling production to have hundreds of thousands of preventative doses or tens of thousands of treatment doses per month by the end of August. We are actively seeking ways to maximize production capacity within Regeneron and beyond.
Two manuscripts published in Science detail the discovery of REGN-COV2 and highlight its potential to protect against ‘viral escape’ of SARS-CoV-2. Viral escape was seen to occur in the setting of a single therapeutic antibody that blocks the ability of a virus to infect healthy cells, spontaneously arising mutant forms of the virus are able to ‘escape’ or evade the antibody’s blocking action. These mutants are then ‘selected’ (i.e., are able to survive and proliferate despite the single antibody treatment) and may ultimately become the dominant strain of the virus. The findings show our antibody cocktail may be able to diminish risk of viral escape by binding to the virus’s spike protein in separate, non-overlapping locations, requiring the virus to mutate simultaneously in multiple genetic locations.
From discovery to large-scale manufacturing, our VelociSuite® technologies provide unmatched precision and speed in developing targeted antibody medicines.
COVID-19 BUSINESS UPDATES
Operations:Given the ongoing nature of this pandemic, we are regularly assessing any potential impact to our business, including aspects of product supply, clinical development and commercial operations. We will share material updates as warranted.
Our team:Our first priority is to protect the health and safety of our colleagues and ensure the continuity of our business. We are monitoring the pandemic situation closely and have established a senior response committee to assess our guidance continually. Currently, it is mandatory for colleagues to work from home if their job allows it. We have taken additional precautionary measures to protect our critical laboratory and manufacturing colleagues whose jobs require they be on site. Given the “essential” nature of our work, Regeneron colleagues working in our labs and manufacturing facilities are exempt from NY State Governor Cuomo’s recent Executive Order requiring businesses to have employees work from home.
Clinical trials:Regeneron conducts clinical trials in multiple countries across the world. We are evaluating impact of the COVID-19 pandemic on an individual trial basis and expect fully-recruited clinical studies to remain generally on track. After briefly pausing new enrollment in certain studies due to the pandemic, enrollment in ongoing clinical studies is now resuming as regions relax their restrictions and health care resources become more available for non-COVID19 activities. We continue to work closely with regulators to follow recent Health Authority and Regulatory Agency issued guidances as it pertains to clinical trial operations.
Supply chain & market supply:As a matter of practice, we are always working to ensure the stability of our supply chain and maintain adequate market supply for all commercialized products. Our raw material supplies and contract manufacturing support have remained stable despite the current pandemic situation. In order to enable the U.S. manufacturing site to produce large-scale quantities of REGN-COV2, we are working with the FDA to accelerate licensing of additional commercial products manufactured at our Ireland facility.
Supporting our communities:Regeneron’s community response focuses on raising critical funds, mobilizing resources and supporting the most vulnerable nonprofits, people and communities around the world. Through Regeneron’s COVID-19 Double Matching Gift Campaign, we are supporting our employees’ giving and select charities with the goal of raising $750,000.
Locally, we are supporting Afya Foundation’s efforts to deliver critically needed medical supplies to qualified, New York-based health centers. In Rensselaer, we are supporting the Capital Region Community Foundation’s COVID-19 Response Fund, which provides flexible resources for nonprofits working with those who are disproportionately impacted. We are planning additional and expanded efforts to support people in need during this critical time and will share more details in this space.
Regeneron’s Industrial Operations and Product Supply (IOPS) team is assisting New York State by making and donating viral transport media (VTM), a critical component of COVID-19 testing kits that has been in short supply. VTM is a liquid used to preserve patient test samples (a swab from the nose or throat) until they can be tested. Regeneron worked to obtain the necessary components, determined formulas and proportions to meet NYS-specifications, and leveraged the specialized skill set of our employees to make sterile VTM and place it into test tubes. We are delivering over 500,000 total VTM kits to New York State and are donating 100 percent of our supplies and labor for this effort, an approximately $1 million in-kind contribution. Learn more.