Clinical Research & Medicines
Moving at Pandemic Speed
August 01, 2021
Rapid Response to Infectious Diseases
We are always looking for ways to make the drug discovery process faster and more efficient, especially in scenarios like the global COVID-19 pandemic where help is desperately needed. To address emerging or rapidly spreading infectious diseases, Regeneron has applied our VelociSuite® technologies and over 30 years of scientific expertise in a “rapid response” manner that parallel tracks certain steps and speeds handoffs between groups to advance novel antibody treatments as quickly as possible. We’ve been proud to apply our homegrown technologies and novel scientific approach to public health challenges like Ebola, Middle East Respiratory Syndrome (MERS) and COVID-19.
Unfortunately, COVID-19 will not be the last pandemic or epidemic the world faces. This is why we see particular utility in evolving our core technologies, conducting deep biological research and investing in large-scale manufacturing infrastructure for antibody treatments. We are committed to doing what’s right, and we believe that applying our resources and expertise to combat dangerous pathogens is crucial to our mission of improving lives through science.
“What can we do to help?”
During the 2014 West African Ebola outbreak, our team was reading increasingly concerning reports and began asking one another, “What can we do to help?” Our eagerness to get involved led to a realization that we could, for the first time, apply our technologies to develop a novel antibody treatment for a deadly viral pathogen, and potentially help address a daunting global health challenge.
We applied our core technologies to generate potent Ebola-neutralizing antibodies at an unprecedented speed and selected a cocktail of three complementary antibodies, condensing a process that normally takes years into less than 12 months. Thankfully, the 2014-2015 Ebola outbreak ended before our investigational compound entered clinical trials, and we instead focused on preclinical and early research to confirm safety in humans. When a new outbreak began in the Democratic Republic of the Congo in 2018, we were ready. We moved quickly to have our investigational medicine made accessible through a compassionate use protocol and included it in an independently run clinical trial to test its safety and efficacy.
Data from this trial ultimately supported the U.S. Food and Drug Administration’s approval of our Ebola antibody cocktail on October 14, 2020.
FEATURED STORIES
Working Together To Provide Covid-19 Testing Components
The Regeneron IOPS team donated time and supplies to create a critical component for 500K COVID-19 testing kits, which were used this spring to fight the pandemic in New York State.
Moving at pandemic speed
When the novel coronavirus, SARS-CoV-2, began to spread globally in early 2020, our team again asked, “What can we do to help?” Building on prior experience, Regeneron scientists applied the same VelociSuite® technologies in record time. We evaluated antibodies derived from human survivors of COVID-19 as well as our proprietary humanized mouse platforms to rapidly develop a large pool of monoclonal antibody treatment candidates capable of neutralizing the virus. The team selected a highly specific, tightly binding, non-competing pair of monoclonal antibodies and began exploring the antibody cocktail's potential to be used as a medicine for prophylaxis and treatment of COVID-19. Improving on our prior infectious disease timeline, this combination was ready to enter human clinical trials just five months after the world first learned the SARS-CoV-2 viral sequence.
As part of our rapid response approach and in recognition of the tremendous global need, we simultaneously initiated clinical trials and our large-scale manufacturing process. Manufacturing biologic medicines like monoclonal antibody therapies is a time-consuming and precise process, and unfortunately biology can’t be hurried along. Despite the risks and uncertainties, we purposefully began this effort as early as possible so that we would have as many doses as possible immediately available for people around the world.
To further increase access outside of the United States, we also joined forces with Roche to manufacture and deliver our COVID-19 treatment to patients outside of the U.S., significantly increasing global supply. The companies shared a commitment to making the antibody cocktail available to COVID-19 patients around the globe and planned to support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
In November 2020, our COVID-19 antibody cocktail was granted an Emergency Use Authorization (EUA) by the FDA, the first combination therapy to receive an EUA and in record time — only 10 months after the program's inception. In January 2022, the FDA amended the EUA to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment. In November 2024, we voluntarily submitted for the full revocation of the EUA. Therefore, the treatment is not currently authorized for use in any U.S. states, territories or jurisdictions.
Viruses, by their nature, mutate over time, leading to variant forms, which means that the activity of antibody treatments may also change or diminish over time. Therefore, we continue to evaluate “next generation” COVID-19 antibodies in healthy volunteers with the intention of progressing candidates that are safe and effective against currently circulating and future variants.
Last updated: December 2024