Clinical Research & Medicines
The Regeneron Journey: 2020 Edition
November 21, 2020
Following an Emergency Use Authorization for casirivimab and imdevimab, Len Schleifer, MD, PhD, Founder and CEO, reflects on what the Regeneron team has accomplished so far in 2020.
By: Len Schleifer, MD, PhD, President and Chief Executive Officer
I remember exactly the moment it hit me. I was watching the news in January with Harriet, my wife of 45 years, and we saw images from Wuhan, China of hospitals being erected virtually overnight. I remember thinking, “It’s the big one. The respiratory virus we’ve all been worried about.” I texted George Yancopoulos, my partner at Regeneron for 30 years, and the scientists who lead our early infectious disease work, and, as usual, they were ahead of me. They told me we had already started working on the “novel coronavirus.” Given our recent success with Ebola, the team knew that our unique antibody technology could again be leveraged to have a positive impact. At the very least, we had to try.
This initial thinking eventually turned into our promising investigational antibody cocktail, casirivimab and imdevimab. The last 10 months have been sadly, utterly devastating for many families around the world. It has also been a long and uniquely challenging journey for the Regeneron team. But there have also been moments of great joy and pride for our company, as we began to see evidence our COVID-19 program could help people in need.
EUA is one marker on an ongoing journey
This week, our investigational antibody cocktail was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) after a thorough review of the data available to date. The EUA allows certain patients in need to access this promising investigational therapy, but I want to be clear that much of the work still lies in front of us. We must complete our well-controlled clinical studies as quickly as possible in order to provide conclusive answers on the full safety and efficacy profile of casirivimab and imdevimab. And we must work to continue rapidly scaling up additional supply, including through our collaboration with Roche which will more than triple total manufacturing capacity.
Casirivimab and imdevimab must be administered together. Casirivimab and imdevimab are not FDA approved for any use. Safety and effectiveness of casirivimab and imdevimab have not been fully established for the treatment of COVID-19. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Earlier this summer, Regeneron moved most of our commercial medicine manufacturing to our Irish facility in order to produce as much casirivimab and imdevimab as possible at our New York site. Even so, 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.
How we got here
Throughout the month of February, we continued our preclinical research with urgency, 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.
By the beginning of March, it seemed that the lives we were hoping to save might actually be our own.
One of the first major U.S. 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.
And we considered a grave conundrum. 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. We organized our own drive-thru testing facility in one of Regeneron’s now-empty parking lots. A group of senior leaders met by Skype daily at 5:00 pm for months to ensure we handled the emerging situation in a data-driven way and responded with care to employee needs.
On a personal level, many of us had friends and family who became sick. Our hometown of New York City felt like it was under siege. Physicians, policymakers and other community partners were calling us daily with reports from the frontlines and requests for help. We responded by instituting a double-matching gifts program for employee donations, providing PPE to hospitals in short supply, and rapidly manufacturing a critical component for 500,000 COVID-19 testing kits for NY State. But we knew the most important thing we could do was to discover a medicine that could help.
Moving forward with two antibodies
By April, we selected the two most potent and non-competing virus-neutralizing antibodies (casirivimab and imdevimab) to become our lead compound, and we immediately began scaling up large-scale manufacturing. We were excited but cautious. Over 30 years of working in biopharmaceutical research has taught me that you always have to hope your medicines will help people, but also have the humility to remember that many programs don’t succeed.
We squeezed every extra minute out of our development and manufacturing timelines. It felt like every person in the company was pulling together toward this goal, pulling out all the stops. I worried that our people were getting exhausted. Their kids were at home remote schooling, vacations and lives were on hold and, still, they were working so hard.
In June, we began human clinical studies and George and I asked for daily updates on enrollment. If there were challenges, we talked it through with the team and they came up with ambitious new solutions. As new parts of the country and the world saw COVID-19 cases emerge, we opened new sites.
In late September, we announced the first encouraging data from patients treated in our non-hospitalized (outpatient) trial showing our antibody cocktail reduced viral load and might have a role in shortening time to symptom relief. Three days later, President Trump announced that he had COVID-19. When we received the request from the President’s physicians for access to the investigational medicine, we weighed it carefully against our established criteria for Compassionate Use, an FDA pathway that, by design, is meant for exceptional circumstances. Given the unique national security considerations of the Presidency, which preclude participation in a clinical trial, we granted the request. We knew it would bring unprecedented scrutiny to our company of nearly 9,000 people. But frankly, that’s not the kind of calculation we do in these moments. Rather, we considered if it was the right thing to do for the patient and if it adhered to our policies and ethical standards. In this case, it was, and it did.
We’re not done yet
In October, we received more promising data from the outpatient trial that the FDA also evaluated in their EUA review. Our clinical trials are ongoing, and there’s much more information and analysis yet to come.
When George and I began our journey at Regeneron over thirty years ago, our mission was to invent medicines for people with serious diseases. It’s a mission that is rooted in science, medicine and human health and extends well beyond any political moment. Today, we are just as committed to this mission as the day we started -- as are the people of Regeneron who have sacrificed a tremendous amount to bring our antibody cocktail forward over the past ten months.
I want to thank the Regeneron team for their perseverance, intelligence and compassion during this difficult year – and for all the work that is yet to come to help people in need.