Regeneron has selected a Sioux Falls-based health care system called Avera Health as a Phase 2 and 3 trial site for the ongoing lab-produced monoclonal antibody combination, known as REGN-COV2, targeting COVID-19. Avera Health, a fully integrated health system covering five states and over 1 million people, shared that the investigational product is of interest not only to treat patients diagnosed with SARS-CoV-2, the virus behind COVID-19, but also to determine if Regeneron’s REGN-COV2 (combination of the two antibodies) can actually prevent COVID-19 from occuring in the first place. Regeneron has received $450 million from the U.S. government as part of Operation Warp Speed.
Regeneron’s REGN-COV2 program is based on a master protocol and involves four studies that have moved in somewhat parallel manner. The four clinical trials in the REGN-COV2 program, including a master protocol Phase 1 and 2 study (NCT04425629) for ambulatory (outpatient) COVID-19 patients; a Phase 1 and 2 study (NCT04425629) for hospitalized patients; an ongoing Phase 1 study (NCT04519437); and interestingly, a Phase 3 trial (NCT04452318) that was launched to prevent COVID-19 infection for those participants that have been exposed to the pathogen via a household contact.
Note, TrialSite will have an updated assessment of the REGN-COV2 program, including some of its unorthodox features. As noted in the Avera Health press release announcing the study, the Phase 1 safety results were “approved to move forward following Phase 1 safety results.” Actually, the Phase 1 studies still continue and, as TrialSite learned from a Regeneron spokesperson, this program included what is called a sentinel population. The combination monoclonal antibody treatment was deemed to be safe by an Independent Data Monitoring Committee (IDMC) while the study data was still blinded to others (including the sponsor). Undoubtedly due in part to pandemic conditions, the FDA has agreed with the sponsor to employ a flexible approach to progressing the REGN-COV2 program.
REGN-COV2: A Powerful Investigational Drug
Upon pandemic onset, Regeneron scientists got right to work leveraging the unfolding knowledge of the SARS-CoV-2 pathogen and powerful drug discovery and development technology Regeneron has developed over the years. REGN-COV2 is actually the combination of two antibodies developed by Regeneron, including REGN10933 and REGN10987. Each one results from Regeneron scientists cranking through thousands of fully-human antibodies produced by the company’s proprietary VelocImmune® mice, which have been genetically modified to have a human system, as well as antibodies from humans who have recovered from COVID-19.
The Regeneron team actually selected the two most superior: that is, potent, non-competing and virus-neutralizing antibodies—which ultimately become the combined REGN-COV2. The Regeneron team have since scaled up the dual-antibody cocktail for clinical use with the company’s in-house VelociMab® and manufacturing capabilities, as reported by the sponsor back on July 6 in a press release.
REGN-COV2 is designed to bind to two different points on the SARS-COV-2 spike protein, reports the Avera Health press release. They have been designed by Regeneron to actually block the spike protein from attaching to the host cells. If it can be proven to work consistently, this biologic treatment would actually serve to protect people from getting infected at all. Therefore, if REGN-COV2 can actually stop the virus from infecting cells, it may serve to not stop COVID-19 symptoms from worsening but could even actually prevent them from developing in the first place—that is once an individual has been exposed to COVID-19. Needless to say, a drug such as this would be worth a fortune.
Avera Health System Embraces Advanced Treatment
REGN-COV2 was developed with antibodies from recovering patients and the powerful Regeneron VelociSuite antibody discovery and development platform. As a health system, Avera experiences the challenges of a pandemic each and every day. Hence the system’s interest in powerful new approaches that can not only help treat patients but also prevent the pathogen from infecting the patient.
Amy Elliott, PhD, Chief Clinical Research Officer of the Avera Center for Pediatric and Community Research, commented on the effort: “COVID-19 has created tremendous medical needs in the areas of treatment and prevention.” The executive continued, “That’s why we’ve chosen to participate in these trials—we’re not just looking at finding effective treatments, but also whether we can prevent people who have recently been exposed from getting sick.”
Avera reports that the clinical trials focus on three different patient groups, including 1) patients hospitalized with COVID-19, evaluating if it (REGN-COV2) can stop progression of the disease; 2) patients diagnosed with COVID-19 but not hospitalized, evaluating if the combination of antibodies can stop progression of the disease; and 3) people who were exposed to someone with COVID-19, evaluating if it will decrease symptom severity or even prevent the disease altogether.
John Lee, MD, Clinical Medical Officer for Cancer Research at Avera Cancer Institute, communicated, “We know the antibody plays a role in neutralizing infection; the concept of these trials is to test this ability as an option for COVID-19. ” Dr. Lee understands the importance of finding ways to reduce or decrease the spread of the pathogen in pandemic situations.
Based on the Avera description, the health system is participating in three of the four Regeneron clinical trials mentioned above.
Principal Investigator POV
Jawad Nazir, MD, serves as the Principal Investigator over all three studies for Avera Medical Group, commenting, “This is a really exciting opportunity to be at the forefront of research in this area.” Dr. Nazir continued, “One of the reasons we chose these studies is they examine various combinations of two different antibodies, designed specifically to target this disease and how it attacks cells.”
About Avera Health
This regional health system based in Sioux Falls, South Dakota, actually has roots going back to 1897. With over 300 locations in 100 communities throughout South Dakota, Minnesota, Iowa, Nebraska, and North Dakota, Avera serves a massive geographical footprint of over 72,000 square miles, 86 counties and a population over 1 million. The fully integrated system includes Avera Medical Group, composed of physicians and advanced practice providers serving patients at nearly 200 secure locations across the region. Avera Health offers a range of 60 specialties and offers a health plan formed in 1999. It is purportedly the third largest health plan in South Dakota.
Avera Health includes a dynamic research operation centering on cardiovascular trials, cancer trials, breast cancer collaborative registry and pediatric & community research. Additionally, Avera Research includes a twin registry, applied research and the Walking Forward program—cancer research for Native Americans.
Jawad Nazir, MD
Call to Action: If you know of someone tested positive for COVID-19, consider contacting Avera Health to learn more at 605-504-3154. For those interested in engaging with this study, Dr. Nazir leads the study as PI; Dr. Lee plays a supportive role while Dr. Elliot and her clinical research team lead the operational aspects of the study.