Clinical investigators at University of Iowa Hospitals and Clinics (UIHC) are participating in a Phase 3 clinical trial investigating Regeneron’s novel monoclonal antibody targeting COVDI-19 known as REGN-COV2. TrialSite News recently showcased this rapidly developed new approach targeting the coronavirus. Regeneron established an early “sentinel” effort with the U.S. Food and Drug Administration (FDA) affording the industry sponsor a fast track for the antibody treatment. Dr. Alejandro Comellas with UIHC recently spoke to local media about the hope associated with this investigational product.
Some Initial Confusion about REGN-COV2-
Actually a combination product, TrialSite News introduced a new clinical investigational site in Mesa, Arizona, also participating in this study and sponsor Regeneron’s $450 million infusion from the federal government as part of Operation Warp Speed. There was some confusion as there was no disclosed Phase 1 safety study for this biological drug yet the U.S. FDA gave the green light based on an independent data monitoring committee greenlight. A company spokeswoman communicated with TrialSite News that Regeneron and the FDA established an approach in advance that an initial group of patients would serve as a “sentinel” population. Hence a way to fast track this whole affair. This clarified how the “Phase 1” safety came about. Regeneron at last communication was still blinded to the data but again the IDMC gave it a thumbs up.
Regeneron secured a $450 million payment via Operation Warp Speed (BARDA/ASPR/HHS & DOD) agreement covering a fixed number of product intended to completion this fall. TrialSite News posed some questions to the Regeneron spokesperson but its too early now for more details on pricing should this product work in clinical trials.
The Investigational Product
Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail for clinical use with the company’s in-house VelociMab® and manufacturing capabilities. REGN-COV2’s two antibodies 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 recent Science publications.
Dr. Alejandro Comellas with UIHC, reports I think that this is one of the ones that we’re most excited about.” He emphasized to CBS2 Iowa that this drug is more targeted that other investigational drugs currently involved in COVID-19 clinical trials. What does he mean targeted? According to Dr. Comellas, “Targets, like what we call the spike protein of the coronavirus, that spike protein is what’s required for the coronavirus to get into the cell.” The spike proteins are those little crown that facilitate the virus’ penetration into the human cell for replication and infection.
The idea, reports Comellas to CBS2 Iowa, is to destroy this process and stop COVID-19 in its tracks. In theory, the severity of the disease is diluted and there will be far less hospitalization and the death rate would decline. What a positive scenario.
University of Iowa Hospitals and Clinics (UIHC)
UIHC has been ranked one of the best health providers and research centers in America. A top employer, ranked high for customer loyalty, employer diversity and commitment to the community, on any given day at UIHC over 13,000 employees, students and volunteers collaborate to provide safe, quality health care to patients. The 811-bed hospital annually admits 37,000 patients for in patient hospital care. Moreover, they managed over 58,000 emergency department visits. With more than 200 outpatient clinics and care areas, UIHC accommodated more than 1 million clinic visits at the main campus and community and outreach clinics.
By 2018, UIHC employed 1,752 physicians and dentists, resident physicians and resident dentists and fellows. They also employed 8,472 non-physician staff, including 2,455 professional nurses.
Alejandro Comellas, Director, Clinical Research Support, ICTS, Clinical Professor of Internal Medicine—Pulmonary, Critical Care and Occupational Medicine
Call to Action: UIHC is taking volunteers for this double-blind study of the COV-REGN2. If you have tested positive for COVID-19 and would like to help, call 319-353-8862 for more information on how you might be able to participate.