Mount Sinai, Emergent, and ImmunoTek to Develop COVID-19 Hyperimmune Globulin Product

A COVID-19 hyperimmune globulin product will be evaluated in clinical trials, including a post-exposure prophylaxis (PEP) study on health care providers at high risk of COVID-19 infection and other high-risk populations.

Mount Sinai Health System (New York, NY, USA), Emergent BioSolutions Inc. (Gaithersburg, MD, USA) and ImmunoTek Bio Centers (Lafayette, LA, USA) will collaborate to develop, manufacture, and conduct the clinical trials to evaluate Emergent’s COVID-19 hyperimmune globulin product, COVID-HIG. Mount Sinai and Emergent will evaluate COVID-HIG in a post-exposure prophylaxis study in individuals at high risk of exposure to COVID-19, such as front-line health care workers and military personnel. The clinical research program is designed to assess whether prophylaxis with COVID-HIG could help protect individuals at high risk of exposure and limit the spread of disease.

Hyperimmune globulin, sometimes referred to as polyclonal antibodies, is a concentrated antibody product derived from the antibody-rich plasma of people who were previously infected with and recovered from an illness; in this case, COVID-19 caused by the virus SARS-CoV-2. In order to produce plasma-derived therapeutics that can be administered to patients in need, plasma must be collected from a pool of human donors and then manufactured, or fractioned, into specialized therapeutic products. Mount Sinai intends to collect convalescent plasma from its broad pool of eligible donors to support Emergent’s manufacture of COVID-HIG and the evaluation of the product candidate in clinical trials, and for potential emergency use or broader patient use as allowed by the FDA. The collaborators will establish plasma collection capabilities at Mount Sinai through an extension of ImmunoTek’s FDA-approved establishment license and the transfer of technical know-how to Mount Sinai. Plasma from recovered donors will support the development and manufacture of COVID-HIG for evaluation of the product candidate in clinical trials, and for potential emergency use or broader patient use as allowed by the FDA.

“There is emerging evidence that convalescent plasma is an effective treatment for COVID-19 patients,” said David L. Reich, MD, President and Chief Operating Officer of The Mount Sinai Hospital. “Therefore, hyperimmune globulin may become an effective option in the prevention and treatment of COVID-19 currently, in the absence of a vaccine, as well as in the future, particularly for patients who do not develop immunity from a vaccine. It is imperative that we have more options to prevent this terrible disease in front-line workers and other high-risk populations and to potentially decrease the severity of illness in those infected. We are eager to collaborate with Emergent and ImmunoTek to advance the science and identify effective therapeutics in the fight against COVID-19.”

“Our collaboration with Mount Sinai, ImmunoTek, and the Department of Defense enhances the response to COVID-19 and broadens our efforts to have a meaningful impact,” said Dr. Laura Saward, SVP and Therapeutics Business Unit Head at Emergent BioSolutions. “The front-line health care workers and others who protect us are a top priority for reducing the impact of COVID-19. Emergent is drawing from decades of experience with our human hyperimmune platform, on which several products have been FDA-licensed, to develop COVID-HIG. Our mission – to protect and enhance life – is at the forefront of everything we do.”

“This unprecedented public health crisis is a critical moment for Americans to donate plasma,” said Jerome Parnell III, CEO and President, ImmunoTek Bio Centers. “Specifically, blood plasma donors from New York impacted by the pandemic could unlock the potential of a viable hyperimmune globulin product to protect our health care providers, military, and first responders, and to treat patients with severe complications from COVID-19. Our unique collaboration honors our hero donors while highlighting the importance of expanding plasma collection capabilities across mainstream communities and diverse municipalities in the fight against COVID-19 and other rare diseases.”

Related Links:
Mount Sinai Health System
Emergent BioSolutions Inc.
ImmunoTek Bio Centers