US Department of Defence throws weight behind industry collaboration to evaluate COVID-19 product

The Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers will collaborate to develop, manufacture, and conduct clinical trials to evaluate Emergent’s COVID-19 hyperimmune globulin product, COVID-HIG.

This includes a post-exposure prophylaxis (PEP) study on health care providers at high risk of COVID-19 infection and other high-risk populations, with $34.6 million in funding from the US Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).

Located in New York City, one of the early epicenters of the outbreak, Mount Sinai has experience treating more than 10,000 COVID-19 cases and was among the very first in the United States to initiate a convalescent plasma program in late March.

A leader in COVID-19 research and clinical care, Mount Sinai developed a serological assay to detect SARS-CoV-2 antibodies, one of the first to receive emergency use authorization from the US Food and Drug Administration (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.”

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.

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