On Jul. 8, 2020, the Mount Sinai Health System, Emergent BioSolutions and ImmunoTek Bio Centers announced a collaboration to develop, manufacture, and conduct clinical trials to evaluate Emergent’s COVID-19 hyperimmune globulin product, COVID-HIG, including a post-exposure prophylaxis 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 U.S. Department of Defense (U.S. DOD).

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 U.S. Food and Drug Administration (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.

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. Under the agreement with the JPEO-CBRND, Emergent will collaborate to collect convalescent plasma to manufacture COVID-HIG for use in a clinical study under a potential Expanded Access Program to support military personnel.