The Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers announced that they will collaborate to develop, manufacture, and conduct clinical trials to evaluate Emergent’s COVID-19 hyperimmune globulin product, COVID-HIG, including a post-exposure prophylaxis (PEP) study on healthcare 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’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 initiated a convalescent plasma program in late March.
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 U.S. Food and Drug Administration (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.
ImmunoTek will provide technical, scientific, and industry expertise in plasma collection and will extend its FDA license as an approved source plasma collection to Mount Sinai, enabling on-site collection at the hospital. ImmunoTek will also provide staff training and compliance information to assist in establishing standard operating procedures and plasma criteria. 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.
Emergent will support ImmunoTek and Mount Sinai in other regulatory and compliance efforts related to plasma collection and supply, as well as activities leading up to an Investigational New Drug application submission to the FDA.
In addition to receiving DOD funding to advance a post-exposure prophylaxis indication for COVID-HIG, Emergent was awarded $14.5 million in April by the U.S. Department of Health and Human Services (HHS) to develop COVID-HIG as a potential treatment for COVID-19. The product candidate will be evaluated in clinical studies by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as a potential treatment in hospitalized patients and patients at high risk of progression to severe disease. Emergent will produce investigational COVID-HIG material from the plasma collected at Mount Sinai to support the post-exposure prophylaxis and treatment clinical trials, for which Mount Sinai will serve as a study site.
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. 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. Hyperimmune globulin treatments have been used successfully to treat other viruses.
