The Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers are collaborating 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 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’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 U.S. 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. FDA.

“There is emerging evidence that convalescent plasma is an effective treatment for COVID-19 patients,” said David Reich, president and chief operating officer, 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.”

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.

“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 Laura Saward, senior vice president and therapeutics business unit head, 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.”

Evaluating COVID-HIG in Clinical Trials

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.

Establishing Sustainable Plasma Collection Capabilities

ImmunoTek will provide technical, scientific, and industry expertise in plasma collection and will extend its FDA license as an approved source plasma collection establishment to enable plasma collection onsite at Mount Sinai. 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.

“This unprecedented public health crisis is a critical moment for Americans to donate plasma,” said Jerome Parnell III, president and chief executive officer, 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.”

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.

Advancing COVID-HIG With U.S. Government Support

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.

"COVID-19 outbreaks in the military cause a significant risk to readiness and the ability to conduct training and perform our mission,” said Army Col. Ryan Eckmeier, the JPEO-CBRND’s Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical). “Military training is often conducted in close contact as a unit or team, which makes social distancing nearly impossible. Our goal is to deliver medical solutions to enable military readiness. Knowing that HIG has been used in other disease outbreaks successfully as a prophylaxis, we are excited to partner with Emergent to develop this potential solution for the military and the nation.”