Together with $34.6 million in funding from the U.S. Department of Defense (DoD), Mountain Sinai Health System, Emergent BioSolutions and ImmunoTek Bio Centers will collaborate on the development of a hyperimmune globulin treatment for COVID-19.
That treatment, known as COVID-HIG, was created by Emergent. The partners will now work to develop, manufacture, and conduct clinical trials on the product.
Mount Sinai and Emergent will handle clinical trials, focusing on the evaluation of COVID-HIG for post-exposure prophylaxis of COVID-19 among front-line healthcare workers and other high-risk populations. They will also support a potential Expanded Access Program for military personnel.
ImmunoTek will handle the extension of its establishment license and provide training for Mount Sinai personnel so that they can set up onsite plasma collection locations.
“There is emerging evidence that convalescent plasma is an effective treatment for COVID-19 patients,” Dr. David Reich, president and COO of The Mount Sinai Hospital, said. “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.”
Mount Sinai was among the first organizations to start a convalescent plasma program in the United States. It also developed a serological assay for detecting SARS-CoV-2 antibodies that received emergency use authorization from the U.S. Food and Drug Administration.
As part of the prophylaxis study, the partners will assess whether it could help protect high-risk individuals and limit the spread of COVID-19. ImmunoTek and Mount Sinai’s plasma collection efforts will focus on New Yorkers, pulling from a broad pool of eligible donors to support the manufacture and evaluation of COVID-HIG in clinical trials.
“This unprecedented public health crisis is a critical moment for Americans to donate plasma,” Jerome Parnell III, CEO and president of ImmunoTek Bio Centers, said. “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.”