A Gaithersburg-based global life sciences company announced Wednesday it will partner with two other organizations to work on a preventative COVID-19 product after receiving $34.6 million from the U.S. Department of Defense.
Emergent BioSolutions will collaborate with the Mount Sinai Health System, based in New York City, and ImmunoTek Bio Centers, based in Louisiana, to develop, manufacture and evaluate Emergent’s hyperimmune globulin product, COVID-HIG, for post-exposure prophylaxis of COVID-19 in frontline health-care workers. Funding for this collaboration came from DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
HIG is a concentrated antibody derived from the antibody-rich plasma of previously infected and recovered individuals. To produce plasma-derived COVID-19 treatments that can be administered to patients, plasma must be collected from a pool of human donors and then manufactured, or fractioned, into specialized therapeutic products. HIG treatments have been used successfully to treat other viruses.
Post-exposure prophylaxis, also known as post-exposure prevention, is any preventive medical treatment started after exposure to a pathogen in order to prevent infection from occurring.
Emergent’s partnership with ImmunoTek and Mount Sinai is relatively unique, said Laura Saward, senior vice president, antibody therapeutics business unit at Emergent BioSolutions. Although the company has already done significant work on HIG treatment for those who are infected with COVID-19, the DOD-funded product would be more preventive.
“This new piece, the idea is, you have people who are at constant exposure, if they have antibodies already on board, then when they encounter the virus it gets very quickly shut down by the antibody,” Saward said. “And it clears. And they don’t get sick. And that’s what we’re calling the prophylaxis indication or sort of the preventative indication.”
HIG products are typically administered intravenously, but Saward said she hopes that, when scientists learn more about dosages, Emergent will be able to concentrate the product and deliver it at a smaller volume, subcutaneously or intramuscularly.
Mount Sinai’s main roles will be to expand the operation’s plasma collection abilities and host Emergent’s clinical trials. ImmunoTek will provide expertise, share its FDA license and help set up collection sites, said Seward.
Choosing Mount Sinai over other hospital systems also provides a unique advantage due to the area’s high infection rates.
“So, by picking New York and this hospital system that has helped many patients with COVID, we can sort of tap into the unique position they are in to set them up to collect the plasma,” said Saward. “This would be really unique, that a company like Emergent and ImmunoTek kind of come together, share their FDA licenses to help to set up a public institution in the health care system to have a significant role in this.”
In addition to receiving DOD funding, Emergent was awarded $14.5 million in April by the U.S. Department of Health and Human Services to develop COVID-HIG as a potential treatment in hospitalized patients, including those at high risk of progression to severe disease. This product will be evaluated in clinical studies by the National Institute of Allergy and Infectious Diseases.
As part of the three-organization collaboration, Emergent will evaluate COVID-HIG in a post-exposure prophylaxis study of visuals at high risk of exposure, such as front-line health workers, alongside Mount Sinai.
This study will assess whether prophylaxis with COVID-HIG can protect these individuals and limit the virus’ spread. Emergent will also help collect the convalescent plasma needed to manufacture COVID-HIG for use in a clinical study and support activities related to regulation, compliance effort, and an Investigational New Drug Application submission to the Food and Drug Administration.
The partnership will establish plasma collection capabilities at Mount Sinai using ImmunoTek’s FDA-approved establishment license. This plasma collection will support manufacturing and subsequent evaluation in clinical trials by Emergent. ImmunoTek will also provide technical, scientific and industry expertise in plasma collection and bolster staff training and compliance efforts.
The DOD is interested in using the COVID-HIG product to help military personnel who are at high risk of exposure, said Saward.