Emergent BioSolutions Inc. announced today that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.
COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.
Robert G. Kramer Sr., president and CEO of Emergent BioSolutions, stated, “In the current pandemic scenario where no preventative or therapeutic options for COVID-19 are available, public-private partnerships such as this are essential to the rapid development of medical interventions. Aside from deploying our HHS-partnered Center for Innovation in Development and Manufacturing (CIADM) to help companies advance COVID-19 vaccine candidates through manufacturing, today’s announcement of BARDA’s funding is a testament to the strength and reliability of our proven hyperimmune platform, which has a successful history of enabling us to produce treatments for serious public health threats. With more than 40 years of experience with plasma-derived therapies, Emergent is committed to the goal of getting COVID-HIG to patients as early as possible, with a potential broader reach under Emergency Use Authorization, and the availability of a commercial supply.”
Emergent and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have agreed to incorporate the company’s COVID-HIG product candidate into one of NIAID’s clinical studies for assessment of treatments for COVID-19 once clinical material is available, and the study begins. Emergent has already initiated plasma screening and collection of human plasma with antibodies to SARS-CoV-2 that will be further purified and concentrated through manufacturing of COVID-HIG.
“We are proud to continue our partnership with the U.S. government to lay the foundation of our near-term response plan. Our mutual objective is to save lives and Emergent is fully committed to working closely with BARDA, NIH/NIAID, the Food and Drug Administration (FDA), and other key agencies to stay aligned on this common goal,” said Dr. Laura Saward, senior vice president and therapeutics business unit head at Emergent BioSolutions. “COVID-HIG will leverage the platform that was established in partnership with BARDA through their investment in our treatments for anthrax and smallpox vaccine complications, and it provides a sustainable capability for responding to emerging infectious diseases such as COVID-19.”
Expertise in Hyperimmune Therapeutic Development and Manufacturing
Hyperimmunes are polyclonal antibody therapeutics that are manufactured from plasma and leverage the natural immune response in humans or animals. COVID-HIG has the potential to serve as both a treatment for severe hospitalized patients and protection for at-risk individuals. In parallel and separate from the COVID-HIG development effort with BARDA, COVID-EIG, manufactured from the plasma of immunized horses with antibodies to SARS-CoV-2, will be developed by the company as a potential treatment for severe hospitalized patients.
COVID-HIG will be developed on Emergent’s human hyperimmune platform and COVID-EIG will be developed on the equine hyperimmune platform. These hyperimmune platforms and related in-house manufacturing infrastructure support several products approved by the FDA, including the company’s treatments for smallpox vaccine complications, VIG [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV), for anthrax, Anthrasil® [Anthrax Immune Globulin Intravenous (Human)], and for botulism, BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)].