Emergent BioSolutions working with federal government on COVID-19 therapy

Emergent BioSolutions is working with the U.S. government to develop a therapy for patients diagnosed with coronavirus, also known as COVID-19.

The partnership is through a $14.5 million grant from the Biomedical Advanced Research and Development Authority (BARDA) to develop a COVID-Human Immune Globulin (COVID-HIG). COVID-HIG is a human plasma-derived therapy candidate being developed as a potential treatment for COVID-19 in severe hospitalized and high-risk patients. The therapy will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.

“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,” Robert Kramer Sr., president and CEO of Emergent BioSolutions, said. “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.”

The National Institute of Allergy and Infectious Diseases (NIAID) has agreed to incorporate Emergent’s COVID-HIG candidate into one of its clinical studies for assessment of treatments. Emergent has already begun plasma screening and collection of human plasma with antibodies to SARS-CoV-2 that will be further purified and concentrated through the 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, 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.”

COVID-HIG has the potential to serve as both a treatment for severe hospitalized patients and protection for at-risk individuals. Also, COVID-EIG, manufactured from the plasma of immunized horses with antibodies to SARS-CoV-2, will be developed by Emergent 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.

“Treatments for hospitalized COVID-19 patients are urgently needed to save lives in this severe pandemic,” BARDA Director Rick Bright said. “We are working with partners in industry and across the government, including engaging long-standing CIADM partners, to make safe, effective treatments available as quickly as possible.”