Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has initiated development of two product candidates for the treatment and prevention of coronavirus disease (COVID-19). These product candidates are being developed on Emergent’s hyperimmune platforms that have a well-established safety database. The hyperimmune platforms and related in-house manufacturing infrastructure support several products approved by the U.S. Food and Drug Administration, including the company’s treatments for smallpox vaccine complications, botulism, and anthrax, VIG [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV), BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)], and Anthrasil® [Anthrax Immune Globulin Intravenous (Human)], respectively.
Robert G. Kramer Sr., president and chief executive officer at Emergent BioSolutions, stated, “As a company focused on public health threats, we are committed to responding to this novel coronavirus and will use our broad capabilities and platforms to advance solutions. On the heels of our collaboration with an industry partner to develop an experimental vaccine candidate for clinical testing, we are pleased to leverage our existing infrastructure to help expedite development of our product candidates for COVID-19, founded on our decades of experience in hyperimmune manufacturing.”
Hyperimmunes are polyclonal antibody therapeutics derived from plasma that leverage the immune response in humans or animals and can provide immediate protection from infection. COVID-HIG, manufactured from human plasma with antibodies to SARS-CoV-2, will be developed as a potential treatment for severe hospitalized patients as well as protection for at-risk individuals. In parallel, COVID-EIG, manufactured from plasma of immunized horses with antibodies to SARS-CoV-2, will be developed as a potential treatment for severe hospitalized patients.
“Emergent is advancing these programs based on our hyperimmune platforms and using existing infrastructure and capabilities that we deployed for our recently completed Phase 2 clinical trial for our influenza hyperimmune FLU-IGIV to treat patients hospitalized with Influenza A,” said Laura Saward, senior vice president and therapeutics business unit head at Emergent BioSolutions. “By leveraging our platform and capabilities that are already in place, Emergent is in a state of readiness to develop treatment options for COVID-19 to potentially protect healthcare workers and others on the frontline, as well as treat individuals who have fallen ill.”
Emergent has initiated plasma collection efforts for both human and equine platforms with a goal of manufacturing clinical material within the next four to five months in anticipation of beginning a clinical study as early as the third quarter of 2020.
The company’s hyperimmune specialty plasma product manufacturing platform has been used to create multiple products that have obtained FDA and Health Canada approval. Emergent’s marketed antibody therapeutics, including VIG, a treatment for smallpox vaccine complications, and Anthrasil®, a treatment for anthrax, are based on the human hyperimmune platform, while BAT®, the company’s botulism anti-toxin, was developed on the equine hyperimmune platform.