As the threat of Covid-19 continues to hit the U.S. hard and is quickly overwhelming hospitals, Emergent BioSolutions Inc. (EBS) - Get Report is one of several companies working on treatments for the disease of which there currently is none.
Emergent's plasma-derived therapies would be mainly for patients with severe cases of the disease caused by the recently discovered coronavirus, and has similarities to a therapy in the works by Japanese drugmaker Takeda and others. Emergent already has programs for treatments for smallpox vaccine complications, the bacterial anthrax disease and botulism as well as other public health threats.
Pushing the Covid-19 treatment effort along, Emergent has won $14.5 million from the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services to support its program called COVID-HIG, one of two the company has aimed at fighting the disease.
COVID-HIG would be made using plasma donations from patients who have already recovered from Covid-19 and have developed antibodies to the virus.
TheStreet spoke through email to Dr. Laura Saward, a senior vice president and therapeutics business unit head at Emergent BioSolutions, about the potential hyperimmune treatment. The company is also working on a "parallel and separate" therapy program, COVID-EIG, that would use the plasma of immunized horses with antibodies to the virus. The following exchange has been minimally edited for clarity and style; the interview was conducted via a spokeswoman who provided Saward's answers.
TheStreet: If the plasma therapy under development proves successful, what is the earliest you expect it to be available for use?
Dr. Saward: We anticipate clinical trials in patients to begin in August. Because we are using proven manufacturing technologies that have been used for other Food and Drug Administration-approved drugs, we are able to move at an accelerated pace to bring a candidate directly to a Phase 2 trial.
TheStreet: Would this be mainly for patients with severe illness and, if so, how would you expect the use to be determined? Could it also be used to develop immunity in health care workers?
Dr. Saward: We believe the greatest impact for plasma-derived hyperimmune treatments would be to reduce the burden on the health care system by treating hospitalized patients with severe Covid-19 and high-risk patients with Covid-19 to prevent progression to severe symptoms. Hyperimmunes may also be used to provide protection to individuals such as the frontline health care workers, like nurses and doctors, that are selflessly putting themselves at such a high risk.
Dr. Saward: We are developing two therapies as we have two hyperimmune platforms: One is human plasma-derived and the other is equine plasma-derived. Both human and equine platforms are well-established and support multiple FDA-approved products. Our human platform is different from others’ approaches in that we pool plasma donations from multiple people and antibodies are isolated through the manufacturing process to create a concentrated dose that provides consistent levels of Covid-19 antibodies.
For our equine platform, we vaccinate the herd to stimulate Covid-19 antibody production and then manufacture in a similar manner to the human platform process to provide a concentrated dose. This provides a scalable source of Covid-19 plasma, which is a consideration for plasma-derived therapy. Again, these are separate platforms running in parallel to accelerate our goal of providing treatments for patients, targeting Phase 2 clinical trial by end of summer.
TheStreet: How would risk of spreading other pathogens be eliminated?
Dr. Saward: We have been manufacturing plasma-derived hyperimmunes for over 40 years with a well-established safety profile. The validated manufacturing process has several steps to inactivate and remove potential pathogens.
TheStreet: What are some of the limitations to making this sort of therapy widely available?
Dr. Saward: Because we are taking a hyperimmune approach -- the collection of many plasma donations for a concentrated, consistent dose -- gathering enough source material is a challenge we are overcoming with the help of partnerships like that of the Biomedical Advanced Research and Development Authority within Health and Human Services, and the National Institute of Allergy and Infectious Diseases announced earlier this week.
TheStreet: How dependent would these hyperimmune therapies be on the development of antibody tests so that recovered patients could donate plasma for the therapies?
Dr. Saward: Emergent started work in January to develop an assay to screen for antibodies to Covid-19 that is being used to identify donors.
TheStreet: Is the therapy expected to be available in other nations, too?
Dr. Saward: Through our partnership with U.S. government, we are focused on providing a Covid-19 treatment quickly to help relieve the burden of Covid-19 on the health care system. Through our many global partnerships, we will explore the ability to collect plasma and manufacture hyperimmune treatments.