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Univ, Industry Labs Study Inhaled Covid-19 Antibodies

Adeno-associated virus

Adeno-associated virus (Jazzlw, Wikimedia Commons)

1 Dec. 2020. Researchers at University of Pennsylvania and Regeneron are studying delivery of synthetic antibodies directly to the nose to prevent Covid-19 infections. The collaboration between medical school professor James Wilson at UPenn and Regeneron Pharmaceuticals Inc. is testing the feasibility of gene therapy techniques to deliver Regeneron’s antibody cocktail for treating Covid-19 infections into mucous membranes in the nose to quickly neutralize coronaviruses without the need for a systemic immune response.

Wilson’s lab is part of the Gene Therapy Program at UPenn’s medical school in Philadelphia. He and colleagues study adeno-associated viruses for delivering gene therapies to patients with inherited disorders, but also to carry vaccines and treatments for infectious diseases. Adeno-associated viruses are benign, naturally occurring microbes that can infect cells, but do not integrate with the cell’s genome or cause disease, and generate at most a mild immune response.

Regeneron, in Tarrytown, New York, develops synthetic antibodies that stimulate the immune system to prevent or treat infectious diseases. The company is developing a combination of two antibodies, casirivimab and imdevimab (formerly code-named REGN-COV2), delivered by infusion or injection, that in clinical trials are shown to reduce viral burden and medical visits among non-hospitalized Covid-19 patients. Science & Enterprise reported on interim results from one of those trials in October, and the antibody cocktail received emergency use authorization from the Food and Drug Administration for high-risk patients with mild to moderate Covid-19 infections on 21 November.

Wilson and colleagues at UPenn, with researchers at Regeneron, are first testing delivery of casirivimab and imdevimab with adeno-associated viruses, or AAVs, and ability of the delivered antibody combination to neutralize SARS-CoV-2 viruses responsible for Covid-19 infections, when larger lab animals are exposed to those viruses. If the first tests are successful, the team will conduct further preclinical tests to prepare for an investigational new drug application to FDA, which requests permission to conduct clinical trials.

Regeneron says its preclinical studies show the antibody cocktail also prevents infections in lab animals. The UPenn/Regeneron researchers will look particularly if the antibodies can prevent infections over longer periods.

“The advantage of AAV in this application,” says Wilson in a university statement, “is they can achieve sustained expression of the antibodies in the nasal mucosa, which is the site of infection, following a single administration. In contrast to traditional vaccines, AAV delivery of antibodies provides a rapid onset of response and no reliance on the need for the recipient to mount an immune system response over time. This latter feature may be particularly attractive in people with weakened immune systems, like the elderly, or people who need rapid protection, like frontline health care workers.”

Regeneron is funding the research, but further financial details were not disclosed. The university will gain the rights to any intellectual property from the collaboration.

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