Oragenics announced the posting of a preprint manuscript in bioRxiv (pronounced “bio-archives”). The manuscript, co-authored by Oragenics and its collaborators at Inspirevax and the National Research Council of Canada Human Health Research Centre, is titled “Intranasal Immunization with a Proteosome-Adjuvanted SARS-CoV2 Spike Protein-Based Vaccine is Immunogenic and Efficacious in Mice & Hamsters.”

The studies described in the manuscript evaluated a novel spike protein subunit vaccine formulation, NT-CoV2-1, containing a proteosome-based mucosal adjuvant designed for intranasal immunization. The studies concluded that intranasal formulation induced robust antigen-specific IgG and IgA titers in the blood and lungs of mice. In addition, the formulation was highly efficacious in a hamster challenge model, reducing the viral load below the limit of detection of the assay. In both mice and hamsters, the antibodies had strong neutralizing activity, preventing the cellular binding of the viral spike protein based on the ancestral reference strain and variants of concern. The studies concluded that this intranasal vaccine formulation warrants further development as a novel SARS-CoV-2 vaccine.

“Intranasally delivered SARS-CoV-2 vaccines could provide increased protection in the nose and throat where viral entry occurs. This could lead to lower transmission of the virus compared to the currently available intramuscularly delivered vaccines as well as offering a needle-free delivery option. We believe the results from these studies continue to support the development of our intranasal vaccine. The findings from this second preclinical study will be a part of our Investigational New Drug filing to the U.S. Food and Drug Administration (the 'FDA'), and should facilitate advancement of the program into human clinical studies,” said Frederick W. Telling, Ph.D., Executive Chairman of Oragenics.