On Mar. 9, 2021, Oragenics announced it had entered into a material transfer agreement with Biodextris for the use of three intranasal mucosal adjuvants in the Company’s Terra CoV-2 vaccine against COVID-19.

Adjuvants are added to vaccines to enhance their immunogenicity. BDX100, BDX300 and BDX301 are proteosome-based adjuvants comprised of proteins and lipopolysaccharides with improved attributes including enhanced immune response, manufacturing efficiency and the benefits of intranasal vaccine administration.

The initial agreement calls for the three intranasal adjuvants to be used in combination with the Oragenics’ antigen vaccine candidate as part of the preclinical immunological evaluation of Terra CoV-2, for the prevention of coronavirus disease caused by infection with SARS-CoV-2 virus. The information generated from the studies employing the new intranasal vaccine candidate would potentially support the U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) application and an application to Health Canada to initiate clinical trials. The agreement allows for the future collaboration regarding the intranasal delivery of vaccine during clinical development with the opportunity to enter into a commercial agreement upon regulatory approval of the intranasal vaccine.

The Terra CoV-2 vaccine plus Biodextris’ intranasal mucosal adjuvants will be studied in the preclinical animal studies, including hamster viral challenge studies, mouse immunogenicity studies and the rodent toxicology study required for regulatory approval prior to the initiation human testing.

In March 2020, Oragenics acquired a non-exclusive license from the National Institutes of Health (“NIH”) for its stabilized prefusion Terra CoV-2 spike protein. Oragenics announced that its spike protein had been successfully inserted into Chinese Hamster Ovary (“CHO”) cells production and analytical development are underway. CHO cells are used to produce a number of FDA-approved recombinant proteins.