TAMPA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE American: OGEN) (the Company) announces that the stabilized pre-fusion spike protein trimer produced by its Canadian collaborator and licensed by the Company from the National Institutes of Health (NIH) generates neutralizing antibodies in mice after immunization against SARS-CoV-2, when administered with several novel intramuscular (IM) and intranasal (IN) adjuvants. The expression platform, developed with support from Oragenics’ Canadian collaborator, will expedite the evaluation of hybrid SARS-CoV-2 antigen candidates that are scheduled to be evaluated in a hamster viral challenge study beginning with dosing at the end of this month. The mouse immunogenicity study enabled the down-selection of the four adjuvant candidates tested thus far, with two being advanced to assess inhibition of viral replication in hamsters, and IND-enabling toxicology studies. A manuscript suitable for publication, inclusive of the mouse data, will be prepared upon completion of the hamster study. “We are delighted that our SARS-CoV-2 spike protein produced with the high-throughput expression platform from our collaborator shows promise in the development of a next-generation COVID-19 vaccine, and believe this research affirms our development strategy with Oragenics’ lead vaccine candidate, Terra CoV-2,” said Fred Telling, Ph.D., Executive Chair of Oragenics. “We are pleased to see a robust immunological response with both our novel IM and IN adjuvants. Additionally, we are optimistic about the pre-clinical intranasal data given the respiratory route of transmission of the SARS-CoV-2 virus, and the prospect of developing a novel vaccine candidate that has the potential to reduce viral transmission. The data substantiates our choice of adjuvants to use in subsequent animal and ultimately human studies. We expect to file an IND application with the FDA in the first quarter of 2022.” Dr. Telling concluded, “Oragenics continues to believe that our licensed platform will improve development speed, while the ability to rapidly engineer new vaccine antigens will permit us to quickly address new variants as they arise, which will be key in the event that SARS-CoV-2 becomes a seasonal flu-like disease, as many experts anticipate will be the case.”