Oragenics (OGEN) Announces SARS-CoV-2 Spike Protein Licensed from the NIH Demonstrates Protective Immunity in Mice

February 2, 2021 8:08 AM EST

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Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announces that the stabilized pre-fusion spike protein CoV-2 S-2P created by the National Institutes of Health (“NIH”) and licensed by the Company demonstrates protective immunity in immunized mice challenged with mouse-adapted SARS-CoV-2 virus.

The NIH data shows that the NIH – created COVID-19 spike protein when dosed at either 0.1 or 1.0 mcg and combined with an adjuvant completely inhibited virus growth in the nasal cavities and lungs of mice when the animals were infected four weeks after their second immunization, compared to the unvaccinated control animals. The adjuvant uses was TLR-4-agonist Sigma Adjuvant System - a TLR-4 agonist that induces T cell activation in mice. Adjuvants are added to vaccines to boost immune responses.

See Dinnon et al for details on the mouse-adapted challenge model - Dinnon et al, Nature 586, 560–566 (2020) located at - https://doi.org/10.1038/s41586-020-2708-8.

The Company previously disclosed that the NIH-produced spike protein adjuvanted with the TLR-4-agonist Sigma Adjuvant System generated neutralizing antibody titers, measured using a pseudovirus neutralization assay and a plaque-reduction neutralization titer assay. In addition, this immunization produced a balanced Th1/Th2 (T helper cells) response. In a well-functioning immune system both groups of T helper cells work together to keep the system balanced.

“We are encouraged that our licensed SARS-CoV-2 spike protein has been shown to hold promise in the creation of a COVID-19 vaccine, and believe these additional animal data supports our continued development of Terra CoV-2, our lead COVID-19 vaccine candidate,” said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics. Dr. Joslyn continued, “Our successful pre-IND meeting with the FDA has allowed us a clear path towards an Investigational New Drug application. We continue to aggressively move forward with our development strategy for this vaccine candidate, as we believe the global need for vaccines against SARS-CoV-2 is estimated to be between 12 billion to 14 billion doses and the vaccines currently being administered are only a first step towards addressing the COVID-19 pandemic.”

About Oragenics, Inc.
Oragenics, Inc. is focused on the creation of the Terra CoV-2 development of effective treatments for novel antibiotics against infectious disease. The Company is dedicated to the development and commercialization of a vaccine candidate providing specific immunity from novel coronavirus. The Terra CoV-2 immunization leverages coronavirus spike protein research conducted by the National Institute of Health. In addition, Oragenics has an exclusive worldwide channel collaboration with ILH Holdings, Inc. (n/k/a Eleszto Genetika, Inc.), relating to the development of novel lantibiotics.

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