Benzinga | Jul 22, 2020 07:35AM EDT

Oragenics Says Preclinical Study Shows SARS-CoV-2 Spike Protein Licensed By Co. From NIH Produces Neutralizing Antibodies

Recently published paper supports the Company's approach to COVID-19 vaccine development

TAMPA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE:OGEN) ("Oragenics" or the "Company") announces that the National Institutes of Health (the "NIH") created stabilized pre-fusion spike protein (CoV-2 S-2P) licensed by the Company has generated neutralizing antibodies in mice during immunization against SARS-CoV-2, the virus that causes COVID-19.

The NIH's preclinical study shows that this spike protein, adjuvanted with the TLR-4-agonist Sigma Adjuvant System (a TLR-4 agonists that induces T cell activation), generates neutralizing antibody titers in both a pseudovirus neutralization assay and a plaque reduction neutralization titer (PRNT) assay. In addition, this immunization produced a balanced Th1/Th2 response. The results are reported in Corbett et al. BioRxiv. 2020 ( https://www.biorxiv.org/content/10.1101/2020.06.11.145920v1).

"We are delighted that our licensed SARS-CoV-2 spike protein has been shown to hold promise in the creation of a COVID-19 vaccine, and believe this research affirms our development strategy with the Company's lead vaccine candidate, Terra CoV2," said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics. Dr. Joslyn continued, "We are particularly pleased to see a balanced Th1/Th2 response, which is one of the most critical parameters used to assess both safety and efficacy of this vaccine candidate. TerraCoV2 is currently undergoing development and we anticipate conducting Phase 1 human clinical studies in early 2021."

In March 2020 Noachis Terra Inc., a wholly owned subsidiary of Oragenics, acquired a non-exclusive license from the NIH for this stabilized prefusion CoV-2 spike protein. The Company recently announced that its spike protein has been successfully inserted into Chinese Hamster Ovary ("CHO") cells and "mini-pool" production and analytical development are underway. CHO cells are used to produce a number of FDA approved recombinant proteins. The transfer to full scale manufacture is expected to commence pending a grant from the Biomedical Advanced Research and Development Authority (BARDA).