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Oragenics, Inc. (OGEN): Advancement of COVID-19 Vaccine Continues; IND Filing in 2021

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Oragenics, Inc. (OGEN): Advancement of COVID-19 Vaccine Continues; IND Filing in 2021
COVID-19 Vaccine Development Continues

Oragenics, Inc. (NYSE:OGEN) is developing TerraCoV2, a vaccine candidate against SARS-CoV-2 (the virus that causes COVID-19) that is licensed from the National Institute of Allergy and Infectious Diseases (NIAID). The vaccine candidate is targeted against the prefusion spike (S) protein found on the surface of SARS-CoV-2 (more details below). Since acquiring the rights to the vaccine candidate earlier in 2020, Oragenics has completed the creation of the antigen producing CHO cell line, with purification methods currently under development. In addition, we anticipate the company announcing a deal for an adjuvant to be used with the vaccine in the first quarter of 2021. We also anticipate the completion of various preclinical studies during the first quarter of 2021 that will include mouse immunogenicity studies and hamster challenge studies. Currently, we estimate that the company will file an IND for TerraCoV2 by the end of the second quarter of 2021, with a Phase 1 clinical trial initiating in the third quarter of 2021. The Phase 1 trial will likely take 8-10 weeks to perform and will examine a number of dosing parameters for the vaccine, including the potential for a single dose, which is in contrast to the two doses necessary for the leading vaccine candidates. A successful Phase 1 trial could potentially lead to a Phase 2/3 trial initiating by the end of 2021.

Oragenics, Inc. is focused on the discovery, development and commercialization of a range of technologies associated with oral health, antibiotics and other general health benefits.

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