Oragenics, Inc. (OGEN) Updates on its potential COVID-19 Vaccine, expects to file an IND in 2021


The biotechnology firm is developing its vaccine candidate against SARS-CoV-2. Oragenics anticipate the Phase 1 trial of TerraCoV2 beginning in mid-2021 following the approval in 2023.

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Shares of Oragenics, Inc. (OGEN) made a strong movement on Wednesday following the Zacks Small-Cap Research that revealed OGEN’s plans and development of its novel COVID-19 vaccine candidate, TerraCoV2.

OGEN stock soared as high as $0.64 before closing the day at $0.48 up by 16.21%.The trading volume was also high above 112 million compared to the average volume of 4.4 million.

The company is developing TerraCoV2 that is already licensed from the National Institute of Allergy and Infectious Diseases (NIAID). The vaccine is based on the main idea of fighting against the prefusion spike (S) protein found on the surface of the SARS-CoV-2 virus. TerraCov2 creates an antibody directed against the spike S protein.

Earlier in 2020, Oragenics acquired the rights to the vaccine candidate, and thus far, it has obtained the basic antigen that produces the CHO cell line. While, the purification methods are under development.

The company also intends to make a deal for an adjuvant that will be part ofthe vaccine and is expected to be announced in the first quarter of 2021. The IND filing for TerraCoV2 is anticipated by the end of the first half of 2021 and following that imitation of the Phase 1 trials in Q3.

The Phase 1 trials will be performed during a time period of 8 to 10 weeks. Oragenics will inspect the total number of dosing parameters that will include single dose potential in comparison with double dose potential. If the company obtains these results in the initial trials it then expects to move to a Phase 2/3 trial beginning by the end of next year.

The company expects the approval of TerraCoV2 in 2023 for its official commercial use. Where Pfizer and Moderna are leading the race to COVID-19 vaccine and expect it to launch by the end of 2020, Oragenics believe that their vaccine will be a post-pandemic vaccine. The people could then take advantage of Oragenic’s potential vaccine.

Moreover, the company also looks forward to some other preclinical studies being completed in the first quarter of next year. The other studies include hamster challenge studies and mouse immunogenicity studies.

Oragenics, Inc. (OGEN) values itself on the basis of TerraCov2, OG716, the cash on hand, and possible cash from warrant exercises. The core focus remains on the vaccine trial initiation and make it successful increasing its market growth.


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