FDA broadly supports Oragenics’ Pre-IND development programme for SARS-CoV-2 vaccine

Oragenics, Inc. announced receipt of feedback to its Type B Pre-IND Meeting Request from the U.S. Food and Drug Administration (“FDA”) that it is in broad agreement with the Company’s planned approach to clinical development of its SARS-CoV-2 vaccine, Terra CoV-2.

As a result, the Company believes its timelines for both filing an Investigational New Drug (“IND”) application and the commencement of the Phase 1 study will proceed on schedule.

Oragenics expects to file the IND by the end of the first quarter of 2021 and commence patient enrollment in the Phase 1 clinical study early in the second quarter of 2021.

“We are very pleased with the FDA’s response to our Type B Pre-IND meeting request as it permits us to maintain an aggressive development timeline for our Terra CoV-2 vaccine,” said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics. “Important points that are supportive of our planned approach received favorable feedback.”

Dr. Joslyn added, “The FDA’s response is an important step as we work to provide a vaccine against SARS-CoV-2 that is focused on the stabilized prefusion spike protein, with a potential profile that may include lifetime immunity to COVID-19, and storage and distribution at refrigerated temperatures. We believe the commercial opportunity for Terra CoV-2 is robust, and that our vaccine will find its place in the global fight against this deadly virus.”

The FDA has requested additional preclinical animal data for inclusion in the IND filing and plans to provide final comments upon reviewing that data and the Phase 1 trial protocol. Oragenics believes that generating the additional data will not impede the overall development timeline.