Oragenics Inc. (NYSEAMERICAN:OGEN) Has announced that it has received feedback from the FDA to its Type B Pre-IND Meeting Request. The response is in agreement with Oragenics’ planned clinical development approach for Terra CoV-2 its SARS-CoV-2 vaccines.
Oragenics within the schedule for vaccine development
Following the response, the company now believes that the timelines for Investigational New Drug application filing and the start of the first phase study are in the schedule. The company expects to file the IND application by the end of Q1 2021 and will commence the enrolment of patients in the first phase of a clinical study at the beginning of Q2 2021.
Alan Joslyn, the CEO, and president of Oragenics stated that they are delighted with the FDA’s response regarding the Type B Pre-IND meeting. This is because it now allows the company to maintain its aggressive development scheduled for its Terra CoV-2 vaccine candidate. Most importantly, the FDA offered feedback on the most vital aspects of the planned approach for developing the vaccine. He added that the FDA response was a huge milestone in its efforts to deliver a vaccine against SARS-CoV-2.
Oragenics’ vaccine can offer lifetime immunity against SARS-CoV-2
Oragenics’s vaccine candidate is based in stabilized prefusion spike protein, and it has a potential profile that includes lifetime immunity against COVID-19. The company obtained a non-exclusive license for the stabilized prefusion Terra CoV-2 spike protein in March 2020 from the NIH. in terms of Logistics; the vaccines can be stored and distributed at refrigerated temperatures. Joslyn said that they are optimistic that the commercial opportunity doe the vaccine will be strong and that Terra Cov-2 will find a place in fighting the virus globally.
Among the things that the FDA requested in the responses is more preclinical animal data in the IND application. There are also plans to offer final comments once they have received the animal data and protocols for phase one study. Most importantly, the company believes that more data will not derail the development timeline for the vaccine.