The company plans to file an investigational new drug (IND) application for Terra CoV-2 by the end of the first quarter of 2021 and to begin a phase I study in the second quarter, it said. The FDA has requested that Oragenics include additional preclinical animal data in its IND, according to the firm.

Oragenics acquired a nonexclusive license for Terra CoV-2 from the U.S. National Institutes of Health (NIH) in March.

Allele Biotech supports COVID-19 vaccine manufacturing
Allele Biotechnology and Pharmaceuticals' current good manufacturing practices-grade induced pluripotent stem cells are being used as packaging factories...

Moderna touts positive vaccine results in older populations
Results from Moderna's phase I clinical trial indicated that its candidate for a COVID-19 vaccine, messenger RNA (mRNA)-1273, is well-tolerated and generates...

Passive vaccines with mAbs may be effective for COVID-19
Monoclonal antibodies (mAbs) isolated from the blood of recovered COVID-19 patients -- known colloquially as "convalescent plasma" -- could be potentially...

FDA halts Inovio COVID-19 vaccine trial
The U.S. Food and Drug Administration (FDA) has halted Inovio's clinical trial of its COVID-19 vaccine candidate, INO-4800.

Nonprofit seeks COVID-19 vaccines for most vulnerable
The nonprofit consortium Human Vaccines Project has launched an initiative to ensure COVID-19 vaccines are developed for vulnerable populations.