On Aug. 20, 2020, Oragenics and Avid Bioservices announced a process development and drug substance manufacturing agreement. Avid will provide Oragenics with analytical method development, process development and drug substance manufacturing services to support development of Oragenicsﾒ novel SARS CoV-2 (COVID-19) spike protein vaccine candidate, Terra CoV-2.

Avid and Oragenics will immediately commence the initial phase of the project, which includes analytical method feasibility and qualification activities. Following completion of these initial activities the companies plan to advance to upstream and downstream process development and CGMP drug substance manufacturing of Terra CoV-2 within Avid’s state-of-the-art Myford facility. These activities are designed to support Oragenics’ goal of advancing its Terra CoV-2 vaccine candidate into human clinical trials by early 2021.

In March 2020, Oragenics, acquired a non-exclusive license from the National Institutes of Health (NIH) for its stabilized prefusion Terra CoV-2 spike protein. Oragenics recently announced that its spike protein had been successfully inserted into Chinese Hamster Ovary (“CHO”) cells and “mini-pool” production and analytical development are underway. CHO cells are used to produce a number of FDA-approved recombinant proteins.