Benzinga | Aug 20, 2020 08:37AM EDT

Oragenics Signs Process Development and Manufacturing Agreement With Avid Bioservices for Coronavirus Vaccine

Avid Well Positioned to Meet Significant Scale-Up Requirements for NIH-Licensed SARS-CoV-2 Spike Protein Vaccine Candidate

Oragenics, Inc. (NYSE:OGEN) and Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), today announced that the companies have entered into a process development and drug substance manufacturing agreement. Under terms of the agreement, Avid will provide Oragenics with analytical method development, process development and drug substance manufacturing services to support development of Oragenics' 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.

"Avid specializes in recombinant protein production, a critical component in the development and potential commercialization of our lead coronavirus vaccine candidate, Terra CoV-2," said Alan Joslyn, Ph.D., president and chief executive officer of Oragenics. "With Avid's existing manufacturing infrastructure, which includes three 2000L single-use bioreactors and considerable space for expansion, they are the right manufacturing partner to scale-up to the significant levels of bulk vaccine substance that would be required to combat COVID-19, should our vaccine be approved by regulatory authorities."

"We are delighted by Oragenics' selection of Avid Bioservices to provide essential CDMO services to support the company's development of its COVID-19 vaccine candidate. As the COVID-19 pandemic continues to have a tremendous impact around the world, there is a critical need for reliable, high-quality development and manufacturing services for potential vaccines that may offer protection against the novel coronavirus. At Avid, we believe that our 27 years of experience in manufacturing complex biologics and track record of excellence in meeting customers' CDMO needs positions us to make an important contribution to the global coronavirus response," said Timothy Compton, chief commercial officer of Avid.

About Terra CoV-2

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.