Thanks to its global manufacturing consortium, biotechnology company INOVIO plans to manufacture 100 million doses of its COVID-19 vaccine candidate, INO-4800, in 2021.
The latest to join the consortium was Thermo Fisher Scientific earlier this week, which signed a letter of intent on the vaccine. Existing partners include Richter-Helm BioLogics and Ology Biosciences. Together, they will help INOVIO to scale commercial production of the candidate, subject to approval by the U.S. Food and Drug Administration (FDA).
“INOVIO welcomes Thermo Fisher to our global consortium of commercial scale vaccine manufacturers, and we look forward to partnering with them on this critically important endeavor,” INOVIO’s President and CEO J. Joseph Kim said. “Thermo Fisher’s global capabilities and scale will be central to our production progress – the organization’s commitment to quality, reliable production will be key to our ability to meet the urgent, global demand for a safe and effective vaccine against COVID-19.”
While INOVIO is actively courting other manufacturers to join the consortium, as a means to quickly and cost-effectively scale production of the DNA-based vaccine, it should be noted that INO-4800 itself remains in an early phase 1 clinical trial in the United States. Full trial results for the first 40 subjects were submitted to a peer-reviewed journal, and plans are underway to begin phase 2/3 trials in September.
So far, the vaccine has shown a favorable tolerability profile and long shelf life when refrigerated.
For Thermo Fisher’s part, plans are to not only manufacture the drug but to engage fill and finish operations at its U.S. facilities. That company alone believes that at peak capacity, it could produce at least 100 million doses of INO-4800 annually.
“INOVIO has truly embraced the value of our end-to-end capabilities – starting with our initial work on clinical trials through supporting their commercial needs today,” Leon Wyszkowski, president of Commercial Operations for Thermo Fisher’s Pharma Services business, said. “We remain extremely well-positioned to support INOVIO on its mission to manufacture 100 million doses of vaccine in 2021.”