Plymouth Meeting, Pa.-based Inovio said in a news release yesterday that Thermo Fisher signed a letter of intent to manufacture the INO-4800 COVID-19 vaccine candidate, joining a consortium of third-party manufacturers that aim to produce 100 million doses of Inovio’s vaccine by 2021, subject to FDA approval.
Thermo Fisher is slated to manufacture the substance and perform fill and finish of the drug product at its U.S. commercial facilities, with a peak capacity estimated to reach at least 100 million doses annually.
The company joins Richter-Helm BioLogics and Ology Biosciences in Inovio’s global consortium. Inovio said in the release that it is engaged in active discussions with additional manufacturers for INO-4800.
“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 president & CEO Dr. J. Joseph Kim said in the release. “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.”
Leon Wyszkowski, President, Commercial Operations for Thermo Fisher’s Pharma Services business, said, “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,” added Thermo Fisher president of commercial operations for its pharma services business Leon Wyszkowski. “We remain extremely well-positioned to support INOVIO on its mission to manufacture 100 million doses of vaccine in 2021.”
In July, Inovio announced that it received $71 million from the U.S. Defense Dept. to support large-scale manufacturing for its Cellectra 3PSP smart device and the procurement of Cellectra 2000 devices, which are used to deliver its INO-4800 COVID-19 vaccine candidate directly into the skin in a matter of a few seconds.
The company is currently conducting a Phase I clinical trial for INO-4800 in the U.S. and plans to initiate its Phase II/III trials in September, should the FDA allow the company to proceed.