Inovio Starts Dosing of COVID-19 Vaccine in Mid-Stage Study

Inovio has dosed the first participant in the phase 2 segment of its phase 2/3 trial evaluating COVID-19 vaccine candidate INO-4800, funded by the Department of Defense (DoD).

The phase 2 segment will enroll 400 adult participants at up to 17 U.S. sites to assess the vaccine’s safety, tolerability and immunogenicity as a two-dose regimen. The Plymouth Meeting, Pa., drugmaker plans to complete enrollment by month’s end.

In addition to funding the trial, the DoD awarded the company $71 million to support the manufacture of Inovio’s vaccine-administering smart device, CELLECTRA. However, the phase 3 segment remains on partial clinical hold until the company resolves the FDA’s concerns about the delivery device. Inovio said results from the study’s phase 2 segment should resolve any remaining questions.

Last week, Inovio announced a deal with Japan’s Kaneka for the large-scale manufacture of INO-4800, asserting the deal will enable the production of “hundreds of millions” of doses for worldwide distribution. Inovio also struck a manufacturing deal in September with Thermo Fisher Scientific for more than 100 million doses annually of INO-4800 and has secured distribution deals with Richter-Helm BioLogics and Ology Bioservices.

INO-4800 can remain stable for 30 days at 98.6 degrees Fahrenheit (37 degrees Celsius) and for over a year stored at room temperature, the company says. ― Jason Scott