Inoivo Pharmaceuticals has received US FDA’s approval to commence a mid-stage study of its COVID-19 vaccine candidate.
The trial for the vaccine, INO-4800, will be funded by the US Department of Defense, the company said.
The US FDA, in September, had put Phase 3 of the mid-to-late stage trial on hold, as it sought more information, including details on a delivery device used to inject genetic material into cells. INO-4800 is administered through a device called Cellectra, which sends out an electrical pulse to open pores in a cell so DNA molecules can enter.
Phase 3 portion of the trial will remain on partial clinical hold until Inovio has satisfactorily resolved FDA’s remaining concerns, the company said.
In June, the US defense department granted $71 million to Inovio to scale up production of Cellectra. It has also agreed to provide additional funding for advanced clinical trials of the vaccine candidate, Inovio said.
Source : Express Pharma