Inovio to start mid-stage trials of its COVID-19 vaccine
The US FDA had put Phase 3 of the mid-to-late stage trial on hold, and sought more information, including details on a delivery device used to inject genetic material into cells
Inovio 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.
(Edits by EP News Bureau)