Inovio Pharmaceuticals Inc has received U.S. health regulator’s clearance to begin a mid-stage study of its COVID-19 vaccine candidate, the vaccine maker said on Monday.
The trial for the vaccine, INO-4800, will be funded by the U.S. Department of Defense, the company said.
The U.S. Food and Drug Administration in September 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 U.S. 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.
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