FDA Lifts Partial Clinical Hold On Inovio’s Phase 2 Investigational Coronavirus Vaccine Study
Inovio Pharmaceuticals Inc (NASDAQ: INO) shares are higher after an update issued by the company on its investigational coronavirus vaccine.
What Happened: Pennsylvania-based Inovio said the FDA has issued clearance for the commencement of the Phase 2 segment of the Phase 2/3 study of its DNA vaccine candidate, codenamed INO-4800, against SARS-CoV-2.
In late September, the company said the FDA imposed a partial clinical hold on the Phase 2/3 study as well its Cellectra 2000 delivery device.
“The FDA’s authorization to proceed is based on its review of INOVIO’s non-clinical data, device information and interim Phase 1 safety and immunogenicity data as well as its design and plans for the Phase 2 and Phase 3 …