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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 segments of the planned clinical trial," the company said.
In early November, Inovio confirmed to Benzinga it had submitted its response to the FDA in October and was awaiting word from the regulatory agency.
Phase 2 Trial Design: The mid-stage study, dubbed INNOVATE, is structured as a randomized blinded, placebo-controlled study to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen, ie 1 mg or 2 mg.
This would help to confirm the more appropriate dose(s) for each of three age groups with high risks of infection, namely 18-50 years, 51-64 years and 65 years and older) for the subsequent Phase 3 efficacy evaluation.
The Phase 2 study will enroll about 400 participants at up to 17 U.S. sites.
Phase 3 Study Remains On Hold: The Phase 3 portion of the study continues to remain on partial hold until questions regarding the Cellectra device meant to deliver the DNA vaccine directly into the skin are addressed, Inovio said.
DoD funding: The Phase 2 and Phase 3 segments are being funded by the Department of Defense. This is in addition to the $71 million funding announced in June for largescale manufacturing of Cellectra 3PSP smart device and the procurement of Cellectra 2000 devices.
In pre-market trading, Inovio shares were surging up 15.51% to $12.96. The stock came under significant selling pressure early last week but has cut some of the losses over the course of the week.
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