The FDA has given Inovio Pharmaceuticals the green light to get back into its groove with a COVID-19 vaccine trial in the U.S.
The agency paused the phase 3 trial in September due to concerns with the drug delivery device the company is using for its candidate, INO-4800. Developed with DNA plasmid, the vaccine dose is delivered intradermally, and then a proprietary smart device, Cellectra 2000, uses quick electric pulses to deliver the genetic material directly into the body’s cells.
Since the trial was paused in the U.S., Inovio has expanded its phase 3 operations for the vaccine in several other countries including China, Brazil, Mexico, Thailand and more.
“We are pleased to have the opportunity for U.S. clinical trial participants to potentially contribute to the enrollment in our INNOVATE phase 3 segment,” Dr. J. Joseph Kim, INOVIO's President and CEO, said in a statement.
News of the FDA’s decision to lift the clinical trial hold bumped Inovio’s stocks up by 4.6% in pre-market trading.
