The regulatory body asked for more details on a device used to inject genetic material into cells. The company said it would answer the questions in October
September 28, 2020 Share on FacebookShare Share on TwitterTweet Share on WhatsAppShare
A medical syringe prior to a human trial of the COVID-19 vaccine conducted at the Wits RHI Shandukani Research Center in Johannesburg, South Africa, on August 27, 2020. REUTERS / Siphiwe Sibeko
The U.S. health regulator has suspended Inovio Pharmaceuticals' plans to begin final testing of its coronavirus vaccine as the agency seeks more information , including details about a delivery device used to inject genetic material into cells.
Shares of Inovio , the second-best performing stock on the Nasdaq Biotech Index this year through Friday's close, plunged 33% before the opening bell . The company expected to begin the trial this month.
The drug's developer said Monday that the US Food and Drug Administration's “partial clinical suspension” was not due to any side effects in its initial study of the vaccine, which continues.
REUTERS / Dado Ruvic
Inovio said it would answer questions from the FDA in October , after which the US agency would have 30 days to decide whether the trial should continue.
The company planned to administer the vaccine to study participants through a battery-powered device called Cellectra.
Inovio inoculation uses DNA to instruct the cells of the body to produce proteins that elicit a protective response. Cellectra 2000 is an electroporation device that uses brief electrical pulses to create tiny openings in cells that allow injected genetic material to enter more easily.
It has received $ 71 million in funding from the US Department of Defense to expand Cellectra manufacturing.
In June, the company reported encouraging results from the early-stage human trial of its experimental coronavirus vaccine, INO-4800. The study on 40 healthy volunteers found that 94% of the trial participants demonstrated general immune responses at week six after two doses of the vaccine.
In August, it said it would begin testing INO-4800 in the mid-to-late-stage study after obtaining FDA approval to begin the trial.
Inovio's development timeline already lags behind rivals such as Moderna , Pfizer and AstraZeneca, all of which have begun late-stage studies of their coronavirus vaccine candidates.