Inovio Pharmaceuticals (INO) shares rose Monday after the biotech was cleared by the U.S. Food and Drug Administration to begin testing its DNA vaccine for the coronavirus.
The first Phase I trial for the drug, INO-4800, will involve 40 healthy volunteers. The first dosing is set for today.
“Preclinical data, which have been shared with global regulatory authorities and submitted as part of the [investigational new-drug application], have shown promising immune-response results across multiple animal models,” the Plymouth Meeting, Pa., company said in a statement.
Each participant in the trial will receive two doses four weeks apart, with results expected by late summer.
"This is a significant step forward in the global fight against covid-19,” Chief Executive Joseph Kim said in the statement.
“Without a new safe and effective vaccine, the covid-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA-medicines platform to rapidly develop and advance a vaccine for covid-19 into Phase I clinical testing.”
The Coalition for Epidemic Preparedness Innovations, based in Oslo, is paying for Inovio’s testing. CEPI itself is funded by public, private, philanthropic and civil society organizations.
Inovio last month was downgraded by two analysts - RBC Capital and Piper Sandler - while Maxim analysts upgraded their share-price target.
RBC Capital analyst Gregory Renza, who downgraded Inovio to sector perform from outperform, said it was too early to count on the new vaccine. But he’s still positive on the company's overall DNA-based platform.
At last check, Inovio shares stood at $8.18, up 5.7%.