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Inovio Pharmaceuticals Vaccine ‘Deemed Safe’ in Phase I Test

Inovio Pharmaceuticals said Tuesday that INO-4800, its experimental coronavirus vaccine, was “deemed safe and well-tolerated” in all 40 of the participants in a Phase I clinical trial.

The Phase I trial of INO-4800 enrolled 40 healthy adult volunteers 18 to 50 years of age at two U.S. sites with funding from the Coalition for Epidemic Preparedness Innovations.

Inovio said 94% of Phase I trial participants demonstrated overall immune responses “at Week 6 after two doses of INO-4800.

Through Week 8, the company said the “INO-4800 regimen was deemed safe and well-tolerated with no serious adverse events.

Three trial participants tested positive for COVID-19 at the study’s entry, indicating prior infection, and one left the study for non-clinical reasons.

INO-4800 has been selected to participate in a non-human primate challenge study as part of the Trump administration’s Operation Warp Speed, a new national program aiming to provide substantial quantities of a safe, effective vaccine for Americans by January 2021

In addition, Inovio said that in a preclinical animal study, INO-4800 provided full protection against coronavirus replication in the lungs in mice that were infected with the virus.

On Monday, H.C. Wainwright analyst Raghuram Selvaraju downgraded Inovio to neutral from buy without a price target.

The analyst said the company’s risk/reward balance “has increased significantly as many open questions remain.” These include the strength and duration of neutralizing antibodies and T-cell responses that may be generated in human trials and the effective protection the vaccine may demonstrate in animal challenge studies.

The recent share rally leaves “uncertain upside,” he said.

Inovio’s vaccine is among many candidates currently being tested in human trials against the potentially deadly lung disease. The U.S. Food and Drug Administration cleared the vaccine for testing in April.

Last week Inovio said it received $71 million from the U.S. Department of Defense to ramp production of the biotech company’s smart devices that administer INO-4800, into the skin.

At last check shares of the Plymouth Meeting, Pa., biotech were falling 9.2% to $28.78.