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Inovio Pharma Announces Interim Data For Covid-19 Vaccine Candidate; Stock Down

Inovio Pharmaceuticals Inc. (INO) announced positive interim clinical data of INO-4800, its vaccine candidate against novel coronavirus or SARS-CoV-2, from the first two Phase 1 clinical trial cohorts. INO-4800 regimen was deemed safe and well-tolerated with no serious adverse events. All reported adverse events were grade 1 in severity, the company said in statement.

However, in Tuesday pre-market trade, INO is trading at $28.20 down $3.49 or 11.01 percent.

In pre-clinical animal challenge study, INO-4800 provided full protection against SARS-CoV-2 replication in the lungs in mice challenged with the virus, the company said.

The Phase 1 clinical trial of INO-4800 initially 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. The participants were enrolled into 1.0 mg and 2.0 mg dose cohorts.

The company stated that 94% of Phase 1 trial participants demonstrated overall immune responses at Week 6 after two doses of INO-4800 in trial with 40 healthy volunteers in preliminary analyses.

One participant in the 1.0 mg dose cohort and two participants in the 2.0 mg dose cohort were excluded in the immune analyses as they tested positive for COVID-19 immune responses at study entry, indicating prior infection.

One participant in the 2.0 mg dose cohort discontinued the study for reasons unrelated to safety or tolerability.

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

In addition, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence.

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