Inovio Pharmaceuticals Inc (NASDAQ: INO) shares were moving to the downside Tuesday after the vaccine maker released interim Phase 1 data for the study that is evaluating its DNA vaccine INO-4800 against SARS-CoV-2, the virus that causes COVID-19.
Inovio’s Interim Phase 1 Efficacy, Safety Readouts: Announcing results from the first two cohorts of the Phase 1 trial, the Plymouth, Pennsylvania-based biotech said multiple immunology assays showed that 94% of participants demonstrated overall immunological response rates.
The readout includes humoral and cellular immune responses conducted for the 1 mg and 2 mg dose cohorts after two doses at week six.
The vaccine shots were administered intradermally using Inovio’s Cellectra 2000 device.
The Phase 1 study enrolled 40 healthy adult volunteers ages 18-50 at two sites. Three participants had to be excluded from the immune analysis, as they tested positive for COVID-19 immune responses at study entry, suggesting prior infection. One was discontinued for reasons unrelated to safety or tolerability.
INO-4800 was generally safe and well-tolerated, and the 10 adverse events that were reported were low in severity and mostly local injection site redness, Inovio said.
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Inovio Joins Operation Warp Speed: The company said it has been selected to participate in a non-human primate challenge study as part of the U.S. government’s “Operation Warp Speed.”
INO-4800 is also being tested in a ferret challenge model.
What’s Next For Inovio: Inovio said it plans to publish the full data set from the Phase 1 study in a peer-reviewed medical journal.
The Phase 1 trial is now expanded to add older participants in additional cohorts, the company said.
The company reaffirmed its timeline for a Phase 2/3 trial, which is expected to start this summer, contingent upon regulatory clearance.
INO Price Action: Inovio shares were tumbling by 11.24% to $28.13 at the time of publication Tuesday, apparently due to investor disappointment over a lack of information on aspects such as neutralizing antibodies.
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