Inovio Pharmaceuticals Inc (NASDAQ: INO) Shares moved lower on Tuesday after the vaccine maker released interim Phase 1 data for the study evaluating its INO-4800 DNA vaccine against SARS-CoV-2, the virus that causes COVID-19.
Safety readings, provisional efficacy of Phase 1 of Inovio: Announcing the results of the first two cohorts of the Phase 1 trial, the Plymouth, Pennsylvania-based biotechnology said multiple immunology trials showed that 94% of participants demonstrated overall immune response rates.
The reading includes humoral and cellular immune responses made for the 1 mg and 2 mg dose cohorts after two doses at week six.
Vaccines were administered intradermally using the Inovio 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 the start of the study, suggesting previous infection. One was discontinued for reasons unrelated to safety or tolerability.
INO-4800 was generally safe and well tolerated, and the 10 reported adverse events were of low severity and mostly local redness at the injection site, Inovio said.
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Inovio joins Operation Warp Speed: The company said it has been selected to participate in a study on the challenge of non-human primates as part of the United States government’s “Operation Warp Speed”.
INO-4800 is also being tested in a ferret challenge model.
The following for Inovio: Inovio said he 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 to additional cohorts, the company said.
The company reaffirmed its schedule for a Phase 2/3 trial, which is expected to start this summer, depending on regulatory approval.
INO price action: Inovio’s shares were falling 11.24% to $ 28.13 at the time of publication on Tuesday, apparently due to investor disappointment at the lack of information on things like neutralizing antibodies.
Related links:
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