What happened
Actions of Inovio Pharmaceuticals (NASDAQ: INO) they sank 11.8% less as of 11:01 am EDT on Tuesday. The decline came after biotechnology announced interim results from an early-stage clinical study of the COVID-19 INO-4800 vaccine candidate. Inovio referred to the data as “positive”. However, industry observers did not think the company revealed enough information to draw meaningful conclusions about the efficacy of the experimental vaccine.
And that
Inovio stated that 94% of the 40 participants in their early-stage study “demonstrated general immune responses” six weeks after receiving two doses of INO-4800. However, the problem is that biotechnology did not provide any details on how many patients produced neutralizing antibodies. These antibodies prevent infection by the new coronavirus.
It even seemed that Inovio might be trying to minimize the importance of neutralizing the antibodies. In the company press release announcing the interim results for Phase 1 for INO-4800, Inovio referenced two studies published earlier this year that found that between 33% and 40% of people who recovered from COVID-19 had low levels of neutralizing antibodies.
Investors appear to be concerned that INO-4800 may not be as effective as other COVID-19 vaccines in development. ModernFor example, it disclosed information on the number of patients producing binding antibodies and neutralizing antibodies in its interim phase 1 results.
However, security did not appear to be a serious concern for INO-4800. Inovio reported that the experimental vaccine was “generally safe and well tolerated in all participants.” 10 adverse events were reported. Each was grade 1 in severity, the lowest severity level. Most were related to redness at the injection site. Inovio said no serious adverse events were reported.
Now what
Inovio hopes to begin a phase 2/3 clinical trial evaluating the efficacy of INO-4800 this summer, assuming the FDA gives it the green light. INO-4800 has also been selected to be part of a preclinical trial funded by Operation Warp Speed, the US government’s program to rapidly develop a COVID-19 vaccine. However, the biotech stock could be highly volatile until investors are more comfortable with the efficacy of the Inovio coronavirus vaccine candidate.