Inovio Pharmaceuticals (INO -3.05%) recently reported encouraging results from a phase 2 study of its COVID-19 vaccine candidate INO-4800. However, the company lags well behind the current leaders in the COVID-19 vaccine market. In this Motley Fool Live video recorded on May 12, Motley Fool contributors Keith Speights and Brian Orelli discuss Inovio's latest clinical results.
Keith Speights: Inovio Pharmaceuticals reported its phase 2 results for its COVID-19 vaccine candidate, INO-4800, earlier this week, Brian, what were the highlights from Inovio's results? Do you think this might be a case of the biotech simply being too little and too late to make a difference in the COVID vaccine race?
Brian Orelli: The phase 2 trial was measuring antibodies, they are not measuring the efficacy of whether it protects people against COVID-19. That wasn't the purpose of the phase 2 part of the trial. It did produce more antibodies, a higher level of antibodies, in the higher dose than in the lower dose, so that's exactly what you would expect. The same thing for T-cells. Produced more T-cells in the higher dose than the lower dose.
On the safety side, the company noted that the side effects weren't worse for the second dose than the first dose. That's actually interesting and could potentially maybe give it an advantage over Pfizer and Moderna that seem to have pretty strong side effects on the second dose that was mild, but a lot of people have them. We're planning on taking the higher dose into the phase 3. Unfortunately, the company didn't give any updates for how it plans to carry out the phase 3. I'll stop short of saying too little or too late, but maybe it was too little data, certainly not enough to gain approval.
Whether they're too late depends on whether Inovio can figure out how to run a phase 3. They need to find a region that doesn't have access to vaccines and a high rate of COVID-19 to run the phase 3 clinical trial. Then if they do that, the question is, will the FDA accept the vaccine for authorization or maybe even for approval if they're running a clinical trial outside the United States. Those are questions that investors in Inovio need to figure out in trying to value the company. It's how can they run a phase 3, and then if they can run a phase 3, can they get authorization or approval in the United States?
Speights: You and I have talked before about Inovio and some of the other vaccine makers that aren't in the lead positions, that they may have an easier time getting authorizations and marketing their vaccines outside of the U.S.
Orelli: I don't know if that's going to be the inevitable thing for Inovio. I mean, it's interesting because I don't think that if you develop a new flu vaccine, I'm not sure that you have to show efficacy or whether you just have to show antibodies. Maybe at some point when we get into the point where we're no longer in a pandemic, maybe companies can develop coronavirus vaccines based solely on the ability to create antibodies.
Speights: I think you could very well be right. There might be at least another year or so before we get to that point, but it wouldn't surprise me that something happens exactly along the lines of what you're saying.