Inovio Pharmaceuticals CEO on Vaccine Development

so much for waiting while we listen to the president. Um. First of all, that headline from Maderna, what's your take on it all? I think it's great progress for the field for developing a vaccine, successful vaccine against COVID nineteen disease. So there's many companies like Inovo and others for blazing the trail just in the last six months or so, trying to make history and in developing several vaccinies UH that can be approved to be used both safely and

effectively against this horrible pandemic. So tell us where you are and what you've learned so far. Dr Kim, Yes,

absolutely so. We just reported on the preliminary data in our first clinical study involving forty healthy volunteers UH in the ages of eighteen to fifty UH, and we demonstrated very strong safety one of the safest vaccine platforms UH in this COVID nineteen race, and also demonstrating greater than of our participants having strong overall immune responses in a balanced way, both in UH antibody responses as well as having PI cell responses, which is another arm of the

immune system that is very important for protecting again sparrow disease. Dr KIM. When that came out, that was a couple of weeks ago, and you're you know, investors certainly reacted to it a steeple, analyst said. Investors are likely to focus on the paucity of information in the release, which

may raise more questions than answers. When are you going to publish your peer reviewed immune response data and and where will you will you publish it at any update and when larger trials will start here, Yeah, the second part of that question. First, So we're looking to start our phase to slash three efficacy trials upon getting regulatory

concurrence this summer. So we're still on track for that. UH. In terms of the Phase one data, we are as we stayed, looking forward to publishing it in a peer reviewed UM publication, hopefully in the next a few weeks as well. So when you think about the timeline here, Dr Kim, what is a reasonable timeline to get your first vaccine available for use? And I think everyone wants

to know when it will be widely available? Yeah, you know, UH in no view as well as other companies are racing against as farest UH to bring us Safe and Affective Act into the public as soon as possible. That all depends on how well the trials go in Phase two and Phase three stafies UH and demonstrating true efficacy and safety of the vaccine. UH. The FDA just released a guidance documents to the industry which provides their thoughts

on what it's going to require. And you know, it's it's it's certainly as rapidly as we're running UH all of us. There's dozens of companies around the world trying to get the vaccine. It's gonna take some time, but I think there's been a lot of incremental successes in Phase one and and many companies going into Phase two, including our plans at inovo is a twenty twenty wide release too much to hope for. Well, I think that's a goal, and that certainly is an aspiration that many

of us in the field have. It really depends and and and ironically it also depends on how bad infection is around us. Uh. You know, that would put a pressure or balance to the benefits and the cost of having a vaccines set of vaccines approved earlier. Conditionally, I mean, these are the things that the FDA and their policymakers

will have to to decide on. What we focused on a Inobio and I'm assuming other companies as well, is to execute the next steps in the development, so next trials, next testing, so that we will be in a proper position to get the vaccines approved, uh, through this gauntlet. You know, it typically takes up to ten years or

longer to get a vaccine approved. And everyone started or you know, from from day one at the same place in January, so you know, we're we're moving in a historical pace, but it's never fast enough because there are people dying every day. You said, though, how bad the infection is around us will determine potentially, I guess how regulators how quickly they want to move things along. If we don't see a second surge or off cases seem to die down, does this whole movement of finding a

vaccine slowed down as well globally? Well, that's that's always a potential, and certainly that would be great for the society. Um but as we're in the middle of still the first wave and there's many experts predicting the second wave, all we can do as vaccine developers focused on our objective, which is to test properly the safety and advocacy of the vaccine and be ready when we're called upon. Some of your peers have received larger government funding or significant

amount of funding. What about for you, guys, do you see getting any additional funds from the government. Well, I think absolutely. I think Udobio has already received extensive external funding from US Department of Defense just recently a couple of weeks ago, as well as from the Bill and

Melinda Gates Foundation and SEPPI in the past. As we events are program as re gu upe for massive manufacturing readiness or a vaccine, and we expect, uh you know, we are also to receive commensary levels of funding support, and certainly US government is a major part of that. So when you think about the nuts and bolts of this, Dr Kim, I know a lot of people are wondering, is this going to be one shot? Is it going

to be two shots? Is this going to be something that we get once and maybe a booster and then we're good to go, or is this a seasonal thing? What do we know so far? Knowing that there's a lot more to learn, What do you know so far? Yes, most likely, I mean up to date information. Is the natural infection, the immune responses wign very quickly, so if you take us any guy, looks like the vaccines may

have to be those and boosted annually. UM. So I think having a safevaccine that can be repeatedly those over time it becomes even more important, not just the initial those things, but having a vaccine that can safely treat for several years to come until this pandemic subsize and disinfection goes away is something that's very important for us as vaccine developers. And so just so I make sure

I understand what you're saying. So you're saying probably two shots once a year, potentially potentially, Well, it's certainly the initial Most of the vaccines are are two doses initially, and I could predict that potentially a booster shot every

year certainly is a possibility. You know, there's so many of you, the biotech and pharmaceutical companies going after a vaccine, and the potential certainly is great in terms of how we can deal with this, But it's also you know, coming up with a product, and I do wonder how much collaboration versus competition is going on, uh in the community. Well, there's unprecedented levels of collaboration, big companies, small companies together

collaborating on assays, manufacturing. There's certainly efforts where we're not competing necessarily with one another, we're actually competing against this virus that's taken so many lives already and and really no end in sight. So we all realize having multiple successful vaccines on the market is going to be the only way to really control this pandemic and disinfection. So I think we all take that at hard and try

to collaborate and work there as much as possible. But at the end of the day, we were hopeful that there will be multiple vaccines that are approved. Just got about when you say multiple vaccines because the virus is there's variations of it. Is that why, well, there's there's really no capacity for even the largest vaccine manufacturers to deal with the global demand the first few years. That's

number one. Number Two, Um, as we have seen the virus mutate, so there may be advantages of one vaccine over the other. Number three, there may be other advantages of stability of the vaccine, the transportation. Uh, you know inobios vaccine doesn't have to be kept in a frozen condition. We can just deliver in a room temperature, which is a huge advantage over other platform vaccines. And lastly, the boosting, So you may need a booster vaccine that can be

booster over and over again. Uh. Some vaccines are more poised to do that, like innobios vaccine. Al Right, Well, we really appreciate your time and best of luck. Um. I think it's safe to say we're all counting on you in many ways and the great work that you and your colleagues are doing. As you say, dozens of companies uh fighting this. It's a race against the virus. So we appreciate you. Dr Joseph Kim, President CEO of an Ovio Pharmaceuticals, joining us on the phone,