Steve Clemons: Welcome to The Hill’s Coronavirus Report. I'm Steve Clemons, editor-at-large of The Hill. Each day we are interviewing consequential leaders and innovators in the battle against the coronavirus. The global race to a vaccine to fight and neutralize SARS-Cov-2 virus is right at the top of the list of national security priorities for nations all around the world. That race is not only happening here in America, but global organizations such as the Coalition for Epidemic Preparedness Innovations, or CEPI, is helping to fund innovative approaches internationally. In the second edition of the Coronavirus Report, we had an intense discussion with Luc Debruyne, one of those who helped establish and now advises CEPI. The Gates Foundation has also been a pivotal funder for new approaches that might hold the answer to fighting off COVID-19. One of the recipients of awards from both CEPI and the Gates Foundation and also now a recipient of funding from the Department of Defense and an acknowledged part of Operation Warp Speed, which we've discussed many times on this show, is in INOVIO Pharmaceuticals. INOVIO is one of those firms out there taking a novel approach to vaccines and creating a DNA-based vaccine, which, as of yet has not been approved by the FDA. But that company has a DNA-based vaccine in phase three trials that attacks pre-cancerous HPV cervical lesions and progress on this front would be revolutionary for many who suffer from that cancer. INOVIO has built its COVID-19 [vaccine] candidate, INO 4800, on the revolutionary success in a previous vaccine, INO 4700, designed to fight MERS. Today we have the senior vice president for research and development, Dr. Kate Broderick, here to walk us through what a INOVIO’s contribution to the vaccine race might look like and what we should expect from this new technology platform.
Dr. Broderick, welcome. I hope I got all of that right causes a lot of this is new language for me. It's also new language for a lot of those people watching. Every day we see you know it sort of Chinese water torture — we get a little bit more on vaccine, who’s up? Who’s down? Can you explain to our audience the unique approach that in INOVIO is taking to try and establish a very revolutionary way to deliver new vaccines.
Kate Broderick: Yes, absolutely. Steve, Thank you. So just to kind of set the scene, and historically, if we'd wanted to generate a vaccine, we would be talking kind of a minimum of three to 10 years realistically to come up and have an approved vaccine. Now, clearly, unfortunately, with the circumstances we’re in at the moment, we don't have that length of time. So really we’re now sort of pivoting to look at new technologies that are able to kind of change that paradigm. And the technology we've developed at INOVIO is one of those next generation approaches that so perfectly positioned to really meet the needs of this pandemic outbreak. As you quite rightly mentioned, Steve, in your intro, we use DNA. So instead of using the virus itself for a protein, were using just a small part of the genetic sequence of the virus. And that allows us to really rapidly design and manufacture a vaccine and have it tested. And just to give you an example: We actually went from designing the vaccine itself to testing our vaccine in the clinic within 83 days. That's really absolutely unprecedented for us.
Clemons: I had spoken to, as I mentioned, Luc Debruyne, not only for the Coronavirus Report, but before CEPI was established. And he said we need to have more instant-respond-platform capacity to take on the pathogens that are coming to us. And one thing I've learned in this Coronavirus Report is not only did many politicians and scientists — Dr. Fauci and others — fear exactly this kind of pandemic coming, they worry about other zoonotically transferred, passed, viruses coming to attack humans. Are we talking then about your technology not only for this vaccine, but — you're essentially creating a platform.
Broderick: Absolutely. And that's completely key at the moment, Steve. As much as we're so laser focused on the current situation with COVID, we really can't lose sight of the fact that, there was a Zika outbreak … there was MERS, SARS. This is not a one off and it will continue to, unfortunately, happen in the future. So now we need to learn. We need to meet the pressing need right now, but also think about the future and how to apply this technology moving forward.
Clemons: Now, one of the critiques that I've seen out there — and I have no way to measure whether this is true — is that some vaccine-makers and developers are trying to get robust responses and T cells and things in our body that fight the virus at more robust levels faster than they argue the DNA platform is doing. Does that critique have any founding, any grounding? Or is that an incomplete read of what's going on?
Broderick: I would say, respectfully, an incomplete read of what's going on. If anything, I actually think that the DNA and platform that we've developed here at INOVIO has the ability to generate incredibly diverse immune responses. And we should remember, Steve — and this might not be comfortable for everybody here — but there's still an awful lot we don't know about the SARS-CoV-2 virus. And so when we're trying to design a vaccine that's going to protect essentially the entire population of the globe, we need to come up with vaccines that have very broad profiles when it comes to immune responses. And INOVIO’s platform really does that. But we also mustn't lose sight of the fact that that vaccine has to be safe and have a really rigorous safety profile. So those two components are absolutely key to moving an appropriate vaccine forward.
Clemons: Now you've had, as I understand it, a phase one completed and phase results released, and I think they're probably two parts of release. I read the press report, but now there's something of a peer-reviewed article coming. And I don't know what you're allowed to share, but I mean, how comfortable, how robust were those results?
Broderick: Yeah, you're absolutely right. So, we are going to be submitting that data to a peer-reviewed journal, which as a scientist that's the right thing to do. It should be peer reviewed by fellow scientists before it's released to the public. And I am extremely excited and encouraged by the data that we've generated in this. It was a small phase one trial. But it definitely is pointing in the absolute direction of a completely safe vaccine, which is something that's so important, but also a vaccine that's able to generate each one of these component immune responses that we believe are going to be absolutely critical to the ability of a vaccine to protect against COVID-19.
Clemons: Dr. Broderick, one of the other elements that I was intrigued with your company is, a lot of times in this report and really in the media today in America we’re focused on America, we’re focused on American firms, American companies. And this is hitting everywhere around the world. Some of your own funding has come from international sources, and you have international partnerships like in South Korea. And my understanding is you have a phase one — I get the phases mixed up … trial going on in South Korea. What is the state of the international ecosystem of research right now? Because I sort of see nationalism rising, a kind of law of the jungle out there. How healthy or not is the research base internationally right now, in fighting COVID and your own company?
Broderick: I would definitely say if there's one positive element that's come out of this dire situation that we're in, it’s the remarkable collaboration that I've seen across the globe because we can't forget, Steve, even if we solve the problem in one country, the problems will still exist all over the globe and it's not going to stop the spread of the virus. So, we have to tackle this as a global problem and do that that by partnering with people all over the world from the perspective of testing and the vaccines. And really, that's what we're doing here at INOVIO. W’re saying, of course we're very much focused on our U.S.-based populations, but we also must look globally because the virus doesn't, unfortunately, respect borders and this vaccine will have to work in all demographics across the globe.
Clemons: How do you deal with the manufacturing challenge? We had Senator Chris Coons on recently and said, Steve, we may get a vaccine, but we need so many doses not only here but globally at such scale and then mechanisms for distribution. And pricing and ways to reach people in vulnerable communities who aren't naturally necessarily part of that normal health ecosystem. I know you’re on the science side, but have you and your company begun to get your head around the scale of what's needed, particularly if you're successful?
Broderick: Absolutely. And it’s kind of these remarkable goals on situations that, frankly, nobody's ever been in before. We've never had to generate a vaccine for a pandemic that's affecting the entire globe and then wrap our heads around manufacturing enough so that it will be relevant. However, certainly at INOVIO that has been an absolute focus for us. Not only is it just generating a safe and effective vaccine, but it's also seeing how do we manufacture enough of that vaccine so that the relevant people can be protected and have access to that vaccine. As you quite rightly mentioned, we have been so incredibly thankful to the support that we get from both the Gates Foundation and from CEPI, both of who have a mission to provide vaccines to lower-income countries and ensure that there's global access to these vaccines. And that's something that’s very, very, you know, solid within our foundations INOVIO that absolutely we want to be there for the American population. And that's something that we're so thankful for the Department of Defense for providing funding for. But we also want to think about the whole globe and provision of this vaccine to whomever needs it.
Clemons: We had Secretary Azar on recently and he was talking about Operation Warp Speed, the resources there and the kind of hedged bet, if you will, that we need to invest in manufacturing capacity and deals even before we know the efficacy of the vaccines. Are you in good shape there? Are those relations good? And are you in line to sort of be part of that network of bets that the U.S. government is making?
Broderick: Again, we're incredibly grateful to the support from the government that we've received so far. They've been an excellent partner and really, you know, no one entity can do this alone. We really are going to have to come together to find a solution. And so, having the support of the U.S. government, the Department of Defense, to really assist us, to partner with us to scale up the manufacturing and to think about global logistics, logistics within America is absolutely key, and we're so grateful for the support that they have been providing us.
Clemons: I've also been reading that you’ve been doing a partnership (and I apologize if I get this wrong) with Kansas City, a place in Kansas City doing trials as well, and that patients have been signing up, not only with your project but across other companies that are engaged in deep pharmaceutical research of finding those that would participate in clinical trials. And I’ve been reading that the scale of what's needed is rather large. How is that going? Do you have trials going on now? Are people signing up? Is that where it needs to be?
Broderick: That's been such a heartening element for us, Steve, is the unbelievable level of enthusiasm that we've seen from the whole population in the U.S. where we've been a running our clinical trials literally, literally people lining up outside doors waiting to try to be part of the clinical trials. And, you know, without those volunteers, without those people making those sacrifices to be part of this clinical trial, we can't push vaccines forward. So we're just so incredibly grateful to the general population that I think have really completely altruistically said, “I can help here by volunteering” and just that — the overwhelming support that we've got from people just actively wanting to be part of a trial has just been so heartwarming for us as scientists and clinicians.
Clemons: As you look at this, and seeing how time has been bent or the curve has been bent to produce something so quickly, given your experience now, hands on, are there other pieces of the vaccine development process that you wish you had more support for? Are there more elements in the development scheme that you felt can even be made more efficient or moved along? Or are we doing the best we can? Is this as good as it gets?
Broderick: I think genuinely, and I do want to convey this message, everybody is doing the absolute best they can. I mean, I cannot overemphasize that everyone is working night and day to move towards a vaccine solution as fast as possible. But certainly, there's always areas we could all do better on. And when we talk about and — this vaccine being required, really, essentially, for every single human being on Earth, of course we can look to expand manufacturing even more so. But I do think that really everybody's focused on those goals and working together to make that happen. So I hope that, you know, the public can take some confidence in that really the partnerships, the collaborations are really starting to be put in place so that we can move as quickly towards a vaccine solution as possible.
Clemons: Let me ask you just finally one unfair question because I know you're working really hard on it. But I asked just about everybody this: how confident or not — take your INOVIO hat off a minute — just, how confident or not do you think we will be in getting a real vaccine solution to this particular virus?
Broderick: I am completely confident that we will have likely multiple effective and safe vaccines against COVID-19. I have no concerns about that at all. However, and this is hard for everybody to hear, but it is going to take time, and it takes time so that we ensure that we get the right, safe, effective vaccines. And we once we have that we will do everything physically possible to ensure that everybody has access to those vaccines.