Lori Walsh: Eddie Sullivan is president and CEO of SAB Therapeutics in Sioux Falls and he's joining us today for an update into research into COVID-19 therapeutics. Eddie, welcome back. Thanks for being here.
Eddie Sullivan: Hi Lori, thank you.
Lori Walsh: All right, for folks who maybe didn't tune in the last time we talked, tell us a little bit about what SAB is doing to address Coronavirus right now.
Eddie Sullivan: Well, as we discussed the last time, SAB is rapidly progressing on a new treatment for this new and certainly, a disease that has affected people all around the globe. We're producing a therapeutic, it's not a vaccine, it's actually a treatment for those that are sick with COVID-19. We're on track to have a candidate therapeutic that is specific to the disease ready by this summer.
However, again, I want to emphasize that the timeline will ultimately be driven by our discussions with regulatory authorities and federal oversight of course, but we have essentially, human polyclonal antibodies that work exactly like our own immune systems that are targeted specifically to these diseases so that we can treat those that have become overwhelmed and can become ill with this disease.
In addition, these antibodies could be used as a passive immunity where vaccines take time for us to develop immunity. Once we give these antibodies to someone, they could be immediately protected from the disease. And this has value and significance for those frontline responders, medical staff and others that are helping all of us but are putting themselves at risk for contracting the disease. So this is what our particular solution to this particular problem has in its value as one of the tools in the toolbox, so to speak.
Lori Walsh: Help us understand the difference between passive immunity and a vaccination.
Eddie Sullivan: Yeah, so a vaccination would be giving someone maybe a protein or a part or an inactivated virus where they're producing their own antibodies. Different from a vaccine, passive immunity or therapeutic immunity is having those antibodies produced outside of our own bodies, purified and then just giving the antibodies to us.
I think that over the last little while, we've heard that they're using what's called convalescent plasma, in other words, taking plasma from patients that have already had this disease and using that to treat those that currently have the disease. This is the exact same, what I would call the exact same process essentially, but we are able to produce these convalescent antibodies so to speak, by vaccinating our cows that produce human antibody and then using that antibody in exactly the same way as convalescent plasma is used.
And why is that important? Convalescent plasma while we are working desperately to find immediate ways that we can treat patients that are sick today, it is extremely difficult to be able to get enough of the convalescent plasma to actually find those that have recovered from the disease and that are suitable to donate and then be able to bring all of that together to treat patients. We have a controlled source in these animals that can do exactly the same thing and we simply scale up by having more of our animals produce the antibody.
Lori Walsh: Do those two things, this notion of therapeutic for people who are sick and this notion of the antibodies that could help provide the passive immunity, are they the same? Are they on the same tracks forward or are they two separate research? How do they intersect?
Eddie Sullivan: Yeah, they are exactly the same. The trick is they're exact same antibodies in both cases. In one case, you're providing the antibodies before somebody contracts the disease and then if they are exposed to the disease, those antibodies will then shut it down before that person would even become sick. In the case of those that are sick, you're simply giving more of what their body is trying to do to respond to the disease. So in both cases, you're using the exact same product.
Lori Walsh: All right, so since the last time we spoke, you said you're on track to have a candidate therapeutic ready by the summer, but that there are variable factors in there. The last time we spoke, what's changed between now and then? How much water has gone under the bridge?
Eddie Sullivan: Well, I think certainly we all know that this unfortunate situation is evolving in ways that I think none of us could have imagined and the effect that it's having on the economy and certainly what's happening in New York City and other large cities around the US, but we have spent nearly two decades developing an innovative technology that harnesses the native human response to disease and to be able to rapidly target to specific diseases that immune response and do that on a large scale. In fact, SAB is the only company that has the capability to develop these therapeutics without human donors and we think that's the best solution for COVID-19.
Speed and sophistication of this platform is another thing that I would mention to you. We are leveraging a genetically engineered bovine to produce fully human antibodies. That enables us to address global health threats in a way that I don't think has ever existed in the history of the earth. And so this is a novel technology so that when diseases like this come along, then we can use this platform to respond to diseases in the future. And certainly, we are learning a great deal about how we can use this technology to respond to things exactly like what is happening today in the world.
Lori Walsh: One of the conversations we had earlier on this program during our first hour was as we go through this and address the immediate needs, how are we also picking up those things that are going to help us to address future needs because this is not going to be the planet's last pandemic, and that's what I'm hearing you saying too is that as we do this, this is a real potential for others in the future to maybe really change the future going forward scientifically and from a public health standpoint. Do I understand what you're saying correctly there?
Eddie Sullivan: Well, that's certainly true because of course the biggest issue that we have is none of us could have foreseen three or four months ago what was about to happen around the world, but yet we have to find better and faster ways to be able to respond as rapidly as possible when these emerging diseases come along. And certainly, that's what we have focused at least part of our company on is being able to identify and respond very, very rapidly when a new and emerging disease comes into focus.
And so I think around the globe and certainly within the biotech industry, I participated this week in a virtual symposium with the Biotechnology Innovation Organization just this last Tuesday and Wednesday where we talked about the entire situation, what is happening. We talked about therapeutics that are being developed, we talked about diagnostics that are being developed and vaccines that are being developed.
And to see the effort that is being put in to the situation by companies and government entities and universities and people all over the world is really something that I think is very, very special and very, very promising, but we know now that we must be ready for the future to be able to respond to these kinds of things in even faster ways than we're able to do it today. And that's exactly what our technology represents is a way forward in being able to respond rapidly to these situations.
Lori Walsh: I want to ask you about this idea of with so many people working on things moving forward, is it a matter of being first at this point? Is it a matter of having the best platform? How do you respond to competitive.... It's very collaborative, it's also competitive. People are working. So help me unpack this idea of getting your solution to the "finish line" in a way that it's going to be heard when there are so many people looking for solutions. Do you understand what I'm getting at there?
Eddie Sullivan: I certainly do. And certainly I think competition is a valuable thing when you're in these kinds of situations because of course, people are looking at different ways to respond. What I will tell you is that the competition that is happening right now is very focused on collaboration in finding the best solutions to move forward. There are a lot of ideas out there on how we can respond to this and not every idea is going to come to fruition, but we have some very good people that are working on selecting through those that cannot only respond in an effective way but can respond very rapidly. So you have to have a combination of both.
And it's not like I view this as a horse race with some other company that we're trying to get there first or anything like that. Certainly we want to do that only because we want to be able to respond to patients that are suffering as fast as we possibly can. And I think that's the motivation that all of the industry is putting towards the response to this. But certainly, I feel it as my responsibility as the president and CEO of SAB Biotherapeutics to put forth what we are doing in our attempt and our process and our technology to respond as quickly as we can and allow the world, the people that are funding these projects and everything else to see what we're doing and how our response can be helpful in this situation.
Again, one of the tools in the toolbox and yes, in my opinion, one of the best tools in the toolbox. But we are having multiple conversations with people all over the world, including those right now that are dealing with the situation in New York City. And I will tell you that in my conversations with them, they are ready to try and find ways to get this to patients as quickly as possible.
Lori Walsh: Is it too soon, Eddie, to ask you what the treatment would be like? What sort of form does it take what people will be able to understand? Is it a pill they're going to take, some kind of inhalant? Is that too soon to know the answer to that question?
Eddie Sullivan: No, not at all. This is done and this is not a new way of doing this. This is a very common way of transferring antibodies. So it's done by what's called an infusion, so through an IV. These antibodies are put into the IV and they go directly into the bloodstream. So that's how it is administered. We are looking at other possibilities for administration of the antibodies and looking at what the future could hold with this, but initially, it will be given by an IV infusion.
Lori Walsh: And what do we know about the process for finding out whether things are safe and effective and side effects and things like that? Walk us through the next stages.
Eddie Sullivan: Well, as I mentioned, the first thing is that SAB has already conducted a clinical trial on a Coronavirus targeted antibody product. Now, this was not the virus that causes COVID-19, this was MERS Coronavirus or Middle East Respiratory Syndrome Coronavirus. And so we conducted a clinical trial and showed that our antibodies were safe in healthy volunteers that this particular product was put in. That was two years ago that we conducted this study. And the study came out, the results were that our antibodies are very, very safe in this case.
And so we are essentially taking the knowledge that we gained from producing that product and we're applying it to this new Coronavirus, and so we're very confident we can produce a product that is safe. We are also working with groups around the country that once we have these antibodies available from these animals, they will immediately be testing it for how it responds to the virus both in the laboratory as well as in animal models, and that will allow us to be assured of the efficacy. And once we have that information available, then we will be able to take the product and put it into patients. With approval of the FDA of course.
Lori Walsh: All right, and so for you, what are the benchmarks that you're looking forward to next? What are we tracking to see if you're on track? What's the next step that you have to complete to stay on track?
Eddie Sullivan: Well, again, we started by identifying proteins within the virus that we could vaccinate our animals to. And I emphasize again that we don't vaccinate to the virus itself, we vaccinate to subunits of the virus that are non-infectious. And so we have identified those, we have started vaccinating animals. Those animals are starting to respond by building their antibodies, these human antibodies, to those components that we have essentially vaccinated the animals with, and then we're in the process of casting those, making the process work so that the animals are actually producing really high levels of antibody that target this virus specifically and then we will take those and do the initial testing. Once we know that we have this product that responds very well to the virus itself, then we will begin the process of getting it into the clinic and starting to test it in humans.
Lori Walsh: That's fascinating stuff and really encouraging too, Eddie, for so many people who are worried about the days ahead to know that you are working around the clock to do what you can right here in South Dakota. Any other thoughts before we let you go Eddie?
Eddie Sullivan: Well, I will just mention that we have a fantastic and dedicated team of scientists and research associates and people here at SAB that are working very hard and their families are understanding the importance of what we do. And we're just proud of our team here in South Dakota and we really do think that we have something that will be helpful. And most important of all is we're thinking of those that are suffering with this disease and the problems that is causing all over the world and we just want to be part of the solution. And so that's why we're here and working so hard. And we appreciate all of the support and well wishes that people are giving us all over the country and frankly, all over the world. So, thank you.
Lori Walsh: Well, well wishes from here in South Dakota. We're behind you and we appreciate your time. We'll talk to you soon, I'm sure.
Eddie Sullivan: Thank you so much. Take care.