Cara Hetland: Biotech companies are working to develop antibody therapies to provide protection against COVID-19 and joining us for an update on the development of therapeutics, we welcome Eddie Sullivan back to In the Moment. He's president and CEO of SAB Biotherapeutics. Eddie, thanks for coming back on the program today.
Eddie Sullivan: Good to be with you today, Cara.
Cara Hetland: So let's start. I think the last I heard you, you have received some funding. You have joined a partnership. So let's update as to where we last left off as to how your search for a therapeutic is going.
Eddie Sullivan: Well Cara, I think you know that SAB produces medicines that fight disease in the same way that our own bodies do. And so we are using a large animal species to be able to make these antibodies, these very unique proteins, that fight disease very much in the natural way that our bodies do. This has been accomplished through some breakthrough genetic engineering that we have done in these animals, which are in this case cattle, to produce polyclonal antibodies against targets. We have produced high potency treatments to a lot of different viruses and now have moved that into our approach with COVID-19.
Cara Hetland: So when you say you've already developed these therapeutics, are they on the market or are they still in research? Where are they at?
Eddie Sullivan: Yeah. So we have some of our antibodies that have been in the clinic. None of our antibodies, to date, have been in the market, but we are continuing to develop antibodies against different viruses, get them into the clinic and that is, of course, is a fairly lengthy process. But in the case of COVID-19, certainly that process is being accelerated by SAB Biotherapeutics, by other biotech companies, of course, and working with federal agencies like FDA. We are certainly pushing towards getting something into the clinic and getting it approved as quickly as possible.
Cara Hetland: So I keep hearing, Eddie, about that you're going to be ready by summer to be into clinical trials.
Eddie Sullivan: So that's exactly right. We are on schedule to be in clinical trials this summer and we have been working with partnerships across our network, including certain funding that we've received from the Department of Defense as well as BARDA, the Biomedical Advanced Research and Development Authority, that funds groups like SAB Biotherapeutics to produce antibodies to emerging diseases. And so, we are on a very rapid timeline to get this into the clinic as quickly as possible.
Cara Hetland: Does it make you nervous as a scientist that it's moving so quickly?
Eddie Sullivan: Well I have to tell you that prior to COVID-19, we had been working on a project with the Department of Defense to be able to rapidly respond to an emerging disease. And we started this contract with them middle of last year, where we were actually in the process of ramping up and developing this platform in a way that we could respond rapidly to an emerging disease. Now little did we know, as we started that project, that we were going to be in the middle of a pandemic at the beginning of 2020. But that process has allowed us to move very, very quickly in a very organized way in order to rapidly respond and target, specifically, these antibody proteins to COVID-19.
Cara Hetland: And so you are partnering with CSL Behring to rapidly develop this. Is this because they have larger capacity to process this? Explain the partnership.
Eddie Sullivan: Cara, that's exactly right. CSL Behring is the largest producer of human derived plasma and human derived IBIGs in the world and so they have manufacturing capacity that they have made available to us in order to process the plasma that we produce from our animals. And so it's certainly been a good opportunity for us to partner with them, in this case, in order to be able to ramp up that manufacturing capacity as quickly as possible.
And that's along with the plans that SAB continues to have to ramp up capacity within our own facilities, here in South Dakota.
Cara Hetland: So the therapeutic that you're going to be ready to test, let's talk specifically about that. I mean, this is a way so you don't... It's kind of the same. We're hearing a lot about studies that are happening right now about plasma donated from recovered COVID-19 patients, right? But this is something different and you're not going to need that plasma from recovered patients for this therapeutic. You're going to manufacture it from the animals.
Eddie Sullivan: That's correct. And so there are some similarities, of course, between what is happening with convalescent plasma. Again, plasma that comes from patients that have already had the disease and they produce the antibodies and then you extract those antibodies or that plasma to transfer into people that are currently sick with the disease. Now what we're doing is similar to that, but there are some very critical differences.
First of all, these animals produce the human versions of these unique proteins that fight disease. Second of all, we are targeting, specifically, the immune response of these animals to get a much higher potency of antibody production. This potency, the potency is the ability of these antibodies to kill the virus at the lowest concentration or lowest amount of antibody possible. And so we can actually drive that immune response to even higher levels than what we see in convalescent patients. And so we're going to have a product that has much higher potency. In vet care, I will tell you that our animals are already producing antibodies that neutralize the SARS-CoV-2 virus.
Cara Hetland: So for the clinical study, you're going to be targeting people who have been exposed. I mean, my point is, this isn't a vaccine. This is a therapeutic. This is for people who have been exposed or have been tested positive? Is that right? This is a treatment, not a vaccine.
Eddie Sullivan: It is a treatment, not a vaccine. So it's different from vaccines. What vaccines do is when we put a vaccine into people, that allows them to produce their own antibodies against the disease. This is very much like receiving the flu vaccination and then we produce our own antibodies that hopefully protect us against the flu. Now not everyone actually responds to the vaccines. Interestingly, vaccine development takes longer to actually develop because you have to vaccinate a lot of people and then see if the vaccine actually protects them and at what level it protects them from getting the disease. So vaccine development takes longer than therapeutic development.
One of the interesting things about antibodies being used, in this case, is that they can be used in two ways. You mention treatment, certainly, for patients that have been exposed, but antibodies can also be used in what's called a prophylactic manner. What that means is before somebody is actually exposed to the virus or at the time they're exposed to the virus, but haven't become sick yet, so that they don't become sick because these antibodies cannot only help to treat the disease once you're sick, but they can also help to prevent the disease much like a vaccine. But in this case, when you give the antibodies, you're not producing your own antibodies to the disease quite yet. And so as those antibodies begin to diminish, there would be a point at which the antibodies would no longer be effective in preventing the disease until you're vaccinated.
Cara Hetland: But this therapeutic only has, what? A 28 day life in your body. Is that right?
Eddie Sullivan: Actually, it's a 28 day half life. What that means is that after 28 days, you have half as much of the antibodies. Another 28 days later, you have half as much. And so you can actually put enough antibodies in, in order to protect over several months.
Cara Hetland: Kind of like a vaccine then.
Eddie Sullivan: Kind of like a vaccine. In fact, I hesitate to do this, but oftentimes we call this passive vaccination as opposed to active vaccination. I don't want to confuse the point, that this is not a vaccine that causes your body to actually produce their own antibodies. It just gives you the antibodies that actually protect. And so oftentimes, you will hear antibody transfer referred to as passive vaccination. And then vaccinating with a component of the vaccine itself, where your bodies produce its own antibodies, is called active vaccination.
Cara Hetland: What are the risks?
Eddie Sullivan: Well certainly, the risks associated with this are that we need to have antibodies that have high enough titers to be able to be effective against the virus. Certainly, we are testing that in the laboratory. We have already had these antibodies from these animals, in human clinical studies, as you mentioned, and found out that half life was 28 days. But more importantly than that, we also found out that these antibodies are safe in humans, that we don't have any immune reaction from humans to these antibodies. So they recognize them as being human and we have no serious adverse effects in these people that received our antibodies. That was, again, a very interesting clinical trial because it was in Middle Eastern Respiratory Syndrome coronavirus. So this is actually one of the most advanced coronavirus immunotherapies in the world and it came from SAB Biotherapeutics.
Cara Hetland: And you mentioned earlier that you are developing the antibodies for the COVID SARS. So explain the difference between the different COVID coronaviruses, virus. How do you pluralize that? That are out there, because they're all different, but yet somewhat similar?
Eddie Sullivan: Well that's right. So coronaviruses are a family of viruses, right? And there are different, sort of different species, of these viruses. And the virus that causes COVID-19 is called SARS-CoV-2, okay? Now there is another coronavirus and we refer to it as MERS-CoV-2 and it causes MERS coronavirus. And there are differences between these viruses. They have similarities and they also have differences. And so what we're doing is producing antibodies that are specific to those differences between these viruses so they can specifically target the virus that is causing one disease or another.
Cara Hetland: We just have a couple of minutes left. Are you confident that this is going to be the solution for this pandemic?
Eddie Sullivan: Well, I certainly will tell you that I am confident that this is going to be one of the solutions to this pandemic. I think we need to remember that there are a lot of potential solutions out there and tools that we need to use. We are offering something, quite frankly, that is unique in the world. Being able to produce highly targeted, highly neutralizing or killing antibodies to that virus, that kills that virus inside of the human in the very natural way that our bodies fight disease. A polyclonal antibody response. And so we are confident that our antibodies will be one of the tools in the toolbox that will be helpful in fighting this disease.
Cara Hetland: And when you say the polyclonal, this is not just attacking one cell in the body, it's providing a larger coverage type of area, right? Do I understand that right?
Eddie Sullivan: Well, so we often hear about monoclonal antibodies versus polyclonal antibodies. That's sort of the idea of many, poly, verus one or two, or mono. And so there are companies out there that are producing monoclonal antibodies that essentially attach to a single location on the virus. Polyclonal antibodies, again, the natural way that our bodies fight disease, bind to multiple locations on the virus, naturally have higher potency because they are binding to multiple places. But the other thing that's important about that is that viruses mutate and the concern with monoclonal antibodies is if the virus mutates in that specific location that a monoclonal antibody binds to, that monoclonal antibody will no longer be effective. If you have polyclonal antibodies that are binding to multiple locations, it's much more difficult to find a mutant of the virus that has mutated enough of those locations, that the polyclonal is no longer effective. So we feel that a polyclonal approach is a much better approach, particularly in viruses that mutate on a regular basis.
Cara Hetland: Eddie Sullivan, I want to thank you very much for taking time and updating us today and we'll have you back and keep this conversation going. Thank you.
Eddie Sullivan: Thank you, Cara.