This conversation originally aired on Wednesday, March 11. Listen to it in its entirety here:
Lori Walsh: Welcome back to In the Moment. I'm Lori Walsh. Today we're bringing you the latest information on the coronavirus and COVID-19 in South Dakota, including research into the complex nature of human disease. Eddie Sullivan is President and CEO of South Dakota's SAB Biotherapeutics and he joins us on the phone now with the latest. Eddie Sullivan, welcome back.
Eddie Sullivan: Hi, Lori. Thank you.
Lori Walsh: Now, you've been a frequent guest on Innovation with Cara Hetland, so many of our listeners know the cutting edge research that's happening right here in this state, but for those who don't, give us a little overview of your lab and sort of the infrastructure you have for research and development.
Eddie Sullivan: Well, SAB Biotherapeutics is co-located here with Sanford Research, and for those that don't know, we have been working on a project for several years to be able to produce human antibodies in these unique animals that we have, in this case it's cattle, where we can produce very large amounts of human antibodies, and we can target those antibodies to specific diseases. And so we have been working in infectious disease for quite a long time, and those diseases include everything from influenza to things like Middle Eastern Respiratory Syndrome Coronavirus, which is one of our most advanced programs. In fact, that program has been through an initial phase clinical trial that was specifically for safety.
And so we're using the things that we learned about that MERS coronavirus to be able to also respond to COVID-19, and so we are currently working on it. Our network all over the country has been lit up, in being able to respond to this. We're working with universities and labs all over the country, and in fact have been in contact with the CDC, FDA, NIH, and all of the organizations around the country that are responding to this, and that's because SAB has the most advanced coronavirus-specific therapeutic that's in the clinic to date. Now we're creating one that's specific to COVID-19.
Lori Walsh: How different are they? How much does that matter that you are on this path already as far as how closely these are related?
Eddie Sullivan: Well, it's certainly given us a lot of information about how to respond specifically to this particular virus. So we don't here at SAB use any live virus, and I want our community to know that, but we use specific sub-units of the virus that we can vaccinate these animals to that are non-infectious, but they create antibodies in the animals that do neutralize the virus. We can take the antibodies from these animals, purify them out, they're fully human, that they have been designed to be specifically human antibodies, and then we can use that to treat people that are sick with the disease. So I want to emphasize that this is not a vaccine, which are, of course, to prevent the disease. This is actually to treat those that have been infected.
Lori Walsh: So for most people, they would think about influenza therapeutics and they would think like a ... Now I can't remember what that medicine is called. But if you went in soon enough, you would get some kind of treatment from your doctor.
Eddie Sullivan: Tamiflu.
Lori Walsh: Tamiflu. Thank you. Am I on the right track there? Am I making the right connection, or is that off somehow?
Eddie Sullivan: It's very similar. The difference is, drugs like Tamiflu are small molecule drugs that are called antivirals. The difference with what SAB Biotherapeutics is doing is that we're actually producing the natural proteins that our bodies use to fight disease. We call them antibodies. And in our case, we are creating the same kinds of antibodies that our bodies would naturally produce in response to this infection. And when we get sick, it's simply because our bodies are overwhelmed with that infection, and so what we're doing is we're producing these antibodies in these animals, purifying them out, and then when someone is sick with this particular virus, we would give them additional antibodies that would help them fight the disease, and these antibodies are essentially working with the patient's immune system in order to help them to recover.
Lori Walsh: That's fascinating. Tell us, you've mentioned being in contact with the CDC and NIH and FDA, and I'm wondering about funding, and if there has been any specific increase in resources on a federal level to help SAB do the work that needs to be done.
Eddie Sullivan: So of course we have been in contact now for nearly six weeks with not only the regulatory agencies like FDA, and those that are responding to the disease like CDC, but also the funding agencies like BARDA, which is a part of HHS. We do work with the Department of Defense as well on projects, and so I think all of us know from the news last week that the President signed an appropriations for $8.3 billion to respond to COVID-19, and of course now these funding agencies are going through the process to provide that funding to those companies that are able to produce solutions.
And so we're in almost daily contact with these agencies on being able to provide information on where we're at with the development of our response, and we started actually producing antibodies in our animals actually last week, and so we're moving forward quite quickly. And of course, as Dr. Hoffman mentioned previous to me coming on the show here, both vaccines as well as therapeutics take time to develop, and that is going to take some time, and of course they are using some drugs that are already available to see if they help with this disease, but simultaneously we're working on drugs that will be specifically targeted to the disease itself.
Lori Walsh: And this is maybe a difficult question to answer, but it's the one everybody wants to know, which is how fast is fast, and how soon could some kind of therapeutic be in the hands of physicians?
Eddie Sullivan: Well, I will tell you that that takes an enormous effort, and SAB will have a candidate available sometime in the summer for evaluation, and then of course it depends on what requirements will be placed in order to be able to move this into the clinic. It will require that there are controlled clinical trials to evaluate both the safety and efficacy of any therapeutic or vaccine that is put out there. And so those controlled clinical trials will happen first, before either the vaccines or the therapeutics will be made available generally. Now, the exception is something that I think has been mentioned, and that would be that in certain cases, the FDA can agree to make therapeutics available under what's called emergency use authorization, but there's very strict guidelines on being able to make that available, but certainly in cases like this that can happen.
Lori Walsh: And then are you in control of manufacturing, presuming that you get to that point when we talk about how widespread can the, or how widely can the therapeutics be distributed? That's another layer there to make things available to the most people, if they do work. Is that part of what you work with, or by the time it gets to that point, is it beyond your scope?
Eddie Sullivan: No, we actually are developing the manufacturing systems to be able to manufacture the product that would be available essentially worldwide, and so we're doing that with our processes here, and then are working very diligently to be able to scale up that manufacturing process.
Lori Walsh: Does that manufacturing happen in South Dakota or in other places across the country or world?
Eddie Sullivan: Well, certainly our animals are here in South Dakota, and so regardless of whatever purification processes happen, there will be a component of that manufacturing that happens here in South Dakota. We have some manufacturing capacity here, and we're currently working very hard to increase the scale of that manufacturing capacity here in South Dakota, but of course we're also in discussions with others that have manufacturing capacity around the country, because it's so critical that we be able to scale this up when we have this product available for evaluation and for being able to put into patients.
Lori Walsh: Right. And if you're just tuning in, we're looking ahead here quite a bit and we're not at that stage yet, so don't misunderstand here. My guest is Eddie Sullivan, President and CEO of South Dakota's SAB Biotherapeutics, and for people, Eddie, who are on the phone and say, "Do you need more cattle?" This is a very special herd. Tell us a little bit about this herd of cattle at the lab.
Eddie Sullivan: Sure. So these animals are at one of SAB's farms here in South Dakota, and they are very special animals, because again, we have done work, very specific work to allow these animals to produce the fully human version of these antibodies, and so they are unique from any other cattle that exist in the world, and they can produce very large amounts of human antibody. The interesting thing about this is because these animals are born producing human antibodies, they actually recognize human antibody as being part of themselves. But the advantage is that when we put these antibodies into humans, humans recognize them as being human. And so that's what allows us to do this very, very safely and allows these antibodies to work within the human immune system.
Lori Walsh: Well, that work is astonishingly, and what a great South Dakota science story. Anything else I should have asked you about this process? We're hoping to have you back as this research develops so we can kind of follow it, but anything else that you wanted to say today before we let you get back to work?
Eddie Sullivan: Well, I appreciate certainly the comments made previously by Dr. Hoffman on all of the things all of us need to be doing, and be prepared. But SAB is hard at work looking for solutions to be able to treat what can be a very serious disease.
Lori Walsh: Eddie Sullivan, thank you so much for being here. We appreciate your time.
Eddie Sullivan: Thank you.