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DRAFT EP200617 Tonix Developing Multiple Vaccines Against COVID-19 Based on Live Synthetic Horsepox Platform with Dr. Seth Lederman Tonix Pharmaceuticals An Empowered Patient Podcast Published June 30, 2020 Karen Jagoda: Welcome to the empoweredpatientpodcast.com show. I'm Karen Jagoda, and my guest today is Dr. Seth Lederman. He is the co-founder, CEO, and chairman of New York city based Tonix Pharmaceuticals. They're a research and development company, T-O-N-I-X, P-H-A-R-M-a .com. the topic today is COVID- 19 vaccine development. So, welcome to the show today, Seth. I appreciate you taking a few minutes. Dr. Seth Lederman: Thank you for having me on the show. Karen Jagoda: Let's just jump right in and talk a little bit about what your mission at Tonix is and what conditions you generally have been focusing on. Dr. Seth Lederman: Thanks. Tonix is really focused on trying to solve important problems facing society. We're a drug development company, and historically we've done a lot of work in the areas of psychiatry and pain, but I am an immunologist, and we've had a long interest in infectious disease. So, when COVID struck, we applied our tools to try to solve this problem also. Karen Jagoda: What's the common thread between your previous work and vaccines for the virus, the coronavirus? Dr. Seth Lederman: We've been working on a platform that's called a vaccine vector. A vaccine vector is like a pickup truck. We can put any kind of vaccine antigen into the payload of the truck. The vector system that we've been working on is called horsepox, and it is a proprietary Tonix technology. We've developed this system and we own it. We've been working on it for years with the idea that a new infectious disease might come along and that society might need a vaccine quickly. The COVID pandemic is the kind of challenge that we've been preparing for many years. Karen Jagoda: Now, I understand that you worked on a smallpox vaccine. Is that work relevant to the work that you're doing right now? Dr. Seth Lederman: Yes, the vaccine, the horsepox vaccine vector system that we're working on actually originates with a virus that we believe is very close to the first vaccine ever developed. That takes us back to around 1800 in England. Edward Jenner came up with the first vaccine for smallpox, and he called it vaccinia. In his first paper on the subject, Jenner predicted that his vaccine would eradicate smallpox. So, 170 years later, smallpox was eradicated using his vaccine. It's the oldest vaccine. It's very effective. It's been deployed on a global basis. So, it could be manufactured even before the molecular biology era. We are developing it as a vaccine to protect against smallpox. But now that we're in the molecular era, we also realized that in addition to being a smallpox vaccine, we could engineer it to express pieces of other infectious diseases. That's why I Dr. Seth Lederman Tonix Pharmaceuticals Page 1 of 5 EmpoweredPatientPodcast.com ©TBI LLC 2020 Developing Multiple Vaccines Against COVID-19 Based on Live Synthetic Horsepox Platform with Dr. Seth Lederman Tonix Pharmaceuticals An Empowered Patient Podcast Published June 30, 2020 likened it to a pickup truck. We can put new viral antigens as payload into the truck’s bed and the payload can protect against other infectious diseases. Karen Jagoda: That sounds like some pretty significant understanding of the whole human body and how vaccines work with the human body. Is it that one vaccine works for everybody, or in this fight for COVID-19 vaccines, is it going to require a variety of vaccines to really treat the vast population? Dr. Seth Lederman: That's an excellent question. I think that solving COVID-19 will require a number of vaccines. Ours is targeted for healthy people who are not pregnant and who have a working immune system. While that's a subgroup of all the people who would be at risk for getting COVID, it's an important subgroup. That's the subgroup that if a vaccine protected them against COVID, then they could really slow or stop the spread of it. Karen Jagoda: Are those people the ones that are most likely to be asymptomatic? Dr. Seth Lederman: Yes, they are. They're the most likely to be asymptomatic, and they are the most likely actually to recover on their own. But the diabolical part of COVID is the way that asymptomatic people spread it. Karen Jagoda: Can you just say a little bit more whether that's a common feature of corona viruses in general, or is this one particularly devious? Dr. Seth Lederman: This one is particularly devious. It's a very close relative of the coronavirus that caused a condition called “SARS”, for Severe Acute Respiratory Syndrome, in Asia in 2003. That virus was not so diabolical. When people got infected with that coronavirus, they knew they were sick and it could be contained. SARS was contained in Asia, and only about 750 people died. Obviously this new one, which fools people into being asymptomatic spreaders is deadlier. The new coronavirus has already killed several hundred thousand people, and it spread around the world within a matter of weeks and months. Karen Jagoda: So, we're talking about a whole other level of a contagion. Tell us a little bit about Tonix' vaccine and how it's different from others that are in development. We're hearing so much these days about vaccines that are in human trials or being considered in one way or another. tell us a little bit about what makes yours unique. Dr. Seth Lederman: That's an excellent question. Ours is unique because it's based on our horsepox vector system for one thing. Clearly no one else is working on this vector system in particular. But I would also say that our vaccine is unique because it's a live replicating virus. There are not many companies working on live replicating viruses. As far as I know there only are three others. That may be an under count, because there are about 200 vaccines in development. A live replicating Dr. Seth Lederman Tonix Pharmaceuticals Page 2 of 5 EmpoweredPatientPodcast.com ©TBI LLC 2020 Developing Multiple Vaccines Against COVID-19 Based on Live Synthetic Horsepox Platform with Dr. Seth Lederman Tonix Pharmaceuticals An Empowered Patient Podcast Published June 30, 2020 virus is one that when it's injected into the arm, it infects cells in the arm, divides to make more viruses and then the new viruses also infect cells in the arm. That's why live replicating viruses engender a very strong immune response. Dr. Seth Lederman: This strong immune response is important because we think that this is what the body needs to be woken up so that it will protect against the CoV-2 infection. Another advantage of live replicating virus vaccines is that it is easier for us to scale up manufacturing to make very large numbers of doses. It is easier to manufacture because the dose that we would need to give to individual people who are being vaccinated can be quite small. One way to think about it is that for a live replicating virus, some of the manufacturing goes on in the arm. We plan to place a certain number of virus particles in the arm, and then they multiply a little bit to make more. Karen Jagoda: So, the treatment would be one shot that would last for... how long would you suspect? Dr. Seth Lederman: That's an excellent question. Well, we believe it will require just one shot. I mean, that's one of the other unique characteristics of our platform relative to some others. We believe our vaccine has the potential to confer long lasting immunity, because we are targeting T-cells. T-cells are a part of the immune system that's a little bit harder to study, so you don't hear about it as much now. I think you will hear more about T cells when people have more time to study COVID. T-cell immunity is known to be long lasting, and that is different from antibody immunity, which is usually quite short. Karen Jagoda: We talk a lot about T-cells on this show, particularly when it's relating to immune-oncology. The idea here is that T-cells have been sort of decoded, I guess, in some ways for other conditions, but is now there now more awareness of what they can also do for fighting something like COVID? Dr. Seth Lederman: Immuno-oncology represents the pinnacle of our understanding of T-cells. And you're right, that immuno-oncology has informed us about ways that we can stimulate T-cells to fight infectious diseases. I think it’s also interesting that we're really coming full circle, because as I mentioned, the vector platform that we're working on was really the first vaccine ever discovered and used. T-cells have been at work in vaccination and immunity for all this time. Now that we understand T-cells better, I think that we're able to target them better. Karen Jagoda: Tell us a little bit about the other work that you've been doing, that I assume you're continuing to do, with PTSD and other neurological conditions. Say a little bit more where vaccines come into those kinds of treatment plans.
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