Nov. 29, 2020

Jeff Galvin, CEO and Founder at American Gene Technologies™ (AGT)

Show Notes
Transcript

Jeff Galvin is the CEO and Founder of American Gene Technologies™ (AGT). He earned his BA degree in Economics from Harvard in 1981 and has more than 30 years of business and entrepreneurial experience including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies, including one in the medical-technology arena that was sold to Varian, the leading maker of linear accelerators used in cancer therapy. Following his startup experience, he retired to become an Angel Investor in real estate and high tech. He came out of retirement to found and fund AGT after meeting Roscoe Brady at NIH.

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Welcome to the Latin MedTech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform. Apple Podcast, Spotify, Google Podcast. Amazon Music is teacher. Tune in iHeart Radio, Pandora or Deser . Welcome back to the laptop Mtech Leaders podcast. Today our guest is Jeff Ging . Hey, Jeff . It's great to have you here on the show today. How are you doing?

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I'm great. Thank you very much for having me, Julio. Appreciate it.

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Awesome, awesome. Jeff , it's real pleasure to have you here. Well, listeners, Jeff Ging is the CEO and founder of American Gene Technologies, a GT. He earned his BA degree in economics from Harvard in 1981 and has more than 30 years of business and entrepreneur experience, including founder or executive positions at a variety of Silicon Valley startups . Several of his companies were taken public and or sold to public companies, including one in the medical technology arena that was sold to Varian , the leading maker of linear accelerators using cancer therapy. Following his startup experience, he retired to become an angel investor in real estate and high tech . He came out of retirement to fund and fund a GT after meeting Roscoe Brady at NIH. So Jeff , it's really a pleasure to have you here. I am really looking forward to our conversation today. I'm sure listeners are as well. So let's start, Jeff , we're talking about your connection with Latin America . In what way have you been involved with the region?

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Well , um, when I started , uh, my career in Silicon Valley, I quickly moved over to a company called Apple Computer, which I think you've heard of. And I was in the international sales division as one of the technical people. I was the international product marketing manager for Macintosh and another product that preceded it called the Lisa . That was sort of the prototype for the Macintosh. And so , uh, Latin America was in my territory. Um, you know, of course one of our bigger markets was Mexico at the time, but we had a lot of connections all throughout all of South America , uh, and distribution there. And I worked with and supported the distributors in that area. So I've got some experience in the computer industry, but now I've moved over to pharmaceuticals, to biotech and drug development. So this is a whole new thing for me. This is the earlier stages. So we're really focused on the US market, but I think it has tremendous implications for Latin America. There's no question that the things that we do, gene and cell therapy are coming on , uh, you know, in rapid, rapid , uh, you know, rates and, and that it's gonna be a , a tidal wave that goes all the way across , uh, the world. But Latin America is, you know, gonna be early on that list. I'm certain of it,

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Certainly Jeff . All right . In what countries have you uh , traveled to in Latin America?

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Well, I've been all the usual tourist destinations, right? So I've been to Brazil and to Mexico, Belize, and um, I can't believe I'm blanking on the name right now, but I think it's just south of Belize. Um, I can't believe I'm having, it's a very popular country for Americans to retire in and I can't believe I'm blanking on the name right now.

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Panama, Costa Rica. Honduras Nicaragua is popular too.

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Yeah, I've been to Nicaragua, but again, wherever the cruise ships land, I've been . Now in the case of Brazil, I actually went down there while I was working for Apple and uh, you know , uh, was in Rio de Jane and uh, so, you know, I spent a little bit more time there. But yeah, you know, a couple of days here, a couple of days there, of course on the Mexican Riviera quite a bit and uh, you know, Cancun and you know, places like that. But yeah.

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What about Columbia ?

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No, I haven't been to Columbia unfortunately, but, you know, it's been very interesting talking to you. 'cause we had a conversation earlier and you know, that really opened my eyes to , uh, what's going on in Columbia and it looks like a very interesting place for biotech. So , uh, hopefully I'll be doing some business there soon. Maybe we'll do that together, .

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That'll be fantastic. Alright , Jeff, talking about a GT, what's the next market after the us ?

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Well, typically pharmaceuticals spread out from the US then to Europe, then to Japan, and then rest of world. So that's sort of a normal thing. Uh , some of the big markets are not so important to us like China. And the reason for that is because they don't have the same sort of legal framework , uh, that the US has. And despite their conformance to a lot of WTO stuff, they've been slow in terms of implementation and maybe there's a lot of ways to short circuit things like IP and and so forth. So that's a trickier place to get into. So that one will lag a little bit, you know, versus , uh, other types of products that American companies make. And that's not been unusual in pharmaceuticals in general. So in the case of gene and cell therapy, the development of these products is so rapid and I think they're so transportable. It's so easy to set up manufacturing anywhere in the world. And these things once proven in the United States would not be difficult to go into any, you know, sort of decent sized country. And , uh, there'd be a lot of different ways to make that happen and to make it happen quickly. So I imagine that, you know , at the same time as we're spreading out into Europe, we'll be already starting to send out feelers into Latin America. And you know , one of the things that you pointed out on a previous call is that in some of the products that we're doing, it may make sense to even start doing human trials in a place like Columbia and to get a proof of concept down there while getting into a position to actually sell the drugs. And it isn't a major investment, you know, in a population of , uh, 50 million people for us to put up a bioreactor , uh, manufacturing plant and to actually create a subsidiary there or create distribution there. So you could open up a market immediately once you could clear a product and get a license, even in a , a country of only 50 million people, that's a business.

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Totally . Jeff , I love those plans . I mean, that's what Latin American desperately needs. I mean, foreign investment in science, technology, innovation. So I applaud your vision, .

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Thank you, .

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All right , so moving along here, Jeff. The other question that I usually ask my guest in the podcast is, what major epidemiological political, social economic trends you see in Latin America that are attracted to you or to your company?

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Well, the diseases that we work with are everywhere. You know, diseases have no country. Uh , we learned that , um, you know, quite profoundly with this recent pandemic spread of covid . It's one planet. And , uh, you know, we are, every single person, regardless of what country they come from, has 99.999% the same DNA as everybody else on the planet. And so we're all struck with all the same diseases, but also it means that in the industry of gene and cell therapy, the solutions are the same and they're relatively inexpensive relative to what it costs to suffer from these diseases versus being cured. And so I think that the differences between Latin America and the United States and Canada are, you know, quite small overall. So, you know, there's not really a regional prevalence of most of the things that we do. Now, there are certain monogenic diseases that tend to be in certain gene pools, subpopulations. Like for instance, we have a cure for Phenyl, Kein Noria . And so in the United States, one in 13,000 babies is born with this horrible disease. Initially it just means they have to be on a special diet their whole lifelong . But the longer term effects are serious neuronal disorders in the brain that cause depression, schizophrenia, and suicidal thoughts. So it's a devastating disease and it's just one in 13,000 , uh, people in the United States. But when you go to the Middle East, it's one in 2,500. So there that one might be naturally pulled into, you know, that region for that reason. But there's enough people in the United States and Europe where it makes sense to go ahead and launch those products. There a lot of people to be served and helped by having those products there. I suspect that in Latin America, if you looked at the PKU prevalence, it's probably somewhere around the same as North America, you know, 10 to 13,000 babies, you know, one per 10 to 10 to 13,000 babies. So, but that's , uh, you know, it's a big deal. It's almost like a slow death sentence. It's horrible for the parents.

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Wow. Yeah. Terrible. Yeah. Alright, so what's your overall perception of Latin America as a place to conduct a first in human or early stage clinical research or to commercialize medical innovations? I mean, I know that you haven't really had direct experience, but you may have heard something from your peers, colleagues, et cetera , or the industry in general.

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Well, when I was at Apple, all of our distributors were basically family businesses. So there were very powerful families in each one of the Latin American countries, and they had access to that market. So once you got into business with them, you had a very smooth, you know, sort of relationship with that country. And I don't know how it's changed. And we're talking about my experiences 25 years old now, 30 years old. So I imagine that, you know, societies move forward, governments sort of refine things, drugs, development, you know, pharmaceuticals tends to be something that is more, involves the government a little bit more than other types of distribution. And so I don't know what the relationships will be like, but I can tell you from working with all of the people that we I worked with at Apple in Latin America, that they were quite reliable, quite predictable, you know, they, they said that what they would do and then they did what they said. And, you know, they handled all of the intricacies of, you know, the local laws and the local politics and society and everything to make a very successful connection. As a matter of fact, if you want, I'll tell you a funny story about Latin America and Apple. I don't know whether this has made it to any of the books that have been written yet, but I was there when it happened 'cause I was in the international division. I think that this may have been triggered by the fact that Xerox Corporation at the time was doing quite well and they had a business distributing in Latin America and they decided the New York part of Xerox decided that it would be a good idea if they made a partnership with Apple and they would manage all the distribution for Latin America, and we could get rid of these small individual family operations in each one of the countries. And I think that Apple was open to it because Steve Jobs had seen something being developed at Xerox Park , the graphic user interface. And he was really intrigued with that. And so as part of the deal, he was like, okay, you gimme access to that and we'll sign the distribution. So this was back in the days when, you know, apple thought of international distribution is sort of like a sideline business because they were making so much money in the United States, they didn't need any other markets. So that was all just icing on the cake, right? So they made a pretty sweeping decision. And I remember a guy named Hector Snia who ran , uh, Latin America, had to call in all those distributors and have a meeting with them to let them know the news. Oh my gosh. It was explosive. And they all just came outta the meeting and they got on the phone and they halted everything for Apple in Latin America. So literally these guys could pick up the phone and customs wouldn't let you in anymore . Wow. So that was hilarious. Yeah. Yeah. So I think, I don't know if that's, you know, still true in Latin America, but Xerox was stymied, right? So what they had, what they finally had to do is Xerox would go ahead and ship to those same people,

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So it was just like another layer, you know, like of margins that had to be paid on the way to Latin America. 'cause you know, Xerox wanted a little bit and you know, the family still got their full margin and, you know, so yeah. But I , I think also that I learned something about, you know, partnerships too is, you know, the idea of pulling out the rug on anybody is going to be, you know, it isn't just an exclusively Latin American thing. This is human nature. And, you know, it wouldn't have mattered whether anybody had done this to anyone else. The feelings would've been the same. And this is a interesting part of my philosophy because I deal with, you know, sort of leveraging discoveries in nature that can have a huge benefit to the human population. And then while I represent those things, what I end up finding is that human nature has a big impact on the adoption, right? And so I always tell people reality happens at the intersection of nature and human nature. Nature will always win, but human nature can hold it back for a long, long time. And you find all these traditionalists and things like that. Like I've been swimming upstream and flying into the wind with all the institutions as I've developed my company, a GTA cutting edge gene in cell therapy company on the eve of curing HIV, we have a an IND package in with the FDA already that should lead to a human trial for an HIV cure that I believe has a very high probability of success within the next six months. And so, you know, we're on the eve of that, but I can tell you that for 12 years, all I've been hearing is it won't work. It's crazy. That doesn't make sense. We can't fund it, we can't take it public, we can't back this. We get the only people that were amenable to this from the start were scientists that understood the nature and they were the easiest to recruit. But as I've moved over to being a company that has been raising money and you know, dealing more with Wall Street and you know, plotting our sort of the next couple of years to liquidity, it's really interesting that that's a very entrenched group of folks who have a very standard model for evaluating everything. This is true about pharmaceutical companies as well. It either fits their model or it doesn't. If it doesn't fit their model, they're like strategic areas, then they won't touch it for that reason. Then if it fits their strategic areas, then they have a very specific sort of way that they create financial products. We invest at this level, we own a third, then two years later we invest more. We now own 52%, then we convert it over to this type of company that's on its way to a public offering, or we merge it into one of our other assets so we can claim victory, close that fund and raise the next fund. I mean, so there's all these different businesses that have to come together, all these different types of humans that need to be to collaborate. We're all fundamentally the same, but we are, you know, what dictates is human nature on that side. And here I am trying to make, bring a revolutionary technology that has the power to cure HIV and even the power to cure cancer. We have another asset where it's showing tremendous capability in clearing cancers without chemotherapy, without radiation. But we think let's

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Talk about that. Yes. I was gonna be my next question, but you are already answering the question. Fantastic. So let's talk about a GT. What is a GT and what is it solving? What problems is it solving in society?

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So a GT was founded , uh, back in , uh, 2008. I met Roscoe Brady that you mentioned in 2000 s , and he showed me something called viral vectors. Now, viruses you may understand are these little teeny capsules. If my whole office was a cell and you can't see the whole thing. But, you know, imagine something that's a very big office viral particle would be about the size of my fist. Yet there's enough information in that viral particle that it can just reprogram that cell to do anything and it can turn the cell against itself. It can even turn the cell against the rest of the body. And so these viruses are incredibly powerful and they're powerful because they carry a teeny bit of what's equivalent to DNA . We call it genetic construct, but it's basically a little snippet of code. And by code I mean the nucleotide sequences that are your DNA because your DNA instructs your cell everything to do what everything that goes on in your cell is somewhere in your DNA and the nucleus actually just takes looks at the DNA and sends out the relevant instructions to the cell. And that's how the cell operates all day long. Well , viruses have a way of inserting new instructions in there and the cell doesn't know whether it comes from the nucleus or from somewhere else. It just starts executing them. That's how covid is. That's how HIV is, whatever. So what these little viral particles are, are tiny little capsules that have the ability to latch onto a cell and inject what's inside of them. And what's inside of them is just little pieces of DNA . So what we can do now, this is called gene therapy. We can take viruses and we can crack them open and we can scoop out the viral DNA , the stuff that makes you sick and throw it away. What's left an empty capsule. It's like a stealth bomber that could carry any payload we want into any cell. So what do we put in there instead? Well, instead of a genetic construct that makes you sick, we can put in something that improves your DNA makes you better. It could fight a virus, it could cure cancer, it could replace a gene that's broken in your body. So you know, it could get a , a bodily function working that you were where you were born with a problem. Anything we can put anything we want in there. We're essentially, if you imagine sort of the digital computer word, we're converting viruses into updates, viruses make you sick, updates make you better. Okay? That's the concept that's called a viral vector. Gene therapy is when we put a genetic construct in there and treat a cell. So we're modifying the base level . Think of it as the operating system of the human cell. Human cell is like a little organic computer. The DNA is just the code, the a order of the acts . Cgs determines everything just like the order of the zeros and ones and your computer determines everything there. So what we're doing is the gene therapy is moving a genetic construct into the cell and fixing the cell in some way. Then there's another powerful thing that sort of sits on top of that called cell therapy. Sounds like it's the same thing, but it's a little bit different with cell therapy. We pull out cells and we modify them and then put them back into your body so we can give them new functions or we can improve their function or repair them outside of the body. And then the cell is the drug that we put into you. So you use gene therapy to make cells and the cells become the medicine. With gene therapy, we can go straight in there. So what, what can we use it for? I mean, this is just fascinating stuff. I, I just love it. I come out of the computer world, but to me this is the software revolution for the next a hundred years where writing new software to , uh, improve the human computer, right? To fix and and improve the human computer.

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I totally agree. Yeah. I I also come from the computer where I have a degree in electrical engineering and I totally understand where you're coming from , uh, what you're doing and where you're coming from. I work for , uh, telecom and networking companies and uh , it is really fascinating. I mean, please go ahead. I mean continue. Yeah.

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And you can see why I'm so excited because I've been involved in all those other tech revolutions, right? And what happens in those tech revolutions, everything gets better. It doubles every year and the cost halves. And what does that mean If you can't solve it today, just wait, you'll be able to solve it later. The tool will come along, right? So there's a lot of low hanging fruit right now that we can fix. We're gonna fix HIV with the current sort of rudimentary set of tools that we have at our disposal right now. But if we just wait 10 years, holy cow, there won't be just 50 or a hundred or a thousand diseases we can cure. There'll be 10,000 diseases that we can cure. It'll be something that will go for the next hundred years where first we fix everything that kills you. And then the next thing is we improve you. It's like, would you like to be a little stronger? Would you like to look a little younger? We can do that with gene and cell therapy, right? Extend your life, replace your organs. I mean the sky's the limit over the long term . I mean that has, you know, some policy issues and you know, social issues, whatever. But in the near term, there are so many diseases that cause immense suffering and early death that we can start to address. We can chip away at these things one by one. That's why I'm so excited about this. It follows a normal tech curve. It's completely unlike pharmaceuticals. Pharmaceuticals. You make a discovery of a molecule. Sometimes you go ahead and create 10,000 molecules and screen 'em down to one or two that are worth testing in a mouse and then one in 20 of 'em makes it into the clinic and one in 19 of those makes it to be a drug. It is a very , very low probability thing. But you know, the standard model for a , for going into that is you go ahead and, you know, screen for two years cost you $10 million. You test in a mouse, you get one thing. You want to go ahead and go into the clinic with you bet a hundred million dollars on phase one. 'cause you gotta build a pill factory in order to treat 15 patients, right? On a dose escalation curve. That doesn't even tell you if it works 'cause it's all healthy patients that you're putting it into, right? Gene therapy is nothing like that. Okay? So number one, we design drugs. So we sit down and we go, hmm , how can we improve this cell? So it'll fix that disease. There could be like we can just go to the library, we can just go up to, you know, the PubMed and we can look at all the articles in the universe about what are the drivers of disease and we can look at our tool set and go, could we get a gene into those particular cells that need it at therapeutic levels in a practical, safe way? If our thought experiment says yes, we can sit down and design it, then we don't have to go into the clinic to test it. Or even in an animal, we can culture cells in a Petri dish, test it at the bench. It's like having a, you know, like remember the old days of radio, right? And PC boards, these surface mount or whatever component boards, you could test them at a bench before you put it into massive production. You'd make one or two, right? And then you do all these testing and you find all the bugs before you manufactured anything, right ? It's just the opposite of pharmaceuticals. Before you can find a bug, you have to put up a $40 million manufacturing plant. So you can treat the first 15 patients, right ? Well, we can test them at the bench and we can anticipate all of the potential side effects, the stumbling blocks, the landmines, you know, all of the different hurdles that we may need to clear in order to get a drug that works. And we have not just the ability to test at the bench, but the drugs themselves, since they're essentially DNA that goes in and rewires the base level of the cell. It's incredibly powerful. It's incredibly specific. We decide exactly which genes we want to increase the expression or replace and which ones we wanna drop the expression or you know, cut out. So it's a very specific thing in your cell. And then the viruses can be steered to certain cells. They can be what's called tropic. So they'll tend to go to the cells that we want. So we can find a virus that delivers it to the right part of the body, sparing all the rest of your tissue from side effects. And then even the cells that it goes into, we inside the viral particle, that drug is attached by what's called a specific promoter, which is an if then statement. It's an on off switch. It can look at the cell and look for any enzyme or protein and if it finds it, it will turn on the medicine. And if it doesn't find it, the medicine will never turn on further targeting it. And those enzymes can indicate a tissue type or even a disease state. So we can design something that's really, really narrow with a high probability of being predictable and reliable in the clinic. Then once we've done all the debugging at the Petri dish level, we don't have to build manufacturing any bioreactor can make any viral vector. So as a emerging biotech company, we don't have to put up a $10 million bioreactor farm and we don't have to staff it and pay all that money. No, we go down the street to a contract manufacturer and we rent time in their bioreactors. It's expensive versus doing our own production, but it's cheap versus building our own facility. So then we can get out through the phase one having spent almost nothing on manufacturing. Maybe all the materials came to a million bucks for the HIV treatment and we did about $3 million worth of cell process development. That's the software for this automated cell processor that actually turns out the cell product that cures HIV. But you know, that's small money in pharmaceuticals and it's still way cheaper than building our own manufacturing. So that's cheaper. And then you're not allowed to test gene and cell therapy on healthy patients. Why? It's too dangerous, right? You would never permanently reprogram a human being, right? As an experiment to see whether something's safe. So you know, you need to show enough safety data so you can go into sick patients. You have an open label, you know, 15 patient study on materials that didn't cost you a lot to make, right? And you don't just get safety, you get efficacy signal. Now you've got an asset, right? So we haven't bet a hundred million dollars in order to get something that we know has value. No. You know, this is much more in the like 10 to $20 million range and we literally are all the way through the phase one and we may come back with something that has undeniable value against a particular target disease that is perfect for a pharma company to end license . Doesn't mean that that's what we'll always do, but you know, that's where these things are considered from a pharmaceutical standpoint to be a valuable asset is once they've shown human efficacy, and this is going back to what we were saying earlier, now it fits in the pharma model, right? They put it in their spreadsheet and they calculate, oh okay, here's the market potential, here's the risk factors, you're at this point and we'll pay you X for it. Now you can start negotiating before that. They're just like, we don't know what to do with you. And they don't say it that way. They just go, yes, there's too many risks, there's not enough information for us to start talking seriously, whatever. Well this is the surprise that's coming from the pharmaceutical industry is that these things happen fast. You know, a lot of the gene therapy products that have come out have gone from nothing to actually showing efficacy in a very short period of time and become major assets that pharma companies have actually overpaid for, right? And the other thing that they don't understand is because this is, you know, sort of these reusable components, we've got a whole platform of reusable components that we own. But the point is, is that this is so much like the computer industry and the software industry in Silicon Valley where if you didn't have the thing that solved the problem in the application you were trying to write, somebody had it down the street and you could in-license it, right? And so there's this whole layered architecture of this new pharmaceutical industry where you don't have to do everything on your own. And so you can go ahead and you can start turning these things out in an efficient manner, like the way Silicon Valley turned out, computers and software and even internet and apps and all those different things because you just have sort of this critical mass of all these different entities that are collaborating with one another in a industry that's rising so fast. Nobody cares about where you get your components from. The point is, is there's so much money being made and Goldman Sachs says this is a $5 trillion new industry. Remember pharmaceuticals is only $1 trillion. So we're gonna five exit. How long is it gonna take to do that? We don't know, but there's plenty of business for everybody. This isn't like, you know, sort of the old pharmaceutical business where there's a huge barrier to entry. There's gonna be a huge amount of competition, there's gonna be a huge amount of parallel development and these blockbuster drugs aren't gonna come, you know, sort of one or two per year. They're gonna come 10 or a hundred per year. How does pharma buy a hundred blockbusters in a year? Imagine when that number turns to a thousand in a year, right? Well then these biopharma companies, they can't sell 'em to pharma. But does that really matter? If you've got a $20 billion market like PKU, our smallest indication is Phenyl Kein , Noria Phia . PKU is a $20 billion pent up industry in a billion dollars per year. New business with babies being born with that disease. That's a company. You don't have to sell that to anybody else, especially when you think about the fact that manufacturing the drug is trivial, right? And as a matter of fact, what you might do is just license like five facilities around the world to make it so that if one goes down, you still have a supply somewhere else, right? Or if one problems that you have in manufacturing, you just shut down that one and go to another one. You can even de-risk your manufacturing in terms of contamination or you know, things like that. So this is a whole new world, a whole new set of economics, a whole new rate of development, a whole new model for, you know, different types of diseases. You know the idea of orphan indications, you've heard that before, right? Orphan indication means that the disease is an orphan because it's not big enough for a pharma company to care about it. It wouldn't hit their bottom line, right? Okay. So you're seeing some people that are developing models where they can actually address these orphan indications, these rare diseases, and they can get 'em to a point where even a pharma company might consider buying them. And you know, some of the early gene therapies are that way, like SMA and um , Libras congenital amaurosis, A blindness have both been sold to major pharma companies. Uh , Lux Tona was sold to Roche for $5 billion and AveXis was sold to Novartis at $8 billion. Their SMA drug. So you can still do rare diseases and there are other examples in other drug development modalities, rare diseases, once you've proven them out, can fetch big money on the pharma market until they run outta money, right? If they're trying to buy 10,000 diseases at $8 billion each, there's not enough money in the world, right? But in this industry, the risk that you take is much lower because with an orphan indication you can actually license it out of a pivotal phase two , you may have done 50 patients total ever before the FDA starts to let you do basically an in-market . Phase three, you may still have to track the results, but there's a lot of advantages that are given to these rare diseases in order to make them addressable by drug developers and gene and cell therapy. Since it's got this component architecture, you can from experience solve these diseases faster and faster and faster. And so the cost of getting them into the clinic keeps getting lower and the tools keep getting better, which also drives the value equation much higher. It's a more valuable drug in a shorter period of time at a lower cost. And so, you know, you might clear a drug from start to finish from the day you started thinking about doing the drug to the day that it is licensed might be four years and $20 million. Well what size market can you address with that? If there's a billion dollars worth of business, was it worth doing? You bet, right? There's a lot of companies that don't have a billion dollar total available market, you know, and have to invest a lot more than $20 million to access it. So this is a whole new economics of drug development that's going to finally start providing solutions for some of the rare diseases on earth that people are suffering from and really have no hope at all in the meantime. You know, you can still swing for the fences, right? And you know we're gonna cure HIV, I think we've got this new approach to immuno-oncology that we think has a very high probability of being effective in what are called epithelial solid tumors. Breast, prostate, lung, liver, colon, kidney, ovarian, pancreatic, head and neck and skin cancers. 900 people a day die of that in the US alone, globally. You know, it's off the charts. And so this is huge, huge, huge stuff. Well we found a way where we can take a small amount of virus and if you have an advanced stage metastatic cancer in that category, and you know how deadly those cancers are, liver cancer, most people die. You get a diagnosis, there's no saving you pancreatic cancer, it's almost a hundred percent die. Even breast cancer once it metastasizes. And the same thing with prostate cancer. It , this is really, really serious. Well imagine you get prostate cancer, you go down to the doctor and he's like, oh , we just found a lump. They biopsy it. They go, oh this is uh , a malignancy so it could be metastatic. So here's what we're gonna need. Now you know what you're thinking? You're thinking I'm gonna need surgery, radiation, chemotherapy, radioactive stents, freezing, whatever. Right? What he's gonna say is, okay, I gotta give you a shot in the big tumor, then you can go home, come back in six weeks and we'll see if there's anything left. Because what happens is that shot into the primary tumor is a virus that causes the cancer to start secreting a stimulatory small molecule that draws all the natural surveillance for that type of cancer from everywhere in your body and activates it in the activated state. There's a type of cell called a gamma delta T-cell that is responsible for chewing away these malignancies. And three to 5% of all of your T cells are dedicated to just that mission. And they clear small malignancies every single day. We've probably, both of us have cleared some small malignancy during this conversation. And as a result of clearing 'em when they're small, guess what? They don't grow into solid tumors and they never threaten our lives. And two thirds of people will make it all the way to something else. You know, they'll get hit by a car or they're die of old age before they get an epithelial solid tumor. But for one third you get escape. So as it's blowing up like a balloon, these poor gamma delta T cells have this bigger and bigger thing that's expanding exponentially, right? Lots of surface area, they can't get back on top of it again. But when we put that stimulatory factor in there, it causes those gamma delta T cells to, on a body wide basis, activate and eat malignancy at 300 to 600 times the normal rate. It obliterates that primary tumor, but while it's obliterating the tumor that we treated, those T cells circulate around the rest of your body and they clear the metastasis and the secondary tumors and even unrelated epithelial solid tumors. So you get treated for prostate cancer and it turns out they didn't realize you had a little bit of breast cancer too , or I guess prostate and breast. Not frequently in the same person . But let's say you had uh , you know, lung cancer or liver cancer, it might mop that up before it becomes a problem because the gamma delta T cells can't tell the difference between skin cancer, breast cancer, prostate cancer, lung cancer, liver cancer. And so once they're activated, it's like they sweep your entire body. It's like turning back your cancer clock. Now it's all talk the way I'm presenting it here, but we do have a thousand mouse study of advanced stage cancer where we're getting 85% of the mice coming back completely cancer free , zero cancer left in their body. It's human cancer. We're using human gamma delta T cells . We know it's safe in humans because the gamma delta T cells have never been seen to ever attack the wrong cell. They only attack malignancy. And in a mouse that's all tissue that's not recognized by your normal immune system. If you took most of your T-cells and put 'em into a mouse, you get host versus graft disease, it'll kill the mouse or kill the cells that you put in. Not with the gamma delta T cells . They don't care. They never attack anything but human malignancy. The mouse never sees 'em . You put'em in there and they actually clear all the human malignancy. So we know it's the gamma delta T-cell doing the work. We know they only do it if we go ahead and stimulate them by treating one tumor. We can put breast cancer on one side of the mouse, liver cancer on the other side of the mouse. We can treat one of those tumors. They both go away. It's remarkable. So this is very exciting stuff. Our collaborator, Stanford Medical School in California, a guy named Dr. Dean Felsher. He is a global globally recognized expert in hepatocellular carcinoma. The worst liver cancer, the most deadly liver cancer. And I think we'll be doing a clinical trial in his clinic probably early 2022. So it's not that far away. But these things happen fast. You know, we've already got a collaboration all across Europe in this immuno-oncology area. And uh , that's a very promising sort of second act for a GT. But you know, this is , there's so many different things that we can go into even our HIV drug. Basically what it is is we take your HIVT cell out, we put in this automated machine for 11 days and at the end of this we get a billion HIV specific T cells that only hunt and kill HIV and they are immune to HIV . The whole problem with HIV is that the HIV virus can get into the HIVT cell . That's why it can't protect you. But we make T cells that are these just slightly modified T cells that are impervious to HIV and what do they do? They clear HIV like you clear a cold. A billion of them we think is three to 10 times as many as you actually need. It's all done in 11 days in an automated cell protocol. And that's how we'll cure HIV. Now we can clear any chronic viral infection that way. What about hepatitis B or human T-cell lymphoma virus? Did you know that HIV was mistaken as HTLV when it was first discovered because it attacks the same T cells So we could actually improve the T cells so that HTLV can't attack them and H-T-L-V-T cells will clear HTLV. Now this is a very serious chronic viral infection, even though you haven't heard of it, or you may have heard of it, but a lot of people haven't heard of it . There's 20 million people in the far east that have HTLV and one in 20 of them will die from an incurable t-cell lymphoma in their sixth decade. That means that suddenly the disease reemerges sort of in their late fifties and it gets so prevalent in their body that it causes cancer in the T cells and therefore completely incurable. Well, what we can do is we can measure the viremia in all 20 million people. It's an easy test. And if it's on the up slope and we know that they're going to get enough of this in their body that they're highly likely to get that lymphoma, we can get them to a 50 50 chance. We can treat both of those patients. So we're treating about two times as many as we need to. But save a million lives that way by treating 2 million people. And so this is another market. It's huge. You know, think about that 2 million doses in the far east. Hepatitis B is huge. Herpes. Herpes comes back as shingles, human papillomavirus can come back as throat and neck cancers. You know, there's a lot of different chronic viral infections that we live with that eventually have comorbidities that can be serious or even deadly. So that's a whole platform. HIV is like teeny little tweak to that platform. All the same patents, all the technology applies and we can go into these other areas. It's just amazing. The future's just incredible.

00:40:45.675 --> 00:41:22.844
This is just science fiction, Jeff . I mean, it's too good to be true. It's fantastic. I'm really happy to hear that uh , you guys in your company are developing this and for the possibilities of bringing this technology to Latin America in the shape or in the form of a clinical trial so that investigators start collaborating with you guys. And that helps. I mean, the impact of the science technology and innovation of the region is just phenomenal. I mean, I love the uh , possibilities. But along those lines, I mean, what makes Latin America attractive to you? I mean, what do you think is gonna really make an impact in your future by working in Latin America?

00:41:23.724 --> 00:55:32.804
Well , what attracts us to Latin America is it's filled with human beings who are sick and suffering. So we're gonna get, our mission is to leverage the power of gene and cell therapy to reduce suffering and early death from serious human diseases. And to get that out as widely and as effectively for as many diseases as we can, as fast as we can. And you know, this is such a big industry that, you know, we don't have to be maybe quite as methodical about it, right? You know, we can go ahead and we can run fast and we can make a few mistakes in foreign countries where maybe the business arrangements are sub optimum because you know, we just didn't have the time to do that. Because when you're talking about a $5 trillion industry, the important thing is to grow, not to be perfect. You don't want perfection to get in the way of doing good, right? So I think, you know , that's the reason is that the economics of this will certainly put it in range of even third world countries eventually. But Latin America is basically industrialized. You know, maybe the rate of poverty, you know, and uninsured and things like that is higher in Latin America than it is in the United States, at least for now. And who knows, the way the US is going, you know, we may have more poverty than uh, Brazil pretty soon, but the bottom line is, is that there's markets there and they don't have to be gargantuan because the drugs are not as risky and they're not as expensive to make and they're easier to transport. The manufacturing is simpler. And then the question is, is , okay, how quickly can we expand? We wanna keep our corporate culture, our culture is all about this mission of doing good in the world. And so we don't want to just hire anybody. We have a person that we think is a HIV person. They're smart. You know, somebody that is self-motivated and you know, self-disciplined and has a good work ethic. But after that it's about passion. That's the secret sauce that takes a smart, hardworking person and takes them from good to great and maybe from great to doing something that is, you know, almost miraculous. And this is what we focus on at at a GT. So we'll grow as fast as we can attract people like that all over the world. And if we can find partners that we believe are that way, then we can trust them to go ahead and create a market in Columbia , create a market in Brazil, in Venezuela, wherever. Right? You know, we're gonna get our piece of it for what we provide. But in a $5 trillion industry, there's plenty of money to go around. It doesn't have to be really grabby and greedy. And another thing I'll tell you about gene and cell therapy, hyper competitive, okay? It's just like the software industry in that once companies get efficient at it like we are, it will be incredibly competitive because there's always more than one way to do anything in software, right? Just because somebody wrote VisiCalc , they didn't rule the spreadsheet market forever, right? Or even 19 years on a patent. No. Lotus came along with Lotus 1, 2, 3 and wiped them out. Mm-hmm . And then Microsoft came along with, you know, Microsoft Excel and wiped them out. Right? Now, why did Microsoft stay as the leader in spreadsheets? It's because of two things. One is they're better at writing software and they have the tool set and the best understanding of the tool set so they can leverage it the most quickly. So what happened is, is that Microsoft, even though at first they were competing with Lotus, they were able to move the feature set forward so quickly, but Lotus couldn't keep up anymore. And so that's how Microsoft stayed in the business. That's our mantra as well. Just 'cause we have HIV cured, we're not done, we're gonna then go back to the lab and cure it better, faster, cheaper, right? We're gonna add features and lower the cost. We're gonna make it so hard for somebody to compete with us in that area. Mm-hmm that we can rule that space for decades. But it isn't gonna be because we just hold one patent. I think the patents, you know, in these patent cliffs will become really unimportant. Patents will be worth, you know, five years of protection and then an alternative way of curing the same disease will come up if we're gonna make sure that we're the ones that discover it in HIV and other chronic viral infections potentially and in cancer. But in the meantime, what we do is we try to make discoveries that are part of that tool set layer. In other words, we wanna have as many components as possible the mix and match to cure a myriad of diseases. So that one day we're the iPhone of disease cures where curing a disease is like writing an app on that phone. And we are the ones who have the platform and we get that piece of it. But we collaborate with all these other companies around the world that say, yeah, I'd rather cure this disease using your platform and start 80% done on day one and be looking at 10 to $20 million to get into the clinic as opposed to starting from scratch. And you know, looking at five years of development and you know, 50 to a hundred million dollars to get into the clinic, right? So it's a great thing for everybody, but you know who it's greatest for the patients because now they're not just getting treatments. Also we're not talking about treating HIV, we're not coming up with a longer lasting antiretroviral therapy, which is the same old stuff, but just time released. No, we're looking at curing people, getting them off of a RT. Why would they wanna be off of antiretroviral therapy? 'cause it's a toxic chemotherapeutic. HIV is the farthest thing from cured. What you have is millions of people that take a pill every day that makes them feel sick, okay? It causes nausea, headaches, fatigue, long term . It causes early aging bone density issues, osteoporosis, liver, kidney, heart disease, and extra cancers. This is why HIV patients actually cost insurance companies about a a hundred thousand dollars a year, even though the meds are only 20 to $30,000 a year. It's all the pain and suffering. It's all the in and out of the doctors. It's horrible, right? But it suppresses the viremia. These people are not contagious and they can't get aids. That's why they take it. Well, it's not a death sentence to have HIV anymore. It's a life sentence. But we've got the God get outta jail free card, right? , we give you a one and done treatment and you are normal for life. As a matter of fact, the only way you're not normal is that you are permanently immune to HIV. So you can't recontract it, , you can go back to your same community. There may be still HIV around, but you don't have to worry about picking it up again. So the value of that is just tremendous. And it's not just in terms of saving insurance companies money or saving society money in a , in something that's an epidemic spread. We get 50,000 new cases of HIV in the United States every year, okay? So it's not over. Polio at its peak was only 60,000 cases a year. So it's an epidemic. So it's a huge cost to society, but it's not just a savings economically for society. It's not just savings for the insurance companies that have to pay a hundred thousand dollars a year. No. What it is, is it's a better quality of life. It's less suffering for our fellow human beings. And that's one of the things that excites us so much when you come to work at a GT, you pop out bed because you know you're going in to do something that is really important and really near and dear to your heart and it's serving other people. So, you know, it doesn't mean that, look, we have to live in a capitalist world. It doesn't mean that we won't make money off of these drugs. But I think what it'll mean is that drugs are gonna be totally different. Nobody will be a hostage audience where their choice is to either buy an expensive drug or give up hope, even if the drug doesn't cure them, even if the drug isn't worth the money, right? No. What you're gonna do is you're gonna buy cures to things that is gonna give you a million dollars worth of extra productivity and life and savings and stuff like that. It's gonna cost a half million dollars, right? Well, why don't you complain about the price of your cell phone , because the value is higher than the price. So you're not like calling your congressman going, Hey, I can't live without cell phones and they're ripping me off, man. Right? But that's what you're thinking about with drugs and you're thinking about that. 'cause there's no competition because all of these major drug companies are essentially collections of siloed monopolies, basically drugs that are maybe the only or one of a very limited set of choices in order to preserve your life. And as a result, they can jack up the price as high as they want, and your choice is buy or die, right? Right. So this is, we can break that, not because we intend to break it, but because nature is gonna break it with this tidal wave of gene and cell therapy cures and this naturally competitive industry of software for the human computer, the human cell. And in the same way that you don't complain about the cost of Excel , you won't be complaining about drugs. You'll be using them all the time to improve your life, but you're gonna say, Hey, I'm getting the value for the money. And the reason that Excel won't become worth, you know, they won't start charging $10,000 for it right now, is because there are alternatives. You think that Excel , you need it. But the fact is, is if it was $10,000, you'll use Google Docs, you know, or you'll move over to Linux. So there's a limitation even on the 800 pound gorilla in the software industry. You know, Microsoft corporation itself cannot raise their prices to an unlimited level. Roche would be shocked. They'd be like, what do you mean you can't jack the price up of your products? This is how we bring more money to the bottom line. We increase the price of our product 3% every quarter no matter what. And you can't, nobody can compete with you because drugs cost $2 billion to get through the regulatory process, but no more, right? If you can get an orphan disease approved at 10 to $20 million, there you go. You've broken that right there, right? If HIV can get out there and it can be sold, a cure can be sold for a half million dollars, eventually there'll be no business for antiretroviral therapies. Right? And so, you know, the idea of creating these siloed monopolies will naturally crumble. And this goes back to what I was telling you about, you know, the reality happens at the nexus of nature and human nature, right? You know, nature comes along and it gives you this new technology and human nature holds it back because all of the powers that be aren't ready to adopt it. It's highly disruptive. Whatever reminds me of when personal computers came out and IBM was like, that'll never sell. Right? And now where's IBM? They're installing personal computers. Where's Burrows? This is a great question to ask anybody that's in the pharmaceutical business. It's like, how's boroughs doing this days? And they're like, who's boroughs? Oh, that was the second biggest computer company on earth before Apple came along and showed everybody the value of personal computers brought the graphic user interface, made it accessible to everyone. And the efficiency of personal computers and the competitive nature of it and the containment of the cost literally disrupted the entire computing industry wiped out. A lot of people have never even heard the word mini computer, but there was a whole mid-tier industry of many computers that existed between microcomputers and mainframe computers. They were the first ones to get crushed in a pinch natural pincer movement. It's called, you know, in Battle Talk , right? But then what happened was these mainframes couldn't come down in price to meet these pc. And so the mainframes were eventually obliterated, right? They became impractical in the face of a much more efficient technology. That's what gene and cell therapy is. It is a more efficient way of developing drugs that have more impact, more value. And they may be expensive right now, but remember, this technology doubles every year in efficacy and it has every year in cost. What that means is just like cell phones , eventually it'll get everywhere at a cost that's justified. Remember, nobody owned a computer, or almost nobody in Africa owned a computer or a telephone. Now they all have the best computer and best telephone in the world in their pockets. Why? Because the value got so high and the cost was moderate enough. It was competitive enough that it made sense everywhere. So you know, that's gonna be the same thing with gene and cell therapy. That's something for people in Latin American markets who might say, well, when's this gonna come to us? Sooner than you think. It's practical, sooner than you think and you will actually be treating people that don't have health insurance. Why? Because it's cheaper to treat them for the whole society than it is to let them be sick and dying. Right? So it actually will even move into the most vulnerable people on earth over time. It will get that good, it will get that efficient. It's not about cheapness, right? It's about efficiency. It's about value per dollar. At some point, the value per dollar is so high that anybody can afford it, right? Yeah. I think it's really bright future for all of us human beings.

00:55:34.085 --> 00:55:39.324
Absolutely. Absolutely. Jeff , I totally love your passion the way you envision this.

00:55:40.414 --> 00:57:31.885
Thank you. Yeah. I'm glad you're excited by it. And I think you've got every reason to be, I'm glad you understand it coming from your technical background and also that you're involved in drug development now, so you really get this transition and I think a lot of people, it's gonna click with a lot of people. That's how we raised all the money for the company. We didn't have, you know, VCs that said, oh, I'm willing to bet on this guy who came from computer software to run a biotech company. Right? That was hard. But I could go out and explain what I just explained to you to investors and they were like, yeah, you know, this makes sense. I sit on panels with VCs sometime and I talk about how much money we raised without a VC and they blanch. 'cause I think they didn't realize that you could do that. But it's a matter of having a very clear vision for the future and being able to tell it in a way that people can connect with it emotionally. And then what happens is, I learned this at Apple. It's called evangelism. You're shining a light and the people that see that vision are attracted to it, and many of them can actually power that revolution. This is where nature can overcome human nature. Trying to hold it back, right? It'll overcome Wall Street. It'll overcome the institutional investors. It'll overcome pharma companies because nature demands it. This is just better. It makes more sense. It'll take a little while till it gets the level of momentum where, you know, maybe Pfizer realizes they're the next boroughs or Sperry , univac or GE mainframe division, right? It may take a while . Right? You know, the hubris of success. They're the masters of the universe now 'cause they , uh, control it all. And so, you know, there's no incentive for them to consider things that could be disruptive 'cause they haven't been disrupted yet. But your first time is the one you remember forever. well

00:57:32.164 --> 00:58:54.045
Said . Well , yes. Yeah. I mean, Jeff, I can't wait to see this technology in Latin America. First, the shape of a clinical trial and second hopefully hospitals. I mean, being done on patients. I mean, these treatments, I mean, fascinating stuff at a much lower cost. And the reason why we started this podcast is because we wanted to, we identified actually two problems. One problem was that us companies usually fail when they enter the Latin American market either to do clinical research or to commercialize their innovations. And second is, patients have not really access to medical innovations that are happening in the first world, so to speak. So we wanna accelerate that access to innovative technologies for patients in Latin America. And that's one of the reasons why I do this, because I think I , I can bridge the two worlds can be that buffer between the two parts of the world where patients are desperately needed for medical innovation, fast and a lower cost . And that's why you're here. I mean, this is fascinating for , uh, the future of the region. That's how I see it. So thank you Jeff. I mean, you are being extremely , uh, good at explaining your vision and your technology and it's been really, really , uh, fantastic to be , uh, uh, talking about these things with you.

00:58:54.114 --> 00:58:59.405
Well, thank you very much. It was a pleasure to get an opportunity to speak with you and , uh, appreciate very much.

00:58:59.715 --> 00:59:05.684
Awesome. Awesome. I look forward to talking about clinical research in Latin America very soon, with you here in the show.

00:59:05.974 --> 00:59:12.005
We're gonna definitely do that. All right . Okay, . Thank you, Julia . Bye bye . Bye .

Jeff Galvin, CEO and Founder at American Gene Technologies™ (AGT)

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