Curing Incurable Diseases with Jeff Galvin of American Gene Technologies

What if incurable diseases like HIV, cancer, PKU, and epithelial solid tumors were completely curable? We're closer than you might think. Really close. 

In fact, Jeff Galvin and his team at American Gene Technologies™ (AGT) have been advancing the research and application of viral vectors for several years with some incredibly exciting breakthroughs on the horizon (hint: curing HIV could be just a few years away). 

In case you didn't know already, viral vectors is a relatively new technology where you can crack open any virus, scoop out the malevolent code and replace it with code to attack the root drivers of what are today incurable diseases. Essentially this creates a "stealth bomber" benevolent virus in your body. The future of this treatment could "send radiation and chemotherapy the way of bloodletting and leeches" as Jeff says in this podcast. 

Jeff has a contagious energy for gene technology and a grand vision of the future of curing the incurable.

If you want to get a peak at how gene technology could quite literally change the world (and soon!) listen to what Jeff has to say.

Enjoy!

About Jeff Galvin

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.

Show notes:

• Jeff's LinkedIn
• Jeff on Twitter: @jeffreygalvin
• https://www.americangene.com/
• Press Release about AGT's FDA approval to continue HIV cure program
• AGT on LinkedIn
• AGT on Twitter - @americangene
• AGT on Facebook - @amerigene
• AGT on Instagram - @americangenetechnologies

Music by keldez

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

Music by keldez

Transcript

Robert Fenton: 0:21

Jeff Galvin is the CEO and co-founder of American Gene Technologies or AGT for short, he earned his BA degree in economics from Harvard 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 these companies were either taken public, 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 Jeff's start to experience. He retired to become an angel investor in real estate and high-tech. After a couple of years, Jeff came out of retirement to found and fund AGT after meeting Roscoe Brady at NIH and witnessing the incredible projects he was working on in gene and cell therapy. Jeff has a contagious energy for gene technology and the future of curing seemingly incurable diseases like HIV, cancer, and PKU. We're a lot closer to cures and you may think. Just listen to what Jeff has to say on this episode of, from lab to launch. Yeah. If I'm really excited, you've made some time to kind of sit with me today and tell me a bit more about your journey and how you got here. I think based on when I entered it stalked your LinkedIn and just some chatting with grant, I feel like I could probably chat with you for quite a few hours, so I will try and be somewhat concise. Uh, But maybe the first question I'd ask is what's your story? What brought you to American Gene Technologies or AGT as I think you colloquially referred to it as.

Jeff Galvin: 1:58

so, I had retired from the Silicon Valley scene, so computers, software, internet, it, apps, et cetera. I had had a good run for about 20 years and in my early forties, I realized I didn't have to work anymore and I'd been killing myself. So the idea of an early retirement sounded really great, and it was great for about five years until I started getting bored. And I thought I'll just go dabble in technology again. And I assumed that what I would do is find somebody in Silicon Valley that wanted a mentor or a board member, or maybe an investment. And as soon as people heard the word investment, I started getting all sorts of business plans over the transom from all over the country. One of them was from a lab at the national institutes of health. And I went out to see it cause it was kind of intriguing. And I was introduced to a guy named Roscoe Brady Roscoe Brady showed me viral vectors. And for those of your listeners who don't understand what a viral vector is, is that for billions of years, about 1.5 billion years, viruses have been around and they carry little code segments, kind of like DNA or RNA. They can drop that code segment into your cell, which will then execute it. So it's like this fake DNA that hijacks your cell to do something. Usually a virus just hijacks it to duplicate the virus. But, uh, viral vectors was this relatively new technology where you can crack open any virus, scoop out the viral code, the malevolent code that's going to take over yourself or something bad, and you can replace it with whatever you want. And so that, you know, once you scoop out that malevolent code, you've got an empty Snoke bomber that can deliver anything. I thought of it coming from Silicon Valley as a discount. A discount for the human computer, the human cell change the DNA. We can change it in any way we need to. And I was like, when he showed me this stuff, I was like, now that we can go in and attack the root drivers of everything in your body, there is nothing we can't do. We can't do it all today. But I said, this is the future of medicine. I got so excited. I started the company and he was retiring and NIH gave us all the stuff that he was working on. Turned out to be some really cutting edge stuff. He was quite advanced in terms of what he had put together in the lentiviral space. And we took it from there and, uh, you know, it was pretty early stuff, it was a long translation path for it, but I was a true believer. I mean, I just had this vision, this ephiphany, about the future of pharmaceuticals, where I told them this at the first meeting, I said, the blind will see, the cripples will get up and walk. The lepers will be healed. We're going to send radiation and chemotherapy the way of bloodletting and leeches. And he was excited. He didn't think about it. And in those sort of industry terms, but he didn't refute anything that I said. And here we are right now on the Eve of potentially curing HIV.

Robert Fenton: 4:51

Oh, wow. Okay. So tell me, yeah I'm bought into the vision. You can sign me up right now. I'm from watching this space over the last decade or so myself and from studying pharmacy, you look at like therapeutics and how that's evolving. While the most exciting spaces that exist right now, if not the most in terms of therapeutics. So tell me where are you right now with the technology and applications?

Jeff Galvin: 5:14

So we have three lead programs. One is a cure for HIV, which is in a clinical trial right now. I believe that this year we get safety and efficacy data on an autologous cell therapy. That would move somebody from being HIV positive, taking antiretrovirals every day to prevent AIDS, to prevent transmission. We could get them completely off their antiretroviral meds. And basically we modified their immune system so they could control and eliminate HIV. So they are permanently immune to HIV. A one and done 11 day treatment. We pull it, do a blood draw. We isolate their HIV T cells. We modified them. So they're actually effective against HIV. So instead of them getting infected, they actually destroy HIV. We culture that up their own cells up to a billion of those cells, put it back into their body. And as the theory goes, and there's a whole arc of this HIV cure, I believe that this is going to be sufficient to maintain HIV immunity for life. No more meds. They're not just normal. They're not, not only don't have to worry about AIDS or transmitting it to anybody else, but they don't have to worry about getting it again. Uh, yeah. I mean, think about that. People that were HIV positive, not just getting normalized, but literally HIV is out of their life forever. That's the lead program. We also have a cure for something called phenylketonuria this is a rare disease, but it's one in 13,000 births in the United States, but one in 10,000 internationally or globally, and, uh, what it is is, uh, people have one broken gene. You know, what, what a monogenic loss of function disorder is you have a broken gene. You're not making something essential in the body. And as a result, it manifests as a disease. phenylketonuria is particularly, uh, painful because you cannot, metabolize something called Phenylalanine which is an all animal proteins and diet Cokes. And fake sugars and stuff like that. You can't have any of that stuff. So you go on a diet that has no animal protein and you have to avoid Phenylalanine cause otherwise the buildup will destroy your nerves and organs. And all it is is you're just missing one enzyme from this one, gene that would break it down into a whole bunch of other central nutrients for what the brain. So even if you don't eat any Phenylalanine you avoid the pain of, you know, sort of the buildup. It doesn't matter because your tyrosine's starvation will leave you depressed at 20 schizophrenic at 30 and suicidal at age 40. One in three people who has phenylketonuria commit suicide by age 40, having not worked in more than a decade. So it's a terrible disease to have, but it's just one broken gene. Well, remember the, uh, these viral vectors, these stealth bombers, I told you about, you can order that gene off the internet. That's how far gene and cell therapy has come. You can package it up in that stealth bomber and you can deliver it to the cells that need it. You turn back on that phenylalanine hydroxylase you restore the normal morphology of the cell and the normal processing of phenylalanine and the disease isn't treated. It's gone. It's really cured. So we have a cure for phenylketonuria it's earlier stage. So it's still in pre-clinicals, but we think it's ready to go talk to the FDA about starting a clinical trial. And then here's the kicker. We have an immuno oncology asset where if you get an epithelial solid tumor, let's say breasts, prostate, lung, liver, colon, kidney, ovarian, pancreatic, head and neck or skin cancers. All the most deadly solid tumors instead of surgery, radiation, and chemotherapy, we think it can be treated by just putting a small amount of virus in the primary tumor. We light it up in the way where it stimulates your natural surveillance for that epithelial malignancy and elevates it to a level where it can chew away solid tumors. So it's almost like a vaccine because that lit up primary tumor attraction, all of your, what are called type two gamma Delta T cells, the ones that are eliminating malignancies as we're speaking right now, and it attracts them, trains them, proliferates them. And the most important thing activates them. They can eat at 300 to 600 times their normal rate. Course they obliterate that primary tumor, but they're circulating T-cells. So they also catch the secondary tumors, Mehta Stacy's and unrelated epithelial, solid tumors or malignancy without further treatment. It's like a flushing of your whole body. So think about that. I can see, even though this thing will take another couple of years to get to the clinic, we have a thousand mice, which are good models of advanced stage epithelial, solid tumors. Multi tumor, multi type tumor in multi location. We treat one tumor. We put human gamma, Delta T-cells in the mouse. It clears all the tumors and 85% of the mice come back. Completely cancer-free. I think this is going to translate to humans and there's this light at the end of the tunnel where we might send radiation and chemotherapy, the way of bloodletting and leeches, just the way.

Robert Fenton: 10:22

Very welcome. Uh, so a lot of huge things, right, right there. Jeff, I think you're you're right. We could go a lot deeper, probably spend a few days, at least digging in here. So tell me, the tech itself clearly has so much potential. And you're looking at some of the biggest applications if you forecast forward. And we look at well, you know, when is the real world going to hopefully get to see some of this timing? I think you mentioned that the lead candidate, every HIV, pragmatically speaking, when do you think that people might be able to start getting access to this?

Jeff Galvin: 10:55

Okay. So if we get efficacy signal this year, Then I think that there would be a big bolus of attention that would be drawn to this project, because this is what HIV infected individuals have been dreaming about a cure, right. Being normal and, uh, and getting off their toxic antiretrovirals. I don't know if you know, but when somebody takes these viral suppressants for HIV, the toxicities are fairly serious. They get nausea, diarrhea, fatigue. That's sort of a normal thing on a daily basis, but long term, they get early aging, bone density issues, osteoporosis, brittle bones, liver, kidney, heart disease, and extra cancers. I mean, it's very serious. They don't get AIDS, which would be even worse, but you know, what they want is a normal life, right? So I think that what will happen is the scientific community can understand efficacy signal. We won't have to have a full statistical study that shows that. Out of 50 patients, 48 of them get durably in remission or whatever. We need to show something that the scientists, the Tony Saatchi's of the world, the experts in HIV look at and go, okay, I can see that that's gonna work. At that point when we have unlimited money, we'll do a phase two. And it's typical in gene and cell therapy that these new treatments get licensed in a pivotal phase two, I would not be surprised if the FDA would allow this for patients that are having particularly difficult reaction to antiretroviral therapy, some people are bedridden because it's so bad. And so I would imagine at that point, the FDA will look at it with. Uh, you know, safety data from the phase one and efficacy signal from the phase one they'll, you know, I'm hoping they'll authorize the phase two, the phase two more, be much, much different. It would just be more patients. But I think we could be looking at within the next three years for people that really needed badly, it would be, uh, available. That's pretty quick. I mean, this is a nice thing about gene and cell therapy is. The amount of time from the initial sort of proof of concept to the market has been drastically shortened. And this is an attribute of gene and cell therapy. When you're reprogramming the human computer, it's very specific. You're not bathing the whole body in a chemical and wondering what will, how will every single cell in your body react to it? We can actually take viruses, steer them to certain parts of your body, have them release genetic constructs in there that have if then statements on them, where they only turn on. If they sense that it's the right cell to turn on. And most drugs, their problems come in human trials from off target effect. Well, gene and cell therapy narrows that off target effect and it makes the overall effect highly predictable. Because of the specificity we're literally going in there and turning on a gene product or shutting off a gene product. So it's a whole new world

Robert Fenton: 13:57

Yeah. Whole new world. I would imagine that. Yeah. People generally speaking, if you talk about like the adoption curve of any new technology, there's possibly some hesitation. Do you think that like the success of the vaccines? not being the same thing, but while the first time times we're seeing people talk about The technologies that are all of a similar vein or at least a similar lineage. Do you think, how do you think that's influenced public interest or

Jeff Galvin: 14:25

So, so MRNA is a narrow subset of gene therapy. Think of it as, instead of taking a virus that attaches a new gene in a cell, it drops in a temporary expression of that gene. And what's so miraculous about these new forms of MRN vaccines is their accuracy. Because what they're doing is they're putting in the instructions to make the part of the virus that won't hurt you, but that will alert your body, that the virus is there and get it revved up. Right. That's the miracle of these MRNA things, right? They're using the specificity of the whole underlying genetic approach to medicine. That is the foundation element of gene and cell therapy to replace vaccines that were approximations of viruses that alerted your body that needed to be tested. And, you know, for years and years before you knew whether it was going to be accurate enough to reproduce, you know, to get you the right antibodies. They're able to go in there and program your muscle cells to spit out the exact spike protein, if that's what they want you to be reacting to or the exact ending. I think that, uh, you know, they're expensive technologies that are more expensive than the traditional vaccines, but the ability to turn these things around fast is the advantage that they have. And yes, I think that this is going to acclimate everybody to lead into some of the basic concepts in gene and cell therapy. And there's going to be a lot of, you know, public excitement over it. And there's going to be a lot of, opportunity to create value as well.

Robert Fenton: 16:01

And on that, Jeff, you mentioned I think at the beginning you came in and you founded and funded the company. And you also mentioned that while looking at phase two, that as this becomes successful, you know, that does open up an incredible amount of resources for you. I'm curious as a company, founder in this pretty, still pretty nascent space, right? It's not every, it's not like a lot of products. It's not like this is going through your retail, Walgreens pharmacy for products like this. Right. So what's it been like funding this through the different milestones so far?

Jeff Galvin: 16:35

It's been a a puzzle, a special challenge, and a very interesting ride. So we didn't fund this in the traditional manner. Because when I got into this, when I got excited by gene and cell therapy, none of the institutional players were interested, the pharma companies, weren't interested the VCs weren't interested. The investment banks were, nobody was interested, but I saw a future in this. Now, one of the reasons that cause you were talking about technology adoption curves, one of the reasons they weren't interested is there was irrational exuberance surrounding viral vectors. And there were some accidents, some very high profile accidents and the FDA pulled back. So everybody else pulled back. And they had sort of dismissed this as something that would was too dangerous or might never work, you know, they might never be able to get a handle on it. So they went into this irrational, you know, sort of, uh, negative Nader surrounding the technology. That's right when I discovered it, but I was thinking, Hey, that's the way every adoption curve is. You always think it's going to do like, think about, I was in Silicon Valley for web 1.0. Right. Think about how many companies, they just put.com in their name. They got rich and then six months later they were broke. Right. You know, so I knew that this was going to have a comeback. There was going to be a gene 2.0, like a web 2.0 in which companies that really understood this were going to do well. So I believed in it. Well, so I'm pushing this for about seven or eight years before VCs start getting interested again, by then, I had already been raising money at a very high market cap. Because I was having to go straight out to high net worth individuals, the same people that invest in VC firms and tell them, Hey, you should take some of your money and put it straight into this vision for the future. And I was getting a lot of people that were excited. I was an evangelist for my personal belief in the future of pharmaceuticals and it was contagious. Yeah. You know, when I'd go out and talk about it and people would lay down the checks and. So, you know, we'd raised about$17 million. We went and did another round for another$17 million at 120 million pre, which is way too much money for a VC to get involved. Now we're just wrapping up a$25 million raise at a$240 million pre, but it's totally justified, but it no longer fits the standard model of these ventures. So that's why we, you know, I go out there and I, I love being on things like this because it gives me a chance to spread my vision for an amazing future where, you know, we won't be the only company that's successful at it, but we're talking about a market, probably a new$5 trillion pharmaceutical market. Think about that whole pharmaceutical market now is somewhere between one trillion one and a half trillion dollars a year. There's a new$5 trillion market on the horizon. You know, that is just incredible. And, you know, don't take my word for it. This was a prediction by Goldman Sachs that came out like a few years ago. So, and now I spotted this back in 2007. When I met Roscoe Brady, I knew, you know, I could project, I could have this vision for how this capability could turn into a whole new way of finding cures for the incurable and treatments for the completely untreatable stuff. And that's all coming true. My vision hasn't changed one iota. And a lot of people have joined me along the way because I've gone and I've sort of been able to explain this enough to all different levels of people from scientists, at NIH who sometimes gave us grants to high net worth individuals who said, you know, this is worth taking a risk on, and we've raised somewhere around$55 million so far. And we've, we've been pretty efficient with that money. Yeah. Think about how cheaply we got to striking distance of reporting safety and efficacy data on a cure for HIV for$55 million. If you're going to develop a drug, you figure$250 million to a phase one, right? So, but that's also the nature of union cell therapy. It's much more efficient because you designed stuff. You're not discovering stuff. It's not random discovery. This is, you can think through. How do I need to change the cell to make it work better?

Robert Fenton: 20:49

Yeah. I, think I love that analogy because that matches what we see is we work with a lot of our customers and look at the next wave of bio or the life sciences industry. It's going to be. We're a firm believer that there's a shift now towards a new generation of companies that look a lot more like the software companies that were built in the last few decades. And it's just this faster iteration. It's more intentionally designed as we start to figure out better how these things actually work. Right. And once upon a time you just tried some stuff out. In fact, wait a second. Still today, people try some stuff out and see what works it's. Yeah. It's actually a miracle it's being effective. And clearly we all benefit from that, the 1.0 approach, but the next few decades is going to be awesome. Uh, Jeff you've inspired me anyway from chatting today. It sounds like you've achieved a lot, right? Raising this capital, um, by going directly to high net worth people like selling the vision, you do that incredibly well. We want any advice you'd have for people coming down the tracks today with a belief in something they want to get going, what would you share?

Jeff Galvin: 21:55

Well, I think raising money is essentially marketing and marketing is really about storytelling, which is what people consume the best. So you have to figure out what the arc of what it is that you believe in you can represent it. Right. And I just turned out to be very good at that just naturally. And also, you know, I cut my teeth at Apple selling, the graphic user interface. I've been through the idea of taking something that nobody believed in. And going around and showing my excitement for it while, you know, the audience's excitement build for it until finally the graphic user interface got accepted. I mean, can you imagine cell phones on the C prompt right now? So, you know, and believe me, when we first launched the graphic user interface, I was at the Lisa division and all the analysts were like, you're never going to, it'll never catch on, which is just hilarious, right. In retrospect. But you know, that's so similar to the way that. Everybody was about gene and cell therapy. When I went out there and started pitching the traditionalist, the status quo, all of the institutions all felt that way. But for the people that had sort of an open mind, you could tell this very well integrated, sensible story about how this nascent technology could explode into all these different applications. And I could explain how I planned to do that. And I could even project how the industry was going to grow. And, you know, at first it was harder, but once people had been with me for a year and saw, Oh, it's actually happening the way that he said it would happen, it got easier and easier and easier. And the rounds got bigger and the price of the stock got higher and the the valuations climbed and things like that. So my advice to people is one, find something you really believe in. Then sit down and, you know, really get to establish a vision in your own head for where this thing's going and how you're going to get there. And then, you know, tell it to anybody who's willing to listen. And if you find people that catch the fire in the belly from, you know, the, the, the story that you're telling, then you're going to find that they gravitate to you in some way, and they help propel your vision. And that happened for me, with scientists came in because they understood it the quickest. Then investors, employees, everything. Right? Yeah. And, and I think, that was very much in my mind, the story of Apple while I was there, especially the graphic user interface days, you know, sort of the, the Macintosh from, barely selling it all to a graphic user interface that dominates the industry now. And I think that that's the case with a lot of technologies. I think it's true about a lot of entrepreneurs is that they are just in love with what they have and they share that love with others and, you know, a good vision, good brains, hard work, and then some luck. Of course and you know, a small team can achieve anything.

Robert Fenton: 24:56

Yeah. Yeah. I appreciate you sharing that, Jeff. Wish we had more time to dig in deeper. Might have to bring you back in nine, 12 months to see where, everything is at, thank you for sharing some of your journey and the absolutely mind blowing progress that you folks are making. I'm excited to follow the journey and keep in touch. Thank you so much. Thank you, Rob. It was a pleasure and love to talk to you again, anytime.