Brian Finrow: Co-Founder and CEO of Lumen Bioscience

July 16, 2022 Brian Finrow Season 4 Episode 49
Brian Finrow: Co-Founder and CEO of Lumen Bioscience
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Brian Finrow: Co-Founder and CEO of Lumen Bioscience
Jul 16, 2022 Season 4 Episode 49
Brian Finrow

Brian Finrow, Co-founder and CEO of Lumen Bioscience, speaks with BioBoss host and biopharma branding veteran John Simboli. Hear Brian’s thoughts about leadership and how Lumen Biosciences is working to unlock the full potential of biologic drugs, whose promise has been held back by the lack of scalable technology. 

Show Notes Transcript

Brian Finrow, Co-founder and CEO of Lumen Bioscience, speaks with BioBoss host and biopharma branding veteran John Simboli. Hear Brian’s thoughts about leadership and how Lumen Biosciences is working to unlock the full potential of biologic drugs, whose promise has been held back by the lack of scalable technology. 

John Simboli  0:00  
Today I'm speaking with Brian Finrow, founder and CEO of Lumen Bioscience, headquartered in Seattle. Welcome to BioBoss, Brian.

Brian Finrow  0:08  
It's a pleasure to be here, John,

John Simboli  0:10  
Brian, what led to your role as founder and CEO of Lumen Bioscience? I started my career practicing law and came out of Harvard Law School. I moved back home here to Seattle. And so I actually practiced law for 10 years as a corporate lawyer representing biotech companies. That was really my entree into the industry. And one of my clients very early on was an agricultural biotech company. And the scientific founder of that company was Jim Roberts, who's my co-founder here at Lumen Bio. And so, as life has a way of doing this over and over again to us, I got to know him, it was almost 20 years ago. And then we went our separate ways for most of a decade. And then, serendipitously, we ended up working at two companies that were across the street from each other. At this point, I had left the law firm, and was working for a company called Adaptive Biotechnologies. And he was across the street. And so I'd see him at this Thai restaurant. And he told me about the technology, and what he was working on, and the challenges they were having. And we, together, hatched this plan to start the company that ultimately became Lumen Bioscience.

John Simboli  1:14  
At some point, did you and Jim say, "This is weird, that it's all coming together like this, but it seems like a really interesting thing?" Or was it very clear, after you'd done this research, that "Hmm, there's an opportunity here?"

Brian Finrow  1:27  
To his credit, the same pitch that Jim gave me, that got me excited about this, we're more or less true to that today, now, five years later. And the story was this concept of really answering the question, what would we do differently if antibody drugs and other biologic drugs were as cheap as small molecule drugs to make and deliver, and qs easy to ship around and as easy to administer as a pill? Now, the details, that's another matter, because there's a lot of twists and turns in the details of it. But we are still, really, honestly, I'm not making this up, still just executing that very original business plan from five years ago that Jim lured me in the door with.

John Simboli  2:16  
Did you and Jim ever, early on, say, you know, "This is an interesting idea, but it sure is a lot of work to create a company from scratch." Did either of you think, maybe we'll approach some biopharma companies to see if they're interested in taking this idea in-house?

Brian Finrow  2:31  
That idea never came up. You know, in order to start a company, I mean, you've got to, there's got to be a lot of things true about you. I mean, number one, you've got to be in for a lot of pain and uncertainty. Because it is, as you point out, a lot of work. But there seems to be another element, is you have to be a bit of a, I don't know, a bit of a contrarian or maybe you've got to have a bit of ego. At some level, the whole idea is built on the premise that you, the founders, know, something that everybody doesn't. I mean, that's pretty audacious, pretty absurd that it ever works out. And that was certainly true for us. So no, we never thought about just trying to take it and peddle it to the big company. I don't know that they would have been interested. I mean, it's so different. I mean, this idea is very strange. I like to think about the people in the early 80s, at Regeneron, and Genzyme and Genentech, and these, you know, these giants of the biotech industry. Back then they were all full of long-haired hippies, out in South San Francisco, working in old warehouses, and how strange it must have seemed to the big pharma of the day, these small molecule colossuses, their billions of dollars in walnut-paneled offices, and how odd it must have looked, you know, when they walked in the door, explaining how they're going to grow things in hamster ovary cells, right? Which is how all antibody drugs are made today. I think that must have been very odd. We take it as a given today. But I think that it's probably as strange to the biopharma executives of these big companies today, when we come in the doors and explain our equally bizarre-sounding, maybe not quite as bizarre as hamster ovaries.

Brian Finrow  2:31  
How did you decide you wanted to lead a biopharma company?

Brian Finrow  4:20  
Well, as I mentioned earlier, there's no small amount of ego that comes into thinking that you can pull off a biotech startup, so maybe that's part of it. I thought I'd look around and, you know, I don't know other people who can do it better. And in particular, the marriage of insights that Jim and I bring to the table I think has been healthy for us. Jim is a scientist's scientist. And he was the head of the basic sciences division at Fred Hutchinson Cancer Center, and he's been deep in the biology of cell cycle molecular biology for a couple of decades. He's really a leader in that field in its grand flowering, whereas I would not ever be confused or taken as a scientist. I'm trained as a lawyer, which is about as far from being a scientist as you can get, I think, in your training. But I came up through the other aspects that are important in building a biotechnology company, which is dealing with all of the challenges you deal with. I mean, all companies run on money and people. So that means you have financial issues, and you have HR issues. And all of these are governed by laws. There are many well-worn paths to ruin by screwing up these other aspects of what we do. And so if you think about it from that perspective, this is the sort of division of labor we have inside the company. Of course, now there are tons of other aspects of what we do—GMP manufacturing, process development, regulatory affairs, quality, clinical, etc. And all of these are equally important. But at the beginning, these were the kind of foundation stones. And so it really just never came up, the idea of hiring a so-called professional because Jim and I figured we could do as well as they could. 

John Simboli  6:05  
So was it at all a novel idea, an odd idea to bring this to life in Seattle?

Brian Finrow  6:10  
Yes, and no. To some extent, Seattle is ground zero for some of the stuff we do. So, in particular, synthetic biology. The way we make and deliver drugs lends itself very well to these breakthroughs in protein engineering and synthetic biology and in silico design, that are coming out of places like Barry Stoddard's lab at Fred Hutchinson, at the Baker lab over at the University of Washington. Now, there's actually this whole ecosystem of synthetic biology companies here in Seattle. So that's been very natural. However, Seattle is, I think, still an also-ran in terms of biotechnology clusters. There's a lot going on here. I'm not going to underrate it, with Seattle Genetics, Juno, and many other great companies and branches of large companies. But it doesn't have the critical mass of Silicon Valley or Boston, Kendall Square. But, you know, there's good and bad with that. I think the downside to being in a cluster like that is there's a lot there can be a lot of groupthink. I mean, we're doing something very different. And even in Seattle, here the biotech cluster is in South Lake Union; we're on the north shore of Lake Union. I think that's been helpful, on the margin. We're close enough where we get most of the advantages in terms of recruiting and being in the mix of ideas. But we're far enough away that we don't feel pressure to fit into the general flow of the intellectual climate.

John Simboli  7:42  
What were you hoping to achieve that could be done at Lumen Bioscience and not at another company?

Brian Finrow  7:48  
At this point, we're five years in, and we've had a lot of success. So the temptation is to look back with the benefit of hindsight and tell a story that makes us look like prophets. I think there's a little bit that, honestly, I was saying earlier, we had this idea that it could be tremendously powerful to make orally delivered biologic drugs. And that's not reinventing history, we know that, for sure, was part of Jim's pitch getting me in and then of course, convincing other people to join us on this crazy adventure. But it would be an exaggeration to say that we knew how it would unfold. Really, the breakthrough came when the Gates Foundation pitched us on an idea, this idea of making not just any old orally delivered biologic, which is a huge category, but actually making orally delivered Camelid single domain antibody-derived therapeutics, and in particular against GI infectious diseases. And the nice thing about being approached by the Gates Foundation with an idea like that, particularly if it's a good idea, which that was a humdinger, is that they have a very big checkbook. And if it's an important thing, which to them, it is very important to solve this problem. And to us as well, but especially nice for them because they come with the checkbook. And that really allowed us to really start interrogating the possibilities of this great idea. It was a great marriage, their idea with the underlying technology that we had. And it was this moment that crystallized what could be possible. And it's really from that point, which was actually after we started the company, that we really started to bring things into focus. So out went the broad focus on all kinds of different biologics that we could do. And then we started, in a very focused manner, on enteric infections, and particularly the ones the Gates Foundation is interested in which still kill all these infants and newborns in the developing world, these terrible diarrheal diseases. They're forgotten in the US, they used to be a problem here, too. And from there, step-wise, we have been expanding that now into C. difficile infection and then into COVID-19. And now with our partnership with Novo Nordisk in the cardio-metabolic disease and also our collaboration with KYORIN Pharmaceuticals in Japan and two other now host-centered diseases. You can see it's sort of been a natural progression. But it's all, again, within this big picture idea that Jim had at the outset that surely, really, just a sneaking suspicion, that surely it would be revolutionary if we could do this. And somebody ought to try; might as well be us. But figuring out the details of all of the many, many things that you could do, is the most important place to start. But that has taken a lot of teamwork and a lot of ideas that have come in from outside. And I'd say on our part, the job from there has been well, first of all, recognizing a good thing when we see it. And it's taken a whole lot of hard work and talents on a million details to turn those ideas into reality and the clinical results that we have today.

John Simboli  10:50  
In the early stages. Did you and Jim, get that question, "Well, if this is such a good idea, how come no one else has done this?

Brian Finrow  10:56  
This question comes up, I think pretty much every single call. It is a little bit of a conundrum. So my favorite podcast host, well, the second favorite now, John, after you, is this guy, Tyler Cowen, He's an economist, and he interviews people. And he interviewed this author. And this guy was explaining how he puts so much work into writing clearly. And he says it's a little bit of a trap. Because if you do your job very well, and you write things very, very clearly, then what happens is that at the end of the day, the reader finishes your article or book or whatever. And they say, well, it couldn't be any other way. It's so obvious that what this person is saying is true. It's so convincing and clear that the thought and the prose is so lucid. And he says the problem is that if it's so good, it's so clear, it's so simple, so approachable, so understandable, then it has the effect of maybe feeling a bit trivial. And I think we run into that. People hear what we do, and we explain it to them. And it really is just that simple. And they think, Well, if this is such a great idea, why hasn't everybody done it before? Fortunately, for us, there is an institutional answer to this, which is that we have a very nice, broad set of patents, now issued by the US Patent Office. And as you probably know, when the patent office is deciding whether or not to give you a patent on a thing they have to assess whether it is a meaningful advance and whether it's truly innovative. And in our case, people had been trying for a long, long time to engineer spirulina, this microbe we use to make these orally delivered antibodies. And you can look, in fact, in the literature. It's hard to find a paper on a negative result, as you probably know, that that's not a sort of thing that is publishable. Here are 10 things we tried and none of them worked. But nevertheless, in passing, if you know how to look for it, you will see people saying, well, we tried to engineer spirulina and, of course, everybody knows it's impossible. And so it failed. And so we went on, and we did something, and that is what the paper was really about. So this is really important for us, because it's a clue that, actually, it is quite meaningful, what we've done. So people have known that, in short, this idea of orally delivering antibody drugs, even antibody drugs directed at the enteric diseases the Gates Foundation introduced us to, people have known about that for a long time. People have been doing that, in fact, for 30 years in clinical trials succeeded over and over and over again, it falls, in my mind, into the dumb trick category of drug development. And what was lacking is a scalable biomanufacturing approach that allows you to do this at an affordable cost. So you could get enough antibodies to do a relatively small Phase II clinical trial, but they could never make enough of it. And of course, then there's spirulina out there growing in these huge outdoor ponds. So you could make enough of it. It's actually cheap enough that you can buy it in the grocery store. But the problem was nobody could ever engineer it. And that story, again, we've written about, but it is another story of serendipity and hard work and talent. But once we figured out that unsolvable problem, that was the final sort of the keystone in the arch, as it were. That's what makes everything else possible. So now we can turn this, what is in the dump truck category of drug development, into a thing that is actually a scalable, cost-effective, globally scalable product that is scalable, even cheap enough at large scale, we believe to serve the goals of the Gates Foundation, which is all about global health and serving these underserved communities in the developing world.

John Simboli  14:26  
How do you spend your time? What does the CEO of a biopharma company do all day?

Brian Finrow  14:31  
I spent a lot of time, honestly, trying to figure out the answer to that question. I talk with other CEOs, this is I think a common question. Of all the things I could put my focus on, what are the most important things? How do I prioritize? Am I doing this right? It's not like like there's a manual for this. Of course, you know, airports are full of manuals that purport to tell you what to do, but they're mostly written, I think, tellingly, by people that haven't done it The bulk of my time, at our current stage of development, I still spend trying to understand the science and follow along with what's going on. On the weekends, I spend a tremendous amount of time reading papers in primary literature. That's been a real joy for me moving into this job is that part of the job. As our pipeline progresses, I spend more and more time in FDA guidance documents and the regulations. And now more and more in clinical trial design and execution, the logistics of that. So I would say, that's all maybe the technical parts of the job. I'm not doing any of these things. But fortunately, we have really talented people calling the shots in all of these areas, but nevertheless, I'm responsible, and I have to explain it, and communicate it. So that takes a huge amount of time, the hardest parts of the job, obviously, anything related to HR, is tremendously difficult. There are so many trade-offs in that field. And we have an HR team. And of course, we talk a lot about this. And this is everything from who do we hire? How do we structure the organization? Who reports to whom? And you have to have an org chart, and boxes have to report to other boxes. And it's a terrible thing that you have to think all of this through. It's very complicated. Finally, you know, I say the least important, but probably the thing that people associate with CEOs the most, there is external communication. So talking with folks like you, John, and talking with investors, talking, working with the board of directors here, talking with, we have a lot of funding from grant funding organizations like the department fence, and BARDA and the Gates Foundation. So talking with those folks, and really communicating what we're doing, what we're excited about, where we're heading, where we're encountering setbacks. I would say that's all the easiest part. But the other things are much, much more difficult and much more time-consuming. I think that may be the opposite of what people think of the job as being.

John Simboli  16:55  
Can you remember when you were eight or nine or 10? That image that you probably had, we all had, probably based on what we thought our parents wanted us to be when we grew up? That picture? It may be from a book, from a TV show. This is what I'll be when I grew up.  Do you remember it? And does it have anything to do with what you're doing?

Brian Finrow  17:12  
Yeah, for sure. I don't know how the idea formed, but I am damned sure I was going to be a commercial airline pilot. Yeah, and I loved airplanes. I read all of this science fiction. There were no rocket ships so it's . . . going to fly airplanes, but we were dirt poor. But I found out that if you want to become a pilot, the key thing is to become a commercial pilot, you got to have a ton of hours. And getting flight hours is very expensive if you're going to do it by renting airplane time. But if you're dirt poor, like we were, then you could go into the Air Force. And then you get all the hours on Uncle Sam's nickle. So yeah, I had it all mapped out. I was gonna I was going to go get an aeronautical engineering degree, I ordered all of these brochures from Embry Riddle and MIT and that was my thing, I was going to become an engineer. But then my eyes went to shit; can't join the Air Force if you have glasses. I think you can now, I think can get LASIK. And they'll let you in if you have certain versions of the LASIK surgery. But that was off the table for me. So I went to college, I went into the sciences, got a political science degree, this, of course, is one of the hardest of the hard sciences, and then went to law school and found my way here. But I think that idea, what as a kid, what's kept with me, is this, this concept of the engineering mindset, I think I've carried with me, I think of that a lot now. And we are in the mode of thinking about drug development as more of an engineering task, which I know is sort of a current thought among the synthetic biology folks. And so I think that does probably still influence how we do things today. But it's very different from flying airplanes. I did finally get my pilot's license, though, several years ago.

John Simboli  18:59  
When you finally climbed in the cockpit and got to fly around, was it every bit as satisfying and thrilling as you pictured it would be?

Brian Finrow  19:06  
It was very impressive for me. Very surprising in certain ways. I was very surprised, for example, what a physical activity it was, or at least was, for me. I mean, it's very nerve-wracking and very stressful, particularly when you're learning. And of course, that's the worst thing you can do. It's like being around horses, you know, you stress them out. And it gives you a heavy hand on the yoke, flying an airplane, if you're a ball of stress, as most people are when they're learning how. But it's also very intellectual and a very, I'll use the word regulated activity. Not like in sort of government regulation, which of course it is very regulated and in that sense, as well. But in terms of everything you do, has a highly refined method to it. And that's all to ensure the safety and reliability of what you're doing. I've never encountered anything like it. Maybe drug manufacturing is at that same level. It's really a marvel of the 21st engineering approach to problem-solving, the fact that our aviation system works, how it does.

John Simboli  20:10  
I pictured, just now, as you were telling the story, in either case, it's a bit of a high wire act, I suppose to pilot a plane or to pilot a biopharma company. It's not for the faint of heart, as they say.

Brian Finrow  20:21  
It's a very direct analogy, actually, John, in more ways than you know. I don't know if you know anything about airplanes, but it's all about balancing forces, right, you've got thrust and drag and lift and weight. And the goal is to keep the airplane in the sky. And if you don't keep all those things in equilibrium, then bad things happen. It's the same thing in a lot of activities. And, I'd say, early-stage biotechnology is the same thing. In the sense that you've got a lot of perturbations that are always happening. In an airplane, you're getting buffeted by gusts of wind, things are happening with the weather, they're causing you to change the altitude, because of air traffic, all kinds of things are always happening. And you've got to manage this equilibrium in the context of all of those perturbations that want to throw you off course or throw you out of equilibrium into a bad situation. And sometimes it does, and then you've got to re-establish equilibrium. The same thing happens in a company. There are good things and bad things that happen in an organization. And they come from all angles, and most of them you don't see coming. And you do the best you can to anticipate them and to build an environment that is robust to those perturbations so that when it happens, then you can reestablish equilibrium,

John Simboli  21:36  
Who is Lumen Biosciences?

Brian Finrow  21:38  
We are a clinical-stage biotechnology company that makes orally delivered biologic drugs. We have products in the clinic. And this is a huge inflection point, as anyone can tell you in biotechnology. It's one thing to draw things on a whiteboard and do things experimentally in mice and cell plates. But moving into the clinic is a fraught exercise. It's when you first are forced to engage with the FDA and other regulators. You're starting to do things with actual humans. So the ethical stakes are much higher. So we're a clinical-stage biotechnology company here, it's important also, that we are product focused. There are lots of biotechnology companies that do different things. There are CROs, and CDMOs, these are contract research organizations and contract development manufacturing organizations, these either carry out research for product developers, or they manufacture products for product developers. We're none of those things. We are a product-focused company. And importantly, here, we are a vertically integrated biotechnology company. In fact, one of the very few since the early days of the biotechnology industry. If you think about it, in the 1980s, before there were the CDMO industry and the CRO industry and all of the different flavors of those two, there were just some, again, hippies in South San Francisco with long hair, working with Chinese hamster ovary cells, of all things, and using old surplus brewing equipment to try to make drugs; so goofy. There was no industry that they could just send off their antibody DNA to and have them, manufacture it for them. So they had to build all of this stuff themselves because they were the first ones. We are the first ones in exactly the same way with this bio-manufacturing host, spirulina. And so consequently, we have the same mandate as they did back then in the early 80s, which is we have our own manufacturing plant, our own regulatory team, our own clinical team, our own early-stage development pipeline because actually, you do some of the early-stage protein engineering. It's very bespoke to the spirulina context. So that's the first part of what I said, we are a clinical-stage biotechnology company, developing products. Now, for orally delivered biologics. Now, the important thing here is, that this is a really acute difference between us and every other antibody drug developer in the world today. Well, actually, except one. And that is that we are making products, not for injection, which 100% of the approved antibody drugs on the market today that are monoclonal antibodies are for injection. Rather, we make them for oral delivery, meaning you can just eat them in a capsule or pill. And this is a critical distinction. And the reason we're doing this is, and this is really I said you could think of Lumen Bioscience as being an elaborate attempt to test this hypothesis scientifically, is that we believe that orally delivering these biologics and putting them directly into the middle of the GI tract or onto the inner surface of the GI tract is a way to address some of these unmet medical needs that have actually resisted solution using traditional drug development tools. And so the easiest starting points, now it's easy to understand why we started with things like traveler's diarrhea, the same actually. causative pathogens cause traveler's diarrhea has caused these enteric diarrheal diseases among infants, and newborns in the developing world. That's the Gates Foundation program. This is why were directed at C. difficile infection, which is another bacterial infection of the GI tract. Other targets there include COVID-19, which has very important GI manifestations that are left unmet by traditional approaches, as well as a range of other programs. And so that's the starting point. Where we've branched out a little bit and gone a little actually beyond Jim's early conception, is that we now have funding from the Gates Foundation and BARDA to develop the same, starting with COVID-19, the same anti-SARS COV 2 antibody cocktail that we made for GI delivery, to reformulate it for intra-nasal delivery. And that's because the intra-nasal or the upper respiratory tract is where almost everybody first gets infected with SARS COV 2, the science is pretty clear on that. So we still have more to learn, of course. And so we believe, and with their funding, we're now investigating whether the same efficiencies that we get from delivering antibodies directly to the GI tract, to treat GI infections, will also apply to the upper respiratory tract, the nasal passages,

John Simboli  26:09  
What's good about being able to take a pill rather than getting an intravenous injection?

Brian Finrow  26:14  
Maybe a good example to start with is C. difficile infection. C. difficile infection, is traditionally called a hospital-acquired infection, and also a nosocomial infection. Actually, a majority of cases are community-acquired now but put that aside. So typically what happens with C. difficile infection is, typically an elderly person or somebody who's got a vulnerable immune system, they get antibiotics for some completely unrelated reason, clindamycin is the worst offender. And what happens is the clindamycin clears up the infection at issue, maybe after surgery or something. But it also accidentally kills the microbiome in your GI tract. And it turns out the microbiome is doing a lot of things down there. A tremendous amount has been learned about the microbiome and its role in human health in the last few years. One of the things that it does is it prevents C. difficile. This bacteria is transmitted by spores from getting in and colonizing your GI tract. You see, C. difficile spores are all around us all the time. In fact, the asymptomatic carriage rate of C. difficile is something like 5-10%. So in a room of 100 people, five to 10 of them have got some C difficile. It normally doesn't matter because your microbiome sort of freezes them out. But with clindamycin dampening your natural microbiota diversity, the C. difficile can get in there, it secretes a toxin, and therefore it sets off all of the awful things that happen, including a very high rate of mortality among those infected, particularly the vulnerable. So one thing that's known about C. difficile is that if you make an antibody that neutralizes that toxin, it's a pretty good way to make an impact on the disease. And so there's an antibody drug on the market today called bezlotoxumab. And this is injected at very high abundance into the bloodstream. And just enough if it gets to the site of disease to make an impact. It decreases your odds of a future case of C. difficile infection by about 25%, which is good for those patients. But there are a couple of problems with this. Number one, it's very expensive, making antibodies in the traditional fashion with sterile fermentation and then doing all of this downstream processing to get the very minute quantities that are safe enough to inject—injecting foreign substances into your bloodstream is a very, very dangerous thing. It is colossally expensive, it costs $100-$200 a gram to manufacture these substances. They're the most valuable substances on earth, in fact. The second, it's inconvenient. Needle fear is a real thing, up to 15 to maybe 25% of the population is afraid of needles. And this is one thing to say, Oh, what do you what are you afraid of? I mean, you're dying of a bacterial infection. But it's a real barrier. And it's no good to minimize it. So trypanophobia is an important thing. Thirdly, as we learned in the COVID 19 pandemic, with availability issues for the monoclonal antibodies, which are universally today IV infused, just the very fact that you've got to book an infusion clinic slot, and you've got all the logistics of getting the refrigerated vial moved around and over to the place where it goes with the patient. And of course, there's another service charge for the facility and the administration and professional staff that are there. So all of that has to do with distribution. So now what do we do differently? First of all, orally delivering the antibody means that we get more of the antibody to where it needs to be in the GI tract. Our product for C. difficile, LMN 201, includes antibodies against the toxin just like bezlotoxumab. That's great because we get more of it to where the site of disease is. The site of disease is not in the bloodstream. It's not like a blood-borne infection. It's all in the GI tract, and only one in 1000th, or less, of an IV-infused antibody, actually gets up through all of the vasculatures to the tissues to where it needs to be. So what we do is we come from the top down, and the antibody just fills up the GI tract. This is why the cost is so important, we just fill the whole GI tract with this antitoxin antibody.

Brian Finrow  30:13  
So that's one advantage, the higher concentration usually gets you better potency. The second advantage is safety, if you IV-infuse an antibody, it's going to go everywhere in your body, by definition, right, it's in your bloodstream. And that means that the risk for off-target toxicities is greater. In addition, with protein therapeutics, in particular, there are risks associated not just with off-target effects, but the protein itself can have immunological effects, can attract anti-drug antibodies that will neutralize it, you can also cause immunological responses to the protein itself, that can be bad, it's lower risk of that now, but in the 80s, it was a real problem. And so oral delivery, you see, of a protein is much, much safer. And that's because your GI tract is, of course, filled with all kinds of foreign proteins, you know, in addition to your normal microbiota, which is all kinds of crazy proteins that are not human, by definition. You're also eating all kinds of food; every time you eat a banana, the banana is comprised of proteins, and all of them are non-human proteins, they're banana proteins. And so this makes it much safer at the outset to orally deliver proteins through the GI tract. Thirdly, the delivery modality is very simple. So distribution-wise, the proteins in these dry capsules, are very shelf stable for a year, even above room temperature. We've tested it up to 42 degrees Celsius, which is great for distribution. This means that rather than bringing someone in to an IV infusion clinic, we can just literally FedEx it to their door, I mean, so Amazon pill pack can mail this right to the person overnight, no problem, put it on Prime; subscribe and save. Whatever you need to do. In addition, of course, you don't need to pay the skilled healthcare workers to then put the needles in and have all this infrastructure, just calculate just opening up a pill. So that helps a lot with the distribution. And then finally, our claim to fame that really got us going in this field is cost. And here, I want to be careful because saying you're making things low cost is a bit of a dirty word in our industry. What investors want to see is $400,000 for a cancer antibody drug. That's really what they want to see. So cost is a little bit of a dirty word. But it's really important. If you're going to go after drugs this way, if you're going to manufacture them for $200 a gram, there's just no way you're going to be able to, first of all, affordably deliver that to everybody. Because you have to, with an oral, you a protein, you have to deliver it every day for some period of time when you want the protection to last. So cost is critical. It's really sort of the key that gets you in the door. But, importantly, the lesson we've learned in a pandemic, I'd say from Pfizer. is that if you can make a product that is cost-effective to manufacture and massively scalable, and this is what our technology allows us to do is, actually, you can make an enormously profitable investment in new products. In this case, I'm talking about Paxlovid and the vaccine that they developed with BioNtech. And any see, you do well by, how's the phrase go, you do well, by doing good. I mean, they're projecting $50 billion of revenue this year off of one product, which sells for $20 a piece, and Paxlovid, I think the list price is $300, which are just minuscule prices. But you see, making it up in volume is something that our industry, in my view, has sort of forgotten how to do. And we're, in a sense, going back to the basics. So at the end of the day, what we're trying to do is build on what we've learned from the hard work of the folks that developed bezlotoxumab. It's a validated target, we know it works. And we know that we can get a higher concentration at the site of delivery. And so the goal is to make a product that realizes the full potential of what they paved the way for, a massively scalable, massively available, affordable, and still profitable for our investors, as well, a product that is both better and safer. This is the sort of magic trick that technology can do for you. And it is the sort of ground change that we saw in the treatment of infections with the advent of antibiotics. And C, difficile, because of its peculiarities, has been sort of left behind. And our hope is to do as good a job as those pioneers did 50 years ago.

John Simboli  34:26  
How does the Lumen Bioscience pipeline express your vision for the company?

Brian Finrow  34:30  
If you can look at it one way, and it does involve a little bit of looking backward and stitching things together, because like I say in the reality, there was a lot more serendipity to it, but I'll say it anyway. You can look at it as a thoughtful and natural clever design. And you see we started with a set of disease targets that have a great deal of clinical evidence to support the mechanism of action—all validated targets as I said, traveler's diarrhea and C. difficile We know exactly the target to go after. And in most cases, it's been demonstrated in both of those cases actually, clinically, that, orally delivered, an antibody or cocktail of antibodies against the target can actually make a huge difference. And so this is the lowest hanging fruit, the easiest targets. And as you probably know, the success rate in the clinic for new products in the infectious disease space is vastly higher than what most of our industry is focused on today. If you count the programs, it's primarily oncology and autoimmune, a bit of CNS. I mean, it's very, very difficult mechanistic problems. And by contrast, the success rates in infectious diseases can be 10 times higher. And so for a small company, building our clinical team, taking our first stab at this, you see, it's just better to start with the easier targets. So that's where we started with. Now, less is known about COVID-19, obviously, because it's new, and less, still, is known about intra-nasally delivering antibodies topically. And so there we're taking a little more risk being a little bit more adventurous. And the logical progression from there takes us into some of these other long-standing problems in human health. Again, more diseases that have been sort of left behind, or where we've only got partial solutions, for GI diseases in particular, here, I would call attention to our collaboration with Novo Nordisk that's directed cardiometabolic disease, our own internal program, and inflammatory bowel disease, that's Crohn's and Ulcerative Colitis. And finally, our collaboration with KYORIN Pharmaceuticals, which we have not publicly disclosed the target, but it's another GI center of disease. Now, the interesting thing about these is, it seems obvious, inflammatory bowel disease you say, well, obviously that's a bowel disease, it's got the word bowel. But interestingly, actually, if you talk with immunologists, most of them will tell you well, no, no, you see, that's a systemic immune dysfunction and it won't work. Because inflammatory bowel disease is a systemic immune dysfunction. Now the rest of us look at this and say, Well, wait a second, it has the word bowel in it. So we have a heterodox view there, a minority opinion, that we can make a difference there. Even more so, you would say, more counter-intuitively cardiometabolic disease, you wouldn't say obesity is a gastrointestinal disorder. Well, but on the other hand, it's just like IBD, it's undeniably got something to do with the GI tract. So we are reliant in these areas on the expertise of our collaborators a lot more than infectious diseases, just because they are more difficult, more complicated to go after. And so this is the current horizon that is consuming more and more of our focus and energy is on the preclinical side. And clinically we've got three programs working through efficacy now in in the infectious disease space, and we're excited to see the results later this year.

Brian Finrow  34:32  
Brian, thanks for speaking with me today. 

Brian Finrow  37:55  
Thank you for having me on, John. I really enjoyed it.