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Vlad Vitoc - Founder and CEO of MAIA Biotechnology · BioBoss

• 0:00
  John Simboli: Today I'm speaking with Vlad Vitoc, founder and CEO MAIA Biotechnology, headquartered in Chicago.
• 0:07
  John Simboli: Welcome to BioBoss, Vlad.
• 0:10
  Vlad Vitoc: Thank you, John.
• 0:10
  Vlad Vitoc: It's great to be here.
• 0:12
  John Simboli: What led you to your role as founder and CEO of MAIA Biotech?
• 0:16
  Vlad Vitoc: I spent my entire career in oncology, in pharma and biotech. I trained as a physician, but went into business from the beginning in pharma and biotech about 50/50 between medical and commercial roles, and along the way, I had the opportunity and privilege to work on and launch some of the most extraordinary anti-cancer treatments in their day. For example, at Bayer oncology, I launched Nexavar, the first tyrosine kinase inhibitor for the treatment of renal cell carcinoma and hepatocellular carcinoma, where we are also going with THIO. This was the first multikinase inhibitor drug used for the treatment of cancer, and reached more than a billion dollars in annual sales.
• 1:05
  Vlad Vitoc: And then later on, at Astellas, I launched Tarceva for EGFR mutated non-small cell lung cancer, which reached a peak of 3 billion annually. At MAIA we are studying our drug THIO, in specifically non small cell lung cancer as well. And I launched XTANDI for four types of prostate cancer. This is now over $5 billion a year, but not one of these was as extraordinary as what we are seeing here at MAIA Biotechnology, with our lead agent called THIO. So this idea of finding treatments, developing them and commercializing them for the cure of cancer is what inspired me to found MAIA Biotechnology and move it now towards commercialization.
• 1:58
  John Simboli: Do you recall when you made that decision to make that transition from being a physician to being, you know, to starting a Biopharma company. Do you remember what it was that made you think "It's time to do this"?
• 2:10
  Vlad Vitoc: Yeah, it was right out of medical school, actually.
• 2:13
  Vlad Vitoc: So some time ago. The decision was not a clear cut one. It was a 51 to 49 type of decision. And I had originally planned to be an oncologist, and the inspiration for that was my mother, who is a very accomplished breast cancer oncologist in my home country of Romania. And my father was the business inspiration. He's an architect, and he started an architecture business, and I worked with him in my spare time as I went through medical school, and that inspired me to explore the business side of things. Which I then did with a number of friends who were working for biotech companies in those days, and made a determination 51 to 49 to go in the business direction, and it has been business ever since.
• 3:06
  John Simboli: To take on something substantial like this, do you have to factor in how it affects everything, including your loved ones?
• 3:14
  Vlad Vitoc: Absolutely, you have to. Yes, there are two things.
• 3:16
  Vlad Vitoc: There is the financial obligation to their families and also the opportunity cost, right? So as is the case with many physicians, physicians usually calibrate their lives around an income to support their families, and also they study medicine only and not business. So they don't know how to run a business. It's not natural to them. They have to l earn it. These are, I think, the main considerations, and are the things that are preventing or making difficult for a physician to turn to business. So it's the opportunity cost of income you don't realize anymore. You know, when you start the company, oftentimes you work for free or for very little, as was the case here as well. I was able to do that because of savings from before and also because my wife is also an executive at a major company. So we were okay financially to take this chance.
• 4:14
  Vlad Vitoc: But other people may not be so okay, especially if they are the only income in the house. So I was, I feel fortunate, though, of this scenario,
• 4:23
  John Simboli: My experience in working with physicians who have become founders of biopharma companies is they've talked to me about change in thinking between trying to help one person at a time in a big way as a physician, versus trying to help a lot of people, they hope.
• 4:35
  John Simboli: But then maybe it'll happen.
• 4:38
  John Simboli: Maybe it won't happen. I know your decision was early on in your career, but did you face that choice?
• 4:45
  Vlad Vitoc: That's a clear choice that is a very real one for even as a practicing physician, you're focused on just the person in front of you.
• 4:52
  Vlad Vitoc: But then as a scientist physician, you now look at the patient population as a whole, and the segments in the patient population that have the specific unmet medical need you want to address. It's very different. Thinking in a statistical manner, you're helping a population, but it's no way identifiable in success.
• 5:21
  Vlad Vitoc: You don't have the result of curing someone you know personally as a patient, or sometimes losing a patient. So these types of elements are no longer part of every day, but at the same time, the knowledge that, in aggregate, you help significant segments of humankind, is also a very powerful motivator. To me, that is the ultimate motivator. If you can make a difference at the human scale, that is the most extraordinary vision and mission in oncology.
• 6:05
  John Simboli: My understanding is that your interest and your background has always been on the oncology side. Did I understand correctly from the research that the telomere side of it was something that came to you later on in your progression? And if that's the case, can you tell me how you made that decision? Like, that's where I want to land. That's where I want to go next.
• 6:24
  Vlad Vitoc: Yes, like many things, it is a question of serendipity sometimes. In 2018, I was in the process of starting a biotech company and was introduced to a number of different scientists at different universities, and one of them, Jerry Shay, a professor at University of Texas, had a number of compounds in his development program in pre clinical setting, and this was one of them. And I have to admit, it was not on my radar up until that point. It was actually new science, certainly the telomeres, telomerase as they apply to the science of aging, were already well characterized in that manner, but how they applied to oncology and the treatment of cancer was entirely new science. And that's what I learned in my first interactions with Jerry at University of Texas.
• 7:21
  Vlad Vitoc: Immediately, it piqued my interest, because it is A, a new mechanism of action that no one else has developed at all before. So it's telomere targeting, utilizing the enzyme telomerase, and later on, also immunogenic. We characterized it as an immunogenic molecule, meaning stimulating the immune system to respond to cancer. So this makes it so broadly applicable. 85% of cancer cells are telomerase positive in aggregate, and some cancer types are 100%, like small-cell lung cancer. Non small-cell is around 85, 90%, colorectal around 90, HCC, around 90. On the low end, you see neuroblastoma or sarcomas with 40, 50% but big numbers. In contrast, in normal cells, less than 1% of normal cells express telomerase. So THIO needs telomerase to work.
• 8:29
  Vlad Vitoc: Without telomerase, THIO does not work. Telomerase's role is to pick up THIO and place it in the structure of the telomere instead of a guanine base. Then the structure of the telomere becomes unstable, the telomere collapses and the cancer cell dies. So this is the main, the first telomere targeting mechanism of THIO, and it's applicable in just about any tumor type. Such an extraordinary target with such a broad applicability only comes around once in like decades.
• 9:07
  Vlad Vitoc: Since the launch of KEYTRUDA in 2014 nothing had been so widely applicable. So I really like this part of it that is so widely applicable in many tumor types, and then also very effective. This direct killing by collapsing the telomeres of the cancer cells happens in 24 to 72 hours, very fast. And then it kills directly 70 to 90% of those cells, very efficient.
• 9:41
  Vlad Vitoc: Then kicks in its immunogenic mechanism. So of the telemeric fragments, it forms micro nuclei that present these fragments to the immune cells, becoming new adjuvants in the immune pathways. They trigger an immune response that is so efficient, if you follow THIO with an immune therapy, we learned later, you get to complete response, no recurrence and anti tumor, immune memory, cure. And we have seen this in pre clinical setting, initially, in many tumor types. In lung cancer, in colorectal, in liver, small-cell lung cancer, brain cancer; the data is so strong that the FDA awarded THIO three orphan drug designations out of three applications. In liver cancer, HCC, hepatocellular carcinoma, in lung cancer, small-cell lung cancer, the deadliest form of lung cancer, and in malignant gliomas, brain cancers, including glioblastoma.
• 10:52
  Vlad Vitoc: So this is, right there, recognition of the effectiveness of the molecule in the preclinical setting. And now we are in the clinic. And in the clinic, of course, you need to test first in as a market entry strategy, in the very sick patients in the later lines of therapy. And here, we haven't seen cures in this setting, but we have seen survival extension like nothing else in this third line of therapy. This is basically, these patients have lost hope at this point.
• 11:24
  Vlad Vitoc: Unfortunately the median survival is under six months.
• 11:28
  Vlad Vitoc: With THIO we have now recorded 16.9 months median overall survival, 3x. This is such a tremendous progress in the setting we plan now to execute on the pivotal trials and go commercial with this, and then move it forward in the therapeutic continuum, from the third line of therapy to first line of therapy, where the chance of cure becomes real for drugs so efficient as THIO is.
• 11:57
  Vlad Vitoc: And that's where we believe we will secure.
• 12:04
  John Simboli: Did you have an image of yourself at any point, like early on that either was like what you turned out to do for a living, or not at all like that?
• 12:13
  Vlad Vitoc: Yes, of course. As you grow up, you want to be different things along the way depends on what touches you first and impresses you more. I remember a moment when I wanted to be an astronaut, maybe I was maybe seven or eight or something, and I was already wearing glasses, so the first analysis was very quick. Vision isn't good enough. So you can drop that one right away. So the idea of being an astronaut and going to places where no one has been before, discover not just new places, but new science in the process. And all this was always appealing to me, just to a very painful level, being aware that it's never going to happen because of physical issues. Vision, in this case.
• 13:05
  Vlad Vitoc: The second such moment was when I watched Formula One racing cars. Also that was at an early age. I said, Okay, I'm not going to be an astronaut. I want to be a race car driver. And there was a champion back then in Europe, from Austria, Niki Lauda, and I wanted to be like him. So I wanted to go into racing. Then, as it turns out, growing up in Romania, there is no racing to be had. So at that point in time, there was not a thing. So then I, you know, the journey is going through different things, but I think doing something extraordinary, making a difference in a big way, in a big, meaningful way, was an idea that with me started then and then along the way I learned. I learned and developed. I learned much more. I started to focus on medicine also, in high school. I started to focus on medicine, and then the business of medicine. And I think this is a journey that I'm very proud and also very thankful to other people around me, such as my parents or my wife or my children or my friends who are encouraging and supporting of these things, and it's all about making a team at the end of the day, to achieve things like this. People say it takes a village. It is. It's true. It does take a village.
• 14:38
  John Simboli: My experience is that when trying to introduce our clients to folks and they don't know the name of the company, and that might be the case with MAIA, depending on people you're speaking with, because it's a new company. How do you describe that? Like, what do they picture you doing? Do they picture you in a lab coat?
• 14:52
  John Simboli: Do they picture you running analyzes? Do they picture you in meetings? How do you get across what you actually do during the day?
• 15:00
  Vlad Vitoc: In a small startup company, you have to do a lot of things. My days are long and very eventful. It's like there's one thing after another. And also, this doesn't stop when I travel or even when I take vacation days. Everything goes with so I never stop. I begin early in the morning, as soon as I wake up, I'm on it. I try to fit in some exercising in there.
• 15:31
  Vlad Vitoc: But what I do, it's really touching every aspect of the business. It is managing every aspect of the business, from things like preclinical testing to clinical development, to manufacturing, to financing, that takes a lot of time. But of course, there you need to, I surround myself with very capable people, true leaders in the field. So I don't need to do all of this hands on every day, because it is simply impossible.
• 16:02
  Vlad Vitoc: It's not scalable. But what do I do every day? I move every part of the organization.
• 16:07
  John Simboli: If someone were to ask you, what's your management approach? How do you make decisions? How do you lead? How would you describe it for yourself?
• 16:15
  Vlad Vitoc: My management approach, it has to be very nimble. And there is, I know, I know there's a lot of science developed around styles of management. I studied many styles of management along the way, as I progressed in my career. But, I think at the end of the day, it is more than anything, a situational leadership scenario in which you have to work with each situation in its own manner. And you know, just make sure that you put the right leadership in play, whether it's yours or somebody else's, which is often the case as well for each of the scenarios. So I made a very important effort to build a really good team. We have a very good team right now. It's a team in which most of them can easily take leadership in their field.
• 17:09
  Vlad Vitoc: So this makes it very productive and efficient, and at the end of the day, that's what matters the most.
• 17:19
  John Simboli: When people ask you for that really tight, terse description when they say, What is MAIA? What's the short answer you give to people?
• 17:27
  Vlad Vitoc: MAIA is a biotech company that develops new agents for the treatment of cancer, and we have the telomere targeting franchise with THIO as a leading agent, and we're going after multiple cancers with non small-cell lung cancer as the first one, then colorectal, liver and others. So we're developing a franchise that we have the next generation of telomere targeting agents in play as well, and we are now pivotal trials ready. We're about to begin them, and we're looking to commercialize in two to three years from today.
• 18:05
  John Simboli: Being the leader in a field sometimes begs the question of, in relation to what? People want to position a company in relation to other companies. Is there a way to explain that you're different, but you're located within some sector?
• 18:21
  Vlad Vitoc: Well, yes, the sector is oncology. We are an anti-cancer company. Within oncology, you can say it's a sub sector of therapeutics.
• 18:28
  Vlad Vitoc: Therapeutics versus supportive care. And then within therapeutics, you can say we're developing small molecules, and you can say that they are telomere targeting agents and immunogenic agents. So it's a targeted therapy, but it's also an immune therapy as well. Which is, it's a new segment, and within this telomere targeting, we are pioneers here. So this is definitely the first in this mechanism of action.
• 19:06
  John Simboli: When people, after hearing the story about MAIA, when people misunderstand and misperceive it, is there a pattern? And then what is that pattern? And if so, what do you do to get them back on track to what it really is,
• 19:20
  Vlad Vitoc: One common misperception that we needed to explain was about telomerase targeting. This is because telomerase has been as an enzyme, has been a target for oncology for some time, and several companies attempted to develop telomerase inhibitors.
• 19:37
  Vlad Vitoc: One of them succeeded. Geron Corporation has imetelstat now commercially approved for myelofibrosis. So telomerase is the enzyme that is very prevalent in many cancer cells.
• 19:53
  Vlad Vitoc: That's not what we target. We target the telomeres and we use the enzyme telomerase. So without telomerase, our drug would do absolutely nothing. It would be inert. With telomerase, it becomes hugely active.
• 20:10
  Vlad Vitoc: Imetelstat in contrast eliminates telomerase. So there will be something like the ying and the yang, or the exact opposites in the same spectrum.
• 20:18
  Vlad Vitoc: So that's a common question that came from investors, especially investors who have already been exposed to telomerase inhibitors in the past.
• 20:35
  John Simboli: With that distinction in mind, how do you explain to people what it would mean for patients if you were to succeed?
• 20:42
  Vlad Vitoc: So I think it will be very much transformative in our first indication. This is in non small-cell lung cancer. In third line of therapy, on the average, we're seeing survival three times longer. And on a specific patient basis, we have patients who have been on therapy now close to two years and doing still well. These patients without THIO and the checkpoint inhibitor in the mix here, most likely would have been dead a long time ago. And they may very well live much longer from here on. I think when we go to first line of therapy, we will see real cures.
• 21:21
  Vlad Vitoc: And that's going to be what we actually strive for all along.
• 21:25
  Vlad Vitoc: We want to go there and show curative effect. Certainly, the first line clinical development is more expensive. The trials are bigger, they're longer. You need more patients. You need to provide competitor, expensive treatments. So those are different budgets, are much, much greater budgets, and usually not even big companies undertake them, unless the drug is already commercially available in a third line, second line, third line, fourth line, setting somewhere, and then invest this type of money, as we're talking about serious 10s, hundreds of millions of dollars. Some programs like Tarceva, for instance, ended up investing more than $1 billion in clinical development projects along the way. So that's a number one investment pharmaceutical companies make ultimately, but they want to approach it in risk conscientious fashion, so they eliminate development risk by getting the drug first on the market.
• 22:35
  John Simboli: How does your vision for the pipeline, what are the pieces of it, and how do they come together to realize your vision for what the company is trying to do?
• 22:45
  Vlad Vitoc: So the pipeline, we have started this project about two years ago, and we have developed 84 new molecules. Some of them are a structural evolution of the original molecule, and others are new structures entirely. They all work in the same way, telomere targeting with immunogenic capabilities. And we tested them all preclinically, in vitro, in cell cultures, first, then in vivo, in animal models. And seven of them proved to be very much more effective than the original molecule in certain tumor types. So we patented them, and we started the first two into the pre clinical development in animal models.
• 23:33
  Vlad Vitoc: And now we are, we are almost ready with this pre-IND testing for the first two, and we hope to get them to the clinic maybe this year or next year. And then there's a third one that's ready to start as well, and we keep four more in reserve. So the plan is to bring them forward in a staggered manner as budget forms to support the development plans, with a priority, of course, at the moment on THIO because this is the closest, most real deal for commercialization. And once we have revenues coming from THIO, then we can go all out in 20 different tumor types with seven different agents. And we certainly will find a lot of cures for a lot of cancers.
• 24:22
  John Simboli: What kind of partner is a good partner for you?
• 24:25
  Vlad Vitoc: These drugs, THIO in this case, has such a broad applicability, it can go after many tumor types. But this requires a budget, and with what we can raise in the market, we're limited to how fast we can go. So we're looking for a partner that would engage with us in a co development agreement under which we co develop the drug. For instance, they give us their drug for a trial we do in, let's say non small-cell lung cancer in third line, we give them our drug for them to do the trial on their own in the first line of therapy. In other cases, we can do 50/50 cost sharing, and this would go a much longer way compared to just financing on your own in the markets. So that's co development and then two, commercialization. So I've been in many commercialization teams along the way. So in oncology, in the US, it's very straightforward, from my perspective, how we're going to build a commercial organization and run it. Ex US, on the other hand, is more complex because you have different regulators, you have languages, marketing is different, distributors are different, so it becomes way much more complex, and that's where I would prefer to have a pharmaceutical company with an established global presence that can take Ex US on and we can keep the US commercialization.
• 26:02
  Vlad Vitoc: Or as a variation, it can be co commercialization in the US as well. So sometimes that's the model that is more adequate for United States as well. So that would be a co development to commercialization alliance.
• 26:18
  John Simboli: How did it come to be that MAIA was headquartered in Chicago?
• 26:22
  Vlad Vitoc: It's simply because I live in Chicago, and I think that's probably the case with the vast majority of the founder entrepreneurs is they start where they are; in their own garage or in their own attic or something. Well, I happen to love Chicago. We have moved to Chicago with a role with Astellas oncology, which was based here in the northern suburbs, and I come to a Chicago that had recently transformed to an extraordinary, modern city and accessible too. You know, it doesn't have the prices you see in Boston, in New York or in San Francisco, where your typical San Francisco, Boston, San Diego, were more typical biotech hubs, right? So for me, it was that role that drew me to Chicago. And then I met my wife, Charlotte, who was with a role in banking, also in Chicago. So we both continued in Chicago.
• 27:16
  Vlad Vitoc: And so it's a great place to be for us. And to, you know, I know people think that the best place to raise a family is in the suburbs. And yes, the suburbs have many merits, for sure, but also the cities do. Now, back to, how do you manage a biotech company? You know, I learned in in my different roles with other companies, where I commuted, I lived in other places is I would just go to the office and then be on a bat phone for most of the time, and the meetings were hybrid or they were just calls.
• 27:50
  Vlad Vitoc: So my idea from the get go is this, I'm not going to move anybody. Talent is where talent is. Don't try to relocate talent. Instead work with them where they are. So I started out with the notion of virtual organization in this manner so that we have a head office, who is in Chicago, or wants to be in Chicago, can be. But I'm not going to move people from Boston to Chicago or from San Francisco to Chicago. It's like if we have now, our people are everywhere.
• 28:25
  Vlad Vitoc: In Chicago, just three of us, but there are others on the West Coast, others in the San Francisco area. Others are in, our consultants are everywhere in the world, really. We have even someone in Argentina, someone in Romania. Some are people in Asia, in Europe, in other countries, in Canada, it's a global organization in no time. And I think this became a working model for other companies as well. In especially since the COVID episode, people were forced into this model in some cases. For us, it works very, very well. The cost of operating is so much more streamlined, and people are so much more happy to just not have to commute. I used to commute from, for instance, in Chicago, from here to the northern suburbs, to Astellas, it was three hours every day going and coming. I mean, yeah, okay, so I'm taking some calls on this time and doing some other things. But it's tiring, it's costly, it's brutal on so many directions. Then I commuted from Chicago to San Francisco, even more crazy. So now you go on a plane and work from the San Francisco office for four days or five days a week, and then fly back. And why? Because it's still a hybrid meeting. Most people are on the phone anyway.
• 29:54
  John Simboli: I'm in New Haven, and the city has been trying to build lab space, because that's part of the deal. Does Chicago provide that for you? Do you need that at this stage?
• 30:04
  Vlad Vitoc: Yes, Chicago has it.
• 30:04
  Vlad Vitoc: They want to provide it. They want to sell it to me every day, but we don't need it. So that's for a different type of organization. So pre clinical, we use contract research organizations to do the testing, and we use our scientists more or less in the function of leaders and project managers. So they do design the molecules, they guide the the other company to deliver. But you know, to have wet labs is costly, and unless you have serious activity going on there, you're never going to recover costs like that. So we're now in the clinic anyway, with the majority of our activity. We also have the preclinical testing, yes, but we don't need the labs.
• 30:52
  John Simboli: Have you staked out territory that you want to pursue? You know, that's specific that you could say, Yeah, I'm particularly interested in?
• 31:00
  Vlad Vitoc: Yeah, I'm particularly interested in treatments for cancer, and I think that cancer is a major problem of humankind. That is, we've made progress as humans in finding therapies and occasionally cures, but it's still growing instead of going away, because, simply because it's a factor of aging. The number one factor is aging, and as I described with aging process with the telomeres and telomerase, these telomeres become so short so fast when you pass a certain age, 70, 80. Then mutations appear, and now you have to deal with this cancer and that cancer and other diseases. By certain statistics you know, once you cross 80, the probability of having a cancer is very high, and by you get to 90, the probability of being diagnosed in your lifetime with a type of cancer is 40% and to die of it is 20%. I've seen around me people have, almost everyone has cancer a type of cancer after age 70, 80. My parents, both of them. It's certainly not deadly, but they have to deal with it. Skin cancer is very common, right? So you got prostate cancer for men, breast cancer for women. It is a problem that will continue to be a problem, even more prevalent as people grow older. We now have 25 countries have their life expectancy over 80 already, and you have in the lead with 85, 86 years life expectancy you have places like Hong Kong and Japan and Korea and the United States is part of this leading group, but it's just crossing 80 now, and people live beyond 80.
• 32:44
  Vlad Vitoc: I think our generation will be confronted with a new set of dilemmas of how to manage aging.
• 32:55
  Vlad Vitoc: You cannot prevent it, but maybe perhaps you can age better. And one thing, one key thing, is make sure you don't die, especially of something stupid like cancer.
• 33:06
  John Simboli: Vlad, thanks for speaking with me today.
• 33:09
  Vlad Vitoc: Thank you for having me.