EntrepreneurRX_Stacy Blain: Audio automatically transcribed by Sonix

EntrepreneurRX_Stacy Blain: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

John Shufeldt:
Hello everybody, and welcome to another edition of Entrepreneur Rx, where we help healthcare professionals own their future.

John Shufeldt:
Hey everybody! Welcome to another episode of Entrepreneur Rx, and I have the distinct pleasure of interviewing Dr. Stacy Blain. She is an internationally known expert in cell cycle and cancer biology, and she's one of the world's experts on p27Kip1, which I actually had to look up, which is probably embarrassing for all those physicians out there who already know what that is. But she has studied cell cycle regulation for over 25 years, is an NIH-funded investigator, and she's also a tenured professor at SUNY Downstate Medical Center. And we'll talk about this a lot, she founded Concarlo, which has capitalized on discoveries that she's made and patented. Stacey, welcome to the podcast.

Stacy Blain:
Thank you very much, happy to be here.

John Shufeldt:
All right, well, you mentioned before we started that you, your Ph.D., has something to do also with cell physics, which just gave me the hair in the back of my neck stand up. So let's go over background a little bit. How'd you get interested in what you're interested? What was your, like what's your first memory of saying, I want to be this when I grow up?

Stacy Blain:
Oh, you know, I was one of those kids that always knew that she was going to be a scientist. I mean, I remember Mrs. Hartsock's class in literally, like, first grade or kindergarten, and got my first microscope when I was eight. I was the kid that took the frog home at the end of the summer so I could continue dissecting it all summer. I mutated fruit flies in the back of the classroom in high school. So I always wanted to be a scientist. I envisioned my life as sort of having my lab in the back of my house, and I would raise my family in part of the day and then run and work in my lab in the afternoon. And my lab is not in my house, but I sort of have achieved that, that I have sort of that balance, and it's been a great, great ride.

John Shufeldt:
Okay, now, I think that's the stethoscope in the background, is that a monocular stethoscope?

Stacy Blain:
No, it's a microscope.

John Shufeldt:
Oh, my gosh, I mean, a microscope.

Stacy Blain:
Actually, this is my microscope that I got when I was eight years old. So I have it here, it still works. I don't use it anymore, but it keeps me as a reminder of the young girl that had big dreams and how you just have to stay true to those dreams.

John Shufeldt:
You know, I wonder if at least in medical school, if they, you know, here I'm calling a stethoscope, that's how old I am, but I remember getting a binocular microscope in medical school and carrying that darn thing around for two years, year, and then selling it off, thinking, I'll never look at this thing again. I wonder, do they even use microscopes anymore?

Stacy Blain:
Oh, sure, we have multiple microscopes in my laboratory that have different degrees of magnification. We look at human cells that grow on plastic dishes and we look at them in the microscope and we look at slides of human patient material. So we use microscopes all the time. They've definitely advanced since this baby in the back here in my office, but yeah, microscopes are still a big part of our arsenal.

John Shufeldt:
Oh, I thought it would be taken to photograph with the image and project the image on the screen, but that's impressive.

Stacy Blain:
Well, we look through the microscope, and then the, it goes to the screen so we can save the digital imagery from what we see. So that's actually a big advance, right? We can then study it really extensively on the computer screen, but we still.

John Shufeldt:
Very cool.

Stacy Blain:
Microscope, yeah.

John Shufeldt:
Okay, so you have your first microscope at eight. What happened after that?

Stacy Blain:
So I went to Princeton University and I actually went there in part because they had a brand new molecular biology program. It was one of the first science programs that really had sort of divided out from evolution and the ecology and the other biology disciplines to really study things in the cell. I did my first bench research really there in my thesis, and then I went on to get my Ph.D. in cellular molecular biophysics, as you alluded to at Columbia, and that was really I started that in the early nineties. I worked on HIV and I think that was a really seminal time for me because it really showed that the work we were doing in the lab had a direct impact on the way we were going to treat patients. You know, we were making major discoveries about how that virus worked that had direct applicability to the way people were making drugs that were going to be moved into patients within a really short period of time. And that stuck with me, that things that we do in the lab that come out of your head can actually be moved into patient care really quickly. I then went on and did my postgraduate work at Memorial Sloan-Kettering Cancer Center, and I worked with a really brilliant, famous man named Sean Massey, who's now the head of the Sloan Kettering Institute, and that was an intense experience. There were like 15 people that all had their PhDs, and we were all like working non-stop and just bouncing ideas, and it was really hard, but also really energizing, my brain was just thinking nonstop. And then I, right after I had started, he had just discovered this protein, p27, and I have worked on that protein for the last, over 25 years. I moved from that environment to start my own lab at one of the state universities of New York, we're located here in Brooklyn, and I got involved in teaching. I run the medical school, a cancer block here, so I really had lots of interfacing with the students, and then I also did a lot of translational work. So doing work with actual patient material, interfacing with the clinicians, the pathologists, the surgeons, the oncologists. And so really, again, seeing how what came out of our brains, what came out of our hands could translate really quickly into changes in patient care. And that was energizing. And then in the mid-2000s, I had a discovery about this protein, p27, and figured out a way that we could sort of leverage p27 to turn cancer cells off in a very unique way, and so we filed some intellectual property. And then in 2017, I formed Concarlo Therapeutics to develop those ideas commercially to try to bring drugs to our patients and in particular metastatic breast cancer patients, and that's where we are today. We've been around for more than five years, and we're now about two years away from having our first lead therapeutic in our first phase-one clinical trial. So it's been a heck of a journey.

John Shufeldt:
Holy cow, wow. Okay, so let's go back. So first off, congratulations. You're two years away from that, which is amazing, but we'll unpack that a little bit. Did you always know that you were going to do cancer research, for example, while you're doing the HIV research, did you think, Well, cancer is where I want to end up?

Stacy Blain:
I didn't at that stage, right? So I was a junior scientist and I just wanted to go work with the best people, and I, in graduate school, you sort of try out a few labs first. And I settled on this lab of a really brilliant man named Steve Gough, who just ran an amazing, he was an amazing mentor. He was extremely positive, but also really allowed his students to become independent and to make their own mistakes. And it was just, it really suited my personality. So I, also this was the early nineties, so HIV was, it still is a huge problem, but it was probably the biggest public health problem, it's what everyone talked about. As a young person, I was very cognizant of that and it seemed like an amazing opportunity to start working on that. But then when I left that environment, I looked around for some other different opportunities and that's when I sort of gravitated to thinking more about cancer and its impact, and then again was also sort of driven to go work at Sloan-Kettering because of this amazing opportunity. I had to work with Sean Masucci and that really sort of, so it was really an evolution, I guess I would say. You know, I kind of followed where good science was taking me, and it was during my time here actually at Downstate that I realized, wow, just the studying this one process, it suddenly, you know, the light bulb went off and said, well, we can harness this process or we can subvert this process to actually use it as a way to thwart the development of cancer or the drug-resistant phenotype. So it was a process, but that idea that what we did in the lab could move to patients, that was always front and center for me.

John Shufeldt:
Yes, and that's so exciting because again, you're taking your intellectual property that you spent two-plus decades working on and now turning it into a business venture. Was that, it seems like for some people that would be a leap that they would not feel comfortable moving into. Why was it easier for you? Because it's as you're have figured out by now, I know it's a totally different set of everything.

Stacy Blain:
Yeah, No 100% agree with that. And I think that it is something that we actually need to be better at as a society because a huge bulk of the innovation that happens in the university setting and then it gets trapped in the university setting and it doesn't make its way into the commercial enterprise. And so I started the company and I really say there was a lot of serendipity that happened. The first thing that happened is I sent a grant into the NIH, which is the major, the largest funder of biomedical research in the United States, and the grant kind of got trashed. And I called my program office and I said, wait a second, I don't understand. This is a really good grant. And he said to me, Oh, it's a great grant. But in 8-3, you sound like you want to make a drug and you can't make a drug in the university. You have to actually get that tech out of the university, start a company and apply for a different type of grant, a small business research grant, SBIR grant. You can't ever get the amount of money into your academic lab to get that drug to market. So that was the first thing that happened. The second was the tech transfer office of Downstate sort of took me out to meet a couple of venture capitalists and naively I thought, Oh, they're going to really love this idea and they're going to give me all this money, and then I'm going to be able to do all this work in my lab.

Stacy Blain:
No, if they like the idea they were going to like, buy it and start their own company, and they ended up passing because they said the idea is really a little, it needs more nurturing. And I said, of course, it needs me. And so then it really, that was the second person that sort of said, Well, then you should start your own company. And then the third thing that happened was I applied for a grant at the New York Department of Economic Development, and I got the grant. And essentially it was to help me write that first SBIR. And then my husband, who's been involved with Concarlo, he is a serial venture capitalist, and he said, We can start a company. It's not that difficult to start a company and we need to do X, Y, and Z. And then the next piece of the puzzle was I had a really good friend who was a serial COO, so to speak. She knew how to start companies, she knew how to do payroll, and she knew how to set up 41kS and all the stuff you need when you have a company. So suddenly we had this three-legged stool, you know, we had someone bringing in the finance, I was bringing in the tech, and someone knew how to run the company. And that ended up happening, And that was sort of the push that needed me. And the last thing was that there was someone in my lab who was graduating, who was getting his Ph.D., and he didn't want to go into a traditional academic setting. So he said, I'll come and work for you at the company. And so suddenly now I had someone to actually work at the company, and we had an incubator, which is a bricks-and-mortar space where small fledgling companies can go and work, And we rented space and we bought some equipment and we were off to the races. And so I think if those things hadn't all aligned, it might have been difficult, you know. But I also think that I was at that stage in my career where I was, had gotten tenure, I was really comfortable. I was doing, getting lots of grants. I was feeling pretty set, but you don't want to get too set, and you did have this yearning to get my drug to patients. And this seemed like, it seemed like the logical transition to what I'd been doing my whole life, and so why shouldn't I take the leap? I just happen to have all these things come together that made it easier for me to make that leap.

John Shufeldt:
Yeah, you definitely had all the ingredients to start, like you said, I mean, husband and venture capital. I mean, that's a huge box to check, Friend who's a COO, huge box you've checked, you have somebody that's working the lab. I mean, you've, you came together pretty well. How hard was it, however, to get it out of the university? I've heard this complaint from other academicians where they have a great idea, and like the person in H said, good luck getting out. Was it, do they, does the university have co-ownership of the IP or co-ownership of the company?

Stacy Blain:
Yeah, so the way it works is the university actually owns the IP. I'm the inventor on the IP, but we had to license the intellectual property from the university to start the company, and that was not trivial, right? It took a long time over a year to work out the terms of that licensing agreement. I think that is another stumbling block for a lot of academics who want to do this. They didn't have the business acumen to do that, or the finances to do that. There are lots of things that have to happen, and so that's one of the reasons that good tech stays in universities. Universities don't have the really, the ability to form companies on their own, and if the scientist like me doesn't sort of assemble that team herself, then it's not going to happen. And then you're sort of waiting for some other venture capital or some other firm to come along and sort of source tech out of the universities, and that's a shame. There should be more pathways. I think now there are I hear about more programs, but when I was doing this in 2016, it felt very, I felt very isolated. I definitely had a lot of pushback even from my academic colleagues who said to me, like, why are you doing this? What's your goal here? Why do you want to do this? And I sort of said to them, Why aren't you doing this right? It's not okay, in my opinion, to take money from the NIH for 40 years, and write in the first line of your grant, this technology might someday cure cancer, if you don't actually do something with it. And so I think that I would encourage other academics to, if you really think you have a good idea and you should, let's see how it plays out. And the other big thing I would say is that it's not, it takes a lot more than just that academic idea to actually make a drug, and that would be what I'd say I've been doing, learning for the last few years, and not all tech is worthy of becoming drugs, but you certainly shouldn't be discouraged from trying if you think you have a really good idea.

John Shufeldt:
Now it seems like so, I know a little bit about this, but it seems like you have to play the ultimate long game because as I recall, it's about a billion dollars for a drug to market. Would you agree with that?

Stacy Blain:
It's a lot. Yeah, it takes a lot. Yep, that's true. I don't know if a billion is the right number. I'm hoping it's not a billion, but it's a big number.

John Shufeldt:
So what I've heard is with some, you know, AI-driven computer models, you can get that number down because a lot of this you can do via computer simulation and get some answers where before it had to be human trials. But you haven't started your first phase-one trial yet, which is that two years off, you said?

Stacy Blain:
Yeah, right, the way we sort of plan it is we're going to get it to that phase-one trial, and then our goal has always been after getting good results in that phase one, that we would probably look to partner with bigger pharma. And my goal for that has always been, there's no reason to reinvent the wheel, right? Pharma, we know Big Pharma is really good at putting drugs in little boxes and shipping it out. And if we've learned anything from the pandemic, right, like Pfizer took a great idea from Biontech and they made it happen. And so there's a lot more than just the great idea, you've got to actually, in terms of that vaccine, they had to make the boxes to put the drug in, and they had to get the trucks to ship the drug. They had to teach people how to use the drug. And so if my goal is to get my drug to the patients who need it faster. I don't need to spend X amount of years learning how to do all of that, when there's big pharma companies out there that know how to do that, that's their bread and butter. So we're always looking to eventually partner with some of those big outfits that can do it. They can just do it much better than smaller companies.

John Shufeldt:
Yeah, they've done it before, like you said, they have the resources to do it, interesting. So I read a little bit on p27 in being an emergency medicine physician, that was as much as I'm ever going to read about it. So can you, but it sounds amazing and like intuitively, like, yeah, that makes all sorts of sense. Can you give us kind of the elevator pitch about p27 just so people are up to speed on it?

Stacy Blain:
For sure, but I always say is that think about a cancer cell as sort of a ball and the cancer cell wants to make another ball and make, so one ball goes to two balls to four balls. And so the way that it decides to make that one ball to two ball to four balls is there are signals that sort of come from the outside of the ball, and then there are signals in the squishy middle of the ball, and then there's the center core of the ball. And we as an oncology field, we've gotten really good at sort of targeting the outside of the ball. We have lots of drugs that go to the outside of the ball. We have a lot of drugs that work in the squishy middle. And where p27 sits is the master regulator in the center of the ball and p27 is this target that will eventually tell that ball divide, make a second copy of yourself, make a second ball, or don't divide. And so we essentially are designing drugs against that core, that ball right at the center of p27, and going right to the final sort of the last soldier before that cancer cell divides, and it's been difficult to do that. I think people would recognize that p27 is a master regulator. It controls these three other kinases that were lots of people are trying to drug, but it's been hard to drug. And in many situations I think people have said, Oh, it's undruggable, we can't do that and we can't do it because we most of our drugs are sort of two classes, they're kinase inhibitors and they're antibodies that recognize the outside of the ball. And to drug p27, to make therapeutics against p27, neither of those classes of drugs will work. So we've had to design brand new classes of therapeutics to go after that core of the ball and to actually target p27.

John Shufeldt:
So should this work on all cancers?

Stacy Blain:
We have data that it works on many, many types of cancers. And so while we initially are focusing a lot on metastatic drug-resistant breast cancer, which is a really large market, about 43,000 women will die this year and men from metastatic breast cancer, we do have evidence it works in ovarian cancer and we do have evidence in pancreatic and we do have some in uterine. And so we are expanding our platform to test our ... therapeutic against numerous other tumor types with the goal that we want to bring several of those other tumor types into our phase one clinical trial.

John Shufeldt:
So, I mean, this sounds like a fundamental change in the way cancer is treated. I mean, it sounds like it's no longer, quote, poisoning all the cells because it's targeted.

Stacy Blain:
Yes, and so we as a field have really been doing targeted therapy, precision oncology for almost 40 years, and that's been the big paradigm shift, right? So the concept of chemotherapy, which we all know people that have been on, that causes a lot of hair loss, it causes a lot of GI distress, skin rashes. That is really a sort of a non-specific poison that definitely will poison the cancer cells, but it's probably also going to poison a lot of your other cells that are also dividing really fast, your hair follicles, your skin lining, your intestinal lining. And so that's the problem with it, right? Toxicity occurs. We can't, don't dose patients at a high enough concentration and patients have to go off the drug because they're just getting too sick. So targeted therapy recognizes that an individual's cancer is driven by one or two individual mutations and we can design drugs against those mutations. And that has really been transformative for the last 40 years, that's the bulk of what we brought into the oncology space, and it has been amazing. The issue we are now recognizing is that a lot of patients become resistant to those targeted therapies, their tumors come back, they leave that remission state, they become drug resistant, and that's where a drug like our drug, IPY, against p27 can come in, deal with that drug-resistant state, and eventually we'd like to move into an earlier state in the lifecycle management of patients. And so, yes, you're going to take your precision oncology drug, but you're also going to take IPY, and so the precision oncology drug is going to deal with 90% of the tumor, but we're going to deal with that 1% that might eventually become resistant and cause problems for that patient down the line so that we hope we can prevent that resistance phenotype as well as deal with patients that are already in that resistance phenotype. And that's really the power of targeting in that core, in the middle of the core, so to speak.

John Shufeldt:
I have a little bit of background in ovarian cancer, which as you can imagine is an unfortunate background, and I was talking to a gentleman who was a, it was an expert, he was a gynecologist, and he said, look, here's the deal, he goes, in a cubic centimeter of ovarian cancer cells, you have about a billion cells. And he said, we can right now erase 90% of them without much difficulty. The problem is you still have really 100 million cells that have mutated and now our treatments don't work, he said, it's that, that's the issue. But it sounds like this inhibitor, that's the target for that inhibitor, those 100 million cells.

Stacy Blain:
Absolutely, it's basically, we sort of think about this as, we're going to clean up what precision oncology leaves behind. We're going to sort of go after those cells that the main therapy that we gave that patient, it just didn't work on. And so the same way that you, when you go to the doctor, you have strep throat and he or she says, take that antibiotics for ten days, you know, the antibiotic kills 99% of the cells in 24 hours, 99% of the bacteria in 24 hours. But it's that 1% that if you don't get rid of it, it's going to divide really fast and it's going to acquire resistance to that antibiotic and that's going to cause the problem. So we want to basically deal with that 1% before it comes back to harm that patient. And then we also can, we think, deal with it once if their patients that are already drug-resistant, we can go in in that setting and really try to shut down that master regulator at that time as well. And so we're really thinking about it both in terms of entering the clinic for drug-resistant patients. And then how can we, with other combinations, move up earlier in different cancers to try to prevent that resistance from happening?

John Shufeldt:
Now, will it turn off the ability for cell to divide in all cells or will it be targeted to cancer cells?

Stacy Blain:
So that's a really good point, and that's the major problem with like those classic chemotherapies I was talking about. They hit all cells that are dividing. So that's your skin and your liver, and excuse me, your skin and your intestine and your hair cells. So our therapy, because of the way we deliver it, it's concentrated in the tumor. And the second is there because it is sort of we're tapping into the way this master regulator normally works, it doesn't appear to work as well in nontumor cells because a normal cell has mechanisms to restrain the therapy. And so we definitely see that we get much better response in the tumor cells versus in the normal tissues. So our toxicity is very low and we, because of the way we're delivering it, we're sort of dosing it and getting it more specifically to the tumor. So we don't believe and we haven't seen in our animal models that we've seen a lot of toxicity, which is more typical with some of the other therapies. So we're excited about that, right? We hope we have a therapy that not only works, but that is actually low toxicity so patients can stay on the drug longer to prevent that 1% from coming back.

John Shufeldt:
Now, you said it's targeted to the tumor cells by the delivery mechanism. What's the delivery mechanism?

Stacy Blain:
So our lead is actually a peptide and it is, so that's like a small little protein and it's actually based on the natural p27 inhibitor. So the normal cell regulates p27 to stop it from allowing that ball to divide and make two balls and to keep it as one ball. And so we basically learned from nature, we took that natural p27 inhibitor, we made it smaller, we made it commercially viable, right? So we could actually synthesize it, we could make it at scale gram quantities, and then we packaged it in something called a liposome, which you can think about is like a fat suitcase. And what the fat suitcase does is it sort of protects that very important therapeutic peptide as it moves through the patient's body so it doesn't get degraded. And then because it's also a fat suitcase, it wants to go into a tumor because tumors end up having something called leaky vasculature, and they, because they have brand new blood vessels growing around them. So there's little holes in the tumor and it sucks in the lipid suitcases more preferentially than a nice tight organ like your liver or your pancreas, where it doesn't really have leaky vasculature. It's nice, you're an adult. It's got nice tight blood vessel walls. And so because of those two things, we can get this preferential targeting to the tumor. Now, liposomes, the most famous liposome now is in the COVID vaccines, right? So those are little fat suitcases that protected that piece of therapeutic RNA, because you just shot that RNA into a patient, it would degrade it instantly, but we put it in this little lipid to protect it so that it is able to be safe until it gets where it's going and then it can do its business. So it's really the same principle, and there are lots of other drugs actually out there that use lipid suitcases, including old-school team chemotherapy. So like Doxil, which is a form of doxorubicin, which is a really potent chemotherapy, we package it in a lipid suitcase to prevent it from causing sort of spurious effects, and you can reduce the toxicity of that. So because of all of these facts, we think that the toxicity will be much lower for our patients.

John Shufeldt:
And so it sounds like I mean, at least intellectually, you're way far down the line. What, why does it take two more years?

Stacy Blain:
Well, for a bunch of reasons. One, we're raising a lot of money to finish our development. And what we are, where we are right now is in manufacturing. So we have to make the drug at scale. So we have to make gram 10, 20, 30 grams of the product to run a clinical trial and that takes time. Then we have to do, we have to finish our safety tox experiments as regulated, mandated by the FDA. We have to show that the drug is not going to do harm in rats and dogs. And we have to show that the drug is stable, that it's not going to break down on its way to the clinic. And so we have to show all of that, and then we will have a nice conversation with the FDA and say this is our data that suggests that this is going to be the standard of care for these patients, and this is how we've shown it's safe, and this is how we've shown the drug is stable, and then they will grant us permission. So two years is a long time, but it also seems very short when we start actually putting everything together, but we have a really good development plan. We have an amazing team that we've assembled and we have a really clear path. And so a lot of what we're doing right now is raising the funding so that we can sort of release the hounds and go as fast as we can to the clinic because those patients are there and we need to get this therapy to them.

John Shufeldt:
That is, literally could not be more exciting, so congratulations. What was your biggest surprise during this? I mean, you went from a tenured academic to an entrepreneur overnight. What was your biggest aha moment during all this?

Stacy Blain:
I think the biggest aha moment has been surrounding myself and learning from all of the different people that are required in this drug development process. It's great to have a good idea. It's great to understand and come up with this discovery, but there's a lot that has to go on. And I've been in awe of the people that we've brought into our team that think about the world differently, and they are the domain experts in that one little piece of the puzzle. And I always say to the people that we hire and that come and work at Concarlo, I don't want to be the smartest person in the room, I want you all to be the leaders and the domain experts in your piece of the puzzle because it really is a big puzzle. And that is a really nice, refreshing difference sometimes from academia. In academia where you have students, you postdocs, there is really sort of I've been doing this a lot longer and people come into my lab and leave. And so chances are I probably know a lot more about the subject than a lot of the people that work for me. But when you go to a company and you're in an entrepreneur, we have people that really all they know is this one thing and they are the world's expert on that, and that is really humbling and awe-inspiring and also keeps the learning curve for everyone very vertical, right? We're in the presence of greatness every day by these different people bringing their different expertise. And so I think that's the biggest thing that I've learned, is that it's, an idea as part of the puzzle but there's a lot that goes on and you better surround yourself with a lot of people that know all those other pieces because you just you can't do everything on your own. And if you think you can, I think you're going to be in a sad shape.

John Shufeldt:
A wise man knows he knows nothing.

Stacy Blain:
Yeah, jack of all trades, master of none, right?

John Shufeldt:
Exactly right, well, where can people find out more about your Stacy? This is really, this has been really inspiring.

Stacy Blain:
Well, please, anyone can reach out to me on LinkedIn, Stacy Blain, and then if you want to learn more about Concarlo, www.Concarlo.com, I'd love to hear from you. And, you know, we're always, I'm a scientist, so I love to talk science, I love to talk about drug discovery and drug development, and so reach out if you have some ideas, or questions, or anything.

John Shufeldt:
Very cool, well, thank you so much for being on this. This was an, absolutely inspiring, and thanks for the work, because you will save the lives of millions. I am quite sure of it.

Stacy Blain:
Well, thank you very much, and have a great day.

John Shufeldt:
Thank you.

John Shufeldt:
Thanks for listening to another great edition of EntrepreneurRx. To find out how to start a business and help secure your future, go to JohnShufeldtMD.com. Thanks for listening.

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