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stanley t lewis, stanley lewis, a28 theraputics

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About the Guest:

Stanley T. Lewis, MD, MPH

Founder & CEO at A28 Theraputics

Stanley Lewis, MD MPH is a graduate of the University of Texas McGovern Medical School in 1994. He completed an Internal Medicine residency and fellowship at the same institution and joined the faculty as Assistant Professor of Medicine. Dr. Lewis has dedicated his professional career to patient care, education, clinical research, and drug development. His areas of interest are infectious disease, oncology, and metabolic disorders. He has participated as an Investigator on over 30 clinical trials, authored over 50 scientific abstracts and publications, and holds a US Patent. Dr. Lewis served as Chief Medical Officer at TaiMed Biologics where he led his team to develop the first US FDA Approved monoclonal antibody for treatment of multi-drug resistant HIV disease.

He later became an entrepreneur founding Eselle Health, a biotechnology company developing new approaches to treating diabetes and other metabolic disorders, and Health First Ventures, a venture fund providing investments to fund promising new ideas in the healthcare industry. Dr, Lewis currently serves as Founder and CEO of A28 Therapeutics where he is developing targeted lytic peptides for treatment of cancer. Dr. Lewis serves on the Advisory Board of several for-profit biotechnology companies and non-profit organizations including the CARER Group that focuses on increasing clinical trial diversity and Life Science Cares, an organization that mobilizes the biotechnology industry to fight poverty.

About the Episode:

On episode 74 of Entrepreneur Rx, John Shufeldt sat down with Dr. Stanley Lewis, internal medicine physician, serial entrepreneur and philanthropist. Stanley’s most recent endeavor is being the founder and CEO of A28 Therapeutics.

Stanley has a diverse background, starting with his medical training at the University of Texas McGovern School of Medicine and his work in patient care, education, and clinical research. He then transitioned to drug development and entrepreneurship, founding companies such as Eselle Health and A28 Therapeutics.

During their discussion, Staley candidly shares the driving force behind his pursuit of drug development, underscored by the pressing need for improved treatment options free from the toxic side effects in diseases like HIV and cancer. With passion, he unveils the distinctive approach of his current company, A28 Therapeutics, which pioneers a targeted lytic peptide for combating cancer, with a particular emphasis on liver metastases.

Lastly, Stanley eloquently underscores the significance of diversity within medicine and the biotech industry. He highlights the profound impact it can have on health outcomes and the importance of representing diverse voices and perspectives. As a seasoned entrepreneur, he imparts valuable advice to those aspiring to make their mark, emphasizing the significance of knowing their “why,” exercising patience, persistence, and fostering a collaborative spirit in their endeavors.

Entrepreneur Rx Episode 74:

Stanley Lewis.mp4: Audio automatically transcribed by Sonix

Stanley Lewis.mp4: this mp4 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, where we help health care professionals own their future. Hey, everybody, and welcome back to another episode of Entrepreneurs. I'm your host, Shawn Shufelt, and today I am really excited to talk to Dr. Stanley Lewis, who I've had a chance to chat with a little bit before he started. Stanley is a polymath. It would be a great description of him, but the long description. He's a graduate of the University of Texas McGovern School of Medicine. He completed internal medicine residency and then a fellowship at the same institution and joined the faculty as assistant professor of medicine. Dr. Lewis has dedicated his professional career to patient care, education, clinical research and drug development. His areas of interest are infectious disease, oncology and metabolic disorders. He participated as an investigator on over 30 clinical trials and has authored over 50 scientific abstracts and publications. Wow. He also holds a US patent. He served as chief medical officer at Talmud Biologics, where he led his team to develop the first US FDA approved monoclonal antibody for treatment of multidrug resistant HIV. He later became an entrepreneur. Founding. Else. Else. Else health healthy at the name right A biotechnology company developing new approaches to treating diabetes and other metabolic disorders and Health First Ventures, a venture fund providing investment to fund promising new ideas in the health care industry. He currently serves as founder and CEO of A28 Therapeutics, where he's developing a targeted lytic peptides for the treatment of cancer. He serves on the advisory board of several nonprofit biotech companies and nonprofit organizations, including Kabr Group, that focuses on increasing clinical trial diversity in life. Science Cares, an organization that mobilizes the biotechnology industry to fight poverty. So you'll have to agree he is a polymath. Stanley, welcome.

Stanley Lewis:
Thank you very much, John. Glad to be here.

John Shufeldt:
All right. So the first question is, how bad did I butcher? Is it Elsa health?

Stanley Lewis:
Elsa You know what? It's funny. It's just. SL Health.

John Shufeldt:
SL Health.

Stanley Lewis:
And it's it's my initials Stanley Lewis. SL.

John Shufeldt:
SL That's all. Health Well.

Stanley Lewis:
I did butcher.

John Shufeldt:
It. Well, welcome. So you have kind of a incredibly diverse background. Give us a backstory. How did you start?

Stanley Lewis:
Well, as you noted from the Biosketch, I did my internal medicine residency and fellowship and then joined the faculty at the University of Texas Medical School. While I was there, I had the opportunity to get a master's degree in public health, and it was through that I learned that I wanted to do more than just treating patients on a day to day basis. While that was fun and very rewarding and very fulfilling, I felt like I could reach a broader audience if I were to step beyond just wearing the white coat every day. So I had an opportunity through a company. That I'd work with as an investigator on one of their clinical trials. The CEO invited me in and asked if I would if I would lead the development program of this new, really cool monoclonal antibody for treatment of HIV. So I thought that was very interesting, conferred with some of my mentors, and they all agreed that, you know, Stan, you want to go do something, you know, something bigger, something more broad, bigger than the day to day treatment of patients. So they encouraged me to do it. So I said, okay, I'll take on the challenge.

John Shufeldt:
That's very cool. What in your background mean guess? You know, I always say Steve Jobs, the whole paint the dots backwards or connect the dots backwards taught that at Stanford. What was your undergrad degree?

Stanley Lewis:
Oh, wow. My undergraduate degree was just biology. I had a BA in biology from a University of Texas at Austin.

John Shufeldt:
So. No. So you were just a straight pre-med kid? No business or anything like that?

Stanley Lewis:
I was a straight pre-med kid. And, you know, John is interesting story how I actually even became a I didn't think about it very much. My dad was a huge influence in my life when I was a kid, maybe elementary school aged. I went to him and told him I wanted to be a policeman and he thought, Well, all kids want to be a policeman when I.

John Shufeldt:
Was a criminology major, so.

Stanley Lewis:
You want to be a policeman? He thought, Oh yeah, that's great, You would be a policeman. A few months later I came back to and said, No, Dad changed my mind. I think I want to be a fireman. And he's like, Oh yeah, cool, That's great. You could be a fireman. And then maybe a year or so later, I came back to him and said, No, Dad, I changed my mind. I think I want to be a doctor. He's like, Yes, but you want to be. And he goes out. He tells everyone at our church. He tells everyone at his job. He tells everybody that his son's going to be a doctor. I was so, you know, impressed by his reaction that I actually never thought about it again. So the first time I ever met a medical student, I was one. I got through college, I went into medical school. And when I got there, I was like, wow, this is a lot. You know, maybe I should have thought this through a little better. But I was always fascinated with science and my why was really helping people. And I know that sounds kind of trite and people say that all the time, but it was really what motivated me. So becoming a physician was, was, you know, a great opportunity in my life. And then it just grew from there. So you want to help one person, the person sitting in front of you with the gown on, that's your patient or you want to help this whole population of people, folks with the same disease, because you're able to develop a drug that physicians can use, give them one more tool to fight that disease. It's all sort of a continuum to me.

John Shufeldt:
Did you have any idea your entrepreneurial way back then?

Stanley Lewis:
You know. No, I really didn't. Well, my dad was an entrepreneur. He was what you'd call a serial entrepreneur. It means he started a whole bunch of businesses, and none of them really, you know, sort of. Worked out the way he had wanted them to. They didn't become Apple or Google or something, right? But he did instill in us that if you ever really want to make it in this world, you're going to have to do some things on your own, right? If you want something you never had before, you're going to have to do something you've never done before. And going out and sort of building your own was his way of teaching us that you want to control your own destiny. You want to be your own boss. And that always resonated with me. So in the back of my mind, I suppose I wanted to do that, but I was really very fortunate with all the jobs that I had that I did have a lot of autonomy. I did have a lot of control, but I always knew there was a boss and some day I wanted to be that boss and that was just in the background. It wasn't a driving thing, but it was just sort of in the background.

John Shufeldt:
Very cool. So are you still doing it much clinical medicine right now? Or any clinical medicine?

Stanley Lewis:
No, I stopped. I still have an active license to practice medicine in Texas, but when I moved out to California in 2018, I gave up clinical practice.

John Shufeldt:
Very good. Was that difficult for you?

Stanley Lewis:
Yeah, in some ways. So it was interesting. I was working for a small company in Houston, a biotech company in Houston, and I had a deal with my with the management team there that as long as we didn't have a drug on the market, I would continue to practice medicine because I wouldn't have a conflict of interest. I couldn't prescribe my drug right. But as soon as we got a drug on the market, I agreed to give up practicing medicine because I would then be in a dilemma as to every time I wrote my drug. Was I writing it really for the patient's benefit or was I writing it for my own personal benefit? So when we got the drug approved in 2018, I officially decided to stop seeing patients.

John Shufeldt:
Yeah, it's interesting. I would not honestly have thought that that would be a concern. I mean, I think it's a there's probably a way around that. Oh, but but you're right. They have absolutely clean hands straddling the line as it could be a tough line to straddle.

Stanley Lewis:
Yeah, I felt like, well, I was really biased, of course, but I felt like we had the best drug, period. So. So. So I knew it would always be difficult for me to say, well, you know, should I write this one or should I write the one that I truly believe in? And that would have always been a conflict for me personally. But you are right. Sure there are. There are certainly ways you can you can navigate around that issue. I chose this route, which was to just sort of put up my stethoscope.

John Shufeldt:
Yeah, No, you chose the cleanest route, period. I've done a lot of entrepreneurial things, but literally can't imagine going into drug development. How did you cross that chasm from clinical medicine to something so scientific and so nuanced?

Stanley Lewis:
Well, you know, the. The life of an academic position, I think sort of falls into 3 or 4 buckets, right? You're teaching residents and students, which is really great. You're seeing patients in your clinic, which of course is really great. And at our institution, you did research and you published, right? So the research part always was the was the part that really was the most exciting for me because I felt like I was pushing the envelope. I felt like I was going beyond just what the tools that we currently had. And I also felt motivated by my patients because there are lots of patients, particularly in the field, that I was focused on, which was HIV disease, you know, the previous pandemic. And I was early in that disease where we didn't have a lot of really cool medicines that we have now. So I watched a lot of patients die. I had to just throw up my hands. I don't have anything else. I can offer you hopes and prayers maybe. And I felt helpless doing that. So for me, I was motivated by the science itself because it was interesting, but also by the fact that there just weren't enough medications for all the patients, for all the iterations of the disease that they might manifest. So I knew we needed a new drug. I also hated the fact that a lot of the drugs gave a lot of side effects. You know, we took an oath, right? First, do no harm. And I felt like a lot of the medications, particularly those early HIV medications, were pretty darn toxic. And I felt like we could do better by patients relative to the disease. I hated the dilemma that they were in, Like, you're going to take this medication and have all these terrible side effects or you're going to not take these medications and and succumb to Aids. It really was a terrible spot. So I wanted to do more.

John Shufeldt:
Yeah. I remember in the late 80s and early 90s, it was you take the medications, feel like crap and die or don't take the medication, feel okay for a while, then like crap and die maybe quicker. And yeah, it was, you know, these poor folks. I mean, thank God that's changed dramatically. All right, so you went from HIV to oncology and you made a pivot. And then you mentioned earlier when we were talking beforehand about your dad tells the story about your dad.

Stanley Lewis:
Oh, yeah, sure. I mentioned to you that my dad was very inspirational to me and why I went into medicine in the first place. But unfortunately, when I was a third year medical student, my father was diagnosed with gastric cancer. He was treated at the MD Anderson Cancer Institute, Houston, where their first objective was to try and conduct a resection surgery. Unfortunately, though, that was unsuccessful. When the surgeons opened my dad, they found his liver was filled with cancer and they were unable to operate. And it was really one of those things where you just feel really helpless and you feel like this is the worst. We have nothing we can offer this man except for hospice, and he ultimately died within the next two, three months later, my wife's grandfather was diagnosed with the same disease, gastric cancer, and he went back to MD Anderson, in fact, to the same doctors that had treated my father. But fortunately for him, they caught his cancer early and they were able to excise the entire cancer. And he lived to 97 years old. He just died last year from Covid, of all things. And. So for me, that same idea, that same motivating factor that I had in HIV disease, that helpless feeling that you had nothing else you could give to patients, and even the things that you were giving patients were so toxic that you didn't know if you were doing any good or if you were doing them less of a service.

Stanley Lewis:
It was true in oncology as well. So I think the state of oncology therapeutics is very much like HIV. 20 years ago, 30 years ago, where patients are stuck with these terrible dilemmas of taking chemotherapy or even some of the newer agents which are extremely toxic and offer you shorter, perhaps a little bit longer life expectancy. But boy, you're going to go through torture to get those extra few months. And so the drug I'm developing now is specifically useful in patients who have liver metastases. In other words, those patients who have their disease has advanced to a stage that's usually not operable anymore. And this drug offers an opportunity, at least from the early data that we've seen, it looks like it offers an opportunity to shrink those liver metastases and perhaps make those patients resectable again, or at least in all the from the evidence that we've seen so far, potentially extend their lives. And the other thing I really love about it is it has very few side effects. So the medicine I developed for treatment of HIV, the monoclonal antibody, which had very few side effects. This new therapy for oncology for cancer has very few side effects as well.

John Shufeldt:
Now, is that through your company, A28 Therapeutics?

Stanley Lewis:
Yes. So I founded A28 Therapeutics in December of 21. I had an opportunity to acquire the assets of a small company that had stumbled in a Phase two clinical trial, and we acquired those assets in early 2022, and we basically sort of took a new look and a new angle on how to pursue this drug. So we have a better assay for identifying, selecting the patients that will go into our clinical trials that basically can very accurately determine who's going to respond and who's not going to respond. We're going to increase the dose because the drugs really, like I said, it has very good tolerability and we feel like we can go up higher on the dose of this medication and perhaps get better efficacy. But we did see an excellent efficacy signal in the subset of patients who were treated. These patients all had ovarian cancer, but in a subset of patients who had ovarian cancer with liver metastases, we actually saw 69% response rate, overall response rate, as well as a 61% increase in overall survival. So we're really excited about this product, particularly for those late stage patients that really don't have a whole lot of options. Patients who have have developed liver metastasis because the biodistribution of the drug, it accumulates in the liver and therefore it has high exposure in the liver. So that's where you see all this activity. We even think that it may be useful in liver cancer. So drug disease that originates in the liver seems to be within reach for this medication as well. So we're super excited about a new therapy to be potentially bringing to the market that can help patients who really have limited options.

John Shufeldt:
Wow, that's amazing. You know, I was on the board of an 501. C three called Colleen's dream is for ovarian cancer patients. And I remember having dinner with a gynae surgeon and he said, listen, John, here's the issue. He said, you know, one cubic centimeter of tumor and they're all over the omentum has about a billion cells and we can kill about 99% of them with what we have now. The problem is there's still 10 million cells flying around the body for each cubic centimeter of tumor. And he goes, they've already mutated and the drugs don't work on them anymore. And that's the dilemma. How is what you're doing? Get over that hurdle. And first off, is that an accurate description? Because this is my retelling it after five years.

Stanley Lewis:
You know, I don't know the numbers exactly, but that's about right. It does describe the the dilemma of the fact that our medications are limited and that there are subsets of tumor cells that are resistant to the currently available therapies or that whatever reason, the drug doesn't reach the tumor and it's allowed to grow. And that's why you get these remissions that are short lived and patients end up eventually having the cancers return the way our drug overcomes that. And I know this sounds like a really bold statement, John, so I'll preface that by saying that we believe to qualify by saying we believe, but it is true that malignant cancer cells all have one thing in common. They all have a negative surface charge. So the surface of the outer membrane of cancer cells are negatively charged. They're just like bacteria. Bacteria are negatively charged cell wall. Right. And our drug happens to have an extremely high positive charge. And it's just like opposites attract. So I don't care how the cancer cell has mutated, it still has this negative charge. Our drug binds to the cancer cell on specific receptors that are found on that we can identify before we ever even treat the patients. And then the lyric peptide portion of our molecule, which is the positively charged portion.

Stanley Lewis:
Lyases the negatively charged cell membrane of the cancer cell causing the cancer cell to die. An immunogenic cell death. A cell death that causes the release of tumor associated antigens that then train the immune system to essentially go around and fight cancer throughout the body. So I think we can overcome some of the limitations of the current approaches to chemotherapy and even immuno oncology therapies with our new modality. Very much like an antibiotic, I can describe it. You know, it's very much like vancomycin. In fact, the side effects are the same as vancomycin. Wow. With a rash. But it's just been retooled to treat cancer. We put a targeting hormone on it and that binds to the cancer's receptors. And then the lytic peptide lysis. The cancer takes about 30 minutes in vitro. And like I said, patients tolerate it really well. Usually the only side effect that we see that's noteworthy is a rash of vancomycin, sort of flushing syndrome. That rash that you get that can be treated with Benadryl or other antihistamine. You can slow down the infusion rate and patients don't develop the rash. So when you start thinking about it in the whole scope of currently available cancer therapeutics, it's a really cool opportunity if we can demonstrate that it works.

John Shufeldt:
Wow. Like I mentioned, I started a number of businesses but would have no idea how to start a biotech company. What were some of the challenges you faced and how did you learn how to accomplish what you've accomplished?

Stanley Lewis:
Wow. Well, don't know if I'm really ready to answer that yet because we we haven't gotten to the goal. But suffice to say, we have left the station, so to speak. I think the most useful thing to. Realize for me is that there is no playbook. Maybe there's an Entrepreneurs for Dummies or, you know, so for.

John Shufeldt:
For biotech dummies, that's kind of my biotech.

Stanley Lewis:
Dummies. There isn't one. Maybe I can write one, but. There is no playbook. And so you really having to sort of make it up as you go to some degree, there are some general guidelines, some general rules. And I would say the most important one is, you know, open your ears and listen to people who've done it before. They can tell you where some of the potholes are and sort of help you avoid some of the mistakes that they made. But I'm sure you'll learn and make new mistakes for your own self. But for me, you know, medical training, certainly medical school, residency, etcetera, did not prepare me for starting a new company in biotech. I think that's something that I've learned working in the industry as a chief medical officer for a while, understanding how drugs are developed and how many opinions are around the table when you're deciding which way, which direction to go, which indication to pursue, you know, sort of how you're going to write the protocol, what are your endpoints and what are you going to try to accomplish? What does the FDA need you to do? What do you need to show to be in compliance with that? There's all these manufacturing and other aspects of the of the business that you really aren't exposed to. If you're a physician sort of down at the end user position, just prescribing the drug. The development process is really complex and it's highly specialized and there are lots of different silos of knowledge and information and things that you have to integrate. So I'll be the first one to tell you I'm learning on the job, as it were. But it's exciting and knowing that you have that ability to see it from the end user's perspective, right? So as a physician, I think I am I do benefit from having actually seen patients, having actually prescribed drugs, having to navigate what side effects and so forth that patients have to endure. So I use that knowledge to inform me on how to develop drugs with the patient in mind, sort of patient centric.

John Shufeldt:
These are, you know, one of the sort of the venture capital company. And we generally don't do any pharmaceuticals because they're incredibly expensive to develop and then go through the different clinical trials. How are you getting funding to do this?

Stanley Lewis:
Through venture capital is the way we're actually in the process of raising a Series A. One of the things that I think is unique about our company is I mentioned that I bought the assets from another company that had stumbled and run out of resources to continue its development. So while we are a startup, our drug, our next clinical trial is actually a potentially registrational clinical trial. So there's been a whole lot of resources that have been put into the development of this product through the preclinical, through the Phase one and even the initial phase two clinical trial that have de-risked the development process tremendously. And we're asking investors to take this one chance, this one small leap, which is to say that the signal that we saw in our previous clinical trial, the efficacy signal that we saw retrospectively, we can actually duplicate that in a prospective manner. We feel very comfortable about the safety. Of course, we'll continue to monitor it. We feel very comfortable that we've worked out the PK and the dosing, although we've got a couple more doses because we feel like we can go higher. The drug is still very well tolerated, but what we really need to do is we really need to show this one simple thing that signal that you saw looking retrospectively at the patients who had ovarian cancer and liver metastases in your phase two clinical trial.

Stanley Lewis:
Is that real? Is that real? If it is, then we've got $1 billion drug on our hands, Right? And if it's not real, then, you know, what else could you do to, you know, sort of make it accessible? I think that if we can get investors to see that value proposition, that the real work has actually already been done and we're moving into this final stage, you know, we're we're in the red zone. We just need to push this thing over into the end zone. I think we'll get funded and I think we'll be off to the races. But yes, biotech, institutional investors are a little skittish right now. They're they're not as sort of free flowing with the capital as they were during Covid times. So we are up against some significant headwinds. But I think things are starting to change and remain an eternal optimist. I do this for the patients, so I don't feel like I have the option to really. Just give up. So we're going to keep knocking on every door until we get this Series A and get ourselves back into the clinic.

John Shufeldt:
I've talked to other folks who do very specific phases of drug development, and then they'll sell the assets like, okay, I got over this goal line. It's going to take $10 million or actually $100 million to get over the next goal line. So I'm going to sell the asset now and they keep just selling it along the way. Is that what you plan on doing or do you plan on taking it really to market?

Stanley Lewis:
Wow. Well, that's a very good question. You know, the wonderful thing is I'd love to have those options right, to say that the work I've done in created value in this company was so monumental that a larger pharma would come along and say, We recognize this value. We're going to offer you a whole lot of money, we're going to acquire your company. But at the same time, I've taken a drug all the way from phase one, all the way through market approval and commercialization. So I know that path and I'm happy to take that path if that be the best way to go for our company and for our shareholders and for this remarkable product. Now, one of the things that has been a concern to me, as I'm sure it's a concern to you and is the cost of prescription drugs and how I don't think we're getting the value that we really need out of these products. I mean, you think about the average cost of a new oncology drug over the last five years is like $240,000 per patient per year. That's a lot in Texas. That was a house right when I lived there. And I think our health care system is burdened with a lot of these costs.

Stanley Lewis:
But even when you think about the cost and you say, okay, well, maybe that's acceptable given what it costs to develop it and so forth, but that's only given me a 15% objective response rate, and it's given me 90% of the patients with, you know, intolerable side effects. So there's no value there. Maybe I pay $250,000. If you could tell me that this is definitely going to work or that at least I'm not going to have any more side effects than what you said or in the label. And those are going to be manageable. So I'm hoping that not only will our new cancer therapy offer hope to patients who have late stage disease, but I'm also hoping that we can use it as a model for value based pharmaceutical drug pricing or drug delivery. And if we could do that, well, I'd love to take this product all the way to the market so we could maybe change the tide and make some headway on both of these ills. Right. The ill of the disease as well as the ill of the burden that it's causing our health care system.

John Shufeldt:
Now, I'd always read that, you know, basically going through all the clinical trials. So drug discovery to market is about $1 billion proposition. Is that still true?

Stanley Lewis:
It can be, yes, depending on the indication how many patients have the disease. Rare diseases are really hard to do drug development for because there's a huge cost of clinical trial participant acquisition. And according to how complicated and complex the molecule is to make and what efforts have gone into the discovery process for our drug, it's actually very interesting because it's solid phase chemistry. It's not a fancy monoclonal antibody or any of these really newfangled complex medical therapeutics. It's actually very much like an antibiotic, as I mentioned. So it's really not as difficult on the scale of medications to produce than those others. Likewise, a lot of the development costs have already been sunk because the phase one and phase two were conducted by a previous company. So while, yes, you can count those costs, it's not going into the cost going forward. Those are already. So I believe we could probably get this drug to the market for well, under this, you know, billion dollars that others talk about. In fact, I think we could get it there for less than a 10th of that.

John Shufeldt:
Well, very good. You know, I've invested in a company that uses artificial intelligence to come up with potential drugs or I guess, chemical formulations based upon what's already known and out there and what different disease states may need, which should shorten the time and decrease the cost of drug development, is obviously the idea behind it. But I can see why pharmaceuticals cost so much money because the development cost is huge now.

John Shufeldt:
Yeah. Down over time.

Stanley Lewis:
Yeah. Think I is going to have a really huge impact on that. I sit on the scientific advisory board of a similar company, perhaps similar to the one that you mentioned that aspires to do exactly what you just said. And they've actually had some some success thus far in designing molecules that appear to be a little bit more thoughtful and certainly a lot less trial and error in the lab than our previous methods pre AI methods of developing products. So I do believe we'll get more efficient and I do believe that will also bring down the cost and the time relative to drug development. But at the end of the day, it's still going to be a phase one, phase two, phase three type of process that ultimately results in a drug approval. And while I may help, especially on that front end of the process, the back end of the clinical development part will still require us to sort of roll up our sleeves and do clinical trials.

John Shufeldt:
Right. Give me your perspective, if you would, on kind of diversity in medicine in general today and then biotech specifically today.

Stanley Lewis:
You know. Thanks, John, for asking that question. I think that really sort of breaks down into three areas. When you use the term as broad as diversity, right? The diversity of health care outcomes, which I think is terrible, that particularly racial diversity and even gender diversity, ethnic diversity, I think it was Martin Luther King said that of all the inequalities, injustice in health care is the most shocking and the most inhumane. And I think he had it right. It's really sad that just by being born black or being born Latina in the United States, it means that your life expectancy is going to be short. That shouldn't be right. So there's that diversity. We need to do better. A lot of that has to do with social determinants of health, poverty and housing and access to insurance and access to geographic.

John Shufeldt:
Deserts.

John Shufeldt:
And everything.

Stanley Lewis:
And all those sorts of things. So I think that's that's a diversity issue when you also think about diversity relative to. The biotech industry specifically, there is this idea of diversity, equity, inclusion and belonging. Et cetera. And you know, what are we doing to make sure that talented students and talented young professionals are having the opportunities to explore their dreams if they're getting the opportunities to be hired, to be promoted within organizations? Is there equity in that? And that's a debate that's ongoing. I think that if you look at the proportionality relative to the population, it's clear that we've still got a ways to go. But having said that, I do think we are starting to make some progress. There is a consciousness awareness that is starting to develop in our industry and I think that's a good thing because I think we're leaving a lot of good ideas and a lot of really talented folks that are underappreciated in organizations that are finally getting a chance to have their voices heard. And then there's finally the inequity in funding, sort of the entrepreneurial end of diversity and the fact that black and brown entrepreneurs only get about 1% or 2% of the of the venture fund dollars is really just a sad commentary on where we still are in terms of integrating the biotech industry and the pharma industry in general, and we need to address that as well.

Stanley Lewis:
I think that diversity and innovation are interwoven and if we're leaving all of these ideas on the table sort of off the side, they never have a chance to be pursued because of bias, because of the fact that people don't feel like there's an opportunity for them, there is no opportunity for them. Or even when they do have the guts to go out and try to create their own company like me, they don't have the networks that are so essential to being able to get your products, your companies funded. That's the real problem as well. So there's a lot of work to do when it comes to improving the status of racial minorities and creating gender equity in our industry. But I'm really glad to see that the conversation has started and then I'm hopeful. I have to be hopeful that we'll be able to improve those numbers going forward.

John Shufeldt:
I mean, it seems like, you know, from the lens of a white 60 year old male, it seems like we're moving in the right direction finally, albeit too long and probably too slow. Do you have a sense of optimism?

Stanley Lewis:
Yes, I do. I think the one thing that is clear to me is that the change has to happen. On two levels, right? It has to be an institutional shift in sort of the way companies operate, that they are conscious and take proactive steps to make sure that their employees who are diverse are heard or that they seek out diversity as they have new openings in their companies. Also, in companies that get funded, are we looking to see if there are companies out there that maybe we've overlooked? Because the entrepreneur that is starting that company, you know, he doesn't go to the same school as our kids do or he doesn't play at the same golf club as we do. And where those who, you know, parts of the process are really played out. It's much easier to invest in someone if you know who they are. Totally. So there's that institutional sort of side and then there's the personal side. I mean, I think that every person needs to look inside themselves and do an honest assessment. You know, do I recognize, celebrate, see diversity? How do I feel about the idea that certain groups of folks have been left out? What can I do personally in my day to day walk to sort of help change that and to welcome in a more diverse group of colleagues who each person has to do that. And I think that's a lot of times why it's really hard is we try to solve things programmatically at a process level and we sort of ignore that individual need to do a personal assessment.

John Shufeldt:
Yeah, I would agree with that. I mean, I've learned over the years that the more diverse group you have sitting at the table, better ideas will get put forth and better outcomes will be achieved. Because it's the old saying, if everybody's thinking like me, we don't need anybody else.

Stanley Lewis:
Exactly.

John Shufeldt:
Diversity helps that because everybody has different constructs. If you come from a background unlike mine, you have a much different construct and often a much better construct than what I have. And so it leads to a better decision making, I think. Stanley, anything else you want to wrap up with? Any advice you have? And I told you earlier, there are many people out there who hear this and be like, Man, I want to be like that dude when I grow up because he's a badass. What advice would you have for physicians who are trying to find their and like practice medicine? And I'm going to start a drug development company. Practice medicine. And what advice would you have for them?

Stanley Lewis:
Wow. You know, I would say no. Your why you gotta know why you're doing this. There are easier ways to make money. There are easier ways to have an impact. There are easier ways to make a name for yourself or whatever that Y is. So you have to really match the two. You have to be sure that what you're doing is really what sort of amplifies your aliveness. Does it make you feel really good? Does it make you happy? You have to be patient. You have to be incredibly persistent. You have to be willing to understand that even if you are a physician and I can remember. You know, being in multidisciplinary teams. But at the end of the day, everyone knew. That I was the physician, right? You may have the pharmacist, you may have the nursing team. You may have all the different groups that are weighing in on how the patient is treated. But at the end of the day, you know, MD stood for makes decision, right? So you knew that was ultimately the hierarchy and you took that responsibility very carefully. You listened to all the folks around you. But ultimately, that decision was yours when to go into drug development as well. It's like the playing field gets leveled and the finance guy is going to have a whole lot to say about what's going to happen next. And you have to take into account all of the, you know, the specialists and the manufacturing guys and the commercial guys have a lot to say about it, too. And so you really have to be willing to work in a very collaborative manner. So if I would sort of summarize it all, I'd say. Make sure you know why you're doing it. Bring a healthy dose of patience and a healthy dose of persistence. And be ready to roll up your sleeves and work together with those folks around you. Because at the end of the day, there's no playbook and nobody knows it all. So it's important that you go into this with this very collaborative spirit and collaborative mindset.

John Shufeldt:
Wow, That's sage advice.

John Shufeldt:
Love that. This will sound really stupid, but I've never heard anybody say MD stands for makes decision. Never have I ever heard that. I'm like, Huh? How did I miss that after all these years? Well, Sandy, where can people find out more about you? And we'll include this all in the show notes as well. But how can they get Ahold of you?

Stanley Lewis:
Sure. Well, I encourage everyone to visit our LinkedIn page, A28 Therapeutics. You can find us on the Web. Our website is A28 therapeutics.com and I can be reached at my email address StanleyLewis@A28therapeutics.com.

John Shufeldt:
Very good. Well, now this has been really enlightening for me and very eye opening. A lot of different fronts. Thank you for taking the time to do this. I really appreciate it.

Stanley Lewis:
Thank you so much, John. This has been really fun.

John Shufeldt:
Excellent. Well, folks, wraps up another episode of Entrepreneur. Thanks for listening. We'll be back to you soon. Stay safe. Thanks for listening to another great edition of Entrepreneur to find out how to start a business and help secure your future. Go to John Shufelt Webmd.com. Thanks for listening.

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About A28 Therapeutics:

A28 Therapeutics is a clinical-stage, biopharmaceutical company developing a targeted lytic peptide platform for the treatment of multiple cancer types. Our lead product, AT-101, is a targeted agent that rapidly and selectively kills cancer cells, without harming healthy cells. AT-101 is a late-stage compound that has been the subject of more than 15 years of development, has been tested in more than 70 pre-clinical studies, and clinically tested in more than 70 patients in Phases 1-2. In its Phase 2a study, AT-101 demonstrated clinically meaningful results against advanced metastatic ovarian cancer: 69% overall response rate in combination with chemotherapy (vs. 16% with chemo alone) and a 61% increase in overall survival in the subset of patients with ovarian cancer with liver metastases.

AT-101 is the next generation of targeted therapies as it possesses all the specificity of Antibody Drug Conjugates (ADCs) with a far more specific and immunogenic cytotoxic payload. Its unique biodistribution to the liver allows for remarkable anti-cancer activity in late-stage patients with liver metastasis potentially restoring the opportunity for resection. The single noteworthy side effect was a transient, treatable rash. A28 Therapeutics’ targeted lytic peptides led by AT-101 are poised to change the paradigms in cancer care.

Key Take-Aways:

    • Explore the breakthroughs and progress of AI-driven drug design and development.
    • Absorb the value of incorporating diversity in the medical field, addressing disparities in race, gender, and ethnicity.
    • Observe the benefits and impact of promoting an inclusive and diverse atmosphere in the biotech industry.
    • Address the inherent funding bias in the biotech industry, particularly affecting black and brown entrepreneurs.
    • Acquire professional guidance geared specifically towards physicians eager to step into drug development.

Highlights:

  • AI revolutionizing drug development: Artificial intelligence (AI) is changing the face of drug development, offering a more efficient and cost-effective approach. Stanley, an expert in the field, highlights the importance of integrating AI with traditional clinical development to optimize results. Although AI can help in designing drug molecules, reliance on clinical trials remains essential for the final approval process.

  • Importance of diversity in healthcare: Healthcare outcomes can show considerable disparity based on race, ethnicity, and gender. Stanley passionately addresses this issue, labeling it as an inhumane injustice that demands attention. He emphasizes improving social determinants of health, such as addressing poverty, housing issues, and access to insurance, to help bridge this gap in healthcare outcomes.

  • Impact of promoting inclusivity: Inclusivity holds significant importance in the biotech industry, especially in terms of diversity, equity, and inclusion. Stanley stresses the need to provide opportunities for talented individuals from diverse backgrounds and ensuring equity in hiring and promoting. Stanley does voice his concern of the current lack of diversity in venture fund dollars, yet he is hopeful that we are making some progress in this area.

Resources:

Timestamped Summary:

00:00:05 – Introduction,
Introduction to the podcast episode and introduction of the guest, Dr. Stanley Lewis, who has a diverse background in healthcare and entrepreneurship.

00:01:51 – Dr. Lewis’s Background,
Dr. Stanley Lewis shares his background, including his medical education and career as a physician. He explains his motivation to do more than just treating patients and his journey into drug development and entrepreneurship.

00:06:33 – Transition from Clinical Medicine,
Dr. Lewis discusses his decision to stop practicing clinical medicine and focus on drug development and entrepreneurship. He explains the conflict of interest he would face if he continued to practice while developing his own drug.

00:09:18 – Motivation in Medical Research,
Dr. Lewis shares his motivation in medical research, particularly in the fields of HIV and oncology. He discusses the need for new drugs with fewer side effects and the desire to provide better treatment options for patients.

00:10:49 – Personal Experience with Cancer,
Dr. Lewis shares his personal experience with cancer, including the loss of his father to gastric cancer and the successful treatment of his wife’s grandfather. These experiences further motivated him to work in oncology and find better treatment options for cancer patients.

00:13:26 – Founding 28 Therapeutics,
Stanley Lewis discusses how he founded 28 Therapeutics and acquired the assets of a small company. He shares their new approach to pursuing a drug, including a better assay for selecting patients and increasing the dose for improved efficacy.

00:14:37 – Exciting Efficacy Signal,
Lewis highlights the excellent efficacy signal they observed in a subset of ovarian cancer patients with liver metastases. He mentions a 69% overall response rate and a 61% increase in overall survival. This drug has the potential to help patients with limited options.

00:16:28 – Overcoming Cancer Cell Resistance,
Lewis explains how their drug overcomes the limitations of current therapies. The drug has a high positive charge, which binds to the negatively charged surface of cancer cells. This interaction causes cancer cells to undergo immunogenic cell death, training the immune system to fight cancer throughout the body.

00:19:18 – Challenges of Starting a Biotech Company,
Lewis shares the challenges he faced in starting a biotech company. He emphasizes the lack of a playbook and the need to learn from others who have experience in the industry. He highlights the complexity of drug development and the importance of keeping the patient in mind.

00:21:24 – Funding and Future Plans,
Lewis discusses the funding for 28 Therapeutics and their plans for the future. They are in the process of raising a Series A round and emphasize the value they have already created through previous development efforts. Lewis

00:28:14 – The Potential Impact of AI in Drug Development,
The guest discusses his involvement in a scientific advisory board for an AI company that aims to streamline the drug development process. He believes that AI can make drug development more efficient and cost-effective, but clinical trials will still be necessary for drug approval.

00:29:17 – Diversity in Medicine and Biotech,
The conversation shifts to the topic of diversity in medicine and biotech. The guest highlights the disparities in healthcare outcomes based on race, ethnicity, and gender. He also discusses the need for diversity in the biotech industry and the challenges faced by underrepresented entrepreneurs in securing funding.

00:32:46 – The Need for Institutional and Personal Change,
The guest emphasizes the importance of both institutional and personal changes to promote diversity in medicine and biotech. He calls for companies to proactively seek out diversity in their hiring and funding decisions. He also encourages individuals to examine their own biases and actively work towards creating a more inclusive environment.

00:34:33 – The Value of Diversity in Decision Making,
The guest explains how diversity leads to better decision making by bringing different perspectives and constructs to the table. He shares his belief that a diverse group of individuals can generate innovative ideas and achieve better outcomes.

00:35:20 – Advice for Physicians Venturing into Drug Development,
The guest offers advice for physicians interested in starting a drug development company. He emphasizes the importance of knowing one’s why and aligning it with the challenges and rewards of the field.