Lewis Bender: Founder and CEO of Intensity Therapeutics

Mar. 21, 2020 Season: 2 Duration: 27:48 Episode: 4

"It would have been a tremendous regret to have never tried—much worse than trying and failing. Much worse." – Lewis Bender, Founder and CEO of Intensity Therapeutics,

Lewis Bender: 0:00

It would have been a tremendous regret to have never tried; much worse than trying and failing. Much worse.

John Simboli: 0:13

That's the voice of Lew is Bender , founder and CEO of Intensity Therapeutics. Listen in now to hear my conversation with Lew at the Intensity headquarters in Westport , Connecticut. I'm John Simboli. You're listening to BioBoss. This afternoon. I'm in Westport , Connecticut at the headquarters of Intensity therapeutics with Lew bender, founder and CEO of Intensity. Lew, welcome to BioBoss.

Lewis Bender: 0:40

Good afternoon, John. Thank you for coming today.

John Simboli: 0:43

How did you find yourself at Intensity?

Lewis Bender: 0:44

I've had a very diverse career over my time since college. I've done a lot of different things and lived in different countries and worked in different industries, not just health care. And I learned a lot from each of them and I effectively was able to apply some learnings from all aspects of my life to arrive at what I hope to be a very helpful and effective treatment for patients with cancer.

John Simboli: 1:11

And along those lines. Some of the CEOs I've spoken with said, "Yeah, I kind of knew what I wanted to do from early on." And I'd say more than half of them and more than half the founders have said, "No, I couldn't see this coming." Do you fall into either of those categories?

Lewis Bender: 1:26

I don't think when I started my career I could see this coming, that I would come up with an innovative idea to treat cancer. But I did see myself as an entrepreneur and I've always wanted to be an entrepreneur. It just took me a long time to finally become an entrepreneur, but I always saw myself in some sort of leadership role in that regard.

John Simboli: 1:52

What was it about being a leader or being an entrepreneur that was attractive? Can you remember from those early stages when you said, " Yeah, that's what I want to do? Do you remember what it was?

Lewis Bender: 2:01

Well, again, leadership, you know, you don't think "I'm going to be a leader", but you think "This is what I want to do. And I have a vision." And I think if you are enthusiastic and you have a vision and you want something to be done, by default, you become a leader. And then how good of a leader you are and how effective you can be and how successful you can be stems from your character and what you believe in and how you treat people. So you don't go out saying , I'm going to be a leader today. You go out saying this is what I want to do. And let me explain it to people and hope that they come on board with you.

John Simboli: 2:44

How did you decide you wanted to found this particular company rather than, for instance, take your idea and take it someplace else where there might be a structure in place you could grow it within that?

Lewis Bender: 2:54

Look, you know, you can't bring an idea to some big company. Expect them to take you seriously. You have to come with data and results and patents something that's g oing t o convince them there's something valuable here. So it was never a question that once I had the idea, I had to find ways to create the value that would allow it to be interesting to people and pharmaceutical companies. There's no way you could just go with this idea without any, you know, proof of concept, let's say and be a t all taken seriously. So you really have to go out and generate the information that's necessary to convince people that you've got something of value.

John Simboli: 3:40

When you first identified that thing that you wanted to take forward and that line of thinking and that scientific approach, and you began to talk to people who might be a part of it, let's say early round investors or others, do you remember what it was, did they say, "Oh, Lew,, that's brilliant? Or did they say "What is that? "

Lewis Bender: 3:58

The people that didn't know anything , who first funded me, who had no bias for or against and just knew who I was—my, my friends and my family—when we showed them the first set of data, they looked at the data for what it said. If you talk to the experts or the people who sort of know, they didn't like it at all, they thought it was an old tired idea that had been tried and failed multiple times and wouldn't take the time really to understand and learn what it was that I had really developed that was different than what they thought it was. So the people who knew me the best were the ones who really invested and believed in it. And the people who knew the industry the best and didn't know me were the ones who were the most skeptical and didn't want to be bothered with something from somebody that wasn't, you know, in the supposedly cancer realm. So it's interesting actually when you think about it that the people who knew me trusted it and the people who didn't know me but knew what they thought they knew didn't. You know there's going to be skepticism. Why is this different than the 15 times where intratumoral delivery has failed before? I'm not seeing the big picture is what humans tend to want to do when it's easiest to, you know, you've got 50 things on your plate and you really want to just get an understanding and move on. So it's not unexpected. That's the way the world works and you just got to deal with it and you can't get upset and you can't . . . . You just got to find ways to work around the problem.

John Simboli: 5:40

There must have been an easier thing to do at that point in your life than to say, I'm going to start a biopharma company.

Lewis Bender: 5:45

I always wanted to be an entrepreneur and I came to the point where I was at the twilight of the opportunities. If I didn't do something when I did it, it would have been very to ever do something. And I knew I had an idea that . . . I'm a pretty good engineer, pretty good chemical engineer and I knew that the physics was with me on this technology. Ans having that desire and knowing that it was going to be something that's not going to get easily recognized right away, I had no choice because it wouldn't have been easy to do anything other than try it. Because you can't come to the end of your life as you've heard me say, thinking you might have had a highly effective treatment for cancer that could have helped hundreds of thousands, if not more, people and never did anything about it. It would have been a tremendous regret to have never tried much worse than trying and failing much worse. So there was really no choice. It was either do it now‚ something that I've always wanted to do and never did. Try and fail or never try. And I was frankly terrified of never trying.

John Simboli: 6:54

What's a typical day for you?

Lewis Bender: 6:56

What I have to do every day is figure out how to raise the capital to get us to the next level. How to continue the programs, how to look at the data, where should we go? What does this mean? Should we change it? Because what we do is not the way drugs are done. It's just not the way drugs are typically dosed. We have a totally different approach to dosing. We have a totally different approach to treating cancer. We have to train the doctors, we have to train the sites, we have to train the patients, even, to understand what it is we have. And we have to learn ourselves. So I'm constantly thinking about how I can communicate better to all of my constituencies. What we do and what it is we should do differently to make what we do better. So that's a little different. This is not, you know, giving IV solution—we don't have that. We don't have a dosing based on your height and weight. We dose based on the tumor and the cancer and the severity of the disease. So it's very different. And so we have to do things differently. And I"m fortunate that I have a great board and a great set of investors so I can focus on the aspects of what's unique to us. The reality of what I'm facing on a day to day to do something that no one's ever done before. No one's ever done it well. No one's ever done it successfully, that what we're trying to do.

John Simboli: 8:16

Lew, what's new at Intensity Therapeutics?

Lewis Bender: 8:18

2019 was a great year. Without doubt, we achieved some wonderful things. We got a fast track designation from FDA for a lead drug for triple negative breast cancer, a highly unmet medical need. We signed a very big collaboration with Merck . We published with the National Cancer Institute, a joint peer review publication. We were selected by the Society of Immunotherapy of Cance, one of the most important cancer organizations, medical organizations, for a podium presentation. We've started our study with Merck . We've dosed the cohort, the safety cohort. Safety looks very good. We're having, real good discussions with the doctors. The enrollment now is accelerating dramatically. Doctors are seeing results with their patients, really good results. I mean, the cancers are being shut down, shut down in a number of people. Now that we can dose a reasonable dose, we can treat people, we're dosing people with immunotherapies where we know in mice it's synergistic. We've got other pharma companies interested in partnering with us. It's a great time because I talked to some of these patients, I've met some of these patients and I can see the benefit of what we're doing for these patients on a daily basis. And the more patients that we treat, the more people we help. And then the more the people get helped , the more doctors put patients in. So I think it's a very exciting time for us because we're now at the point where you give this drug into tumors and those tumors, we can see a lot of them now, are dying . . . don't necessarily go away, but they don't look like they grow and a lot of them shrink. So we're seeing a benefit to people and that's very satisfying and we're moving into now later stage development, into phase two studies , , later this year. Hopefully additional cancer types will be treated. So it's a very exciting time to finally see the culmination of this work starting to really help a lot more patients.than it was when we were dosing very low amounts. So it's very satisfying and it's very exciting and it's very new.

John Simboli: 10:35

What is it about your approach that distinguishes it from the way other people tried to take on cancer?

Lewis Bender: 10:42

What we do today is you look at cancer as both a regional disease where you can see the tumors and a systemic disease where you can't see the cells or the tumors that are in the body somewhere. So you have this local aspect of it and you have this whole body systemic aspect of it. And I think as an engineer you have to treat the big that you can see and you have to treat the small. And the big is being treated by, surgery, radiation, ablation where you melt it away or freeze it away. And the small is being treated by chemotherapy, targeted therapy or immunotherapy. And they're not synergistic per se. They don't really work together. They work on each component. And what we try to do is to make that local approach synergistic with that systemic approach so we try to kill the tumor in a way that they can be now recognized by the immune system. We're bringing together the two ways of treating cancer that are discoordinate. Patients in our study don't have these horrific side effects. They go home the same day that they got treated. The tumors stop. There's an immune activation going on in many cases and if you can do that effectively and understand it better, I think we're going to have a new era in cancer treatment where it'll be a chronic disease for most people, not a death sentence. And the fear, the fear of the disease being equal to the fear of the treatment will both go away. You can get people to not fear the disease and not fear the treatment. That's the goal. Better results without the fear. That's what we're trying to do.

John Simboli: 12:24

A certain number of people are going to say, "Oh, I get that Lew, I'm interested. I would like to talk more with you." And a certain number of people are going to come back and say, "Oh, I heard you say" . . . , and it actually wasn't what you intended them to hear . But people filter things in funny ways. When they get it filtered and you have to come back and help them, "No it's actually this." What is that conversation like ?

Lewis Bender: 12:46

The biggest perception when we tell them what our drug is is, Oh, it's just chemotherapy, old rotgut chemotherapy. And while we're using those agents, this is not chemotherapy as your grandmother knew it. This is an attenuation of a tumor in a way that keeps its three- dimensional confirmations. The diffusion that we bring to the chemotherapy throughout the tumor kills it in a way that makes it still look like cancer or is better looking as cancer. And that attenuated tumor converts into a highly recognizable site for the immune system. So I try to explain that when they see the product, they don't think chemotherapy, they see the product, they think tumor attenuation, immune activation. Attenuation and activation, not poisoning throughout the whole body. That's where I'm constantly trying to communicate and to make sure that people understand that what we're doing uses similar elements to what they're familiar with, the agents themselves, but in a completely different way than what's ever been done before.

John Simboli: 14:01

What is it about your approach that allows the immuno response to unmask or to defeat the way that the cancer can evolve or hide itself?

Lewis Bender: 14:12

Well, if you remember, cancer comes from your own cells. So the immune system is trained not to harm your own tissue, most times. So the idea is try to make the cancer more recognizable to the immune system because the body is normally trained not to attack itself. So right now the immunotherapies work mostly in people who have certain markers in their cancer that are high in these particular markers, whatever they are. And we're trying to get the cancer to be non-cloaked and recognizable to the immune system as something that's foreign. Because there are enough differences in the cancer , in the way it looks and the way it's shaped, the way it grow—that we can, I think, exploit with our technology in order to make it train the immune system more effectively The immune system will go after things in the body and if we can get it to the point where the immune system now is going after the cancer because it's attenuated and no longer cloaking as well, but still looks enough like cancer that's still living elsewhere in the body, we can get this immune response in people that will, I think help a large number of people who no longer, who do not benefit from classical immunotherapy, which is now kind of where all the research is going. So the idea—better recognition effectively is what we're trying to achieve. To prevent the immune system from being blocked by the cancer.

John Simboli: 15:49

I can imagine someone hearing that and saying, it almost sounds too good to be true. How come someone else didn't do that? I'm sure you've been asked that. How do you answer that?

Lewis Bender: 15:58

I don't know if it sounds too good to be true. It's like, show me, more is the attitude. But the data speaks for itself and that's what you have to do. You have to generate data to convince not just the FDA but the physicians that this is going to benefit their patients, that this is going to give them longer life with better quality of life. And it's just that's the data we have to generate. It's a show me type of attitude and that's what we're trying to do. So I think the idea is we're going to generate the data. There's a real good mechanistic reason why this works. We've published that and now we're testing it. And the data is, it works well, i doesn't work well, or something in between. But in between is good enough to get a product that's going to help people. And works really well, we'll be a blockbuster product that will help a lot of people and shift the use away from these methods that are not working that well into methods that work well. That's the nature of our business and that's everything that you do. You generate the data and eventually it comes to the point where the skepticism goes away. It has to go away because if it works and helps people, the people are going to want it. The doctors are going to want it and everybody else will have to follow along because people are desperate for better solutions. The patients with whom I've spoken are desperate for help and their families are desperate and their caregivers are desperate and their doctors are desperat. And a better idea will overcome any skepticism or any doubt, but y ou g ot t o generate the data to do it. There's no doubt about that.

John Simboli: 17:40

A scientist was asked about the process of finding the thing that he could take forward. He said it, for me, he said, I think, for many scientists, it's not a Eureka thing—I suddenly get it. It's more like "That's funny. That's odd." Do you recall any moments like that as you were thinking about just where, "Huh?"

Lewis Bender: 18:00

I didn't really have that. I thought when these immunotherapies were coming that the problem was they can't recognize the cancer. And I knew from my experience before that I had a way of killing, I believed, killing tumors in situ by using a diffusion technology. So I didn't have this aha moment on the invention, but we had an aha moment when we were looking at the data with the National Cancer Institute. And it was like, you know, these tumors continue to go down after three weeks of use, where the drug's half-life is like 20 minutes to an hour and we stopped dosing in three days. Why are they continuing to go down? And the thinking was, I thought,, are we getting an immune response, just with our drug alone? The answer was yes, but that was kind of a "Huh?" Because I didn't really think it would be that potent of stimulating an immune response by not acting on the immune system. It's simply gives the immune system a target to go after. That was kind of an aha moment because we, at that point we said, well maybe we're seeing immune activation without these immune activating agents being necessary. So that was kind of a big aha moment when we started to see that. And we've started testing for it. And sure enough, we see immune activation without immune activating agents being necessary. And then when you add them, they catalyze the immune activation that we already have generated on our own And that could be very exciting if it starts to translate now in people. Because we are seeing for our drug alone, in humans, immune activation. In several patients we see un-injected tomors going away. Distal, very far away from where we injected in many, many cases. So that's, that's pretty exciting, that if we had an aha moment, it would be that this is stimulating the immune system without acting directly on the immune system. I remember rushing up, my wife was in her sewing room and I said, "Look at this data!"She's like, "What the hell are you talking about? Go away, why are you bothering me" I said, " Look, it was good and now it's bad and now it's good and now it's bad!" So that's pretty exciting.

John Simboli: 20:30

What can you tell me about the pipeline and how it helps to differentiate who Intensity is?

Lewis Bender: 20:35

I think the pipeline starts off, with most companies, is their first product. Then you start to see applications in more than one cancer type. So this drug has worked in many, many different cancer types. So we're working with our drug in combination with Merck's product, Keytruda. We hope to bring on some others and we hope to use it as a monotherapy. In addition, we are understanding a lot more about the mechanism by which our drug works and what we might need to do and so we have research going on to build the next, better, Intensity Therapeutics product. We have a series of experiments in process. We've generated some early data already and we're excited about the fact that we can improve upon our product alone and that's what we're looking to do. And hopefully we'll have identified a candidate by the end of the year that we could then bring into further clinical trials. So we'd have two very potent agents coming in with new patent life and all this other thing .

John Simboli: 21:33

What kind of partners are a good fit to Intensity?

Lewis Bender: 21:36

There are partners that help us do research, so we partnered with the National Cancer Institute right away when I started this company because I know I didn't have the cancer expertise and they did, it's in their name. So , the National Cancer Institute, you figure they know what they're doing and they do, and they did. So they were really spectacular in helping, basically, a guy try to pursue an idea and a dream. So that's a partner of immense value. My staff partner, Ian Walters , he came on and helped us get into the hospitals. The hospitals then partnered with us, did tests of an idea, an intratumoral idea. So they were our partners there The first hospital that dosed a patient was Princess Margaret. We've partnered with USC, we've partnered with Johns Hopkins, we've partnered with Columbia,. We've partnered with UMASS. We partnered with the Fox Chase Cancer Center who allowed us to talk to some of their patients. So all of these are partners and we've partnered with Merck now. We have discussions with other big companies. Merck has the leading drug in cancer right now, Keytruda, tremendous product. We're grateful that decided to help us help patients by combining their expertise with ours. So, you know, partnering is a continuum, as you advance what you're doing. And so, you know, I partnered with the NCI and the research with Ian, with Merck, with the hospitals, with the doctors and hopefully with more companies, with investors—all of whom I consider my partners and my board. They're all partners and we're all trying to do this to do the same thing, which is to help patients and doctors treat patients and their families in a more humane and more effective way.

John Simboli: 23:38

With all the time that's going into understanding the data and, and working with your academic and hospital partners and pharma partners—with all the time that goes into the thinking about your approachh, do you allow yourself, do you still have time at this point rather than whenever months, years from now to think, "I think I can do some good. I think I can really change one life and maybe many lives for the better." Do you have that opportunity or are you're so focused on just . . .

Lewis Bender: 24:10

Oh no, no. I'm blessed to have been able to meet some of the people we've helped and spoken to them. We had a patient who was about to have his arm and shoulder amputated, over two and almost two and a quarter years ago. He still has his arm and shoulder. I think it's already something that is beyond my wildest dreams of where I ever thought this would go.

John Simboli: 24:32

And do you think that in your hopes it will be a few people whose lives have been changed beyond belief? Or do you think it could be, potentially, more than a few?

Lewis Bender: 24:42

Where medicine is going and where we're hoping to lead it to, it will get to a point where cancer is a chronic disease. The average age will move up from 72 at age of death, now, as I believe to way beyond that. And younger people will not die. People can go to weddings for their kids. They can see their kids grow up. Men, women, fathers, mothers, brothers, sisters. That the age of a cancer death will be remote and old if it happens. That's my dream and that's what we're going to work towards. And I believe that will happen. I do believe it.

John Simboli: 25:26

Founders and CEOs who've been on BioBoss—some work here in Connecticut some in Boston, some Cambridge, some in Europe. It's somewhat unusual to be able to build something like this right here in Westport and I'm sure you had felt at some point, maybe you would go someplace else with it, but you succeeded in building what your belt built right here. Do you find satisfaction in creating, something not only potentially profound, but something that's right here in this community?

Lewis Bender: 25:58

I've lived in Connecticut almost 25 years. My mother's from New Haven. My parents' graves are here in Connecticut. I had a job in Massachusetts and I commuted for five years and didn't want to really move because I like my community. It's a nice place to live. So, you know, I like Connecticut, I love Connecticut. I like living in Connecticut, but as the CEO of Intensity Therapeutics, my objective is to get patients the care and the drug that they need to live better lives. And if that happens in some other state, then that's where I'll go to. To be where the best chances are for success are going to be.

John Simboli: 26:38

Thanks for speaking with me today, Lew.

Lewis Bender: 26:40

John, I really enjoy every interaction you and I have. I find it to be very thought provoking and enjoyable.

John Simboli: 26:49

Lew Bender told me it would have been a tremendous regret to have never tried. Much worse than trying and failing. Lew''s " Give it a shot" approach has two drivers. One is "How could you let people down who suffer from cancer?" The other is his passion for leadership. As Lew says, "You don't think 'I'm going to be a leader', but you think "This is what I want to do. And I have a vision." A vision for a future where people with cancer will have less fear of their disease and less fear of the treatment. A vision for cancer to become a chronic disease where younger people will not die from cancer, where they can see their kids grow up and someday go to those kids' weddings. As Lew says, "That's my dream and that's what we're going to work towards, and I believe that will happen. I do believe it." And I believe that Lew believes. I'm John Simboli. You're listening to BioBoss.