Episode 15 | Entrepreneur Spotlight - Kiyatec

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Episode Guests

Michael Weingarten, MA

In this role, Michael Weingarten leads a team of nine Program Directors who manage all aspects of the NCI SBIR & STTR Programs including a portfolio of $182M in grants and contracts annually. The SBIR & STTR programs are NCI's engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. Weingarten has implemented a set of key initiatives for optimizing the performance of the NCI SBIR Program at the NIH. These include the establishment of a new model at the NCI for managing the program - the SBIR Development Center.

Matthew Gevaert, PhD

Dr. Matthew (Matt) Gevaert is a cofounder and board member of Kiyatec, Inc. Kiyatec is disrupting cancer therapy selection with patient-specific prediction of response to drug therapies, prior to treatment. To date, Kiyatec has been awarded more than $5 million of competitively awarded federal funding, including contracts from the National Cancer Institute, cultivated clinical collaborations at leading national cancer institutions, and built productive relationships with premier biopharmaceutical companies developing the cancer therapies of the future.

Matt is a graduate of the University of Waterloo (BS, chemistry) and of Clemson University MS and PhD, bioengineering). He serves on a number of professional and community boards and occasionally teaches an MBA graduate course in technology entrepreneurship for professional business students.

Programs Mentioned in Episode

Explore the programs mentioned in this episode:

• I-Corp at NIH

Episode Transcript

MICHAEL WEINGARTEN:    Hello and welcome to Innovation Lab, your go to resource for all things biotech startups, brought to you by the National Cancer Institute’s Small Business Innovation Research, SBIR Development Center. Our podcast hosts interviews with successful entrepreneurs and provides resources for small businesses looking to take their cutting edge cancer solutions from lab to market. 

     I'm Michael Weingarten, Director of NCI SBIR and today's hosts. In this episode, you will hear the journey of Kiyatec, a company funded by the NCI SBIR program, which developed an innovative 3D cell culture platform that uses patients live tissue to assess and predict how tumor cells respond to therapies and inform more personalized treatment paths. Kiyatec co-founder and board member Matthew Gevaert will provide insights into how the company used SBIR funds to support its micro tumor research, which contributed to the development of its now commercially available platform for addressing glioblastoma and high grade glioma. 

     Well, Matt, I want to thank you for joining us today. Maybe a good starting point would be for you to talk a little bit about your entrepreneurial journey and, you know, how you made the move from working in the lab to actually starting up your company. 

MATTHEW GEVAERT:    Where the idea came from, in terms of the turning the corner from the lab to small business and it did come from the lab, at the time I was working on a novel biomaterial and I was looking at its biocompatibility, right, so really trying to understand this new material that you could put in somebody's body. What's the result? What's the body going to do when you put that material in? 

     And my committee and my supervisor, and very appropriately, I add, had me working on this ASTM standard for biocompatibility. And I remember going into the supervisor for this works office and saying, “I don't believe any of the data coming out of the standard because it's really not reproducing the conditions to answer this question.” So I was sort of angling to not do not do the work because I didn't believe in the data and my advisor laughed at me, said, “I agree with you, but you got to do the work anyway because it’s sort of what we've got,” to answer that question, to answer the question of, you know, what is the cell, the body's response to things we put into it? 

     And in a way, that's where the idea behind Kiyatec, for me at least, was born, which is to say, you know, I said, “Look, if you want me to answer that question, I can do it, but I'm going to grow the cells a lot differently than I would in this ASTM standard.” And so that was, that's where Kiyatec was born to, to -- My co-founder and I shared entrepreneurial aspirations around this topic, and we founded the company on the opportunity to grow cells differently in order to really maximize that biological fidelity to the real biology of people, you know, my biology, your biology, cancer patient’s biology. 

     If we can accurately, accurately recreate that in the lab, we can do a lot of good. So that was the jump, if you will, from laboratory work to the idea of founding a company to accomplish that. 

MICHAEL WEINGARTEN:    From the time you were doing your research, you always had the interest in going and starting up a company based on the technology development work that you were doing. 

MATTHEW GEVAERT:    So I would say that I saw founding the company as a vehicle, you know, as a, as a, as a means to the end and the end was to just, you know, to do better, to, to basically solve the problem in a better way and in this case, it happened to be that forming a company was the means to that end. So entrepreneur, again, back to the practicality, right, you want to change the world, how you going to do it? In this case, through founding a company to do something new. 

MICHAEL WEINGARTEN:    Can you maybe tell us a little bit more about the technology and really kind of the unmet need that that you're addressing? 

MATTHEW GEVAERT:    We regularly give cancer patients drugs that don't work, so the unmet need is that low response rate and to unpack that a little bit further, a big contributor to that is really the basis for the decision on who gets what drug. So if you recreate, you know, in your mind, a doctor looking across their desk at a patient, the drug selection for that patient is really based on an extrapolated probability that the patient in front of that doctor is going to have a response outcome like patients with similar biomarkers did in the past, right? So they're looking at clinical trials results from a defined population that's like the patient in front of them, but it's an extrapolation, it's a probability based extrapolation, and you can really only get so far with actually understanding what's the person in front of you’s biology, right? And how is that biology going to interact with that drug? 

     And so the, you know, to some, the unmet need is that today's tools, they have a natural ceiling that they're going to bump up against when it comes to positively predicting, you know, a given patient’s future response before you've ever started a treatment, and I believe, and there's many that believe, that you can really only get there by using their live cells. And the opportunity then is to bring in those live cells and really fill that information gap and understand the interaction of live cells plus the drug, you know, before treatment begins and use that information to inform, you know, the selection of the therapy for that individual. 

     And it's kind of an intuitive solution. We've known that that's the best way to do it, when push comes to shove, the best way to understand a bacterial infection is to pick an antibiotic is the evidence of that person's bacteria dying, you know, when exposed that antibiotic that's anti antimicrobial susceptibility testing, it's a big industry and it's very successful. And so, in a sense, it's intuitive that evidence of, you know, live cell death or live organism death, if you want, as a basis for that drug selection decision is a great basis and is frankly, as a better one than probability. 

MICHAEL WEINGARTEN:    So if I'm a patient and I get diagnosed with a cancer, how would I directly benefit from the technology that you're developing? 

MATTHEW GEVAERT:    So if you're a cancer patient, what do you and your doctor really want? You want dead cancer cells in your body, right. You want to take a drug and achieve the outcome of those dead cancer cells. So, you benefit when we use your live cancer cells that we're getting from your surgery or your biopsy, and we use those cells to unlock information that's been previously inaccessible and that information as, you know, the interaction of your live cells with these drugs. And that information then can inform the clinician's choice of which drugs you receive with that included in the basis for their decision making. So, and that really leads to tailored and personalized cancer treatment that have a better response rate. 

     So, we take those cells, we bring them into our laboratory and in controlled and proprietary conditions, we basically introduce FDA approved and cleared and then sometimes investigational drugs, we measure those interactions in what we call, you know, a 3D micro environment, basically a complex cell culture that's set up to have fidelity to, you know, inpatient biology. But we do all that outside the body, we do it pretty quickly in the clinical instance of our work, you know, we're trying to turn that result around in seven days, you know, well before the doctor really needs that information to do that, to inform that therapy selection. 

     And then ultimately, the measure of success is the correlation between, you know, the results in our test using that patient's live cells and then their outcomes. And so, if we get it right, if we create that correlation, and in simplistic terms, if cells die in our laboratory, the cells will die in the patient’s body because we've got that fidelity, right, that enables a really good basis to decide on what therapies they get with that kind of evidence beforehand. 

MICHAEL WEINGARTEN:    That's really fascinating. So is this, is this something that's available right now for patients? 

MATTHEW GEVAERT:    If they're diagnosed with high grade glioma, then the answer is yes. So basically that's our first product that's on the market. High grade glioma is a very deadly kind of cancer and it's popularly, you know, known or it's known by most people as its predominant form which is glioblastoma, GBM, so for those patients. And then by the way, technically, when we get that tissue is usually at a surgery that they're getting the tissue through which they do the pathology to confirm the diagnosis. So technically, they're suspected high grade glioma, suspected glioblastoma. 

     But yes, for those patients, we have a vision that is ultimately to add many indications beyond high grade glioma, ovarian cancer. We published data about the tests correlative accuracy there. And then we have, we certainly do work for our biopharma partners and clients that spans many solid tumors, so lung, breast colon, you know, the, the predominant ones in terms of their prevalence. So it's a broad approach. It's is applicable to many solid tumors, in fact, everyone that we've tried. But in terms of the commercial offerings today, it's for glioblastoma and high grade glioma. And then we'll add those commercial offerings over time as we're able to, given, you know, resources and capitalization etcetera. 

MICHAEL WEINGARTEN:    Can you maybe tell us a little bit about how NCI SBIR and what role the funding played in helping you develop the technology and also grow your company? 

MATTHEW GEVAERT:    For the two big projects that were funded at the level of a phase 2 contract, for one, really the -- our clinical tests right now, the one for high grade glioma and glioblastoma, so the relationship between the, the grant activity or the contract activity and today is that that micro tumor work. Micro tumors are sort of complex cultures that we develop for their complexity. So, they're not this spheroid platform that we use in the commercial facing test, but that micro tumor really contributed to expanding our work in the spheric [phonetic] platform into GBM, which ultimately, as you see, was our first commercially available product. 

     And so, we were -- under that contract, where we did some great work to recreate that complex biology and then to go ahead and hit it with the drugs and then correlate our measurement, you know, in the lab versus clinical outcomes. And so, that was really a great contribution to the arc of that technology. 

     And then out of the complex micro tumor itself, that contributed to the body of work that we do today in terms of predicting response and understanding the dynamics of immune oncology therapies. So, in that micro tumor work for that contract, we really, for the first time for us, were incorporating, you know, immune cells and complex biology of immune cells, including T cells and macrophages, so that work was really instrumental and sort of the foundational, foundational piece for our IL program, which is very successful. And biopharma partners, you know, are coming to us for the technology and the capabilities that we've developed, you know, around that, that body of work. 

MICHAEL WEINGARTEN:    Just from your own experience, do you have any advice for new applicants that are looking at the SBIR program for the first time and that they're actually considering applying for an SBIR? 

MATTHEW GEVAERT:    New applicants should really think about this like a relationship, as opposed to a sterile kind of interaction where you submit something and then you walk away and then something appears later in your e-mail, right? So, in the context of thinking about that that way, you know, the government is a different entity, you know, than, than, you know, private sector, commercial entities, or different entity than a university and an educational, it comes with its own rules. And so that's why if you think about it, the relationship, you have to invest in that relationship to understand those rules, understand how things work and then really fit your solution to that. 

     I tend to go back to first principles, right? So, you know, the government is here and wants to solve problems on behalf of the citizens of the country. So, it has a mechanism for doing that and it's sort of on you to understand that mechanism and work within it to develop those relationships. So, along those lines, doing the proper steps that you need to, having the filings done. I can't tell you how many people want to file for something and then realize, wow, I had to, I had to get this number or this identification, you know, and it takes a month to get it, so I can't, I can't make this deadline because I didn't properly prepare. 

     And then even with that, underneath the -- once you've done all the preparation, it's really developing and understanding being part of the community that is putting out, you know, an RFP, putting out a grant solicitation. To be part of the community so they understand what do they really want? Like, what's the goal here? What's the importance? And fitting your solution into that through that investment and relationship. 

MICHAEL WEINGARTEN:    Did you interact with program directors at the NCI as you were going through the process? 

MATTHEW GEVAERT:    Yeah, and they were really helpful. So Todd Haim [phonetic], for example, is somebody who I really celebrate the, the interactions I've had with him over time. I think he was a great program director and a great representative of the NCI, because he was good as the job, at his job and got the work done that the government wanted to do through these programs. Once we sort of understood the system enough to realize, OK, there are individual people here and when I say develop a relationship, it's, you know, they're the tip of the spear for implementing the government goals through these programs. 

     And then your relationship with them is really important, again, for the understanding. What are they really trying to achieve? Are you really in position to actually, you know, try to deliver that? And then as you do it, the relationship is through the big work of the grant or the contract and it's administration.

MICHAEL WEINGARTEN:    Now, once you were in the program, did you -- have you participated in any of the other programs at NCI SBIR? 

MATTHEW GEVAERT:    Yes, we have. So, we've been the beneficiary of programs to basically connect us to investors and that's a good, that's a win-win because I, as a taxpayer, right, I'd like the government, after they've invested in the work, they're in a position to also continue to invest in a little bit of a different way, and that is to connect the product of the work with people to take it over relative to its funding and relative to taking it, you know, up the football field, if you will, to the goal line which is affecting patients and affecting citizens. 

     And so the nature of those programs was through an NCI program to bring forward certain companies and have them participate in investor facing events, but with the known affiliation to the NCI, and that's really helpful because the NCI is a great institution with a great reputation. And so, as a small company, it's, it's nice to go into those investor interactions with that known relationship that the NCI believes in us, that the NCI funded us for this work, and so, therefore that's a good basis to invest, to interact with investors on. 

MICHAEL WEINGARTEN:    Do you want to maybe talk about just a little bit more about the personal impact that you've been able to see by developing this technology that can help identify, you know, what the right treatment path is for a specific patient? How that has affected you personally in terms of your desire to be able to make a difference with cancer patients?

MATTHEW GEVAERT:    You know, one of the reasons that we even founded the company, it was the end to -- it was the means to an end and the end being to do better, right, to do better for cancer patients. And so in some instances, we can actually talk about those results, when all the boxes have been checked for making disclosure. And in this case, you know, point to a case, a real life case from our collaborators and clinicians at Roswell Park, in which case they published a really remarkable instance where a patient on a multiple relapse, you know, their therapy selection was informed by test results. The therapy that they chose was one that was, you know, in the ballpark, meaning it's one that is known, it's a known combination of cancer drugs, but the doctors tell you it's not one that they would have necessarily favored for this patient absent our test recommendation. 

     And so that patient received that therapy, which happened to be a combination of carboplatin and etoposide, and then that patient was basically progression free for well over two years, and that's a remarkable outcome from a therapy. And that was rewarding to me and the team to, to know, OK, you know, we're making a difference in that patient and in other patients. So, it’s those case studies that we actually get to see once in a while through the lens, through the eyes of the doctors and these treatment outcomes that personally are really enriching. As well as the overall idea that the company being the means to the end to change the world, and that comes with a lot of good, too. So we're able to do great things at the company. And I walk through our labs and I see our employees and I think about, you know, having created a business that offers jobs and is really doing this good work and offering lots of people that opportunity. 

MICHAEL WEINGARTEN:    You've grown your company too. I think, as I recall, you're in Greenville, South Carolina. I think there were just a couple of you when you first started. Maybe you can tell us a little bit more about kind of where the company is and how it -- what it's meant to your local community too? 

MATTHEW GEVAERT:    Yeah, I'd be glad to. So we're up to about 25 to 30 people these days and that's been sort of, you know, growth over time. As you remember, in our first ones we were, we were just a handful. A part of our, you know, our company’s arc has been the decade that we spent inside a cancer institute in Greenville, South Carolina. And the reason for Greenville, it's a great city, but it happens to be close to Clemson, where me and the co-founder did our graduate work. So, we're sort of in the universe of places when we thought about, OK, this is what we want to do with the company. And the opportunity to live inside of a cancer institute was really, really rare. 

     So it makes a lot of sense, right? If you're going to develop a solution to a problem of cancer, you know, being down the hall from the room where the cancer patients are sitting, receiving their therapies has a lot of advantages. But most hospitals don't have the kind of innovation culture that would facilitate, you know, that kind of relationship, but this hospital did and we were there for decade. 

     So that's being a part of the Greenville community. And that partnership with the hospital was really, you know, important and valuable to us and meaningful. And then the decision after that, which is to say is OK, you can only grow so big inside a hospital, you need, you need to find a new home. The decision to then move the company into downtown Greenville was a second version of that community relationship that's been really meaningful. It's a little bit unusual, so not many laboratory companies are sitting on the main street of a thriving, you know, a thriving city like Greenville, but we are, partly because of the innovative spirit of the community to realize like, hey, this is a good thing. 

     If we can grow this industry that is, that is a piece of the future that everyone agrees is going to be a great industry for many, many years, we can bring those jobs and that talent, and those individuals into our downtown and make them part of that, and they recognize the value of that and we've experienced the value of that since really being here. Me and the executive team and then actually our CLIA lab, which does the work for the clinical testing, we've been here for the better part of two years, but there was some construction where the rest of the lab team that does the pharma services didn't relocate until the last, this past February. 

    So we've been all together under one roof now for those months and it's been really great. The experience of being down here, it's a thriving, vibrant city. You walk outside our offices onto a sidewalk where there's life and energy. And let me put in the plug, it’s Greenville, so the weather is great, you know, the vast majority of the year. So lots of good things that come from that.

MICHAEL WEINGARTEN:    I just wondered if you had any pieces of advice that you'd like to offer someone who's in the lab right now, you know, they're developing a technology they think they have a really promising innovation. They may have filed around the technology to, you know, protect the IP and they're thinking about actually starting up their company. Do you have any advice for that, that person who's thinking about making the leap? 

MATTHEW GEVAERT:    Yeah. I would say, first, to really be thoughtful around and be humble, frankly, around your understanding of what does the world really need, right? Who is it that's going to benefit from your innovation? And do they really need it? And are you going to be offer it and inform that they're going to be able say yes to it? And so I've seen programs that really do a good job of helping people in the lab understand, you know, sort of product market fit and it emphasizes on asking a lot of questions to make sure you know the customer and you know it's not what you think you know, but it's what you actually have tested. 

     And frankly, on day one, we didn't know what we would do to the degree that we did, that sort of there was some, you know, some inflections over time, if you will. But ultimately what we do know now is, like I said, there's a response problem and there comes with it a tremendous opportunity. So the opportunity for us and the product market fit is, you know, think about a world where patients routinely responded to their drugs, think about a world where effective new drugs are frequently approved instead of failing so often in trials along the way. You know, that's the world I want to live in and I think that you would too. 

     So to be able to understand that need and your ability to meet it is my advice. Like, do invest the time and be humble in terms of your development of your understanding of that product market fit and then how your idea, how your technology can really meet a real need in the world, getting more efficient about that and getting good at that should be the foundation of then making the jump from the lab into the market, because it will help you and it'll help the investors who support you, that the better you get it that, the quicker you get at that is kind of really important. It's gonna have a big ripple effect on you and your success. 

MICHAEL WEINGARTEN:    I think that's some great advice, and if they're thinking about, you know, who they should be talking to first as they're starting to explore the possibility, do you do you have any thoughts on that? Again, this is someone who's still in the lab. They don't, they really know nothing about starting up a company and they're just starting, really just starting the process. Who would you suggest they might want to talk to? 

MATTHEW GEVAERT:    I actually think it's, maybe this is not the answer you're expecting, I think it's, again, invest first in creating a network where you actually get information from the – ultimately, you know, the market or the end user or the client or however you want to say it, but in my case it's go to cancer conferences and actually understand what's going on around you so that you understand when a company is looking to find a new cancer drug, what's important to them? Understand when they're looking to develop a new test to inform therapy selection, what's important to them? 

     So start with your broad knowledge of how things work and what the needs really are. And then that knowledge and those relationships inform the, OK, now I've got an idea that comes from my lab that actually needs something. And then in a university environment, which is where most of the lab audience that you're talking to is going to be, you know, your tech transfer office and going to them to say, OK, here's my knowledge base and my network that's telling me this is true. Here's what I've done and it's relationship, you know, it's fit with that, you know, their job at tech transfer, and I say that because I used to be one, a technology commercialization officer, their job is to really then assess OK, you know, on behalf of the university or whoever the owner of that intellectual property is, let's take a look at its legs relative to its potential to deliver something that’s going to be helpful and used in the marketplace. 

     So that's what -- That would be the sequence. Develop a good, a good network and a good market knowledge of the space that you're likely the impact. Have that network and knowledge, inform what ideas you pursue in your lab, and then once you have that, then you're going to your tech transfer office and working with those individuals. 

     Be humble in terms of your assessment of the strength of your own knowledge, and then frankly, put that aside and go develop an investment in other people's knowledge and other people's opinions of what's needed and all that, and go with the latter, you know, have the latter be the basis of decision making. It's a lot more credible, it's a lot more productive, and it'll be a lot more successful. 

MICHAEL WEINGARTEN:    What you said, be humble, maybe that's the best lesson to learn, because there's just so many steps involved in becoming an entrepreneur, and there's just so much to learn, that you can't walk in thinking you already know everything. 

MATTHEW GEVAERT:    Yeah. And notice I said, I didn't say be shy, there's a difference between being humble and shy, right? So you have to be a communicator, you have to invest in a relationship, you have to grow your skills. On those soft skills that they're, they're not the skills at the lab bench when you're buried, you know, in the hood conducting an experiment, they're the skills when you're not doing that and they're really, really important because, again, back to the practicality of means and end, right? You could have this great end that you're trying to do, but the means to get there is absolutely going to be driven by communication skills and the ability to work with others and so the humility is on that part. But it's also communication, like I said so, to differentiate, not recommending being shy, I am recommending being humble, two different things. 

MICHAEL WEINGARTEN:    Right on. Well, listen, Matt, this has been great. Thanks so much for taking the time today. And I learned a lot by talking to you. So, thanks for doing this. 

MATTHEW GEVAERT:    Well, I'm glad to do so, for a lot of reasons, but also in recognition of the help that the NCI contracts have been to us and the good work that we've been able to do because of them. So, thank you, Mike. 

MICHAEL WEINGARTEN:    Thanks for sharing Kiyatec’s exciting journey with us today, Matt. As always, don't forget to check our website sbir.cancer.gov for the latest opportunities and commercialization resources to support your journey from lab to market. This was Michael Weingarten from NCI SBIR. Please join us again for the next installment of NCI SBIR Innovation Lab and subscribe today wherever you listen. If you have questions about cancer or comments about this podcast, e-mail us at nciinfo@nih.gov or call us at 1-800-422-6237, and please be sure to mention Innovation lab in your query. 

     We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks so much for listening today.