From Lab to Launch by Qualio
From Lab to Launch by Qualio
Continuing Early Cancer Detection with David Suhy Co-founder of Earli
In this episode we bring David Suhy, co-founder and Chief Scientific Officer at Earli back to the podcast. David shares the heartfelt founding story of Earli, the company's mission to make cancer a benign experience by catching it early, and their unique approach utilizing synthetic promoters for early cancer detection and treatment.
He discusses challenges faced in clinical trials, the importance of quality and safety in research, and provides advice for other startups in life sciences. David also talks about the recent advancements at Earli, their funding journey, and offers valuable insights on navigating the dynamic field of scientific innovation.
The episode concludes with a light-hearted discussion about David's passion for making pizzas in his backyard wood-fired oven.
00:00 Introduction and Podcast Overview
00:37 Guest Introduction: David Suhy from Earli
01:19 The Founding Story of Earli
04:24 Earli's Unique Approach to Cancer Detection
06:33 Challenges and Innovations in Cancer Treatment
10:06 Clinical Trials and Lessons Learned
15:30 Funding and Financial Strategies
18:56 Future Plans and Developments
21:14 Quality and Safety in Research
23:43 Advice for Entrepreneurs and Scientists
25:27 Fun Facts and Closing Remarks
https://www.earli.com
https://www.linkedin.com/in/davidsuhy/
Qualio website:
https://www.qualio.com/
Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast
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Music by keldez
Hi there! Welcome to the From Lab to Launch podcast by Qualio, where we share inspiring stories from the people on the front lines of life sciences. Tune in and leave inspired to bring your life saving products to the world.
Meg Sinclair:Thanks for joining us on from lab to launch today. I'm Meg from Qualio and it's my pleasure to be your host and introduce you to innovators in life sciences. If you haven't already, please subscribe. And we'd love it if you could give us a review on Apple or Spotify. And if you want to be on the show, please see the application linked in the show notes. Today, we're talking to David Suhy, co founder and chief scientific officer at Earli. We actually had him on the podcast almost two years ago, so we're looking forward to hearing the latest on his work in oncology. According to Earli's website, 40 percent of us will develop cancer in our lifetime and a third will die from it. But what if we found and treated the cancer early enough so that the majority of us could live? That's early's mission to make cancer a benign experience by catching and curing it early. What an inspiring mission. So let's bring David in and back on the show. Welcome David.
David Suhy:Thanks Meg. It's a pleasure to be here again. Nice to speak with you today.
Meg Sinclair:For those of our listeners who are new to the podcast and haven't heard the story of early, could you tell us a little bit about how it really got started? It's such a touching story.
David Suhy:Yeah, absolutely. Earliest company, it's approximately six years old now, but really started first out of a relationship between my co founders, Cyriac Roeding and Sam Gambier. Cyriac was a serial tech entrepreneur who had just sold his internet company. For a fairly large sum of money and was looking for his next thing in life and took a couple of years off to explore what was next. Um, whether it would be in the Internet or the tech side of things or something else. And of all things, he got on Thanksgiving Day. a flyer in the mail that was a local publication by Stanford University talking about Sam Gambier's life as a professor at Stanford University. And more importantly, how he had just recently lost his son to cancer. Sam's son unfortunately developed cancer at age of 16 due to an inherited genetic disorder. And on Thanksgiving day, Syriac picked up the article, read it. wrote Sam a personal email saying he was touched by the story, particularly on a day such as Thanksgiving and was inspired by Sam's story and would really like to meet him. And Sam immediately responded. If anyone of you out there knows Sam, that's Sam regardless if it was his birthday or Thanksgiving, um, but suggested they meet together. And talked about the inspiring story behind Sam's own journey. Not only as a training as an oncologist and clinician, but how it impacted him personally throughout cancer. And they, they started talking about what was next in the field of cancer and what was on the horizon. Um, and it was really that relationship that over the course of the next. Six months or so really developed into the early stages of forming the company now called early. I was brought into the mix when it was clear that, you know, this was more than a an idea that we really wanted to put a company behind it. Syria contacted me out of the blue through LinkedIn and we got together for a coffee and over the course of the next three to four months really developed a relationship between the three of us. Talking about how we could really truly develop this as a company, um, and take for this novel concept of terms of how to manipulate the very genome behind cancer and the genetic changes that cancer imparts on the cell to develop into a business. Um, and so the company was born roughly then in June of 2018.
Meg Sinclair:Thank you for that introduction for our new listeners. Can you explain to us a little bit about how Earli is unique in approaching early cancer detection and compared to traditional approaches?
David Suhy:Yeah, we like to say that the company is not only just in diagnostics, but also therapeutics. And if you think about traditionally genomic medicines or cancer treatments, the specificity of delivering those compounds to the tumors. has greatly relied upon either the composition of the lipid nanoparticle. For instance, things like doxorubicin have been packaged in lipid nanoparticles, but it's the lipid nanoparticles that directs That docs to the tumor alternatively for viral vectors. It's the protein inside of the capsid. Or is the capsid protein that directs that viral vector to the cancer. Now, gene therapy in the last 5 to 10 years has now started to realize that how you express proteins becomes important. And so, although in gene therapy, you might have tissue specificity, there's been very little efforts towards trying to tap into the genetic dysregulation, to hone your promoter sequences, to only be selectively expressed within the context of malignant tissues, and essentially remain transcriptionally silent. In either normal adjacent tissues comorbidities or other types of comorbidities are benign lesions as well. So that the whole concept behind early is how do we identify those dysregulated pathways? From the thousands of cancer samples that are out there, how do we create something that has broad specificity in terms of asking is a cancer or not, but also works across different genetic backgrounds in terms of sensitivity? And then how do we take advantage of that to create some sort of molecular output to either diagnose the disease or to treat the cells themselves?
Meg Sinclair:And so what are some potential challenges with forcing cancer cells to reduce those synthetic biomarkers or challenges that practitioners and patients have in adopting this method?
David Suhy:Yeah, I think it's a really great question. Um, you know, to be clear, what we're essentially doing is, is creating molecular light switches that only turn on in the context of malignancy to any substantial degree. If you have the ability to develop these synthetic promoters, then the world's your oyster in terms of payloads. One of the ways we do this is we produce proteins that are expressed as epitopes on the cell surface that allow us to use clinically validated or commercially available radio tracers to identify exactly which cancer cells have been transfected and now have been turned into a factory to produce that epitope. The same way you can exchange the payload to express a therapeutic protein to be able to kill the cells. Now, the trick of the system and what the biggest limitation is, is that by using lipid nanoparticles, we're not talking about achieving transfection rates of 75, 80, 90%, or even 10%. We typically see low single digit percentage transfection of cells. which means that the number of cells that actually express the payload has some significant limitations in terms of how the output is going to be perceived. For diagnostics, It's fairly straightforward because essentially you just need to produce enough signal to noise ratio to be able to see the signal. Now, I once had an investor challenge me and say, David, I don't understand how that's possible. You're going to transfect one or 2 percent of cells. How are you going to see the tumor? And I explained it to him this way. I said, do you have a Christmas tree? He said, sure. I said, do you put lights on every single needle within the Christmas tree? He said, no, of course not. We just put a string of lights around it. And I said, what happens when you turn off the overhead lights? Do you know where in the room the Christmas tree is? Do you know the size? Do you know the shape? And so for diagnostics, a low transfection efficiency, it's not such a substantial barrier. For therapeutics, it's a very different story. Can't produce a toxin that's going to kill 1 percent or 2 percent of the cells. Can't turn a radioligand Diagnostic into radio ligand therapy, because even if you are using an alpha or beta meter, you're not going to kill enough of the cells. And you certainly won't express enough to use something like an ADC to be able to kill the cancer. Instead, we take advantage or we, we work within the restrictions that is low transfection efficiencies. And for our therapeutics, We tend to focus on things that can be expressed locally, directly out of the tumors and into the tumor microenvironment. And as we know, and as we've learned through all cancer over the last 10 or 15 years, it's not always about directly killing the cell, but how do you start to chain reaction? How do you kick over the first domino of many dominoes to essentially, um, have the ability to effectuate? Some sort of therapeutic outcome, despite having limited impact on the number of cancer cells to treat.
Meg Sinclair:Great. Thank you for that explanation. Last time we spoke, we had talked about a clinical trial starting in Australia. What lessons have you learned or how has the platform moved on from that clinical trial now?
David Suhy:Yeah. Thanks, Meg. It's a great question. When our initial clinical product was using a cancer activated motor to express secreted embryonic alkaline phosphatase. right? A molecule that once produced from the cancer cell would be shed into the bloodstream. And the real question was, is would it provide you an answer? Do I have cancer? Yes or no. And but not much more information beyond that. And the promoter system that we used was a very bare basic promoter that came out of Sam's lab at Stanford University. What we quickly realized is, is that with other competing technologies, for instance liquid biopsies or any of those other early cancer detection modalities, that they were not only getting an answer of was there cancer, yes or no, but in many cases, things like the methylation pattern. Um, Would tell you the tissue of origin, although not specifically where the cancer was located. So a couple of things we learned from this clinical trial, we we've discontinued the product just to be clear, but the very valuable learnings from the clinical study is, is that first from a regulatory standpoint, it's very rare to use the expression of a nucleic acid as a diagnostic product as a therapeutic. Sure. Certainly as a biomarker, of course. But to have the direct product being produced as part of a diagnostic, it's a bit atypical. So going to agencies such as FDA and ultimately we ran the the clinical study in Australia and understanding the regulatory impact was very important. Second, um, we understood clinical utility and how clinicians view the platform as a whole. And I think it's very important. Um, because At the end of the day, you don't want to work for five, six years on a product that clinicians ultimately don't want. And so getting that real time feedback was ultra critical to be able to shape the company's strategy moving forward and how we're moving on to this diagnostic platform. Because for us, what were critical thing we learned from the clinicians, yes or no was not a good enough answer for them. Their biggest challenges is oftentimes there's clinical symptoms, but they don't know a specific location of the malignancy and by creating now a localization product, that image is exactly where the cancers are going to appear. Gives a, a much more greater clinical utility for the clinicians. Um, so I think in combination although the product did not move forward and many people would consider that a failure, we actually see it as a success because it, it informed us not only the regulatory path, but exactly where the clinical utility was going to be moving forward. And it has thus shaped the, the company's path as we progress into the future.
Meg Sinclair:Great. Sounds like a great use of time and energy in that case. Are there any other lessons learned that you'd share with other organizations going into their first phase of clinical trials?
David Suhy:Yes, absolutely. First try not to start a clinical study when COVID's going. We happen to do this in Australia and Australia. Um, Behind China was probably the second most locked down country in the world in terms of cities and populations. And when we had clinical endpoints, um, that required patients to come in several times after being dosed within the first couple of weeks, super challenging. Second thing I would say, though, is, is that. move quickly to get your first product into the clinic. Um, I think really quickly, you can always be two years away from your next clinical study. And for young companies, that can be a killer. Um, it is important to help you narrow your focus by defining what the product is, what the technical challenges are, and more importantly, understand the feasibility of the entirety of the process. Um, and that's something you want to define fairly early. And not until you are six, seven years into a life cycle of a company, and then figure out that either from a technical capability or some sort of strategic standpoint, it's simply not going to work. So my advice would be. Always keep an eye towards the clinic. Push, push, push to get into the clinic. Of course, within the bounds of making sure you have the appropriate safety and as well as efficacy, but push to get into the clinic. It's super important as a young company to define those hurdles and figure out ways around them to be able to move forward for your future progress.
Meg Sinclair:That's great advice. Um, speaking of, you know, startups, your team has raised significant funding from notable investors, and it can be challenging for founders to raise capital in today's market. How do you approach funding today and how has your backing supported your research and growth?
David Suhy:Oh, wow. Fabulous question. Um, we've been very fortunate. Um, you know, we were supported in a very large seed series round. Um, A16Z was the primary investor there. COSLA came in in a series A and then like many biotech companies, we went to seek the elusive B round particularly in the last year and a half. Um, it's been called by many publications, sort of the Valley of Death Um, for many of those companies out there trying to raise capital. It was difficult for us. I'm not going to, um, make any sort of excuses. I think, you know, we saw many of our peer companies fall apart. I think the existing investors. Have many portfolio companies in trouble and it's asking going back to the well is like asking them to save their favorite child. Um, and so that became challenging for us as well. So, you know, I think the key for us was being flexible and adaptable. And certainly while it's in not a founder's greatest joy to take a sideways round or even a slight down round. You do what's acceptable and needed to be able to bring in capital to keep the doors open and to be able to move forward. And so ultimately that's what we were resolved to do. Instead of being able to find a very strong lead for a Series B, When most new investors were just trying to save their existing companies. Um, we were forced to essentially take a sideways round. We got buy in and pro rata from, from our investors. Um, but just enough to be able to raise smaller size chunks of money to be able to keep the company. Fiscally, um, in a, a good position and happy to report that we've continued that fundraising, um, have been able to raise 92 million over the entirety of the company with, with the last 32 coming in the last few months. So, um, it's been a. A difficult process. Um, my advice to founders is turn over rocks. You wouldn't necessarily think to, um, we're all certainly aware of the traditional venture community, um, where we found a little bit more traction as a company is not only looking at places like family offices, but also international sources of income. Um, and I think, you know, um, you claw, you scratch, you fight. And you pull together the round that's going to be required to keep the company moving forward. And by doing so, then you put yourself in a position to succeed and produce more results to be able to raise additional monies on top of that. I
Meg Sinclair:think that's great advice to look in different places besides just your usual place for money to behind the couch cushions is always a good place to look. And that's no small
David Suhy:change, but
Meg Sinclair:metaphorically, um, what are your plans for the next phase of development with all the funding you've got now?
David Suhy:Yeah. So we're, we're super excited where, um, the company is preparing to lock down its next clinical product. Um, around localization and essentially without getting too deep into the weeds in terms of the science, this involves a completely synthetic promoter that we have shown has, um, not only a great specificity, but great sensitivity across different backgrounds of various human primary tumors that are derived from lung tissues. Um, but on top of that. What I'd say is, is that we've made such substantial progress in terms of developing these synthetic promoters that it has given us confidence that the off tissue specificity for things like therapeutics, um, are, is, That much better. And so more recently, we've now started building out the therapeutics arm of what the company is. It's still based on the same platform of cancer activated expression. It's just simply swapping out the payloads from an epitope that it. Again, it would be expressed on a cell surface for detection and instead focusing on proteins that could be secreted locally within the disease tissues itself to broaden out the therapeutic window and really have an impact on the tumor and tumor microenvironment as a whole. So, the company has been ramping up very quickly. We've been hiring like crazy and and um, And from a hiring perspective, um, it has been significantly less challenging because many of our sister and brother companies are struggling. A lot of layoffs, but a lot of great talent available to pull into the company. And so, for us, it's been a little bit serendipitous and we've really, um, are excited about the team that we're building and more specifically about these programs we're moving forward.
Meg Sinclair:I'm excited for the team you're building and the products you're building too. We'll have to have you back in another two years for another update. As a quality management software provider, we have to ask about Earli's approach to quality. How does your team ensure the highest standards of quality and safety in research and clinical trials?
David Suhy:Yeah. You know, it's, it's such an, it's a really critical area that if you're not paying attention to it early and often, it's going to come back and bite you in the behind later. I would say, um, from early's perspective, we always, and it goes hand in hand with our, our rationale of getting into the clinic quickly. Um, but you have to think about quality. You have to think about safety. You have to have systems in place to understand what the product is and what the process is. There's an old saying in the field, your process is your product. And the quality behind that process and the quality behind the product really defines how you're going to go There's nothing worse in this world getting to late stages of a clinical submission for an ind Or be halfway through a clinical study and need to reproduce product And suddenly or have a an sae or an ae occur And suddenly you realize there's something that you overlooked or there's a box that you haven't checked or um You You know, it becomes so blatantly obvious after the fact. And so really, um, again, my advice to any of the younger companies out there beyond this, right from the get go, understand what the process is going to be, understand what the product's going to be, have those checks in place, set that up early, because if you're doing it last minute. It's a recipe for disaster. Um, and more often than not, you will suffer, um, setbacks, delays, or even worse consequences if you don't pay attention to your quality systems, the quality of your product the planning, you know, an ounce of. I don't know what the saying is. I'm terrible with sayings, but I think it's a ulcer prevention is worth a pound of cure or something like that. And it's really the same, um, the same basic philosophy in terms of setting yourself up for success in the future.
Meg Sinclair:That's great advice. You've been imparting our listeners with lots of wisdom today. Since we last spoke in June of 2022, do you have any other lessons you've learned that might be useful to our entrepreneurs or scientists listening today?
David Suhy:Yeah, I would I would say, you know, the scientific field is a rapidly changing, um, dynamic environment. Um, don't be afraid to take risk. Don't be afraid to stretch your wings. What we see today as the current state of art, even just two years ago, from the last time we talked has dramatically changed AI was, was not much of a, I mean, it existed a few years back, but it is inherently pervasive in everything that we do. But understand that if you are going to be on the bleeding edge there's risks, inherent risks but really try to differentiate, um, what you're trying to do. Try to understand the clinical utility. Try to think ahead. try to be two steps ahead of where everyone else is. And I think if you do that, not only are you providing potentially better outcomes for patients, but also key differentiators for yourself to be in the field such that, you know, when Funding does get tight or there's a dearth of products that are Me Too products that you will stand head and shoulders above everybody else. And that more than anything else helps ensure your success moving forward.
Meg Sinclair:Great advice for our listeners. And our last question is more of a fun one. I usually ask about books, but I saw on your biography that you are passionate about making pizzas in your backyard. Wood fired. Oven. So I thought I would ask, what's your favorite pizza topping?
David Suhy:Oh my gosh. Oh, wow. I could talk for another half hour about this. I I'm blessed that I have a really beautiful wood fired oven in my backyard. And, um, I live in Northern California where artisan ingredients are everywhere. My favorite pizza at the moment is a rip off of Chris Bianco's pizza. He calls the Rosa. And it's a combination of hard cheeses such as plavé vecchio and a little bit of a melty cheese, like a fontina that goes with pistachios. rosemary, red onions, and then an orange honey. And I gotta tell you, it sounds like the most atypical pizza in the world. But I started making it about a year ago. And every time I have family or friends over, it's the one that they're always clamoring for. You've got one pizza more to make. We have already eaten one. We want another one of those. So that, that would be my go to pizza at the current moment.
Meg Sinclair:Okay. Well, I'll be looking up. You and the next time I'm in Northern California for that pizza, that sounds delicious, David.
David Suhy:Absolutely.
Meg Sinclair:Well, thank you so much for joining us today and updating us on Earli's progress. Where can people go to learn more, follow along and connect with you?
David Suhy:Yeah. So, on LinkedIn, my name, D A V I D S U H Y is a great place to connect with me directly. If you're interested in learning more about the company, certainly the company website at early. com. E A R L I. Um, and it's a really happy to connect with listeners and more importantly, should take a look at the website, get a little bit more insight behind what we're doing. And if you're interested, certainly reach out to me directly. And we'll see where the conversation takes us from there.
Meg Sinclair:Great. Thanks so much, David. We'll post all that in the show notes for our listeners. Thank you so much for all your sage advice today. And we made me hungry for some pizza now.
David Suhy:Thank you, Meg. And, um, Who knows? Let's see where we are two years from now. It'd be great to check back in then as well.
Meg Sinclair:That would be great. Thank you so much, David.
David Suhy:Okay. Take care.