Can a chemical found in citrus fruit curb cancer and save lives through early detection? Today on the show, we'll talk about the possibilities with Dr. David Suhy, Cofounder and Chief Medical Officer of Earli. Earli was founded with the mission to make cancer a benign experience by catching and curing it early.
According the the American Cancer Society, 40% of people will be diagnosed with cancer at some point in their lifetime. And a third will die from it. What if there was a way to detect and confirm the presence of cancer by inducing synthetic biomarkers? You could catch cancer when it's most treatable and save countless lives. Learn more about this exciting technology and get inspired by David's insights.
About David Suhy
Dr. David Suhy is the Chief Scientific Officer and Cofounder of Earli. He is a gene therapy expert, experienced in bio ventures both private and public. He has led gene therapy ideas from inception through Phase 2 clinical trials, and is recognized as a leader that science teams love to work with.
Before Earli, he was the CSO at Benitec Biopharma where he oversaw development paths for products in or near term clinical studies, including Hepatitis C Virus (HCV), Head and Neck Squamous Cell Carcinoma (HNSCC), and Oculopharyngeal Muscular Dystrophy (OPMD). He developed the first non-withdrawable, systemic RNAi compound used clinically in human subjects. He previously held scientific leadership roles at Tacere Therapeutics, Takara Bio, Anatara and PPD. He earned his PhD in Biochemistry, Molecular Biology and Cell Biology from Northwestern University and completed his post doctoral training at Stanford University.
He's a father to three teenagers, and he loves making pizza in his large wood-fired oven in his backyard. David is married to a neuroscientist, Dr. Joyce Suhy, who knows the risks of science, and is convinced that with David’s passion, Earli will accomplish its purpose.
Earli was founded in June of 2018 by Dr. Sam Gambhir, Cyriac Roeding and Dr. David Suhy. Earli is developing a technique, originally from Stanford University, to trigger the production of synthetic biomarkers as a means to detect, target and destroy cancer cells. Earli is currently enrolling for their clinical trial in Australia.
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Hello there. Thank you for joining us on from Lab to Launch today. I'm Kelly from Qualio and it's my pleasure to be your host and introduce you to these innovators in life sciences. If you haven't already please subscribe and give us a review on Apple or Spotify. We'd love that. And if you wanna 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 of Earli. We love bringing innovators on the show who are addressing issues that many, if not, all of us are impacted by and cancer is certainly one of them. According to Earli's website, 40% of us will develop cancer in our lifetime. A third of those will die. But what if we found and treated cancer early enough so that the majority of us could live? That's Earli's mission, to make cancer a benign experience by catching and curing it early. What an inspiring mission. We're excited to talk to David about the catalyst for this company, how it's going and the future of cancer detection and treatment. Let's bring him in. Hello, David. Thanks for joining us today.David Suhy:
Thanks for inviting me. Happy to have the discussion.Kelly Stanton:
We love hearing how people found their way into life sciences. Give us an overview of your path to how you got here.David Suhy:
Yeah. So, you know, when I started my undergraduate career, like many of us, I wanted to be a doctor because who doesn't wanna be a doctor coming out of high school? Luckily I was fortunate enough that as a freshman at the University of Pittsburgh I couldn't afford to go to college. My dad had been laid off living in Pittsburgh, you know, it was the early eighties. Steel had collapsed. And so to be able to go to college, I essentially got a, what was called a work study program. And as part of my work study, I was fortunate as a freshman to go work in the laboratory of a breast cancer surgeon pioneer called Bernie Fisher, who essentially invented the use of the lumpectomy along with chemotherapy to treat breast cancer. And from there, it, it essentially, you know, as an 18 year old, fresh faced kid out of high school, had the ability to jump into some pretty intense clinical research, right from the get go and really stoked my passion for science and quickly I realized that if I was going to make an impact in the world, it wasn't necessarily gonna be one patient at a time. But working towards drugs, we really had the ability to treat hundreds if not thousands of patients and change the paradigm of medicine. And so very quickly within that first year, I became hooked on science and I knew that this was gonna be my career path in life.Kelly Stanton:
That's really exciting. I think I was 13 when my mother was diagnosed with breast cancer and underwent a lumpectomy. That also would've been yeah, late eighties. So similar timeframe. The story behind Earli is really touching for those who don't know. Can you give us the founding story from your point of view.David Suhy:
Yeah, absolutely. The original research came out of the lab of early cancer detection pioneer named Sam Gambhir. Sam was an amazing scientist and even better human being. But with Sam, you know, he has had a long and distinguished career of, you know, helping invent PET as an imaging modality for cancer with people like Michael Phelps at UCLA, and he was really recruited to Stanford to develop these incredibly pioneering technologies. And the technology that Earli was founded upon actually came out of Sam's lab. And we can get into what the technology is in a bit. But what I would like to say is, is that, when founding early it was Sam, myself, who was really recruited because I had worked on novel applications of nucleic acids for both therapeutic purposes as well as diagnostic purposes. And my, our third co-founder is Cyriac Roeding, who's a serial tech entrepreneur who's done everything from start CBS Mobile from scratch back in the day to founding eCommerce based companies. And the idea was really based on this incredible concept of, you know that as it currently stands, cancer detection is a watching game. And the watching game is generally dictated by the progress of cancer. When does cancer get big enough that it reveals itself to us and shows that there's a problem in your body? And then how the information we get from that helps inform doctors and how to treat the disease? Well, in most cases, by the time that happens, it's been too late. The cancer's late stage, it's grown too fast. It's metastasized. Instead of having a single genetic background, it might have dozens of genetic profiles, even within individual tumors, which makes it very difficult to treat. And so Sam spent a lifetime of developing technologies to be able to detect cancer at earlier stages when it is more treatable. And when it has the, the capability of being revealed to the doctors in such a way that we can do something about it, that makes it significantly impactful. The sad part of it is, is that, three years in, after founding the company, Sam sadly died of cancer himself. Three years into the company for a man who spent his entire developing diagnostics and therapeutics against early stage cancers, he sadly only detected his own cancer when it was stage four in cancer of unknown primary origin. So, you know, it's, it's, it's sad, but we, we continue on developing the technology and the platform to be able to honor Sam's memory, but really to make a difference the way Sam had intended, when we initially formed the company.Kelly Stanton:
That is really touching. And it's also awesome and exciting to see you guys continuing to take that forward. What is unique about how you and the team at Earli are approaching those early detection methods as opposed to the traditional approaches?David Suhy:
Yeah, it's a great question. You know, traditionally cancer in the past has either been diagnosed either by clinical symptoms. You know, you may feel dizzy or have double vision which may lead your doctor to suspect maybe you have a brain tumor or you may use traditional mamography for detection of breast cancer, by and large, the most recent technology that people in the field tend to use clinically is, is something called the liquid biopsy. And the liquid biopsy is, is you take a passively drawn blood sample from a patient, and you look for biomarkers or parts of the tumor that have been shed into the bloodstream, whether it's proteins that come out of the cancer or it's the cancer cells turning over themselves and they release their DNA into the blood. And a lot of companies within the field are trying to use detecting these or sniffing out these bread crumbs that cancer drops behind and leaves in the blood and say, yes, cancer's present. The problem is, is that those technologies work really well when the cancer's very aggressively growing. And grows to large dimensions. So a lot of tumor, a lot of these biomarkers get shed into the bloodstream. Where Sam became frustrated with the process is, is for early stage tumors, tumors that might take five or 10 years to grow and be minuscule within your body. They produce very little biomarkers. So Sam said, can we flip this paradigm around? Instead of passively waiting for cancer to produce biomarkers, can we now interrogate? Can we introduce something into the body that directly acts, as a molecular spy and interrogates whether or not cancer is present and where it's located? So imagine the following scenario, you go into the clinic and you receive an injection from your doctor that contains a formulated nucleic acid. That formulated nucleic acid will randomly enter some healthy cells. And if any exists, we'll also enter cancer cells, but only in the context of cancer cells will that nucleic acid become transcriptionally activated to produce what we call a non-human synthetic biomarker, such as limonene. Limonene is in oranges and lemons, not in humans unless you've eaten one. Yet, if you take the injection in two days later, you exhale limonene, you might have cancer because the cancer was forced to produce limonene synthase. The idea is, and we're not doing this with limonene currently in the clinic, we're using a blood based biomarker, but the idea is, is instead of waiting for cancer to produce something at the cost of giving something back, can we interrogate the very dysregulated pathways that cause the malignancy, and then force the cancer to produce a signal to say, "Here I am, I'm present." And depending upon the payload that we introduce, we can even potentially locate specifically where the tumor might be and how to treat that tumor overall. So it's a completely different paradigm shift than the way cancer is currently diagnosed or, or treated as it currently stands today.Kelly Stanton:
Wow, that that is exciting. I was again thinking about my mom, you know, she had a ER positive, not very dense tumors. And her biomarkers are always negative. The doctors insist every year on doing the blood test, cuz that's what the insurance will pay for. It is always negative, but her cancer came back 14 years later, same story, totally negative for the biomarker test and the insurance wanted to stop there, but she insisted on further diagnosis and sure enough, it had returned. So this is really exciting. This really would be a major game changer from that diagnostics perspective as well as standard of care. You know, the insurance, of course being a bit of a hurdle, but...David Suhy:
yeah, and there's always going, you know, as much as great sciences as there is, there always needs to be a way to be able to pay for the science at the end of the day. And so, yep. It's our job to show clinical validation of this technology so that it makes sense to healthcare the, the payers within the healthcare system, to be able to say, you know, in your mom's case specifically, if we're able to catch her, relapse of the cancer. Can we have the ability now to go back in and treat and pull those tumors out where they may exist so that, you know, the healthcare system's not gonna be burdened, you know, five years down the, the later in that significant health consequences to people like your mom, because now you're treating late stage disease instead of an earlier stage disease where it makes more sense to do so.Kelly Stanton:
Definitely, a lot less invasive from a treatment perspective, too, you know, lumpectomy versus modified radical versus radical mastectomies. Right. Well, the mention of clinical trial, you guys are getting started down in Australia. How's that going and why Australia?David Suhy:
That's a great question. So Australia I actually, prior to co-founding Earli, I was actually the Chief Scientific Officer of an Australian gene therapy company. And without going into the story, I knew the ecosystem quite well in terms of the way the clinics were set up. But also why Australia is very important is, is that for early stage clinical trials, there's not a central regulatory agency, like the FDA exists in the United States. Instead the regulatory requirements for setting up early stage clinical trials is run either at the state level or at the institutional level. And what this means is that from a regulatory standpoint, that process can be very much streamlined, shaving months off of that process. Now Australia, much like the United States, has a very well developed clinical science and, and hospital system that can run these trials efficiently. And the ability to import the data back into the United States, using FDA guidelines is very simple so that it would be supportive of additional clinical studies. So, that would occur in the United States. Now, initially we went to Australia because of speed reasons. And then this little thing happened a couple years back called COVID and the world went on lockdown. And in particular what I'd like to, to probably mention here is, is that Australia, at least the healthcare system believed much more in COVID science than perhaps the American healthcare system. And so, within the first year to year and a half, some of these cities in Australia were some of the most locked down cities in the world, outside of countries like China. And that is, is that, the healthcare system itself became very restrictive and it was very difficult to even have patients visit the clinics without having PCR confirmed tests. And the way our clinical trial is set up is is that once the patient is injected with the compound, looking for the presence of cancer, they need to come back in every three to four days to get a blood draw, to show the presence of this biomarker we're producing. And it became a very challenging ecosystem within Australia to navigate, considering that a patient had to have a negative COVID test before they came in. Oh yeah. So the clinical study that we thought would take a year, has now stretched out to a year and a half. We've enrolled just under about half the trial at this point. It's designed as a traditional three plus three type of study, and now we're hoping that since the economy and since the hospital system and the COVID restrictions are lifted that we have the ability to enroll this trial at a much greater pace. And we're hoping to be able to complete the full enrollment of those initial nine patients by the end of this year.Kelly Stanton:
Good deal. Yeah. That COVID threw a monkey wrench into...David Suhy:
a lot of plans, not just ours,Kelly Stanton:
...a lot of clinical plans. That's for sure. It's it's good to start to see some movement there though. And I think things are starting to unlock again, so that's good. We can all move on. Tell us a little bit about some of the potential challenges with forcing cancer cells to produce synthetic biomarkers or challenges, you know, with the practitioners and patients adopting this new methodology.David Suhy:
Yeah. I, I think it's great. I think anytime, you know, starting with the latter question first, anytime you would introduce something that is very orthogonal to what's being used, you're always gonna have the, the challenge of making sure that the clinicians and the, the payer system will be accepting of the technology. I think one of the largest challenges from that perspective is that there's no other confirmatory evidence other than using new types of technologies that what you're detecting is actually gonna turn out to be a tumor and then furthermore, by catching the cancer at earlier stages, whether or not you're gonna achieve significant outcomes for the patient. And so, the frustrating part is, is that from a molecular perspective, I think technology has gone crazy. And it's a, you know, think about where we were scientifically even just 25 years ago. You know, we're now talking about personalized medicine and we're now talking about using nucleic acids not only for vaccines, but in our case as diagnostic agents moving forward. And the reality is, is that sometimes it takes the clinicians in the healthcare system to, to catch up it's it can be controversial as we know with some of the vaccines. But you know, by and large, just because you can invent it on a bench top doesn't mean that you will always get readily accepted new procedures that are gonna be integrated into the healthcare system. In terms of the technology itself, I think our largest challenge is, is that we are interrogating cancers by looking at dysregulated pathways. So cancer is a genetic based disease. And, it's genetic in the fact that you've got differential changes in gene expression and because cancer itself is multifactorial and a multi tissue type of disease. There's no one size fits all solution. Lung cancer's gonna be very different from breast cancer. It's gonna be very different from colon cancer. And even in breast cancer, as you mentioned with your mom, you've got ER, positive, triple negative breast cancers, and you've got all these different types of genetic markers and genetic programming that leads to differential pathways being dysregulated. One of the beautiful thing about the nucleic acid based system though, is, is we can multiplex. We don't interrogate just one dysregulated pathway. We have the ability to sort of mix and match and interrogate multiple dysregulated pathways. And by doing so you can now start writing multiple logic and/or gates, to either increase the specificity, meaning the ability to call a tumor, truly malignant from a benign tumor, or you have the ability to increase sensitivity, which is looking in the multiple different types of tumors that exist. So, you know, I think that the, the challenge is that science isn't always straightforward. And for us, it actually... there's multiple disciplines that we're pulling into this to be able to attack these problems, not only including biology, but bioinformatics and engineering principles as a whole, to be able to cobble together these solutions and really interrogate cancer as a multifactorial disease by taking multiple approaches. It's challenging. It's not overcomable. It just takes time. It takes effort to, to get there, to, to be able to experimentally validate what you're trying to show.Kelly Stanton:
Definitely definitely. Earli's website talks about a new era of synthetic biopsy. Can you tell us a bit more about how you see Earli in this technology evolving then in the coming years?David Suhy:
Yeah, I think, you know what we've described in the clinical trial as a blood based biomarker to be able to interrogate the cancer status of patients. At the end of the day, though, one of the largest problems. So let me give you a clinical example. Let's say that you were a lifelong smoker and if you were a lifelong smoker. Smoke two packs a day for the last 20 years. Chances are that when you approach your late forties or early fifties, your doctor's gonna say to you, "Hey Mrs. Smith. Hey Mr. Jones, it's time to get a low dose CT to look to see what's going on in your lungs." You've put your lungs under a lot of different stress. Chances are that because you've smoked for so long that when you take the image of your lungs, you're gonna see multiple nodules appearing within those lung tissues. Now lung nodules can be there for a wide variety of reasons. It could be a malignant tumor, but it also could be damaged, caused by viral infections, by bacterial infections or by the very smoking, that that has led to this. And what happens is, is that your immune cells sometimes ball up together and form this little electron dense thing that looks like a nodule, and they're called granulomas. They may look like tumors, but we can't really tell if they're tumors or not. So chances are, if you get a low dose, C T you may have 5, 6, 7 different of these lung nodules, the problem is, is that we know statistically that 96 to 98% of those are gonna be benign and only a few percentage are gonna be malignant tumors, but because they all look the same, no one knows which ones are gonna be malignant. So the current standard of care, do you know what the current standard of care is today?Kelly Stanton:
So at that point you would biopsy, right?David Suhy:
No, because in, in the case of lungs, in most cases, these may be inaccesible. Mm. And you've got, you know, you may be able to take a lobe resection out of the lungs, or it may be positioned, but in most cases, they do nothing. They say, come back in a year and it's called watchful waiting. And in that year's time, if you're even able to get the patient back into the office, those small tumors may grow out to be very large tumors, which now then a doctor say, it's now it's actionable. Now we can do something with it. By definition, you've lost a year off the ability to treat those tumors. Wouldn't it be great if we had a technology that could go in and interrogate in situ the molecular status of those tumors? And this is one of the programs we're trying to develop at Earli. Can we now inject something into your body that has the ability to get into these nodules, stay silent in the case of where it's going to be a benign nodule or a granuloma or a hematoma, but only light up within the context of a malignant tumor. This is where we're trying to push the technology. And that's why we call it a synthetic biopsy. It's essentially not gonna be done by invasively cutting something out of your body, but at, at the cost of again, giving a nucleic acid back, the question is, is can we differentiate between what's truly benign and what's gonna light up as malignant tumor, thereby providing clinicians and physicians actionable information to cut it out and say, "you know what, we're gonna take care of this while it's a four to six millimeter tumor, four to eight millimeter tumor, instead of letting this thing get over a centimeter or more across before we, we take it out."Kelly Stanton:
Wow. So that it's almost like a residual marker, then it hangs out in there and fires off? Or the, the monitoring requires repeated doses year after year?David Suhy:
Yeah. And I, I wanna be clear about this. The flavor of the technology that we're developing right now is meant to be transient, meaning that once it's injected, it'll be cleared out of your system within a few weeks time. You know, there's been some discussion of whether or not you would wanna install a system prophylactically to basically hang out for several years to only activate when it becomes problematic. I don't think from a regulatory perspective, we're quite ready to get there.Kelly Stanton:
I was gonna say, that's a big trial.David Suhy:
From a public perspective, in terms of safety, you know, you've got worries enough about mRNA vaccines that are gonna persist, right? For a few days to weeks' time before they disappear, it'd be quite another thing to say, "we're gonna put something in you, that's gonna last for the lifetime of the patient." I mean, we're doing it for gene therapy. For treatment of rare orphan diseases, but for diagnostic, I think that there's still a long way to go both scientifically as well as a perception from the public and from payers and, and patients and physicians alike to, to get there. So currently we're using a very transient method.Kelly Stanton:
Interesting. Well, I'll definitely be following. I think I'd much rather have that thing hanging out than having to do a mammogram and an MRI every year as a screening tool, which again, from a payer perspective, right. A little bit more expensive, I think to have to go do my MRI, my MRI every year. SoDavid Suhy:
I would agree with you. I think that's a hard road to go though, but maybe we'll get there.Kelly Stanton:
Definitely. Well, it'll be interesting to keep an eye on that. On a more personal question, if you could go back and tell yourself something at the start of your career, what would that be?David Suhy:
It would be a sponge. Sit in meetings, you don't belong in. Try to understand as much of a business as you can, right from the get go. I think, you know, we all come out as young scientists and we wanna stay in our lane and we wanna stay what we're comfortable in. And we wanna learn our craft and impress our superiors. And our coworkers but really quickly I think if you're interested in becoming an entrepreneur or you're interested in having more than just a job and, and what I'm describing in these terms is, is when we all come out of school, initially, we all want a job because we all wanna pay the rent and we wanna put food on the table and we wanna pay off student loans. And I think that that's great, but what I want to tell younger researchers, or if I could go back and tell myself what I would say is, is you don't want a job. You wanna become part of a mission. You wanna learn your craft, not only what you're doing with your hands, but what's going on around you, what your company's doing, how you take drugs from a whiteboard to working on the bench, to how it's going to translate into the clinic and how ultimately the company thinks about that. And I think, you know, once I learned that lesson, science became enriching. It became rewarding. I got outta bed in the morning because I was gonna accomplish something that was gonna help humanity and not just simply collect a paycheck. And I think that by becoming part of a mission and by learning the craft across the entire breadth, you feel personally compelled that your actions are going to make a difference on a day to day basis. And I, it, it is a difference in mindset. And honestly the quicker you can impart that or you can take on those sort of feelings it's gonna change, not only your career, but sort of your outlook on life and, and really feel that what you're doing is, is something truly meaningful and not just simply collecting a paycheck.Kelly Stanton:
That's awesome. I was just thinking about that in the context of life sciences in general, much like you, I came outta school with a science degree. I, I wanted to be a vet, not a doctor, but still medical stuff, but yeah, 20 something years later in life sciences, then I get to help companies like yours navigate that, from that quality perspective, it, it really does make it worth it. At the end of the day. It's not just a paycheck.David Suhy:
And you're making a difference, right? Yeah. You're making a difference, not on an individual level or not, but you're making truly a difference and it It just, you know, I'm not in general... scientists in general are not very spiritual, but I think it changes your entire aura of how you approach science and, and the impact that you have the ability to make by just simply shifting your mindset. So love the fact that, that you also get that feeling and understand exactly what it is that I'm talking about.Kelly Stanton:
That's incredible. I can, I can relate to this on so many levels. Thank you so much for sharing all of that. Where can people go to learn more, follow along and connect with you?David Suhy:
Yeah, I think you know, the website is Earli.com. E-A-R-L-I Dot com. If you wanna connect with me, I'm on LinkedIn. Shoot me a note on LinkedIn. I'm easy to find, easy to connect with. I'm happy to talk science, to talk careers. You know, I think one of the things that I find most fulfilling is not only helping the company perform what we believe is going to be transformational medicine, but, you know, my goal is, is not only to make the company successful, but to make the people who work with the company successful. Right. And I believe that. My give back is to help develop people to take over my job. Right. I'm I'm gonna be an old fart, some point, and I'm gonna be out of the game and I want people to sort of look back. Right, because people are gonna come and go within the context of the company. And I want people to be able to look back and say, yes, I learned something at Earli. This has shaped my career. I'm gonna be disappointed if half the people in the lab behind me, don't go out and start their own companies in the next five to 10 years. So my job is to inspire them, to show them how to do this. So if you wanna reach out to me and connect with me, more than happy to talk science, more than happy to talk career advice. It it's part of what we do as scientists and just as human beings.Kelly Stanton:
That's amazing. Thank you so much for your time today, David. Really appreciate it.David Suhy:
Thanks, Kelly. Thanks for having me on. Certainly enjoyed the conversation.