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T1D Therapeutics: Two Health Transformers Tackle Type 1 Diabetes at the Source · StartUp Health NOW Podcast

• 0:00
  Welcome back to StartUp Health NOW, the podcast where we celebrate the entrepreneurs and the innovators who are transforming health. I'm your host, Logan Plaster.
• 0:09
  [piano music] A couple of years ago, StartUp Health joined forces with the Helmsley Charitable Trust to launch a Type 1 diabetes moonshot.
• 0:17
  The idea here was to organize and support a global community of founders working towards the same audacious goal.
• 0:24
  It's been truly amazing to see this community come together, support one another in different ways, form partnerships, and just grow faster than they could have otherwise.
• 0:34
  From the beginning, we've been careful with how we phrase the goal of this moonshot.
• 0:38
  We say that we want to improve the detection, and the management, and the treatment of Type 1 diabetes, but we don't talk a lot about curing the disease.
• 0:47
  Mainly, that's because there have been a lot of big promises about a cure in the past and a lot of disappointments.
• 0:54
  That said, we'd be remiss not to share some of the fascinating developments being made on the therapeutic side in this community, developments that, if not a full cure, could make the disease extremely manageable.
• 1:07
  Today, we'll hear from two founders doing this kind of work. The first is Warren Marcus, PhD, the CEO and co-founder of Wink Therapeutics.
• 1:15
  Warren is on a mission to cure Type 1 diabetes using the body's own natural glucose control system, its beta islet cells.
• 1:23
  In our interview, he'll give an update on that important work and a timeline for clinical validation. Then we'll hear from Mike Marotti, the CEO and co-founder of Sensulin.
• 1:33
  This team, really a dream team of drug developers that Mike's put together, is creating a glucose responsive insulin, so that when blood sugars go too high or too low, it automatically responds with what the body needs.
• 1:45
  Let's start with my conversation with Warren Marcus. I caught up with him on the floor of the American Diabetes Association annual meeting. [upbeat music] I'm Logan Plaster.
• 1:56
  We're here on the floor of the American Diabetes Association annual scientific sessions, and I'm here with my friend Warren Marcus, the CEO and co-founder of Wink Therapeutics. Good to see you, Warren.
• 2:07
  Good to see you too. How you doing? Uh, I'm doing well. Uh, it's, it's been an exciting couple days, and it's exciting to see what you're developing 'cause you're really getting at the, uh, pathogenesis.
• 2:18
  Is that the word? Pathogenesis. There you go. Uh, the really the root cause of Type 1 diabetes, which is, uh, uniquely challenging and very exciting. So tell us what Wink Therapeutics is all about. Well, thanks.
• 2:28
  Um, well, what we're doing, like you said, is trying to get to the pathogenesis. We're not trying to deal with the symptoms. We're trying to actually cure the disease at the fundamental level.
• 2:35
  And so, as you know, Type 1 diabetes is an autoimmune disease.
• 2:39
  You have your own T cells that think that your beta islet cells, which are your insulin producing cells, they think that those are foreign, and they're trying to eliminate them.
• 2:47
  And so what we're doing is actually replacing the cells that were lost. We have RNA. It's, actually, interesting enough, it's a single strand of RNA, and we use that.
• 2:56
  And what it does is it actually takes the brakes off of what's stopping the cell from proliferating. So for good reason, most of your cells stop proliferating after a while.
• 3:06
  You know, other than your hair, your blood cells, they continue to proliferate. But other cells, you want them to stop, or you'll essentially have a tumor. You don't want that.
• 3:12
  So, um, beta islet cells, they stop growing, and y- you know, we've been trying to find different ways, how do we get them to increase in number?
• 3:20
  And so our technology is, again, RNA that stops the thing that's stopping it. We're taking off the brakes, but only temporarily, for a little bit, so that they can replace, uh...
• 3:30
  What we find is that, you know, we can replace about 20%. With every injection, we can replace about 20% of cells. So you do that enough so that you can replace all of the cells that were lost.
• 3:40
  And on, on the other side is also, like I said, the autoimmune attack, so we have another, uh, drug that we, that we use, and what that does, it, it allows for expression on the surface of this thing called PDL-1.
• 3:52
  And it's well known that that can actually s- uh, exhaust T cells that want to attack the islets. So we have a way to replace what's lost and then protect them- Yeah... using individual strands of RNA.
• 4:03
  So it's actually really interesting technology. That's very interesting. This kind of work takes a lot of persistence, takes time, takes capital. Um, talk to me about why you are so passionate about this.
• 4:16
  I mean, it's gonna take years to make this come to reality. Well, this all started, oof, many years ago. I don't want to give away my age right now.
• 4:23
  But, um, between the ages of, you know, when I, from when I was born until 14, I lived with my grandmother. And, um, my maternal grandmother, and I saw what she went through.
• 4:32
  Now granted, she had Type 2, but to be honest, complications can be the same between the two. And so I saw, you know, what she went through. She, she lost her sight. She had to undergo dialysis. She lost both legs. Wow.
• 4:44
  And then eventually, you know, it took her heart.
• 4:46
  So, you know, I, when I saw this, I, I always said to myself, "If there's something that I can do to try to help out with, help, you know, help out, help people with diabetes, I want to get involved."
• 4:56
  And so, you know, I will say my career started off in the cancer area. Unfortunately, that's hit our family a lot as well. But I, I, I saw this technology, and I said, "You know, this is really interesting.
• 5:06
  We need to find a way to get this cu- to commercialize this." Yeah. And so, um, so here I am. [laughs] Help us understand the therapeutics landscape right now.
• 5:14
  You come to a meeting like the ADA, and you see a broad range of posters and devi- and, uh, exhibitors, whether it's an a- an AI app or a way to help monitor your glucose.
• 5:26
  Uh, but therapeutics is a s- specific, uh, area that, you know, has had years where there were some promise and years where maybe there wasn't so much happening. So give us a sense of the landscape.
• 5:37
  Well, right now, there's, there's a lot of buzz around Vertex. Uh, Vertex actually announced some results here on Friday.
• 5:44
  Um, that is aA, a, a cell-based method in which they've taken stem cells and, uh, they've differentiated them into, uh, uh, beta islet cells, um, and then they had a, had a trial in which they're using that.
• 5:57
  Um, and they see that a lot of the patients can actually come off of insulin. And I, and I actually think that that's a, a, an interesting technology for people that have no beta islet cells.
• 6:08
  One thing you may pick up, for our technology to work, you have to at least have some beta islet cells.
• 6:13
  For those who do not, I actually think that Vertex's method is actually really interesting, um, and, and, and, and it's looking very good. So there's a lot of buzz about that.
• 6:21
  Literally within an hour after them presenting that, um, there was, like, a news publication out about it. Wow. People were texting me 'cause they saw that. [laughs] Okay. Wow. So, so, so that, that's really exciting.
• 6:30
  I actually saw another, uh, another young lady, um, I forgot what university she was at. She was doing something with nanoparticles that can target beta islet cells, and I, I, I thought that was interesting as well.
• 6:40
  I mean, I, I, I think what we're doing is more interesting, but [laughs] I, I assume that that's good energy versus, like, competitive energy. Like, like, more thought, more, more funding. Is that true?
• 6:49
  Yeah, I think, to be honest, you know, I welcome, you know, more things in this space, more, more, more ideas, more technologies, because, you know, that will allow for more funding. People...
• 6:59
  It's been a long time where things have not worked, and so, you know, investors are very weary to go into areas where just things just aren't working.
• 7:06
  But now you see the Vertex's, you see T Zealand, even though I have thoughts on that. But anyway, you see T Zealand.
• 7:12
  You know, so now there are finally things that are showing promise, which I believe will help, you know, anybody who's working on, on, on therapeutics. Because it's not gonna be one thing.
• 7:20
  You're gonna need a r- whole range of solutions. Th- these analogs help ev- all the rest of us understand, okay, this has worked, this may work, this may work. It gives us a, a baseline. Uh, what's next?
• 7:30
  What are you excited about for the next six to 12 months of Wink Therapeutics? Well, right now we're, uh, we're doing some fundraising. Uh, I'm hoping that we can do...
• 7:37
  [laughs] get that closed within the next few months. After that, then do- Couple details about that raise?
• 7:42
  Um, well, right now, uh, we're, we're talking to various people, so we have various investors that are interested. Um, you know, we're just trying to make sure we get around, you know, valuation and all that good stuff.
• 7:52
  I don't, I don't want to bore you with the details, but we are... We, we, we do have interest, s- strong interest.
• 7:56
  So, you know, I'm hoping that'll be closed soon, and then after that, really just hit the IND-enabling studies. Like, we really just need to finish all of the...
• 8:04
  You know, there's a, there's a myriad of them, but complete all the IND-enabling studies so that we can get these to patients, get these technologies to patients as soon as possible.
• 8:11
  If everything goes as you hope it could go, when could this possibly help patients? If everything goes, I believe this could be in the clinic within two to three years. Wow.
• 8:22
  Is that- Putting patients in two or three years, yeah. That seems pretty fast. Is that fast? Uh, s- yeah, relatively. I mean, there's, there's been a lot of work done before. Yeah.
• 8:29
  So to be honest, I mean, to get to this point is, like, six years. So it's taken a lot [laughs] of work just to get to this point. Wow. So another two or three years will now be a, a total of eight.
• 8:39
  So I mean, you know, it's, it's... Unfortunately, you know, that's drug development. What's your experience been like in the T1D moonshot? It's been e- very interesting.
• 8:47
  I, I, I really love that there are other CEOs going through the same thing you're going to, going through, and so, you know, we can bounce ideas off of each other. So it's... I, I, I just enjoy the community of it.
• 8:58
  You know, that's, that's been the main thing. And, and also, you know, they've also helped me to get in touch with some investors as well, so I... That, that, that's really good.
• 9:04
  But I think most of all is the camaraderie, because, you know, it, it can be lonely out there. It can be very lonely as a CEO, especially, you know, o- our company is virtual. I'm at home most of the time.
• 9:14
  You know, very rarely do I get, you know, interaction with others. So, you know, office hours really gives me a chance to communicate and talk to others, so I, I, I've really been enjoying my time.
• 9:24
  Well, we've appreciated your involvement as well. Warren, thank you for giving me the update, and we wish you all the best as you just get into this next clinical phase of bringing this, uh, therapy to market.
• 9:33
  So thank you. Thank you very much. All right. That was Warren Marcus from Wink Therapeutics. Next up, my interview with Mike Muradi, the CEO and co-founder of Sensaline.
• 9:44
  [upbeat music] So we're gonna start by attempting to understand the, uh, very interesting work you're doing at Sensaline at a non-clinician level.
• 9:53
  I know you've been an, an academic, a researcher, and what you're doing is, is complex. Uh, explain to us what Sensaline is. Yeah. Thanks. So glucose responsive insulin, basically it's like a chemical pancreas.
• 10:06
  Uh, it sits in the subcutaneous tissue and releases more insulin when you need it, less when you don't.
• 10:10
  Uh, so the, the hope would be that from a patient's perspective, it's very passive, uh, and helps them manage their blood sugar throughout the day without too much effort. Why hasn't this been developed in the past?
• 10:21
  This is... It sounds like kind of a holy grail of, uh, insulin-dependent patients. Um, why hasn't it happened before? It is incredibly difficult. Uh, many, many large companies have tried.
• 10:33
  A couple have put things into the clinic that just didn't work, uh, for a variety of reasons. Some weren't quite sensitive enough. Uh, some had potentially safety issues.
• 10:41
  And, but having said that, it's a big enough opportunity and a big enough challenge that we expect, uh, there, there will be more competition in this space, and we see that as a good thing.
• 10:50
  I think at the end of the day, a patient should have several options for their glucose responsive insulin, and certainly we hope to be first in class, best in class.
• 10:57
  But, uh, at the end of the day, we're all in this together, uh, and we're all, we all have ties to patients, so we want there to be the, the best option available f- uh, uh, for, for patients when, as, as they need it.
• 11:09
  My understanding is that you've got a pretty stellar team. You've really kind of formed the group of people that it's gonna take to do something this complex. Tell us a little bit about the team.
• 11:17
  Yeah, very excited to have a, a number of former Amylin scientists and executives working with us. Amylin was the company that, uh, commercialized the first GLP-1 drugs 20 years before everybody else.
• 11:27
  Uh, one of our other co-founders was a principal inventor of what is now Afrezza, uh, the, uh, only non-injectable insulin approved by the FDA.
• 11:35
  And the, the team of scientists around us are mostly, you know, diabetes experts, uh, in, in San Diego.
• 11:41
  So very, very excited, uh, 'cause frankly, you know, n- nothing happens without a great team, and we're very proud to have a, a, the perfect team for a company at any stage of its, uh, life, but particularly at this stage of, of Sensaline's life.
• 11:52
  A- and, and what stage is that exactly? So we are pre-clinical. Uh, we are trying to finalize the candidate formulation, uh, this year.
• 11:59
  Then, um, it's gonna take nine to 12 months to prepare for and run first in human thereafter.Uh, but very excited to be in that last little bit of lead optimization. All right. All right. We're here at the ADA meeting.
• 12:10
  You are a researcher. You're very familiar with the poster hall that we're right next to here. Um, what are you maybe curious about? What are you interested in seeing?
• 12:20
  Maybe things you've already seen since you've been here. Like, what's piquing your interest?
• 12:24
  You know, I, I've been really intrigued by this sort of marriage of, of tech bio, where you have, uh, traditional pharmaceuticals that are influenced by, you know, AI as a drug development tool or, you know, the integration of, uh, you know, smart sensors, you know, helping people, uh, dose.
• 12:40
  And I haven't had a chance to walk through the floor yet, but usually I just find the posters that have the big crowd of people around them and just try to go learn that way, and it's always worked well for me in the past.
• 12:49
  Very nice. What are you most excited about for what Sensaline is gonna be doing in the next six to twelve months?
• 12:54
  Uh, well, we're gonna finalize the candidate, and we're gonna get it into the clinic, um, and- Sorry, when you say finalize the candidate, bring that down to my level for a second. Okay. So basically, uh, in order to,
• 13:05
  uh, to choose the, the clinical candidate that, uh, uh, you know, w-we have to, uh...
• 13:11
  Well, there's a little bit more in vitro testing, you know, just basically lab work, and then, uh, you know, the FDA requires that you do a, a large animal species, which for us is a mini pig model.
• 13:20
  And, uh, provided that we see the right, uh, response, that that would be the, the drug candidate that we put into the clinic. Very nice. Very nice. Well, Mike, excited about what you're building.
• 13:30
  This is a, uh, an audacious goal. You formed the right team. You've got amazing experience and seem like you're the right folks at the right time to do this.
• 13:38
  And so, uh, I wish you the best, and I hope it's a great meeting. Yeah. Thank you. And if, if we do this, it's a true moonshot. Uh, it'll totally change everything, which is why I'm so excited.
• 13:47
  [upbeat music] Thanks for listening to Starter Health Now. We'll be back again with another episode next week. [upbeat music]