Innovative and Meaningful Medicines With Sanjay Shukla of aTyr Pharma

Startups get the party. Startups get the party started. Startups get the party. Startups get the party started. You want tech and tacos, Tacos and tech you know we got tacos and tech is on smash border green guacamole keeper captains counting beans Contador quentan frijoles Founders trying to raise some queso la vida San Diego school of rappy rapping fire tortillas round jalapenos in these modern times a crappy my coding yoga posse fold the body origami we be surfing coronado eating tacos el gordo the tacos standing puesto lucha libre and sombrero Got a shout out to cost angels by the ocean watch the sunset la Jolla shores Entrepreneurs trying to get funded When San Diego Startup Week is popping in the summer Oceanside, the Tijuana Estee be full of hustlers from couch surfing to penthouses right on the beach Tech leaders believe stars are within reach. We interview and founders who be shooting for the moon SD Tecos with your host Neil Bloom. Startups get the party. Startups get the party started. Startups get the party. Startups get the party started.

Welcome to the Tacos and Tech Podcast. I'm your host Neil Bloom and I'm thrilled to have you here. On the Tacos and Tech podcast we interview builders of technologies, of companies, of communities and we do it weekly. So thanks for tuning in. Every Tuesday a new interview and on Fridays we talk about what's new in the San Diego tech ecosystem from a news perspective. So make sure you join us there as well too. We also have a tech newsletter that comes out every other week@freshbroodtech.com you can subscribe to listen to it without further ado. Enjoy this episode and welcome back to the Tacos and Tech Podcast. I'm your host Neil Bloom and I am thrilled to have on Sanjay Shukla, the president and CEO of Atire Pharma. Hey Sanjay, thanks for being on the pod.

Hi Neil, thanks for inviting me.

Absolutely. It's good to have you on here. I've actually been, I've seen your company out in the stock market for quite a while in tracking how companies, especially biotech, are doing here and I'm really looking forward to kind of telling the story more on life changing technology that San Diego companies focus on because I think that's something unique that we have so many, I wouldn't just say biotech like companies that are really interested in building technology that changes the world. So with that we'd love to hear you Want to give us a quick overview of what ATAR is?

Sure. And I think we are in that ecosystem trying to do big things here. I think I'm proud to be part of that ecosystem as whether you're talking about biotech or tech, hybrid tech, you know, informatics, you have a lot of companies here trying to do really big things. We are trying to tackle some really rare diseases at Atire. And it's really built on a platform of a rather new area of biology that was discovered right here in San Diego at the Scripps Institute out of the lab of Dr. Paul Schimmel. Dr. Schimmel discovered about 20 years ago that we all have an underground system of immunology within all of our bodies that could be really useful in helping certain patients who maybe have less control of their immune systems. And Dr. Schimmel is somebody that has been a transformative scientist in San Diego. He's founded companies like El Nylam and Repligen, Cubist Alchemies. These are 10, 15, $20 billion market cap companies now. But his passion was really around this area of biology that ATIRE is really trying to tap into, learn more about. And we're seeing already some really nice or nice findings here in some rare diseases, in particular lung disease, which is really where we're focused with our initial opportunity.

Wow. All right. We have a lot to tap into on what you guys are working on now, but I kind of want to hear how it got here. Where have you always worked in the kind of this part of a pharma and biotech or what took you down this road?

So I've been in industry for just over 25 years and really always focused on drug development. Drugs that basically need to be interrogated in patients to see if they obviously show efficacy and they must be safe as well. So the last 25 years or so I've been involved in drugs in oncology, autoimmune disease, heart disease, both at big and small companies. So early in my career I've worked at large pharmaceutical companies in the New Jersey area. Actually, the first quote unquote drug I worked on was not really a drug. It was Listerine toothpaste. I worked for a company called Warner Lambert and I had to run it clinical trial like you always have to run. But there it was about reducing oral microbiology fauna so we could get that ADA stamp. And then from there I worked on a brain cancer drug. So you kind of treat the data in the same way, but obviously two very, very different types of opportunities. One, one in toothpaste and one which actually did, did really nice things and is the only approved therapy thus far for a very rare form of brain cancer, glucoloblastoma. Really bad, rare brain cancer. But my specialty in my area has already always been around data. I'm a data scientist. I have a background in biostatistics, but I also have a medical degree. And classically, I guess my training is in epidemiology, but really in industry I've been focused on rare disease drug development. It's always fascinated me. And I've worked in areas like lupus and myasthenia, which is a rare neuromuscular disease. And before coming to atar, I was actually working in Switzerland for a large pharmaceutical company, Novartis, working in areas like psoriasis and Ms. But what brought me to Atire was really around this fascinating area of biology and how can we really move it forward and make medicines from it. So really not necessarily romantic about one area of medicine, but also really passionate. I think what I'm really passionate about is trying to develop therapies for patients who maybe have less opportunities with new therapies. That's always been an area that has interested in me for the last 25 years.

Got it. Okay. So working in those areas, it's not surprising you found your way to San Diego, which has obviously a pretty big density of these kinds of companies working on these kinds of technologies. But what specifically brought you here? Was it a company, an opportunity or change of life?

It was Atire, you know, the opportunity to work for a company founded by Paul Schimmel, at least in my area and the work I've been involved in the last 20 years. He's sort of a known famous person who famous scientist who's created some amazing companies that have led to great discoveries that have translated to new medicinal products. So with atar, the challenge was he discovered this new area of immunology. And then the quest now has been how do we harness this knowledge and create new medicines from this new area of biology? And in a nutshell, not to get too scientific, we all in our bodies have these enzymes that help us make proteins. They're called synthetases, tRNA synthetases. And what Dr. Schimmel discovered is for some reason, these enzymes break apart into small fragments and they migrate out of our cells. And they do a very different role. They almost have a construction worker type of job during the day and at night they are immune policemen or, you know, they basically perform a completely different role. You know, maybe they're Bruce Wayne by day and they're Batman at night. So at night and when they migrate out into different organ systems, they play a real role in helping modulate and control inflammation and fibrosis. And this is something that we have learned over the last say 10 years. So my challenge and what got me into a tyrant and moved me here to San Diego was really to say how do we basically translate these discoveries into medicines that make sense and medicines that we've targeted where disease.

So where is ATAR now? And kind of, it's, I'm guessing it's going through trials on a few versions of some of these.

So ATAR recently demonstrated proof of concept and this is basically taking that those early pre clinical signals, you know, stuff you see in the petri dish and then you start to see animals react positively to it. We then ran a multi year trial in a very rare disease called sarcoidosis. Sarcoidosis is a disease that causes a lot of inflammatory damage to your lungs. We don't know what causes it, but it's probably an environmental agent. Agent. All the nine, 11 workers, I lived in New York City during that time, they all developed sarcoidosis when they went to clean out that debris. And essentially what happens is your lungs become really chronically inflamed and you then eventually become fibrotic, you need a lung transplant and, or you will even then you may die. So a very serious bad disease causing a lot of symptoms and morbidity. ATAR recently produced the best data really in the last, say 20 years in sarcoidosis. And we have advanced to a phase three trial. Now that data that we put out last year was extremely promising. It showed that we could help these patients with their symptoms, help them also with their lung function, and perhaps more importantly, remove steroids, which is really the mainstay of therapy. But steroids for these patients are quite toxic. They cause a lot of problems and it's really unfair these patients have to choose to take a toxic therapy to live a normal life. We believe we have a therapy now that is safer, less toxic, much less toxic, and frankly is producing really nice early signals. So we are now in a global phase three trial where there are about 70 or 80 centers around the world, US, Japan, Europe, that are participating in this trial. And we hope in a few years this may be an approved therapy and it would be the first approved therapy for sarcoidosis, a disease that is not really well understood. But in the medical community we know we have to do better and is a Real serious condition.

Wow, that's exciting especially to be in phase three, but still obviously trepidation of knowing and waiting. Right. To get it out to obviously to the customer in that regard. I'm curious, you've been in industry, you know, 20 plus years. What technologies have changed, do you think? Like, why couldn't this have been done 20 plus years ago? And why is it being. Why is what AT is working on now and having success there?

Well, there's several reasons, I think. First of all, just from a medical point of view, diagnosis capture, knowledge about rare diseases has really advanced over the last 30, 40 years. One might say in the 70s and 80s, using chemical entities, we took care of sort of the big box diseases that we all know of. Hypertension, diabetes. Yes, we can still do better, but we created a lot an arsenal of therapies largely around chemical entities that did a pretty good job in helping people. As you started to then look at rare disease, you started to learn more about them. These are harder to treat. And that's where you have to use novel types of technology and novel agents. So in the 80s, 90s and 2000s, things like monoclonal antibodies, things of that nature. Now you get into gene therapy, which is being used for those sort of diseases. So technology, medical knowledge and technology have advanced the ability to attack some of these other diseases out there. And then discovering things like ATAR has discovered kind of a new class of immunology. You see companies who have harnessed companies like Alexion, you know, back in there in Connecticut, they focused on a area of biology that really was untapped maybe 20 years ago. And now there are drugs focusing on what's called the complement cascade. You have companies focusing on recently RNA and RNA technology and making vaccines. You see what that's happened with COVID That took technological advancement as well as knowledge and understanding around the biology. And then you basically say, okay, now that I have this knowledge and I have a better understanding of technology, how can I basically attack in that case, you know, something like Covid? In our situation, it is looking at something like sarcoidosis where there has never been an approved therapy. So I think it's a combination of knowledge. You know, I think in about 50 years something like steroids will be in the medical textbooks as like, wow, why did we use steroids? That was such a horrible toxic drug. You know, when you watch like Star Trek episodes and they use that little thing where they just do surgery, you know, Bones would do that thing. But I'm doing Star Trek 1 when I was a kid and he just do that little thing, he'd whiz over someone's head and they'd be like, oh, he's got like an intracranial Brit lead. You know, it's because he was using some magic new technology. And, you know, you don't need to bore holes in people's heads to kind of get that intracranial pressure. So I think it's a combination of advancing knowledge. Last thing I'll say is data. Capturing more data and more understanding of data and mining that data. You really start to get more precise in saying, hey, here is a population of patients that we need to do better, or here's even a drug that maybe is not helping these patients. They have a resistant type of cancer. Therefore, we need to actually focus on, learn more about that resistance and then target that. So I find it something that I'm learning every day as a drug developer and I need to stay sharp, not only with regards to medical knowledge, but also technology and also learning more about the data that exists out there and saying, where are opportunities for us to make a meaningful medicine?

You bring up a great point about the data, which I think is something of San Diego's superpower, which is kind of the blurring of the lines between biotech and tech. Right? We are just as much seeing data science and IoT and coming into the body. Right? And vice versa, taking things that we're learning from, say, DNA and RNA sequencing and applying it to code bases. On the tech side, do you think that's something special, unique in San Diego because we have so much of tech and biotech, or you think that's just the new modern way that you run a biotech company is that you have to be a tech company, like a software tech company, too.

Well, I am going to give a shout out to San Diego and say they've always kind of done this, right? In the sense that you take what are previously asymmetric industries and you put them together. So I started as a data scientist before I was a physician. So I was drew from my sort of computer science and programming and that sort of database background that I had in the early 90s. And by the way, that was already advanced in the financial industry. They were using relational databases in the late 70s and 80s. And then someone said, well, how can we move this into healthcare? Healthcare tends to be slow in adopting that kind of technology because it needs to be very validated. But I do think that the new modern way to actually especially get precise medicines is to really harness and Learn around, you know, all the data that's out there now. Sometimes it can be overwhelming sifting through all that data and sometimes that can lead to some kind, sometimes a paralysis in where do we go? Because you can look at 10 patients and then look at 100 and 1000 and 10,000 and 100,000 and you'll learn something different along the way. You'll hopefully learn more. Sometimes you'll validate the signal that you've seen in those first 10 patients. But you may very well, once you get to a million patients, learn that you know what that signal is not necessarily amplified. Maybe it only helps x a small percentage of patients, but then at least you have a drug that can be part of the tool of addressing hundreds of thousands of patients. And hopefully along the way you're doing this. Getting back to drug development is not finding new safety signals because that's another thing that's really, really important. And it's something that I've always tried to pay attention to my career. It's not just good enough to produce a really game changing type of therapy. Keep mining the data to make sure that you are transparent. You learn about the risks because that's something that biotech can really learn from. Tech and say this is about capturing more data, being transparent with our patients and saying, look, this is what we're learning. Everybody wants to get on recently, doctors like Dr. Fauci, who, you know, I was lucky enough as an undergrad to meet and say, well, you know, doctors change things. I mean, doctors are going based on the data that they have available and then they learn things and then they, what they do is they update treatment guidelines and those come out every, say four to eight years. They update things. That's based on data and knowledge.

Yeah.

And so I think it's an industry that is embracing a lot of that. I think San Diego has a hidden advantage because of this sort of synergy between tech and biotech. And I'm kind of excited to be involved now in this ecosystem.

Yeah, no, you bring up some great points around that data. The flip side of data, which is that trials sometimes maybe bigger than they need to be because you need to capture a lot of data. And I think having genomic sequencing and others being able to do personalized medicine and building interesting trial classes that are more applied, specific to certain people. Are you seeing the flip side of that as well around building good cloud trial classes with data in mind?

Yes. It can work to your advantage or disadvantage. And I'll highlight two ways. It can certainly help you become more precise and more targeted in therapies. This occurs quite a bit in cancer, for example, where we are getting more and more sophisticated in understanding genomic data, sequencing of looking at RNA signatures, biomarkers, and we can be really, really pinpoint. But those therapies can be quite toxic. And you want to be really sure about, you know, targeting the right tumor type, for example. The flip side of that is collecting more data and getting more precise. It narrows your potential patient population. And then you have this other element where you talk about the economics of producing new technology, how expensive it can be to the health care system. So I've always looked at this in a balanced approach and I just try to take it down to the patient level that you can work on a therapy like our drug and say, well, this improves your force vital capacity by 3%. This will get all the pulmonologists juiced up. But if I was still seeing patients in York, Pennsylvania, I would lead with, you know what, this might actually help you get off prednisone or decrease your prednisone. And I know that keeps you up at night. It helps, you know, you've gained 60 pounds because of it. That speaks to the patient. So at atar, we always have in our top value patient first we have to not be so esoteric with the outcomes here. You've got to relate it to the patient and say, look, this therapy can be safer. It can really impact your day to day life. And oh, by the way, for all those docs and scientists who want to see some biomarker move, yes, we also got that objective response. So I think this is where marrying those two things is really important. And because there have been a lot of therapies, got to say, in my last 25 years where even I looked at those therapies and I said, gee, did we really need that kind of a drug? Is it really a game changer for patients? Because now they got to pay for something that is just making incremental progress. You know, I know there's a place for that, but I've always tried to say, look, let's try to be maybe a little bit of a pioneer here and try to basically look at those areas where there are no good drugs because you can really then impact and help a significant part of the population and be a little bit of a trailblazer too to get other companies interested in these rare diseases, because you're going to need, and I know a lot of my investors and my stockholders don't like this, but you're going to need more companies involved here. So I'm still a clinician and scientist here. I want to see these diseases us peel off more and more efficacy. It starts with that first drug getting 10, 20, 30, 50% of the population doing well. And then you basically get into those really, really hard to treat patients speaking.

To, not to the shareholders or investors, but say just from a running a public company piece. And to those who are building, you know, private now, know they need to get public later. Like, what's the difference in, in your mind of building, running a public versus private company and the distractions, but also the opportunity and access to the marketplace while you're trying to obviously cure real diseases?

Well, let's. I mean, I can say from my experience, it's easier being private. It just is easier on your life. You don't have to be as transparent. You can sort of just keep things under the hood. You have maybe less ownership. So it's just easier. But I never liked easy. You know, I think for me, I enjoy, because there's an education element teaching people that, look, sarcoidosis is an important condition. I've talked to people recently who didn't even. I was talking to some folks in Boston. They didn't know Bill Russell had sarcoidosis. You know, he recently passed away. I talked to people in Chicago. They know Bernie Mac. Bernie Mac died from sarcoidosis. It primarily afflicts in a much more severe manner, black women. This is something that I think people just need to learn. For me, I enjoy teaching people about, look, this is an important disease. You can only really do that, I think adequately, because you've got that sort of demand to learn more as a public company. I think there's a responsibility for public companies in biotech to also be very transparent. We try to do that. And I always think about that patient too, is you're trading on hope. Be very careful about that. So be careful how you message things. I tend to be really, really conservative in the same manner as I would maybe if I was seeing a patient to say, look, I think this can help you. Here's the data we know, but you got to be careful overselling things. If there is one advice I would have to my biotech brethren, not only here in San Diego, is we don't need to oversell and overhype things. Let's just bring everything down back to the data. Let's get real with our patients. Maybe then we get more credibility with actual investors. You know, I know with COVID you saw A lot of companies saying, oh, we can do all these amazing things. We can cure this. Come on, guys, can you really. You're not going to cure a endemic virus. I know this is an epidemiologist. It was just going to be how do you control and, you know, help the hospital workers from not being overwhelmed here? It's going to go endemic like every other coronavirus a day did. So I think it's about, for me, I try to, you know, maybe sort of lead. Lead a little bit by example by saying, look, let's know what we know. Let's basically be really truthful about it. This will help us in the long term. The type of shareholders I have, they view us as a high credible type of organization. We don't really, you know, throw the ball all over the field and try long passes and Hail Marys. We try to be structured in how we advance things because that's how I get also credibility from those worldwide pulmonologists and ultimately those patients have to look at you and say, is this drug really going to help me? Yes, it's going to help. We've killed therapies, meaning internal pipeline things that it's not working. People didn't like it, shareholders didn't like it. But it's better for me to be honest about that than rather me spend that money that doesn't belong to me. I'm basically shepherding someone else's capital that they basically are saying, they're trusting me to say, spend it in the most wise way. Make sure you advance things forward. So that's one thing that, you know, not to get too preachy, but I am, I do think that we are trying, I'm trying to lead a little bit of a. I want the JD power of biotech companies to be high. Why is it always so low if we're doing all these amazing things? I think it's the manner in which we message and do things is also really important.

Oh, that's incredible. And it's right. I mean, especially for how long. You have to. You are public while you're working through trials. Like, you have to be real with, with everyone in that regard to maintain the multiple years. You're going to be telling people, hey, stick around and trust and believe in us. We do think we, we have something special we're working on and if we don't, we're. You're going to be upfront about that too, which I think is a great approach.

It's a long slog with this. With our most advanced therapy, epsofitamod you know, I've been working on it since day one. I joined here at atar. It's been six, almost seven years. We're in this last leg of the journey. I mean, I can see we swum out and I couldn't see the shore on the other side. I can see it now at least. And we're closer to the shore than where I left from. Okay, so this is part of a journey. But you know, it takes 10 years to get a drug from like the initial signals you see in that petri dish to eventually getting it approved. And you've got to navigate all kinds of challenges to get there. I've done it before. I've done it with a couple therapies. Fortunate enough in my career, I do think this, we have a chance here. And whatever happens here, we're going to learn a whole lot that hopefully at the end of the day helps the sarcoidosis community and those experts. But I think we have a really good shot here of having a, you know, transformative therapy.

Well, we're super excited to continue to follow along as phase three, you know, works its way through and the results from it. Your semi recent sending. It sounds like you've been here a bit now six, seven years. You must have navigated a few taco spots in your day. Now do you have a favorite?

I have been able to. That might be the second reason I came to San Diego so I could have better, better tacos than in New Jersey or Switzerland. A big fan of fish tacos. And I will tell you recently down in convoy, Elvijon for me it's in convoy where you see mostly Japanese or Korean or Chinese. Great food down there. But Elvajon, recently I found a phenomenal fish taco there and they also do some great octopus and you know, other other kinds of food tacos. But check out El Dejon in the convoy area. They do a fabulous fish taco there that you can also have with your favorite Mexican lager as well.

Love it. It's a new one to us for sure. So we will add it to the taco database which we now have visualized and we now have actually added. We've got a whole website with visualization so your data science side might like this. We'll send it to you to show.

Yeah, I want the heat map of the taco spots because then I'll just, I'll. I'll know which ones to go to that way.

Yep, exactly. We will send it over. But Sanjay, this was so great to have you on the podcast, spend a little time with you, get to know what a tier is building and we're excited can follow along the continued journey. Thank you.

Thanks for inviting me Neil.

Cheers. Thanks for tuning in to the Tacos and Tech podcast. You can find all of our episodes on freshbrewedtech.com as well as on Twitter at Tacos and Tech Pod. Also follow Fresh Food Tech on all of your social platforms and make sure to share and give a review on Apple Podcast, Spotify or Google Play. Thanks again.

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