Business Of Biotech
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Business Of Biotech
Improving Cardiovascular Outcomes With Immediate Therapeutics' Atul Deshpande, Ph.D.
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On this week's episode, Atul Deshpande, Ph.D., CEO at Immediate Therapeutics, talks about partnering with American cities to conduct clinical trials during ambulance rides to the hospital, with the goal of preserving heart function and reducing mortality related to acute cardiovascular events, including heart attacks. Deshpande reflects on his previous experience developing and commercializing Dupixent at Sanofi, describes the history and mechanism of Immediate's glucose-insulin-potassium (GIK) candidate, IMT-358, and explains why there is more to intellectual property than just patents.
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Welcome back to the Business of Biotech. I'm your host, Ben Comer, chief editor at Life Science Leader, and today I'm pleased to speak with Atul Deshpande, Ph. D., CEO of Immediate Therapeutics, a clinical stage biotech focused on delivering therapies to patients before they arrive at the hospital that reduce heart muscle damage and improve outcomes, including mortality associated with acute coronary syndromes. Atul worked in consulting before joining Sanofi, where he, among other things, worked on dupilumab as it progressed through clinical trials and then led global operations for the Dupixent franchise. Next, he joined Harbor Biomed as chief strategy officer and head of US operations, helping to take the company public in 2020 on the Hong Kong Stock Exchange, raising $400 million in the process.
Ben Comer:After that, he joined Immediate Therapeutics as CEO, then left to work as Chief Strategy Officer at Peptalogics for nearly three years and then returned last April to Immediate Therapeutics as CEO, a job he says he had to take if he wants to sleep at night. Atul is not currently taking a salary for his work as CEO at Immediate. We'll hear more about why, as well as learn about the unique clinical development program Immediate is pursuing the company's IP strategy for a combination product comprised of glucose, insulin and potassium known as GIK, and what's next for the company. Thanks so much for joining me, atul.
Atul Deshpande, Ph.D.:Thank you, Ben. It's a pleasure to be here tool.
Ben Comer:Thank you, ben. It's a pleasure to be here. You are originally from India. You got your bachelor's and master's degree in Mumbai before coming to the US for a PhD at UC Irvine in neuroscience and a postdoc at UCLA. Then you went into consulting. What made you decide on the entrepreneurial path a tool versus becoming an academic or a physician?
Atul Deshpande, Ph.D.:Yeah, ben, fantastic question to start my journey there. So, yes, I did my bachelor's in microbiology biotechnology back in Mumbai and did a master's in neuroscience, which is what you know led me to come to UC Irvine, one of the leading institutions for neuroscience research, and there I joined the lab of Jorge Basiglio. I was working on Alzheimer's disease, down syndrome a topic that is extremely close to my heart, given even now we don't have any treatments or solutions for these patients, and the numbers seem to be growing rapidly treatments or solutions for these patients, and the numbers seem to be growing rapidly. Then I did a short postdoc at UCLA with Greg Cole, another fantastic mentor, and decided to leave academia to go join the industry as a consultant. The reason for doing that was twofold.
Atul Deshpande, Ph.D.:One, jorge who you know till date remains a mentor and a close friend actually said hey, you have a mind that is different than an academician.
Atul Deshpande, Ph.D.:You think you know more in terms of what can we do to bring treatments to patients, and so you should be pursuing a path that allows you to do that rather than just staying in academia. Your mind is not built that way, and that's what planted a seed in my brain to kind of explore those options. Eventually, when I went over to Greg's lab at UCLA, there were some industry collaborations that I was already working with and part of, so that got me exposed to the way the industry works and what are the key considerations in terms of basic research versus translational research, and how do we take drugs through clinical trials to bring them to the patients. And that's what ignited the spark of, you know, saying, okay, lab work or bench work is not for me. I really want to do. What I want to do is help patients, and the sooner I can, you know, do that, the better it is going to be, which is what started me on the journey of going into consulting.
Ben Comer:Yeah. So then you went into life sciences consulting for a few years and then joined Sanofi. What experiences stuck out for you at Sanofi? What did you learn while you were there?
Atul Deshpande, Ph.D.:Yeah. So the consulting journey was, first of all, interesting. I did a few years of consulting, then went to London, got my MBA, which also then opened up the doors of being able to speak your language. You know, as a scientist, I was already speaking the language of science, but now, with the consulting background and the business degree, I was able to talk about NTV and I was able to talk about, you know, what is important from a business side of things as well, and that's a very interesting and unique combination which allows you to challenge yourself as well as challenge the industry from a couple of different perspectives. And that, I think, has helped me tremendously through my journey, because when I go to investors, I can speak both languages. I can go and dive deeper into the signs and the mechanism of matching and the targets, but also pull that up to a 60,000-foot level and say, okay, this is how it's going to help the patients and this is why we need to look at supply chains or pricing and reimbursement and how to bring these drugs actually to market and not just get, you know, get stuck in the route of discovery, discovery, discovery.
Atul Deshpande, Ph.D.:So, you know, after my MBA, I did another couple of years of consulting and I was exposed to emerging markets during those two years. So, you know, I'd been in touch with Sanofi after my MBA and the conversation reignited when I was asked to join Sanofi in Shanghai. So I was based out of New York at that time and decided to take this opportunity, which was very interesting. I was asked to head the R&D strategy for Asia Pacific and under that purview I was based out of Shanghai, but I had Japan, china, australia, india, russia, southeast Asia high. But I had, you know, japan, china, australia, india, russia, southeast Asia, all under my, you know, purview of looking into what new products from the Sanofi portfolio should we bring to the Asia-Pacific region, and then, of course, the clinical trials related to it and so on and so forth. So that was a fantastic experience.
Atul Deshpande, Ph.D.:We were there for about three years and I learned a lot.
Atul Deshpande, Ph.D.:I learned a lot in terms of not just thinking about the traditional way of drug development, but I also learned about, you know, what considerations do you think about when you're thinking about emerging markets?
Atul Deshpande, Ph.D.:You know you have Japan and Australia, which are Western markets in a sense, and you're looking at you know how do we, you know, include them in the global clinical trials. But then you have China in the mix and you have India in the mix, where you know they want their own patients, you know, to experience the drug before they approve anything. And so you know those might be bridging trials, those might be, you know, participation in global trials. And then it becomes a conversation of, oh, am I going to slow down global trials for regional, you know, approval? And so all of those complexities kind of expose you and make you think about what is the optimal drug development pathway, not just for Western markets, but also making sure that emerging markets and other markets are taken into consideration. And we are not only thinking about bringing drugs for those who can afford, but also bring drugs to market those who cannot afford, or think about a different business model to bring these drugs to patients who really need it and can benefit from it.
Ben Comer:Right, had you ever been to China before you landed in Shanghai?
Atul Deshpande, Ph.D.:No, I hadn't. That was the first time. And I landed there, one of the first things that struck me there was, visually speaking. I was passing over one of the flyovers that you know are there in China, all over the place, and I saw, you know, clothes hanging outside, you know, to dry off apartment buildings, and I was like, wait, that just reminds me of Mumbai. And I was like, wait, that just reminds me of Mumbai and that, just, you know, clicked right there. That, you know, coming from Bombay and having spent my whole childhood, and you know, growing up in Bombay, I was like, yeah, I can fit here. And then, you know, spending that all that time in Shanghai, both my wife and I, we learned the local language, you know, we assimilated as much as we could into the local culture and the ecosystem. So we, you know, thoroughly enjoyed our stay there.
Ben Comer:Yeah, and then you, after you left Sanofi, you worked at Harbor Biomed, as I mentioned, helped with the IPO on the Hong Kong Stock Exchange. So you know, you have some real experience, not just in mainland China, but also in Hong Kong to some extent. And this is a prelude to the question I wanted to ask, which is you know what and this is also separate from the main discussion we're going to get into, but I'm just curious because it's such a hot topic what can you say about the amount of of deal making and innovation that that's happening in China's biotech sector right now?
Atul Deshpande, Ph.D.:Yeah, you know it is a hot topic at this point in time and you see a lot of these. You know deals coming through for big pharma and the Chinese biotech ecosystem. But you know, one of the things, ben, that really helped me as I was going through this journey is after I came back from China still, you know, with Sanofi, to the Bridgewater site in New Jersey, I was the unit management auditor, which means managing the operations for the immunology and immunology portfolio. As I was going through that experience, I got an opportunity to work on Dupilumab, which was one of the leading products in the immunology portfolio, and then eventually, given the combination of languages that I was able to speak, as I said before, science and business and you know, presenting in the meetings and everything I was actually asked to lead the global operations for the launch of Dupixent, you know, which then took me from Bridgewater to Boston and, you know, then responsible for the overall launch for the Sanofi Dupixent franchise.
Atul Deshpande, Ph.D.:So that that, again, was a fabulous experience. I mean, you know, very few people honestly get that exposure to launching a drug and what it takes to launch a drug. I was right in the mix of it right from the get-go, understanding the clinical trial, because I was a global project manager for a year or so before I jumped into the commercial side of things. So, again, bringing that scientific curiosity and data and positioning into the conversations that are now pricing, reimbursement, marketing, how do we position this, what the competition looks like, what are they talking about, and so on and so forth. So, again, a fantastic exposure. I was there right from the get-go of the launch preparations, launch readiness. I set up the whole operations around launch readiness.
Atul Deshpande, Ph.D.:Fortipixent launched atopic dermatitis, the first indication. Fortipent in the US and 52 other countries. So you know, managing all of those operations. And then, you know, eventually we got through the launch of Depixent for asthma in the US, prepared Europe for the launch, and then I was, like you know, exhausted at that point. You know, like I said, you know very few people get the experience of launch readiness and launching a drug. I was fortunate enough to have that two times in two different environments, if you will, because with atopic dermatitis, you're creating and shaping the market. It was the first drug coming to the market.
Atul Deshpande, Ph.D.:So it's a very different conversation, whether it's with pairs or KOLs, or you know physicians or even patients. So it's a very different conversation, whether it's with pairs or KOLs, or you know physicians or even patients. That's a very different, you know level of engagement. And then you're launching Asthma, which is, you know, we were fifth to market at that point in time. It's an already established market.
Atul Deshpande, Ph.D.:And now you're thinking about okay, how do I position myself, how do I differentiate myself from what is already there in the market, but also what the competition looks like. You know behind me. And then you know, is that a way to grow the whole pie and then take a small you know piece of it, or am I just going to get into the mix and just fight for the same patients? And so those learnings were amazingly, amazingly critical and you know, learned a lot over those three years or so. And so after I did that, you know I was in true sense exhausted to a certain point because, managing global operations, the only point that I would have, you know, a minute for myself would be down in the basement of the car park, which is the only place where I would not receive any signal on my cell phone.
Atul Deshpande, Ph.D.:But you know, it was a lot of fun and I really appreciate it and I still keep in touch with all the colleagues that you know work with me and I work with in terms of the Depixent launch. It was a fantastic team and a fantastic experience that I carry close to my heart again. So, after I decided to, you know, kind of put a stop on the PIXIN story and then move on to something else, a friend of mine had, you know, started this company, harvard Biomed, and he and I, you know, always used to keep in touch. He was out in China, used to travel back, and he and I actually had worked together in the Sanofi office. So he was the head of Sanofi China at that point in time, jingxiong Wang, and I was, of course, the strategy officer or R&D strategy, and so, keeping that connection alive, we used to pass based on what's happening with his company, what's happening with the overall environment and the direction of research and bringing new drugs to market. And so one of these conversations, you know, I was like you know, I'll be looking for something else, you know, in a time period soon, and he was like well, if you are going to be looking for something else. It would be fantastic for you to come join you know, harvard Biomed as the chief strategy officer. Given the experience that you have and you have, and given what we aim to build, I think it would be a fantastic match to do so, and so, in 2019, I precisely decided to do that joined Harbor Biomed as the chief strategy officer.
Atul Deshpande, Ph.D.:When I joined the company, it was primarily a platform company with a couple of different mouse models that were capable of generating human antibodies, and there were a couple of other small drugs different mouse models that were capable of generating human antibodies, and there were a couple of other small drugs in the portfolio, primarily from in-licensing. The internal pipeline was still growing at that point, and so what I did over the next two and a half years or so with Harbor Biomed was basically focus and push through assets into the clinical portfolio, thereby building the overall portfolio for the company, which is what then allowed us to kind of make a name for ourselves in the broader market, but then also justified the valuation when we decided to go into fundraising in 2020, both through the VC channels as well as ended up doing the IPO, as you mentioned before, at the end of 2020. So we raised about $400 million through those rounds. $180 came from venture capital funds with quick succession. So one round closed in March, I believe, and then another one in June, collectively for that 180.
Atul Deshpande, Ph.D.:And then we went on to do the IPO in the Hong Kong exchange for $220 million, given that pretty much all the operations were in China. We had a small lab here in Cambridge and then operations in China. We had a small lab here in Cambridge and then operations in Netherlands, and I was managing both Europe and US. At that point, it obviously made sense for us to go to the Hong Kong Stock Exchange. One of the things that we also did notice, at least at that point in time and the picture might be a little bit different now is the Hong Kong market was quite hungry for IPO and companies with our profile, and so we were able to really make those connections, build the rapport that we needed with investors in the Hong Kong Stock Exchange, which gave us a successful IPO that we were planning for.
Ben Comer:That's excellent background. Thank you so much for that, atul. We could probably spend some more time talking about Hong Kong and the Hong Kong Stock Exchange, but let's bring it up to immediate therapeutics, your next step after Harbor Biomed. What circumstances led you into that CEO role at immediate therapeutics initially?
Atul Deshpande, Ph.D.:Yeah, into that CEO role at Immediate Therapeutics initially. Yeah, so while I was doing Harvard Biomed, I was introduced and then got associated with MassBio, which is a three-year organization here and that runs a program which is a mentoring program. So you know, through MassBio I did, and still do, mentor several companies that you know come in through that program. Most of them are early stage companies, and so you know there's a conversation around not just you know the research piece of it, but then also the long-term value and have you thought about you know the market and where are you going to position the drugs, and so on and so forth. So a team of us sits down with the founders and the CEOs of the company and discuss these things. That allows them to think beyond. Hey, this is just exciting science, right. And so, as I was doing that, there was this new program that MassBuy started to bring in some late stage companies into the mix, and immediate therapeutics was the first that came in. And so, again, a few of us sitting around the table every I believe it was Thursday morning with the founder and his team, you know kind of pressure, testing what has been done, what needs to be done. Have they thought about this, have they thought about that? And so got really engaged and involved with the mentoring process.
Atul Deshpande, Ph.D.:And so, you know, with the mentoring process, got introduced to Harry Selker, who's the founder of the company. What I was very, very, very impressed with was the data that Harry had in his hand at that point in time. And so when he first came in, you know, the initial conversation was like oh, this is an academician, you know who's done a clinical trial? Harry's actually, you know, based out of Tufts Medical Center. And so we were just sitting there waiting to hear you know what this story is all about, and after a few slides, he showed us the data of the immediate one trial and I was taken aback, you know. From that point, you know I'll tell you the data in a minute.
Atul Deshpande, Ph.D.:But, you know, through that conversation, through those engagements, I started thinking, you know, I really have to, you know, find an opportunity to either help Harry or work on it myself, to bring this asset to people, because it's going to be a game changer. It's going to save, you know, I believe, millions of lives and have a positive impact on patients, but then also the society in general, and that's what got me excited to work on this. So at one point in time, as we went through Harvard Biomed and I was thinking about, the IP was done, the portfolio is established, what are my next steps? One of the things that I started exploring was whether I could, you know, work with Harry to bring this disrupt the market, and that's what you know again got the conversation started, and so, in April of 2021, I decided to, you know, to quit Harvard Biomed and join immediate therapeutics as the CEO.
Ben Comer:Right, excellent. And then you left for a little while and I do want to get back to you know that data that really caught your eye and you know what you think the opportunity is. We'll get into GIK, but you left and came back to immediate therapeutics as CEO. Can you talk a little bit about you know that decision.
Atul Deshpande, Ph.D.:Absolutely so. You know, when I joined in April May of 2021, you know I joined it with a lot of excitement. I was like you know, the data is amazing. It should be a no-brainer for us to raise the monies that we are looking for in, you know, in this stage of the company so being a late stage, you know, phase three ready asset I was like you know, this is perfect, this is what we should be doing. It's significantly de-risked and has a lot of support. It should not be that difficult to bring this through the investor channel, get the investment and start the clinical trial soon.
Atul Deshpande, Ph.D.:But, you know, as fate would have it, timing is everything and we were coming out of the funding boom of 2020 and early 2021. So, as we prepared and started hitting the market, the funding started to trickle down. And so, you know, when I joined the company, the company had already raised $40 million in non-dilutive funding and had used up all of that money for the phase two clinical trial immediate one. And so when Harry was, you know, pitching this at the MassBio events, the company did not have any money. But I had a lot of conviction in the data and so the risk that I had taken was to join immediate therapeutics without a salary, just on the basis of equity, using my own runway also, you know, with a little bit of investment going back to the company to keep the operations running. And so that was a decision that you know my wife fully supported and helped me with.
Atul Deshpande, Ph.D.:Uh, she was like you know, uh, you're, you seem very passionate about it. I can hear it in your voice. You should go do what you want to do, but make sure there's a deadline to it. And this, you know, we can't just keep going for forever. So we had mapped out uh, you know, to give this everything that we have for a year, and uh, so we tried, we tried all possible.
Atul Deshpande, Ph.D.:You know, to give this everything that we have for a year, and so we tried, we tried all possible. You know avenues in terms of fundraising for that one whole year. We had really interesting conversations with pharma partners, strategics. We had very engaging conversations with venture capitals, but just the macroeconomic environment and funding cycles were such that we were not able to close the round that we were looking for for the clinical trial. And so, come May of 2022, that's where, you know, I had to take the hard fall and a strategic decision for myself as well as the company, to put it on a strategic pause, put it on the side for now and you know, and find something else that is going to again allow me to bring in the salary that would allow me to make sure I have enough cash to pay my bills.
Ben Comer:Yeah right.
Atul Deshpande, Ph.D.:And that's when I decided to join Peptalogics. So again, a great journey with Peptalogics. No-transcript. We had to fundraise and you know again the last couple of years of you know kind of stressful fundraising environment we had to kind of, you know, revisit strategies and think about how do we position ourselves and things like that.
Atul Deshpande, Ph.D.:So you know, earlier, this event, earlier this year, then I decided, you know, that we were able to make some progress with PeptoLogix.
Atul Deshpande, Ph.D.:So I decided to, you know, kind of take a close on the PeptoLogix story, because it was at a position where I could, you know, kind of step back and they would, you know, continue to move forward. Which is when I decided, hey, you know, the ecosystem seems to be changing a little bit. There seems to be again, seems to be a little bit of money freeing up from all these investments that VCs have done and, given the stage of the asset that we have, I think it would be a really good time to go back to the market and see what we can do about it. And so, in April of this year, I decided to again take a plunge back into immediate therapeutics and see where we can do about it. And so in April of this year, I decided to again, you know, take a plunge back into immediate therapeutics and see where we can go with it, again, with the blessings of my wife, with a runway towards till the end of the year to again keep it going and give it everything that we have.
Ben Comer:Well, if you can convince your wife and family to allow you to work, you know, without a salary, then I think you're probably in good shape. You know, with investors as well. Let's talk about glucose, insulin, potassium, gik, three substances commonly associated, you know, with the metabolic system, specifically diabetes. What is the history of this triple combination? And heart disease? Because it goes back a number of years.
Atul Deshpande, Ph.D.:Absolutely, and actually, if you look at I believe it was a 2023 review which Harry, who's the founder of the company, and the chief scientific officer. Jim Udelson, who's the head of cardiology at Tufts Medical but is also the chief medical officer for immediate therapeutics, and Gene Braunwald, who I believe a lot of people in the cardiovascular world know as potentially a godfather of cardiovascular. He's with the group up at MGH and he was the one who had initially done these experiments about 50 years ago, and so in 2023, they wrote a review, you know, altogether capturing what has been done about this in the last 50 years, and there's a lot actually that has been done in the last 50 years. There actually were several trials that were done in Europe with GIK that were started in patients that you know had ACS symptoms or had a cardiac arrest and you know were brought to the hospital symptoms or had a cardiac arrest and you know were brought to the hospital.
Atul Deshpande, Ph.D.:Now we have data from about 20,000 of these patients that had been exposed to GIK and one of the biggest difference about what immediate one was compared to the previous trials that had been done, was the timing of administration, and so you know, all the previous trials that were done were done after the patients arrived at the hospital, which was, you know, six, seven hours, three, four hours typically from the onset of the symptoms of ACS, of acute coronary syndrome, whereas immediate the trial, the way it was done, was done in the pre-hospital setting, so in the ambulance, which is where you are reducing or minimizing the amount of damage that is being done to the heart. So it is a very interesting mechanism of action. The way the combination works has shown to be extremely safe, like I said, not just in our trial but then also the previous trials that have been done. But the efficacy was what we were able to show in our immediate one trial and the efficacy was sorry, go ahead.
Ben Comer:No, go ahead. No, I was just going to say that it seems like what you're saying is that the key differential is when it's when the drug is administered. You mentioned the studies, that some studies that have been conducted in Europe that you know weren't necessarily as strong as the data that I think you saw in the immediate one trial. Is that what you're getting to? That it has to be administered very quickly, you know after the onset of symptoms, and then you know that becomes tricky in terms of how you conduct a trial that captures those patients.
Atul Deshpande, Ph.D.:Absolutely. And again, going back to, you know, not just my immediate faith of timing is everything. With immediate timing is everything. And so you know the combination, the way it works. And let's talk about the patient journey a little bit before we get into how the drug works. Right, imagine you and I are having this conversation and you know I start having some minor, you know chest pain.
Atul Deshpande, Ph.D.:Most of the time people tend to ignore those kinds of things, assuming that it's, you know, indigestion or anxiety or something else. They'll try some home remedies, you know, for the first 30 minutes, even an hour, before they actually think, oh, this is something serious and I need to do something medically about it. Once they realize, you know, they end up calling 911 or decide to drive to the nearest hospital themselves, even though it is not recommended to do so. About 50% of the patients drive themselves to the hospitals. Of the patients drive themselves to the hospitals. If the ambulance comes in, or if you do, you know, reach the hospital, the first thing that they're going to do is, you know, check for ECG and once they see an abnormal ECG, you're qualified as a suspected ECS patient, which is when you are, you know, driven back to the hospital and then starts you know, the whole process journey of blood work, imaging, and then eventually the therapy which comes in the form of you know the whole process journey of blood work, imaging, and then eventually the therapy which comes in the form of, you know, a balloon or a stent, or potentially a bypass, depending on where the clots are, how many there are and how bad the arteries might be clogged. And so, from the time that the ACS onset happens which is the minor, you know, chest pain that you experience, which is when the heart is actually calling out for help through the time that you actually get any therapeutic intervention, it could be anywhere between three to four hours in urban settings and it could be even more in rural settings, because the ambulance just takes time to come in and take you back to the relevant hospital.
Atul Deshpande, Ph.D.:Now, in that period of time, the only thing that is a typical standard of care is aspirin and saline, and both of them don't really protect the heart in any way. It's just hydration. And aspirin, we know, does work to a certain extent in terms of dissolving the clot, but not to the extent that it's really going to help the heart get the nutrition and the oxygen that it's looking for when it's choking on the blood supply, and so that timing plays a critical role in terms of the amount of damage that the heart experiences over that three to four hours. And so the combination that we have tested and come up with, it's a combination of glucose, potassium, insulin, and the way it works, in a very simplistic way, is glucose, you know, it's energy for the cells. We all know that you're making it available in the simplistic forms that the heart muscle can really absorb very quickly, and so keep on doing its regular function. Potassium, in this case, is anti-arrhythmic and so that you know, for Lehman's term is the messenger that heart muscle uses to talk to each other. And so, because you have potassium in the right quantity reaching the heart, in that scenario the heart muscle, you know, communicates and keeps on beating in the rhythm that it needs to for the heart to keep on functioning. And so that becomes, you know, a kind of communication channel for the heart muscle to keep doing what its usual job is.
Atul Deshpande, Ph.D.:And then, last but not the least, one of the critical components here is insulin, and insulin, in this scenario, is given at a supraphysiological level, and this is important because I'll talk about one of the reasons why, you know, we also have a good and this is important because I'll talk about one of the reasons why we also have a good support down the line is, at these supraphysiological levels, insulin actually acts as an anti-apoptotic, through the AKT pathway, and as an anti-inflammatory. So when the cells are under stress, insulin gets there and tells the heart muscle dude, it's okay, don't die, I'm going to help you. And for the amount of damage on the heart muscle that has been done, when the immune system is getting activated to come clean it up, you know it's also telling the immune system it's okay, I got the heart under control, I'm going to help it survive. Do not over-activate or do not do anything rash or crazy, I'm here to control the situation. And so in that kind of a mechanism of action, it does give the heart muscle what it's looking for.
Atul Deshpande, Ph.D.:Even if small amounts of blood is reaching, because the concentration of these three components is that high at supraphysiological level, even that small amount of blood is able to deliver what the heart needs at that point in time. And that's why the timing of administration is critical and really important in terms of, you know, giving that heart muscle the chance to survive and not, you know, go through a huge infarct size, and this was then visible in the data that we have shown. So immediate one. The trial that we ran was actually done, as you know, kind of a phase three clinical trial. So it was, you know, placebo, randomized, double-blinded, everything that you would look for in a placebo-controlled trial. It had 891 patients sorry, 871 patients enrolled in the trial and what we were able to show as a result of this trial that we did in a placebo-controlled environment was a 50% reduction in cardiac arrest, a 50% reduction in all-cause mortality in the hospital within seven days and an 80% reduction in infarct size.
Ben Comer:Wow, yeah, that's definitely eyebrow-ra. I can see why you know it caught your attention in that initial meeting. Immediate's GIK candidate is IMT358. We've been talking about Immediate 1, which is a phase two trial. It was completed in 2012. You've just mentioned some of the results and a fairly large number of patients were enrolled in this trial. Can you talk a little bit about how the founders of the company managed to do that? I'm just curious about how you you know how you enroll patients. You know ahead of having some you know heart attack symptoms, right.
Atul Deshpande, Ph.D.:Yeah, this was a very innovative way of you know running the trial honestly, ben, because you know doing pre-hospital setting trials is one of the most difficult things that you can do in a, you know, in a clinical trial environment. And so you know this was run out of Tufts Medical Center with both Harry and Jim, you know, involved in running the clinical trial. The other thing that is critical in running this kind of trial is, you know you don't have sites that are hospitals in running this kind of trial. You have cities that are sites in running this kind of trial. Because imagine, you know I'm sitting here and you know I have this onset of the event. I'm not going to tell the paramedic, take me to this hospital because it's a site for IMT358. Or the paramedic is not going to recommend that I take you to a hospital five miles away when there's another one three miles away because that is a site for IN2358.
Atul Deshpande, Ph.D.:So the way the trial was designed and done was we had to buy in all the hospitals and all the ambulance services in a specific city and we had 13 cities that bought into running this clinical trial. So we had Boston all the way from Boston down to Dallas, all the way up to Alaska. You know we had these 13 cities that participated in this clinical trial and, given the safety profile of IMT358, we were able to convince the IRB that it should be started as early as possible. And, in terms of consent from the patient, we were able to work with the IRL to get oral consent in the ambulance setting that you know they're okay to move forward with this administration of IMT35A and then sign the actual paperwork once they are stabilized and once everything is done down at the hospital. So by doing so we were able to, you know, get the consent, get the patients enrolled and get the treatment going as quickly as possible.
Atul Deshpande, Ph.D.:The other thing that we also did was we had an algorithm that we had developed internally within immediate, that's called ACI TIPI. Now this ACI TIPI, in collaboration with, you know, stryker and a couple of other companies, was installed in the defibrillators that is, in the ambulances, and so what it does is it will look at the ECG in real time setting and give you a probability of that ACS converting into a full, you know, heart attack. And if you, you know, kind of look at the number and it says 75% or higher, then you know that there's a very high likelihood that this ACS patient is going to, you know, convert into a full-blown heart attack and would benefit from this kind of administration of IMT358. And those were the patients that we enrolled in the trial, giving them the background of IMT358, the safety of it and how it could potentially help them. And, you know, that is the result that we saw from the clinical trial.
Ben Comer:Yeah, it's a very impressive operation. I mean, not only did you get the 13 cities on board and the hospitals in the 13 cities, but also the, you know, the EMTs and getting into the even in, you know, into the ambulances that are then delivering patients, and then you know kind of I don't know, is that a novel process of getting that initial consent and then signing after stabilization. Was that? Is that unprecedented, or is that done in other, you know, with other types of medicines that are used in a kind of ambulatory setting?
Atul Deshpande, Ph.D.:I? You know, honestly I don't know the answer to it. I haven't looked at, you know, too many drugs that were in that setting, but we did face. You know from what I hear from Harry and Jim, you know there was a lot of apprehension, if you will, in the initial conversation. But once we showed them, you know the data from all these clinical trials, the safety of the drug and everything else, and you know the ACI-TP, combined, you know, with identifying the right patients that would be enrolled in the clinical trial, then the conversation got a lot more easier, where they were like yeah, these are the patients that are obviously going to benefit and the safety profile looks extremely good. You know this is the way to do it.
Ben Comer:Yeah, and helpful too. I'm sure that these are three kind of known entities. You know they've been widely researched for a number of years and so I you know there could be some confidence in the safety profile which I'm sure helps, you know, ease that operation of delivering it in that kind of unique setting. So the founders conducted this trial, had incredible data, took it to the FDA. What happened? What happened next?
Atul Deshpande, Ph.D.:Yeah, you know everybody was excited. This data was then presented at the ACC meeting as a late-breaker, you know, session, and you know, then Harry and Jim proceeded to go back to the FDA to have a conversation about a phase three clinical trial. Now, one of the things that happened before immediate one or during immediate one was the trial initially. Immediate one initially was designed as a trial. You know, that would have about 15,000 patients. It was supposed to be done both in the emergency room setting or the ER setting and the ambulance. But you know, given the complexity of this enrollment that we just touched upon, you know the enrollment started as a slower recruitment rate. Now, this trial was also, you know, funded by the NHLBI, part of the NIH at that point in time, to a tune of $40 million. And so, as we were reviewing, you know how quickly the trial was moving one of the suggestions that came on board from the NIH or NHLBI was hey, why don't you focus on the ambulance setting instead of, you know, both the ambulance and the ER and reduce the number of patients? Because that's where you'll be able to get to the patients fastest and you know, you will see whether this actually helps the patients or not, and so the trial number was reduced. But, you know, when INITIAT-1 was originally designed, the primary endpoint was progression to AMI, and when the trial design was changed, after, you know, conversation with the NIH and the FDA, one of the things that Harvey and Jim missed on doing was changing the endpoint from progression to AMI to the three pre-specified secondary endpoints that we already had accounted for. So, you know, the primary endpoint in the big trial, the 15,000 patient trial, was progression to AMI. The secondary endpoints was cardiac arrest mortality and infarct size. They were predefined, so there was nothing that was done ad hoc in terms of the review. But because these were secondary endpoints, when they went back to the FDA, the FDA was like, you know, the data looks really interesting.
Atul Deshpande, Ph.D.:But one question that we have is does infarct size really linearly, you know, correlate with the number of heart attacks that people have? And so that was a big question that Harry, jim and a few other collaborators that worked with them including Greg Stone, you know, had to answer. And so, after 2012, they had, you know, conversations with the FDA in 2013, 2014, and then eventually, 2015, 2016,. The whole team worked on a big, you know, project that was, you know, kind of in-depth meta-analysis of multiple, multiple studies that were done, looking at infarct size and looking at, you know, impact on cardiac arrest and mortality and everything else. And so, in 2016, they came out with a publication that showed that, yes, infarct size is directly correlated with, you know, eventual cardiac arrest and mortality, and which is when they were able to go back to the FDA, showed them that, okay, there's a direct correlation and we should be able to use cardiac arrest, mortality and infarct size as the primary endpoints for this next trial. So that was a very interesting, engaging conversation and you know, as you may know, ben, if you don't meet your primary endpoint in your phase two clinical trial, typically companies don't, you know, keep pursuing it, thankfully for us.
Atul Deshpande, Ph.D.:You know Harry and Jim both were very insistent that you know the way the drug works. There is a path forward. They went back, they engaged with the FDA and the FDA was better receptive to, you know, the safety profile and the data that they had seen here. So not only did the FDA engage, but what they were able to achieve, what Harry and Jim were able to achieve with the FDA was to get a special protocol assessment from the FDA.
Atul Deshpande, Ph.D.:Now, what does special protocol assessment mean? It's basically, you know, that the FDA and the team, the sponsor, look at and design the trial together to a certain extent, and so you know the primary endpoints are well-defined the timing of administration, where we are going to do the trial, how we are going to do it. The trial design is already all agreed upon under the SPAR, so there's not going to be any surprises when you get to the far end of actually conducting the clinical trial. The other thing that we were able to work with the FDA was, you know, given the delta that we had between the placebo arm and the treatment arm of, you know, 50% and 80% that I mentioned before, the trial actually is a very small trial. It's only a 1,600-patient trial compared to, you know, tens of thousands of patients.
Ben Comer:For most cardiovascular trials? Yeah, much larger.
Atul Deshpande, Ph.D.:Most cardiovascular trials exactly. So this is only a 1, for most cardiovascular trials, yeah, much larger interim readout at 900 patients, and if the data for cardiac arrest and mortality looks the same as we have in the phase two, it does not really make sense to continue exposing people to placebo. We should be converting them into a treatment arm, and so the FDA agreed with it, and what we have right now is, under the SPAR, we have this, you know, 1600 patient trial, but also an interim readout at 900 patients, and if we are able to show the same data as we had, we would get pretty much a full approval or an accelerated approval to bring IMT358 to market as quickly as possible, and then, depending on what the data looks like, we may, you know, continue to run the remaining 700 patients and then follow these patients for a period of two years to understand the long-term effects and the benefits of IMT-358.
Ben Comer:And IMT-358 has also received a breakthrough therapy designation from the FDA. I guess what are the biggest benefits that you see with that designation?
Atul Deshpande, Ph.D.:Right. So the breakthrough designation has been really, really helpful for us, because what it allows us to do is, you know, have a constant engagement with the FDA. Whatever questions we may have, you know it's where they. You know they're really receptive and looking to work with the sponsors for, you know, for these breakthrough therapies, because they really believe that these could have a significant impact on patient lives. These could have a significant impact on patient lives, and so it's a lot more collaborative, congealed conversation that we have with the FDA that we have continued to this day. And the other thing that it also gives us is a shorter review period. So, instead of a year-long review that the FDA typically takes for NDAs or BLAs, this would be a six-month review period for bringing this drug to market.
Ben Comer:Got it. And then I want to get to the phase three trial and your upcoming plans for this product, how you're going to get that trial completed. But I had one more question about IMT358, which it's been given a BLA pathway. It's considered a biologic, which is interesting. Can you explain why? Because typically, as you know, Atul and, as we talked about, insulin has not been considered a biologic historically, and neither is potassium and glucose. How were you able to get a BLA pathway and have this drug be considered a biologic?
Atul Deshpande, Ph.D.:Right. So there's a couple of pieces of that story there. Ben One is you know, if you look at the BLA designation the biologic so there's a very you know well-defined criteria for what is considered a biologic and it has to have a certain number of amino acids and insulin basically falls under those number of amino acids you know to be considered a biologic. So that is why traditionally it has to have a certain number of amino acids and insulin basically falls under those number of amino acids to be considered a biologic. So that is why traditionally it has not been considered a biologic. But where we were able to argue with the FDA was that the amount and the concentrations of insulin that we are giving to these patients are at a supraphysiological level, not at a insulin replacement dosage that we typically do for diabetes and other conditions. This is much, much, much, much, much higher concentrations and therefore, given that form of insulin that is going into the body, it should be considered as a biologic. And we were able to convince the FDA that that rationale should hold true versus everywhere else where insulin is typically used. And that is how we were able to convince them about the biologic license application or biologic or the BLA designation. The benefit of that is multiple fold, as you can imagine.
Atul Deshpande, Ph.D.:On the IP side of things I'll come to the IP story in a second. You can imagine On the IP side of things, I'll come to the IP story in a second. But you know, with glucose, potassium insulin, there's no composition of matter IP that it can put into place. I mean, the USPTO or any other you know agency across the world is not going to give you, you know, for combining three different things that are already out there in the public domain. And so what the BLA does in lieu of a composition of their IP is gives us 12 years of exclusivity.
Atul Deshpande, Ph.D.:Here in the US, typically, if you look at any drug coming to market, you know patent life is about 20 years. You know, on an average, any drug takes anywhere 10 to 12 years to come to market and you're left with, you know, maybe eight, maybe 10 years of patent exclusivity in the marketplace. But with the regulatory exclusivity that we have, we already are from the onset. As soon as the trial is done, the BLA designation kicks in and we have 12 years of exclusivity from the time the trial is done to make sure that we are able to make this and keep this in the marketplace under the immediate umbrella.
Ben Comer:Yeah, and intellectual property is it? I'm glad we're coming to that next. It's a key piece of any biotech's valuation and something that I'm sure is probably the first question that you get from potential investors, which I would assume are what's standing between you and the launch and completion of the phase three trial. So what you know, what else can you say? Is there anything else to say about? You know your IP holdings around GIK? You've just laid out, you know, through the BLA, that you, you know you get some runway, good exclusivity there. Is there anything else that you want to share just generally about the IP holdings that immediately? Is there anything else that you want to share just generally about the IP holdings that immediately?
Atul Deshpande, Ph.D.:Yeah, absolutely Ben. So one of the things that we have done is kind of built a moat around the INT358. And part of the moat is obviously this you know, bla designation. It's a big one. It's a big win from an intellectual property perspective. Traditionally, if you, you know, kind of look at intellectual property, it unfortunately gets equated to patents. But there's so many other ways of intellectual property or protection, know-hows, and patents are part of it, trademarks are part of it. The know-how around doing this clinical trial is a big one. As we discussed before, there's a lot of tacit knowledge that sits with the team to carry out this last phase three clinical trial. One thing that I mentioned to forget in terms of the SPA designation was also for the phase three, we actually don't have to do two clinical trials. We only have to do one 1600 patient clinical trial, because the phase two would be considered as the second pivotal trial.
Ben Comer:Oh, okay, so no confirmatory phase three Excellent.
Atul Deshpande, Ph.D.:Exactly, exactly, and so going back to the moat around that, the BLA is obviously a big win. But the other thing is also we have a companion diagnostic that I mentioned before, which we already have a patent for. It's called GIKTP, and again, that's a tool to identify, you know, which patient is going to benefit the most from administration of GIK. Now you know that is something that we'll have to, you know, kind of think about when we bring this to market, because what we want to do is give the benefit to all of our patient population. You don't know which patient is going to convert at what point in time into a full-blown heart attack, and so that is something that we'll look into. But a companion diagnostic is again a beneficial way of protecting your intellectual property portfolio.
Atul Deshpande, Ph.D.:The other things that we have also done is around the process of manufacturing and the way it's packaged. If you look at the way insulin is typically shipped, it's shipped in glass vials or in glass syringes, and the reason for that is insulin is a little bit of a sticky substance. If you put it in a PVC bag, it's going to stick to the walls of the PVC bags and the ratio is going to change and you're not going to see the benefit, and so we have worked already with a couple of manufacturers that can manufacture bags that are inert to the insulin stickiness. And those are some of the provisional IPs that we have already filed, and you know, as we go through the process, the next steps will be finding, you know, conformatory patterns around them.
Ben Comer:Interesting. It occurred to me that if you're using a kind of souped up version of insulin, is there any risk of hyperglycemia when you administer that to patients, or is it too small of an amount?
Atul Deshpande, Ph.D.:Yeah, you know, the combination that we're giving is such a balanced combination that with all these patients in our trial, but then also the other trials, we haven't seen any side effect whatsoever. Hypo hyper glycemia you know it has been given to diabetic patients, you know kidney disease patients. We haven't seen any down, you know, or side effects of this extremely balanced combination, you have the glucose component.
Ben Comer:that's balancing.
Atul Deshpande, Ph.D.:Exactly, got it Exactly, exactly, and so you know. One final point on the IP thing as you said, you know that with four major law firms here that specialize in IP and life sciences and kind of scored where the IP portfolio for IMT358 might fall against some of the other blockbuster drugs in the market and you know I was surprised myself when we ran that exercise the IP portfolio for IMT 358 is pretty much neck to neck with some of the blockbusters that are already out there in the market. So that gives me a lot of confidence that you know not only that we have the BLA and everything else, but this is a product that can stand its own and hold its own in the marketplace without the risk of generalization in at least the first 12 years that we bring it to market risk of generalization in at least the first 12 years that we bring it to market?
Ben Comer:Have you engaged payers about this product? And granted, it's got to complete a phase three and be approved ultimately by the FDA before it reaches the market. But what kind of feedback? If you've engaged with payers, have you heard from them about this?
Atul Deshpande, Ph.D.:That's an excellent question, ben, because a lot of times, as founders or as clinical developers, we forget that the clinical benefit is only a part of the story. The other question that you need to ask is who's going to pay for it and how much, and so that was one of the first things that we did in June of 2021, is I have an excellent scientific advisory board member, ed Pazella, who comes from United, having worked several years at United, and brought that exact same conversation to us. What we did at that time was actually have a peer ad board where we had two national level peers and two regional pairs come sit around the table with us and exchange what we have in terms of IMD 358 and what they think about the profile of the drug and what they would be willing to pay for the drug eventually down the line, once we bring it to market. The response was phenomenal. Honestly, one of the things that I have and I go back to those notes all the time is one of the pairs actually said it's not a question of if this comes to market, it's a question of when this comes to market, and that was looking at the target product profile for the drug and the safety profile for the drug and the data that we showed them from the phase two clinical trial.
Atul Deshpande, Ph.D.:Not just these three things that I told you about mortality, cardiac arrest and infarct size but also at the molecular level, where the free floating fatty acids, which is one of the critical components which increases in heart attacks, is reduced significantly very early on as you start the treatment. So it's not only affecting the signs, but also not only affecting the symptoms, but also the signs, the underlying, you know molecular pathways of infarct size and heart damage. So, going through that conversation, it was a very interesting conversation as we went to the next part, because the question was okay I like your answer of, when it comes to market, how much are you willing to pay for it, and so one of the things that we did was working with Peter Newman at Tufts Medical, who was one of the leading, you know, cost effectiveness economists and thing, and Josh Cohen and his team. We had looked at what benefit would this drug bring to patients. Imagine leaving the hospital with a 30% infarct size or a 20% infarct size not getting IMT358, versus leaving the hospital with a-person infarct size, because you got IMT-358 on time and were able to stop that infarct right in its path.
Atul Deshpande, Ph.D.:And so when we look at, you know, potentially the less number of days in the ICU or the hospital overall, less number of readmissions, less, you know, rehabilitation, a better quality of life, so on and so forth, you would have a significant amount of cost offset that you would get from giving the patients IMT-358. And so we showed them the numbers. You know runs into tens of thousands of dollars with just one single administration of IMT-358. And they were, you know, convinced that. You know whatever you know price you come back to you know it should be supported, you know, in line with some of the other drugs that are out there in the market. We also did a QALY analysis. So at 150,000 QALY, typically what we look at is what would be the price at which the drug would provide value, and 150,000 QALY, the price could be potentially a $24,000 drug.
Atul Deshpande, Ph.D.:But, that is not where we are going to position it. We are very sensitive to market access because our mission is to get this to patients, it's not to profit crazy off of pricing it way higher than it could, and so our position there is we want to bring this as a drug that is given to any symptomatic ACS patients as quickly as possible, and therefore it has to be accessible and affordable at that point of care.
Ben Comer:Excellent. So what are your next steps? Are you in full fundraising mode at this point? Atul, you know what I guess best case scenario. What would you? When would you like to see the phase three, you know, started and even you know those first readouts being announced or publicized?
Atul Deshpande, Ph.D.:Yeah. So, yes, right now we are in a full fundraising mode. It's a $50 million fundraise. Most of it is going towards the clinical trial and the manufacturing piece of it. So we have our CROs lined up to do that. We have our manufacturer lined up to manufacture and bring the product to market. We have our shippers lined up to do so. So the idea is to hopefully close the round before the end of the year and get the trial preparation started in Q1 of next year. We anticipate taking about a year to enroll the first 900 patients. So we are looking at mid-2027 to come out with the first set of data from the interim readouts and then, depending on what the data looks like, we might be in the market by the end of 2027 or potentially six months after, if you have to continue carrying out the remaining 700 patients through the clinical trial.
Atul Deshpande, Ph.D.:One of the things, then, is when you know, when we think about the way IMD-T5-8 works, the mechanism of action it's not only limited to heart attacks or ACS the way we are looking at it is the underlying red thread around this is ischemic injury, and ischemic injury can happen in a lot of different circumstances.
Atul Deshpande, Ph.D.:It could happen in trauma Someone falls down from a ladder or gets into a car accident, still the standard of care is aspirin and saline If someone is undergoing high-risk surgeries. These patients, because of the comorbidities and everything that they come in with liver transplant, kidney transplants, you know, joint replacements, they may have cardiovascular complications, and so you know a good number of patients with all these comorbidities may be at the highest patients that will benefit from having something like this during and after surgery given to protect the heart. And then eventually, you know there are other kinds of ischemia, for example stroke, where a combination like this may also be beneficial. So we're kind of building a portfolio in a product approach to make sure that we are able to address those you know ischemic emergency, and just define a new global standard for those ischemic emergency rather than just you know, the standard of care which hasn't changed for decades in the form of aspirin and saline.
Ben Comer:So you will pursue those additional indications you know following, you know, a successful phase three and market launch in the initial indication. Is that your plan?
Atul Deshpande, Ph.D.:That is absolutely our plan. Acs is our first indication but we already have, you know, plans lined up, clinical trials thought about for the additional indications. And not just that, there's actually a list of 15 other indications that we have reviewed, looked at the scientific data, looked at the underlying mechanisms, including, you know, one, expanding into oncology, where patients could benefit from it. And you know, as I started reaching out to cardiologists across the world, all the way from Alaska to Australia, cardiologists have been coming to me and asking hey, have you thought about this indication? I mean, you know there was an event history around oncology and cardiovascular in my own family, but this cardiovascular oncology connection was also proposed by another leading cardiologist here in the US who actually said you know, if you want, I can run this trial for you.
Ben Comer:Wow, interesting. Well, that leads me to ask you know you mentioned you have your CDMOs in place, your manufacturing in place. Do you anticipate needing a commercial partner to launch this after it makes it across the finish line and is approved by FDA?
Atul Deshpande, Ph.D.:We would absolutely love to have someone who has the right channels established into the place where we are going to position this, which is the emergency rooms. So if there are companies, strategics, that are interested in partnering with us in, in commercializing this, we are more than open to that conversation. But we are not limited by that conversation. And that again, you know, takes me back to my depiction, experience of launching depiction and having the knowledge base and the know-how of of how to bring a successful blockbuster drug to market. And so you know we would love to partner with the right partners to bring this to market and to patients as quickly as possible. But we are not limited by that, given the experience that sits within the organization to do it ourselves as well.
Ben Comer:And so you would look at global markets as well, and you're willing to become as exhausted as you were after Duplexant with this product.
Atul Deshpande, Ph.D.:Absolutely.
Atul Deshpande, Ph.D.:You know, honestly, I would love to do that because you know, every single time that we hear stories about patient success, about how to benefit from, you know, any of the drugs that we come to market, that you know it.
Atul Deshpande, Ph.D.:It it channelizes you, it energizes you, it, you know it allows you to focus and you know it gives you the purpose, why you're doing, you know what you're doing, and so the idea here is, even with the phase three clinical trials right now, as we speak, ben, we are exploring potentially having sites in Europe, we are exploring potentially having sites in Australia. You know we have had a conversation with a couple of, you know, agencies in the Middle East in terms of, you know, potentially bringing disruptive market there, and so we're not just thinking US, we're thinking way beyond US because the benefit that this combination can bring to patients is, I think, you know, just unbelievable and there's no reason why we should limit it to any specific market. Or, like I said, there's no reason why we should not look beyond the initial indication of cardiac arrest. But, you know, think about where this combination can be cardioprotective, where this combination can be neuroprotective and therefore, you know, give the maximum benefit to all the patients.
Ben Comer:Atul, thank you so much for coming on the show and sharing your journey, as well as what immediate therapeutics is up to. I really appreciate it.
Atul Deshpande, Ph.D.:Thank you for taking the time and really thank you so much for allowing me to share what we are so passionate about.
Ben Comer:We've been speaking with Atul Deshpande, phd, ceo at immediate therapeutics. I'm Ben Comer and you've just listened to the business of biotech. Find us and subscribe anywhere you listen to podcasts and be sure to check out new weekly videocasts of these conversations every Monday under the Business of Biotech tab at lifescienceleadercom. We'll see you next week and thanks, as always, for listening.
