Research is Always About Rising from Failure
Episode

Ulf Hannelius, President and CEO at Diamyd Medical

Research is Always About Rising from Failure

Brought to you by   | hosted by Joseph Kim

 

Advancements in Research Is Never a Straight Line

 

In this episode, Ulf Hannelius, President and CEO at Diamyd Medical gives us an inside scoop on their development of an innovative medicine for Type 1 Diabetes and explains how the path to success is often a function of tenacity, focus, and community. Ulf starts by talking about the business model, explicitly outsourcing and manufacturing, around an asset like Diamyd. He tells the story of Diamyd’s failure, the approaches they tried to bring positive results, and what they learned from them, like discovering the molecule’s effect with the right HLA haplotype. He explains why investigator-initiated trials have been vital to continuing development with scarce resources and why he believes science is at the cusp of a significant breakthrough in Type 1 Diabetes.

 

Tune in to learn about the research work at Dyamid and how they came back from the ashes!

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Research is Always About Rising from Failure

About Ulf Hannelius:

Born in 1975. Ph.D. in Molecular Biology from Karolinska Institutet in Stockholm and Executive MBA from Stockholm School of Economics. Prior experience in business development in the biotech and MedTech industries, as well as from academic research in the fields of genetics and molecular biology. Chairman of Diamyd Properties AB, Board member in MainlyAI AB. Joined Diamyd Medical in 2015, CEO since 2016.

 

Research Confidential – Ulf Hannelius: Audio automatically transcribed by Sonix

Research Confidential – Ulf Hannelius: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Joseph Kim:
Welcome to Clinical Research Confidential! On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health. But it’s not for the faint of heart. And so on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry, now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
Hi everyone! Today I’m here with Ulf Hannelius, the president and CEO of Diamyd Medical. Ulf, thank you for joining us. It’s great to have you here.

Ulf Hannelius:
Thank you for having me.

Joseph Kim:
So we’re going to talk about something very interesting today at Research Confidential, and that is the idea that research doesn’t always come out the way you want. So while a great many people out there in the general public think, you know, pharma companies and medical device companies and people who are working on healthcare, you know, we create studies that always are stacked, right, that are loaded and will always come out successful. And having worked at Lilly myself, I’ve seen billion-dollar drugs fail. And so, Ulf, you have a very interesting story as well with one of your compounds that we’ll get into in a moment. So but before we go there, let’s talk a little bit about your personal journey in medicine and research, because as I understand it, you started out really at the, at boots on the ground level as like a research assistant. Tell us more about your education and your first foray into clinical research.

Ulf Hannelius:
Yeah, I mean, so I’m originally from Finland and then I moved to Sweden about 20 years ago. So I did my, after like the high school and college, I went to university and started in chemistry and reached over to biochemistry, which was closer to medicine, which sounded more exciting, exciting than just plain chemistry. So that’s probably where my interest in like medicine started, like having this biochemistry background. And I did my master’s and I got the opportunity to move to Sweden with my professor at that time, who became a professor at the Karolinska Institute in Stockholm, Sweden. So me and a few others from his lab moved to Sweden to start up a couple of labs, and that’s how I started my PhD studies as well in molecular biology and genetics. So that’s kind of my research background, like biochemistry, molecular biology, and genetics, and then I did a postdoc as well in cancer genomics. And in parallel to that, I guess my interest towards the business part of the field started, I felt that I probably didn’t want to have a research, like an academic research career, I wanted something different. So I started an MBA education on the side like this executive MBA with a healthcare focus. And that obviously was a big catalyst for getting in touch with a completely new network of people. And I also had the opportunity to go to Silicon Valley in a different, like governmentally funded program, and I worked in a startup in Silicon Valley in like a gamification field, which again put me in contact with a completely different, very interesting field. I visited Google and LinkedIn and all these companies. So I think that probably that single one month in Silicon Valley was the trigger for me to say that I need to do something different. So I actually quit academia, started my own consultancy company with these concepts from Silicon Valley, and started working as a consultant strategy research and market research, which was, in retrospect, kind of a naive decision to just quit your job and start your own company. And I thought that everyone will buy this concept immediately because it’s so cool, but it was much more difficult than I thought. I mean, I realized that the difficulty of sales that you also have to sell things before you can actually do the things. But I think that it’s been one of the most important decisions in my life because it taught me the value of like a month of salary, how much work is behind just a month of salary when you work as a single consultant?

Joseph Kim:
Sure, and then, and the contrast between like your academic training, which is very scientific focus, a lot of bench work too, I imagine. And then you’re moving through, you know, coming out of the lab and into something, the real world. Like, tell me how that evolution landed on you.

Ulf Hannelius:
Yeah, I think it’s, it started with me and some friends having, like, talking a lot about, like, more the commercial business side of things that we were all in the academia but felt that we want something else like we want to move into the industry world but how do we do it? We just don’t want to maybe be the ones who sell pipettes and stuff like this, but we want to probably change the world like everyone else. But there was this interest and a feeling that just following the academic wasn’t really my thing. I wanted to differentiate my profile so that both the MBA and then that sort of starting your own company did that sort of forced me to intern, like outside my comfort zone, and that opened up my eyes completely. I was ready to basically work in any industry as long as it’s interesting and rewarding for me. It didn’t have to definitely be in life science, which was my background. And I was also very inspired by this Silicon Valley mentality where it doesn’t matter what your background is, as long as you’re interested, hardworking, and smart, you can work with anything. Whereas maybe in Europe and Sweden, the Nordics is a bit more conservative, where you have to sort of stick to your background and don’t move like outside your background, which was, but this sort of created some kind of mental freedom for me that I could pursue anything that I was interested in. Then it happened that I still was working a lot with life science because I knew that field, so I did most of the consulting in that field. And then I happened to come across an ad in a paper for this, Diamyd Medical was looking for a business development person, and I did get some pushback from home saying that maybe you should get a real job at some point. And that’s also always healthy to have someone to bring you back to Earth and say, well, maybe you should get real also now and find like a real job for a change, and then this just happened to be there. I knew about the company since before, the business development sort of role fit me perfectly because it was a mix of science and business. So I applied and I got the work and the rest is almost history, and I got offered the CEO position half a year later, which was a surprise, but I said yes, and that’s probably the second most important thing in my life.

Joseph Kim:
Yeah, good for you. For those in the audience who may not know what business development might mean for a company like Diamyd, give us a quick overview of what you were doing day to day.

Ulf Hannelius:
Yeah, so we, Diamyd Medical is a biotech company. In many aspects, virtual, like many smaller biotech companies are. So we sit on the project management, the financial strategy, obviously, on business development strategy, but most other things are outsourced, like manufacturing, clinical trials, work with a lot of consultants. Now we are growing a bit, so we actually insource, now we sit on manufacturing ourselves, which is a pretty big thing, so we became more of an integrated company now. But for a, like most biotech companies have a business model where it’s all about out-licensing. So you do the development up to a certain point and then you out license to a larger one or a few larger pharma partners who both bring in the financial resources and the commercialization competence to take it all the way to market. So for a business development person in a biotech company, it’s about maintaining contacts to potential partners, updating them with the advancements, and obviously aiming for like an out-licensing deal and agreement. Co-development out-licensing or going to collaboration deal and we are a publicly listed company so, but for any company, shareholders are the main stakeholder. I mean, you are working for them, they give you their money so that they could actually make a profit so, and that’s why you want to make the best possible deal also for your shareholders.

Joseph Kim:
And unlike, say, a big pharma company who’s got established commercialized medicines and revenues coming in the door, biotech traditionally doesn’t have that huge amount of revenue, right, it’s mostly investor. So it’s very critical to have the drug, the molecule you’re working on actually get to a point where it’s proving some value because that out-licensing is the, your lifeblood.

Ulf Hannelius:
Exactly, so, yeah, the out-licensing then it’s usually coupled with both an upfront payment, usually quite sizable, depending on, again, the partner and the indication you are in, and then certain milestone payments and then royalties on the future sales. So that’s, it’s very important obviously, and it’s in our business model as well. And we most likely want to, if possible, retain certain commercial rights as well, like for example, the Nordic markets to start building a true commercial company, but you need to, you need the, at some point, the help from the larger partners who have the whole logistics in place, because it’s not rational for a small company to think that with your first asset as you will just cover the whole world yourself, you need to piggyback on someone and then you can start growing if everything works.

Joseph Kim:
Yeah, and so this is what, now we come to the story of one of your molecules where I think, this was phase three, and it was a global trial and you know, the amount of public trust has been eroded in science to some degree. And I think for a long time the true cynics out there or conspiracy theorists believe that pharma companies, biotech, medical device are creating studies that, of course, will prove positive, but that’s not always the case, and you have a real-life example of a molecule where it didn’t actually pan out the way you planned. Tell us about that story.

Ulf Hannelius:
Yeah, first of all, it’s important to know that like most molecules that are developed never end up on the market. So the like, the likelihood to succeed is very small if you start with a preclinical molecule. So you are still in animal testing and then from there to go all the way to market like into the clinical testing across all the phases and then successfully commercialize. I mean, it’s not many percent that make it that far. Obviously, larger pharmaceutical companies usually step in in a later phase. So the biotech companies take the, let’s say, largest development risks. So you should show the proof of concept that the likelihood that it works is quite high, but then you need to do that final pivotal study to show safety and efficacy and obviously the commercial potential and everything, and it’s still not clear that that will succeed. So we had an asset which is a protein. It’s, we call it Diamyd, just as our company, it’s an antigen-specific immunotherapeutic. So it’s, quite simply it’s a protein that belongs in the body. So we have the same it’s a recombinant version of that same protein formulated in alum, which is the very standard formulations used in many vaccines, for example. And what we want to do with that therapeutic is that we want to specifically reprogram the immune system regarding how it sees this protein, because in an autoimmune disease, in type one diabetes, which is an autoimmune disease, the immune system attacks the insulin-producing cells, and we know that one of those targets that the immune system in a, wrongly recognizes as something dangerous is this protein GAD, which is expressed in those cells. So we want to just show that same protein to the immune system and tell you that this is not something that is foreign, it belongs to the body, stop attacking. And this research comes originally from UCLA that we license the company, or when in the nineties it started with licensing of this patent from UCLA, and then it was taken through the manufacturing preclinical phase, through the clinical phases, all the way to phase three, and that’s where Johnson & Johnson actually stepped in as the partner, while that phase three trial was ongoing. But what happened is, and everyone believed that this would work, I mean, it was almost like a clear case. It was, it just has to work. But the, when the results came, it wasn’t significant. So we did see a clear trend of efficacy, but it wasn’t a significant effect. You didn’t like, it wasn’t below the P-value of 0.05, that magical, like a P-value around 0.1, and then, well that, it was basically then a failed phase three trial. We regain back all the rights from J&J, they obviously pulled out when it didn’t work, and then we went back to the drawing board saying, well, it’s very safe. I mean, there’s never been any serious adverse events ever with this thing, and there’s clearly an effect, but how do we make sure that it, how can we enhance the effect.

Joseph Kim:
Right. So looking back, because to get to phase three, it means you’ve had a positive phase two. Tell us a bit about the phase two, whatever you can, and then where that transition didn’t happen in phase three, what were your suspicions?

Ulf Hannelius:
So exactly, so there was a phase two trial there, like there were many trials. So these first a small dose sort of finding studies and then, actually, a smaller phase two trial in another related indication called blood-related immune diabetes in adults, which is like type one diabetes, but in older people, some people call it autoimmune type two diabetes, which looks positive as well, and then there was this phase two trial in type one diabetics and that met the primary endpoint. And also there was a subgroup analysis in that trial showing that, well, if you take individuals who are very recently diagnosed, the effect seems to be even better. So then, the phase three was based on that, the phase three will be in recently diagnosed type one diabetics, otherwise basically a copy-paste of the phase two. So the phase two was successful, and then you go into phase three where you obviously have three times or more, more patients, you go to more clinics, you have more patients, so more individuals are exposed to the same trial. We had one trial ongoing in Europe with around 300 individuals and in parallel also trial in the US with around 300 individuals. And then it was the European trial that first had the readout and that showed the nonsignificance and then everything stopped, like the phase three in US was stopped prematurely because of history and Europe didn’t work. The rights were handed back to us by J&J. Obviously, the share value tanked 85-90% in a single day. So it was very disruptive and obviously, everyone thought was thinking, well, what went wrong? What happened here? Because before that everyone was so, I mean, everyone believed that this would work. We, our shareholders, like J&J, everyone.

Joseph Kim:
Patients, I’m sure. Clinicians, right?

Ulf Hannelius:
Exactly, I mean, I wasn’t with the company at that point, but it’s kind of, what I see now as well to some degree that I know that they were almost like patients knocking on the door to the company demanding that they can be part of a clinical trial, so to a huge demand. But I sort of stepped into the company around seven years back now. So it’s, when all of this had happened like it was very disruptive, the company split up into two parts. The diabetes asset became its own company with a small amount of financing, and most of the other money that was cash went into a different company that became basically an investment company. And then there were a number of small trials started, like pilot trial, investigator-initiated trials to see, well, what would be a way to enhance the efficacy of different combinations, way of administering the drug, because investigators knew that it’s a very safe drug, there’s no risk to the patients and there’s most likely a benefit, but there’s no risk of it. So it was very popular for investigators to try different combinations with this one. And these small trials were ongoing when I stepped into the company and we started seeing the first sort of signals coming out from the small trials.

Joseph Kim:
Yeah, what did, what were these small trials examining? How are they examining the drug differently such that you were seeing different positive signals? What were they doing exactly?

Ulf Hannelius:
So there were different combinations, like with one trial was with our sort of the immunotherapeutic together with an TNF alpha inhibitor to see, well, if you first suppress like the TNF alpha part and then you add the antigen, maybe that could be a way of sort of creating more of an allergenic response. There was one combination with a mild sort of anti-inflammatory molecule. We also had vitamin D in a few of these trials, which we still have actually, because we know that vitamin D many people are vitamin D deficient, and vitamin D is important if you want to create a total allergenic response. You don’t never definitely don’t want to be vitamin D deficient, so we actually have that just as a sort of pre-treatment or that you make sure that no one is deficient in vitamin D, but these were different. And then there was one small trial which is tested, injecting our protein directly into a superficial lymph node, which was the first time ever in an autoimmune disease. So it’s usually you usually do subcutaneous or intradermal. So we have done subcutaneous, one of our investigators wanted to try this superficial lymph node injection that had shown success in the allergy field with allergen-specific immunotherapeutics.

Joseph Kim:
Interesting.

Ulf Hannelius:
See? Well, what if you do this in an autoimmune disease? Do we get a better effect? Rationale being that you want to bypass the transportation from when you go subcutaneous to the protein is picked up by antigen-presenting cells and transported to the lymph node and then the reaction happens. Now we went directly into the lymph nodes and that with a much smaller dose. So these, and that was actually the concept that we focused on and raised money to do a phase two B trial. So then we see it looked like that looked very positive that we get a much more pronounced immune response and it’s very safe, and the clinical results in an open-label trial looked very promising. We didn’t have a placebo, but the big thing actually which happened in 2019, is that we always had these different theories of what went wrong in the phase three, because if you look at the postdoc analysis that was done in that publication in New England Journal, in the big, big treatment, almost everything pointed to the right, like, to the significance part when you always subgroups age, different genotypes, different baseline criteria, only a few things were on the left side, so everything looked very positive. But there was like a gender effect that looked like it works better in males, it looked like it works better in the individuals who received it during the springtime, and looked better in non-Nordic individuals. So these trigger different hypotheses that well, in the Nordics we have the swine flu epidemic, and almost everyone got vaccinated. It was impossible, even if it was in the protocol, that you should not get another sort of vaccine or immunotherapeutic close to the, our immunotherapeutic. It was impossible to stop basically people from being vaccinated. So there was this theory that maybe that sort of affected negatively our results or maybe this vitamin D thing seasonality thing in spring, it’s more sunlight higher. I mean, maybe that’s the thing, but there were also you could see on this HLA, which is the key actually. The HLA genotypes that are a risk genotypes four or haplotypes four. That one, we could see that many of them really looked significant or borderline significant, so that was also a hypothesis. And then at some point, I’m not exactly sure what, how the stars aligned. We sort of started looking into that saying, well, we can just sort of superficially look at the data and have speculated we need to do the proper analysis and proper meta-analysis, and that was picked as the hypothesis, by hypothesis, because we knew that HLA is not only a risk factor, the main risk factor for type one diabetes and most autoimmune diseases. It’s, also seems to determine which kind of autoimmunity you get, depending on which gene you have gene variants. So if you have a certain one, it’s usually these individuals get, autoimmunity against GAD or a protein. If you have the other one, you get autoimmunity against insulin, and since we treat with GAD, maybe we should treat individuals who have the specific HLA that associates more with autoimmunity against GAD. So we did then that, we had file pattents previously, but then we did the proper analysis in 2019 and it very clearly show that there is a significant interaction effect between treatment effect and HLA haplotype and that the, all the effect seems to be in this one subgroup that carries the what’s called HLA 3dq2, which associates with … and autoimmunity.

Joseph Kim:
So.

Ulf Hannelius:
It sort of, everything made sense.

Joseph Kim:
It’s a pretty amazing story because as you looked at the postdoc, as you said, a lot of other hypotheses sprung up, but that would have been very expensive to test all of them out and separate them.

Ulf Hannelius:
And it would have been like a fishing expedition, would have been a problem because you want to link your hypothesis to a clear biological rationale because there was this hypothesis that maybe it works better in males, but what’s actually how do you what’s the rationale? Yes, we do know that especially in children like puberty, immune systems develop a bit differently in males and females, but it’s still kind of far-fetched. Why would GAD exactly work better in males than the females? And you don’t only want to be restricted to treating like males or boys, because those kind of, so, but this HLA made sense because HLA codes for the receptors that bind antigens and present them to immune cells and then that formed immune. So now it’s sort of, it’s almost like why didn’t we know it then? I mean if you treat with an antigen, obviously you need to know that it will be presented differently depending on your genetic variants in the HLA.

Joseph Kim:
Yeah, so was it the combination of that genotype and injection into the lymph nodes that really sort of supercharge the ability for the molecule to do its thing?

Ulf Hannelius:
Exactly, so we know that the intralymphatic injection seems to like pronounce the effect is even better compared to subcutaneous, so we get a more pronounced immune response. It’s like, it’s a much smaller dose. It’s very convenient, like no hospitalization, nothing, but you need to treat the right individual. It’s not enough, the intralymphatic, which we believe first, that maybe it’s enough that you go with the intralymphatic that will work so much better, that it works across the board. But it’s still the fact that you need to pick the right individual, and then that’s like it will create, like the effect you want. And it’s, but it’s just so interesting that it’s so rational in retrospect. It all makes sense, but then you wonder, why didn’t we do it so much earlier? But the thing, the reality is that there are so many things happening when you have these negative phase three trials, a lot of ideas all over. It’s so disruptive that it’s, you need the time and the field needs to advance enough for everyone to sit down and sort of do that proper analysis. And in this case, also the type one diabetes had advanced to the point that people talked about, like this primary autoimmunity potentially may be in the types of the disease. And then we sat on something, wait a minute, and then we press release this analysis just a month later, like a paper in diabetes research, talking about precision medicine is the way forward for type one. We need to start looking at these, maybe some groups, one size doesn’t fit all. We have this HLA, maybe there are different diseases that lead to type one. Here is one, here’s the other, and we just sort of, the month before that press release that we found our responder group. So it’s totally like everything came together.

Joseph Kim:
And, you know, I think the silver lining is now you found a drug that works incredibly well if you have the right genotype. Is there a companion diagnostic that comes along with that? That is part of standard of care so that you can identify the right patients for the ….

Ulf Hannelius:
So what we do is we exactly we do a pre-screening now in the phase three pivotal trial. We pre-screen all the individuals to check if they have the right HLA haplotype. And we haven’t developed our own diagnostic because HLA genotype or haplotype has been, existed for decades. Basically, it’s used routinely in the transplantation field where we do HLA matching of the donor and the recipient. So there are a lot of these IBD diagnostics around HLA already approved and in use, so we don’t need to invent anything ourselves. There are actually a few clinics I know, at least in Sweden, that routinely do HLA genotyping for any type one diabetic, it’s, so we don’t even have to, we already know that this individual will have the right HLA. I think that will become standard quite soon. It probably will be standard for any autoimmune disease because it’s so integral to any autoimmune disease like the HLA.

Joseph Kim:
Yeah, it’s, it’s funny, not funny, but it’s interesting how as we do more research and uncover more knowledge about diseases, we recognize that what we thought was one disease is two or three or a dozen, right? Cancer used to just be one thing, now it’s dozens of diseases and now we’re finding these subtypes in type one and it continues to create new opportunities for better therapies to target that specific subtype.

Ulf Hannelius:
I think like cancer and oncology field, it’s a very good example of what like the kind of incredible advances you can make when you suddenly sort of start focusing on responders and getting I mean, someone told me that, well, if you had done this sort of subgroup identification maybe 10 years or 15 years ago, everyone would have thought it’s a bad idea because you’re sort of, you’re going from a relatively, well, it’s a large market, but you’re going to only 40% of your potential markets, so that’s a very bad idea, but now it’s completely different. Everyone knows that, define your responders, focus on them, and that’s like the key to success, and that’s very clear being in oncology, like with all these blockbusters like Keytruda, which is also all of these, kind of today, like the blockbuster, like super drugs have a very interesting story, kind of similar where they were almost abandoned and like the program was almost like put on ice or no one wanted to finance it, but then suddenly something happens and then it’s developed and then it’s like because it’s massive, big thing. So there are so many examples you should, maybe the biggest drugs have never had like an easy way to market and probably which have some reflections around that. But I think it’s, because I think the low-hanging apples have all been taken already, like the very simple drugs where preclinical models directly just translate to humans, but in reality a mouse isn’t human. So we think it’s, you need to realize that humans are a bit more complex, and that’s why you need to find those responders.

Joseph Kim:
Well, I love about this story is that you took a hard look, and like you said, you did the proper analysis. There’s a biological component to the upside, and by opening it up to investigator-initiated studies who also had some good ideas in terms of methodology, those two things converge and created a really optimal way to deliver the asset in a way that’s going to help people directly.

Ulf Hannelius:
I think it’s been really key, like both the persistence of the company and our founder. He’s still like, he founded the company in the beginning of the nineties when his youngest daughter got diagnosed with type one. So his vision has always been to cure the disease and that’s, the whole story is just fantastic, I hope there will be a book written about this at some point, maybe a Netflix series or something like that. But it’s, like the persistence, and that like that driving vision is very important and that you have a founder who is, doesn’t give up and who can, during these very turbulent times, control the company, make sure that it doesn’t go, sort of, off track into something else but keep going, like pursuing it. And then these investigator-initiated trials, they have been key for us to be able to continue development with very scarce resources. Because it’s very costly to do sponsor trials, but with investigator-initiated trials, you can do a lot with much less money so that, without those, I don’t think we would have come as far in being able to do that analysis and then be where we are today.

Joseph Kim:
Yeah, it’s a fantastic research model. I think the other backdrop to this is, COVID was, during the COVID era, it was the first time the general public saw the messiness of science, right? There was fits and starts, two steps forward, one back, two steps. And you know, in behind closed doors, you live this every day. Scientists live this every day where they see barriers, things don’t look like they come out as planned, they go back, reevaluate, go into a slightly different direction, and can get some good results that way. You should be very proud about what’s happened under your watch. What’s next for Diamyd?

Ulf Hannelius:
Well, one, right now, it’s like, it’s operational, it’s all about the phase three, like patient recruitment, like getting all the clinics up and running, these things. Obviously, we are in discussions like we’ve been for a long time with partners, given our business model again, out-licensing, making sure that we find the right partner and the right financial terms, all of these things. Manufacturing is very important. We are, like I said in the beginning, we are, we have taken over the manufacturing of the product, it’s not outsourced anymore, so we are building our own manufacturing, which will, I believe, bring a lot of opportunities in the future. But it’s obviously a challenge to do that as well, to build your own manufacturing capabilities. But that’s, most of the focus is really the phase three manufacturing right now, making sure all of that work is done as well as possible. We have another asset in the clinical trials as well, but we will quite soon get the topline results to see if and how we will focus on that as well, it’s also in diabetes. And we are going into the prevention space as well, so we are now the phase three, so-called stage three type one, which is recent onset type one, clinical type one diabetes, but we are also moving into the stage one, stage two, so high-risk individuals, which we’ve done before in actually investigator-initiated trials, looks very promising, there are same hypothesis. It looks like the right, with the right age, a high likelihood of working so. And then we recently disclosed results from a small trial in this larger indication, like the autoimmune type two, which also looks very promising, and same HLA thing there, with …. HLA, it seems to work. So there’s a lot of opportunities. So I guess like for any biotech, any time but especially now, it’s all about even more resource-prioritized. How do we, like, maximize value with the resources we have and financial strategy’s very important in these times as well. So it’s a lot about these things. Like we know that we have a fantastic asset in place, but now we need to sort of do the operational work and all these things and see what would bring most value to the company with the resources we have and all these things. So it’s, there’s a lot to do, but it’s very exciting.

Joseph Kim:
Very exciting, I think, for this condition where there’s been no good, no good long-term therapy for real. This is, this provides real promise to patients with diabetes.

Ulf Hannelius:
It does, and well, again, I wasn’t with a company when the previous phase three program was run, but I know then there were several phase three programs with different big pharma partners involved, like, and so the type one field was really close to like a breakthrough then. I think the whole field thought that now it happens like, before 100 years of insulin, we will get something new. Well, it didn’t happen, all those phase three sort of failed for one or another reason. Now, it’s been 100 years since the insulin, but it’s, I have the feeling, I’m a bit biased, but that we are back in that same, it took ten years to sort of get back for the type one diabetes to recuperate from those phase three failures. It’s very similar to the Alzheimer’s field with all these failures, one after the other, and like investors sort of get disappointed and move somewhere else. Big Pharma gets disappointed, does something else, and then suddenly, you first have, well, we had one approval, which was obviously discussed, if it was correct or not, like with the … and these things. And now we have the biotech, a Swedish company with a sign Biogen, again coming out with fantastic results. So I feel that the Alzheimer’s field is going through something, like major breakthrough right now, and I have the feeling that type one is very close to. Same thing that now, we are again, that cusp that might be, the field is changing the treatment paradigm. So it’s very exciting, I feel the whole field is sort of now getting a lift.

Joseph Kim:
Well, for now, Ulf, this has been a fantastic conversation. Thank you for sharing this story. Too many success stories out of the gates get told and it’s good to see something that has fell but then came back like a phoenix from the ashes.

Ulf Hannelius:
Yeah, exactly.

Joseph Kim:
Yeah, thanks again for spending time with us today.

Ulf Hannelius:
Thanks.

Joseph Kim:
Thank you for tuning into Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you’d like to debunk a clinical research myth, share some war stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to [email protected] This show is presented by ProofPilot and is powered by Outcomes Rocket.

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Things You’ll Learn:

  • Most biotech companies have a business model where they develop up to a certain point and then outsource many other areas within the process to make it into the market.
  • It’s not rational for a small company to think that it can scale from its first asset. 
  • Most small companies need to piggyback on another company and start growing if everything works out.
  • Most developed molecules never end up on the market. 
  • The most significant drugs have always had a challenging way of getting them out into the market.
  • Not only is HLA (human leukocyte antigen) the leading risk factor for Type 1 diabetes, but it also seems to determine which kind of autoimmunity one can get, depending on which gene variants you have.
  • As more research is done about diseases, many that were thought to be just one, like cancer, are discovered to be multiple diseases.
  • Scientists meet barriers all the time. Things don’t always go as planned, so they go back, reevaluate, and take a different direction until they find a way to get good results.

Resources:

  • Connect with and follow Ulf Hannelius on LinkedIn.
  • Follow Diamyd Medical on LinkedIn.
  • Explore the Diamyd Medical Website.
  • For more information about Research Confidential, please visit ProofPilot.com.
  • If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to [email protected].