Podcast – Reshaping Misfolding Enzymes

Voice Over:

Welcome to the Dementia Researcher Podcast, brought to you by University College London and the NIHR in association with Alzheimer’s Research UK, Alzheimer’s Society, Race Against Dementia, and the Alzheimer’s Association. Supporting early career dementia researchers across the world.

Dr Sam Moxon:

Hello, everyone. Welcome back to the Dementia Researcher Podcast. I’m a regular blogger, Dr. Sam Moxon, and today I’m joined by Matthias Alder from Gain Therapeutics. So hi, Matthias, welcome to the podcast.

Matthias Alder:

Hi, Sam. Thanks for me having me, real pleasure.

Dr Sam Moxon:

So how are you feeling today? You’re good?

Matthias Alder:

I’m good. Actually, just covering from COVID, I guess, these days it’s something normal, but it’s-

Dr Sam Moxon:

Yeah, it seems quite common at the moment. I lost my voice last week and I’m not sure what caused that. I had some sort of a throat thing as well, so it’s just coming back. So I think we should start by instructions and tell us a little bit about yourself and a little bit about Gain Therapeutics as well, so that listeners know how we’re going to frame this discussion.

Matthias Alder:

Awesome, thank you. And thanks for having me here and I’m happy, really pleased to be able to tell your audience a bit about gain therapeutics and the important work we’re doing at the company. So Gain is a computational drug discovery company and I’ve been the CEO of the company for the last six plus months. I’ve been with the company for about 18 months and have been in the biotech and pharma industry for essentially the entirety of my career since almost 30 years ago. Started out in one of the big pharma companies in Switzerland. I was actually originally a lawyer by training, so I’m not a scientist. Started out in the legal field, but I’ve always worked in the pharma and the biotech industry and working with many companies. And one of the things I’ve learned is to take complex scientific concepts and translate them into more simple ways for normal regular people to understand.

And I hope I can… Well, it might not be necessary for this particular audience. I think simplicity is always a good thing and the greatest ideas are often just the simplest ideas. And that’s what we have here again with our program where we’re focusing on a genetically defined subpopulation of Parkinson’s disease patients and with a mechanism of action that is actually the potential disease modifying and can stop the progression of the disease, an incredibly powerful mechanism, incredibly exciting opportunity. And the exciting part is that we have taken this all the way from the discovery where we used our computational tools to find the molecule all the way through preclinical development and are now ready to take this into the clinic in the middle of this year.

Dr Sam Moxon:

That’s really exciting and I want to go into a bit more detail on that a little bit later on. But I think we should start by talking about the technology platform and how it works. So is it SEE-Tx? S-E-E-T-X? Is that the technology? So how does that actually work? How does that help you find therapeutic targets for diseases like Parkinson’s or Alzheimer’s disease?

Matthias Alder:

Right, thank you. So SEE-Tx is a physics and structure based discovery platform. I know that AI is sort of the big words today, Artificial Intelligence, machine learning and all that. And that always requires a lot of preexisting data to teach a computer system, a program to do what it needs to do. That is different from what we’re doing at Gain, which is a physics and structure based approach. And so, in order to discover new molecules, what we’re doing with the platform is find novel, never seen before, binding sites on the surface of proteins and then find small molecules that bind onto those binding sites and have a therapeutic effect. It’s a structure based approach in that way the only thing we need is the protein structure. And these days, and we are using AI in that context in that we can use things like AlphaFold that can generate a 3D structure from a 1D oligo sequence in no time. And these types of predicted structures from AI-based tools, we can use to run our platform and then use that structure to discover new binding sites and small molecules that bind.

Dr Sam Moxon:

And so, do you work with other companies or universities? What sort of people do you work with as part of these kinds of projects?

Matthias Alder:

These are just actually… So we are working indirectly or I guess, with a university in that the platform was developed at the University of Barcelona. And our chief technology officer who is with the company today was actually the person who originally developed the initial concept and software to run this kind of a modeling exercise. And obviously, over the years has continued to refine that and so, we’re using that platform that was developed at the University of Barcelona now. Again, it’s exclusively licensed to us as a company and so, we are using that both for ourselves to develop new development programs in different therapeutic areas. So we’re also using that in collaboration with partners in the industry, small biotech companies, large pharma companies that have an interest in accelerating drug discovery as we can enable with our tool.

Dr Sam Moxon:

So it’s quite a collaborative effort, which is good to hear. So I took a look at the company website earlier and it seems like you’ve got a lot of different candidates for different therapeutic areas and clinical trials. It’s not just dementia, there was stuff with cancer and another, but we’re going to dial into the dementia side of things today. And it seems that the one that’s the most advanced is for Parkinson’s disease and it’s based on a specific genetic mutation that leads to the most drastic cognitive decline. Is that correct?

Matthias Alder:

Correct. So the focus of our lead program is GBA1 Parkinson’s disease and these are Parkinson’s disease patients who get the disease because they have a mutation of the GBA1 gene. And because of that genetic mutation, that gene expresses a misfolded enzyme GCase. And that GCase, because it’s misfolded, it gets retained and ultimately degraded in the cell and it’s not able to perform its role. And what we’re doing is we’re restoring enzyme function with our small molecule by binding to that GCase enzyme restoring function. And as a result, we see the beneficial effects of having essentially restoring a healthy cell. And the reason why there is that connection to dementia is what you refer to is that the GBA1 Parkinson’s patients, they have the more severe form of the disease. They get that it’s an early onset of the disease in these patients so that they get it earlier in their lives.

It’s a faster progressing disease and the disease is early on already associated with cognitive decline. Which typically in an idiopathic normal Parkinson’s patients, you only see towards the backend of the disease progression in these GBA1 Parkinson’s patients, that happens as the disease progresses. And so, the ability with our molecule to get to these patients early and stop the disease progression has a beneficial effect and obviously not just on the behavioral deficit, maintaining their behavioral function, their low commotion functions, but also stopping that cognitive decline.

Dr Sam Moxon:

I think that’s really important as well because most neurodegenerative disorders with something like Parkinson’s, it is a case we’re trying to stop it as early as possible. I guess, reversal is always a hard pitch because even if you can somehow engineer new neural networks, have you lost what was in the old ones? But on that topic, is there then also potential to use something like this in trying to treat Alzheimer’s disease early as well? Because the problem with Alzheimer’s disease is usually after diagnosis, it’s almost too late. So do we need the development of better early diagnostics before we can start looking at therapies like this or can this be something that can be used now to help patients?

Matthias Alder:

Well, I think the better diagnostics are always helpful. And in fact, we just recently on the Parkinson’s side had a very significant breakthrough with the Michael J. Fox Foundation that sponsored the program to identify diagnostic tests. And this is now a test based on alpha in new clean, which is one of the hallmarks of Parkinson’s disease. And that allows, with that diagnostic test they have found, made the correlation able to identify patients very early on even before they start to exhibit symptoms. And that is huge and that’s exactly where the field needs to move and where therapies that we are developing that actually maintains the healthy cells that restores healthy cells is key. As you said, once the neuro cells have been impaired and died off, it’s really hard to come back from that. So the idea is again, to get to these patients as early as possible. Maintaining them at the very high level of cognition and locomotion function as opposed to seeing that continued slide into the severe phase of the disease.

Dr Sam Moxon:

So what stage are you at the moment then in terms of the Parkinson’s disease therapy clinical pipeline? How far progressed are you? Are you into trials yet or are you still in preclinical?

Matthias Alder:

We are actually, that’s for us as a company, a very exciting stage. We’re just finishing up the preclinical development. So we finished up the finals of animal talk studies that we needed to complete and are ready to take this program into the clinic in the middle of this year. So we’re just about to make that transition into a clinical stage company, which for if you’re in biotech, that’s a big, big step forward and we’re really excited to be able to accomplish that with this lead program.

Dr Sam Moxon:

It means you’re sort of gone way beyond proof of concept and it starting to look like you actually have something viable at that point. So what country will you be doing the trials and clinical evaluation in?

Matthias Alder:

Yeah, so the first study is a phase one study and because it’s in focused on Parkinson’s disease, it has to be a healthy volunteer study. So I used to work in oncology companies where you can go directly into patients in phase one. Well, unfortunately, in neurodegenerative diseases, that’s not possible. And so, we’re looking at first a phase one study in healthy volunteers establishing the safety profile in humans and then take that into the next phase into patients in a phase 1B and phase two study to establish the actual effect in humans. We’ve shown the effect in animals very well, multiple animal models, multiple approaches and so forth. And it works and very consistent results across all of the experiments we’ve done. The proof will be in the pudding once we’re in humans.

Dr Sam Moxon:

So I want to ask a slightly different question now. So I’m obviously a university academic, but I’m also now exploring the other side of the coin, looking at commercialization and industrial biotech and that kind of thing. Approaching this from the angle of a biotech company like yourself, how do you think the research focus and pipeline differs to academia? Is it more easy to focus on that clinical product and trying to get it to market because that is your primary goal and it’s not necessarily papers and grants although you need funding. Do you find that it’s easy to have that focus on the clinic by coming out of this from an industrial angle?

Matthias Alder:

I think it’s interesting. The way I think about it requires both academia and industry really work together and they have different roles in the space and that continues even during clinical development. You have in investigator initiated studies, so even doctors in so clinical centers who look at a product in slightly different ways and think we could try it out in these patients for example. And then something as a company would probably not want to invest money in because it’s experimental and speculative, but that could contribute if it works or it could be really helpful. And the same is true for the research leading up to one finding a molecule and then taking it in into the clinic.

It takes that initial fundamental research that enables a lot of the breakthroughs that ultimately then translate into a product that ultimately leads to a therapy that can be used for patients. And so, it requires everybody pulling together and making, contributing to ultimately this to that success. And a lot of the things that we’re now taking for granted, that’s knowledge that everyone knows based on which we’re developing our lead product, that was developed in an academic setting to create that basic knowledge that allows us to actually draw the conclusions that allows us then to develop to find the product and develop it.

Dr Sam Moxon:

It’s interesting. One of the things that I’ve learned as part of exploring this sort of commercialization element is sometimes your main application for an idea isn’t the thing that you thought it was going to be. So when you started or when Gain started, was Parkinson’s disease the main target or is this something that’s developed along the way?

Matthias Alder:

That’s a very interesting question because that is what happened. So the company originally started out based on the technology platform, that discovery platform that works really across any therapeutic area. So initially, the company had to… The first choice was, okay, what are we going to do with this platform? Incredibly powerful, incredibly fast, incredibly versatile, but as a small biotech company starting out you have to focus your efforts on one part particular area. And so, the company initially actually focused on lysosomal storage disorders and specifically on restoring, enhancing enzyme function. That’s where SEE-Tx, the name comes from the right side direct enzyme enhancement. That was the origin of the company, the initial focus.

But because it was a biotech company depending on funding from investors, we were trying to figure out how can we create the most options for us as a company going forward. And so, one of the things in terms of looking at within the last, so storage disorders that we initially focused on is which ones are we actually going to do? And so, initially, for this what is now the GBA one Parkinson’s program, we actually started out looking at crochet disease, which is a rare childhood disease where it’s also caused by that same genetic mutation of the GBA1 gene. But at that time already thinking, well that might have broader applications. And so, as we were developing the product starting first in the rare disease, we now have the opportunity to actually expand it into a much broader application here.

Dr Sam Moxon:

So almost like if the Parkinson’s disease therapy gets through clinical trials, then I guess, it’s a good case study for a technology platform like yours where you’ve used it to first find the therapeutic target and then test it pre-clinically and then move it through clinical trials and hopefully into clinic. What have been the biggest challenges to that? Or has it been quite a smooth process or has it come with difficulties?

Matthias Alder:

You’ve been in research, you know. It’s not difficulties, but it’s just you never get unexpected results that’s just part of the nature of the beast of the field that we’re working in. And the trickiest way to make the best of the results that you have, that you get and figure out how you can apply those for the next steps that you need to take forward. So no, it’s never just straightforward from start to finish. First with our platform, we find a molecule, then you need to optimize the molecule so it actually it penetrates the blood brain barrier because we’re trying to affect CNS diseases. And then you need to optimize it along various parameters to avoid toxicities and things like that and make it more bioavailable. So there is always a hurdle that you need to overcome. But it’s in that sense, it’s been normal course of business because that’s what you would expect in any clinical development program, really.

Dr Sam Moxon:

So let’s be on the side of optimism. Say you get through clinical trials and you get approval, there’ll be clinicians listening to this podcast who perhaps work with Parkinson’s patients and are interested and want to know if this ends up in the clinic, when and how would it be administered to patients? So in terms of delivery method but also stage of disease.

Matthias Alder:

And I think one of the things we have looked at and thinking about, so the bumps and hurdles and things to address is exactly that, anticipating that ultimately the therapy that we’re developing needs to be convenient for patients in order to make sure that they actually take it and adhere to the therapy. And so, we have focused on the development of a formulation, it’s a small molecule, so it can be administered orally. And it’s an oral administration, actually the phase one study is going to be in a liquid formulation, but we’re working actually on creating a capsule that then can be easily taken by patients as well. So it is an oral formulation that we’ll be having that we can make available to patients. And in terms of frequency, that’s the other thing that people are looking at. So it’s either going to be a once a day or twice a day, in the morning and evening type of capsule that patients would have to take. But all of that will now work through as we’re going into humans in the clinic and actually figuring out the most convenient way for these patients.

Dr Sam Moxon:

Because if you can have it as once a day or twice a day, I think that that’s already an improvement for patients because I’ve spoken to a few Parkinson’s patients in the past through work, and one of the complaints you have about their medicine is it works better on some days than others. And because of the severity of the symptoms, and I have to almost try and tweak the dose up and down depending on severity and it’s hard to really get into a routine with it. Whereas if there’s a thing that they can take once a day that’s going to control the symptoms, that’s a huge improvement for the patients. So that’s a great benefit.

Matthias Alder:

Part of an [inaudible 00:20:57] touch on actually alluded to it is right now what is available for Parkinson’s patients is symptomatic treatments. So you try to treat the symptoms as opposed to the underlying cause of the disease. The symptoms are one thing, the cause of the disease is the death of dopaminergic neurons and being able to intervene with these patients early on before that they’ve lost too many of their dopaminergic neurons. That’s the trick. And then you have that convenient once or twice a day administration and that really should help smooth that out and stabilize these patients early on before they have these big swings and a severe impact of the symptoms. Because we’re able to get these patients early on before those severe symptoms develop.

Dr Sam Moxon:

So as a biologist, I want to ask then, does it stop the accumulation of toxics on nuclein? Is that how it stops the death of the cells?

Matthias Alder:

Yes. So the GCase enzyme that we are targeting with our small molecule, the job of GCase is to go into the lysosome, the waist spin of the cells. Sorry if I talk too simplistically here for the audience.

Dr Sam Moxon:

I was going to say we have a very broad audience. Not everyone is a biologist, some people are care workers, some people are nurses. So we have a really broad… So simplifying it means everyone is on board.

Matthias Alder:

Awesome, thank you. So what the enzyme does is it needs to go into the lysosome, the waist bin of the cell and there remove the cell waste, the substrate and create sort of a healthy lysosome, a clean waist bin. And if the enzyme doesn’t work there, it doesn’t get to the lysosome. There’s a buildup of these materials that ultimately the waste spin overflows and the cell dies. And what we’re doing with our molecule is restoring the function of that GCase enzyme. It gets the lysosome, it does its job and as a result you have a clean waste, a healthy lysosome. Which then causes the cell to be healthy and survive compared to not. And so, we have seen that in terms of the effects that we have shown pre-clinically, both in cell based patient derived cells but also in animal models is that we have exactly that effect.

So we see enzyme levels going up, we see more enzyme going into the lysosome, we see the depletion of the toxic material, we see the depletion of alpha-synuclein, we see a reduction of inflammatory markers in the brains of the animals and we see an improvement in locomotion. So you’re essentially seeing all the effects. And to mention, we see improved survival of dopaminergic neurons and an increase in dopamine production. So essentially hitting every step of the way in terms of the mechanism that we need to achieve. And that’s why we’re really super excited and optimistic about the program and about the effects that we’re going to see in humans.

Dr Sam Moxon:

It’s like kickstarting a really positive chain reaction essentially. That’s really exciting. As CEO then, so what does your average day look like? What role do you play in getting this moving forward?

Matthias Alder:

A lot of it is just team leading and that is at different levels. If you are working with groups of people, you need to bring them together and get everybody focused on the things that need to be achieved. And that’s essentially when you have the job you have to do as a CEO, at least internally within the company. And so, I’m working with my management team to make sure that we’re all focused on the right things and anticipating hurdles and working on solutions before problems occur so that we’re always prepared and able to move things forward smoothly. But the other job as a CEO is a lot of interactions with external stakeholders.

So shareholders, investors, just the general public, like patience to tell the story and just telling our audience here because I think it’s a very strong and powerful story to tell that that should be the cause of great optimism for patients. And just getting that out there and there’s 8,000 or so public biotech companies and everybody has a story to tell. So it’s a matter of just being focused and being out there and telling that exciting opportunity. That opportunity that we have here again is to make sure people are aware of it and appreciate it.

Dr Sam Moxon:

And sort of the last segment of this, I want us to talk a little bit about that sort of commercial side of things because it’s something that we don’t often talk about and I think it’s an interesting avenue to go down because I think we’re starting to notice more and more people now leaving academia to go into industry partly because of more job security and that kind of thing. And it’s interesting to see a company like yours that’s making the progress that they are. And so, I want to know, you will meet with academics, you’ll meet with clinicians, you’ll meet with stakeholders, they’ll all want different things from you in terms of output. So how do you balance getting the best result for the patients while also keeping the stakeholders happy, you have to ensure returns and investments and that kind of thing. Or does a therapy like this essentially pay for itself once it gets straight to clinical trials? Because it is a first of its kind?

Matthias Alder:

Ultimately, I think we all want the same thing. If you are in a researcher in a biotech company, if you are a manager, CEO in a biotech company, if you’re an investor in a biotech company, if you are a clinician working with a biotech company or looking at programs, ultimately, that’s the great thing about the industry that we’re in. We want to ultimately have a great outcome and a product that actually helps patients in a very meaningful way. And I think that that creates just an inherent alignment of all these tactically maybe deferring interests. But ultimately, the goal is to bring an impactful therapy to patients and if we’re succeeding in that, everybody wins.

And that ultimately is the main message that we always come back with. And people may have short-term interests that that need to be addressed and talked through, but ultimately it’s all about the long term goal that we have here and that’s really all there is to it. And then just bring it all together. And that’s part of, again, the job of the CEO is like, okay, taking all these things and packaging it and making sure everybody stays aligned and focused and that’s what we do.

Dr Sam Moxon:

I think another thing people might want to know as well, if they’re interesting going down that route of commercialization, I had this misconception that you had to have been through clinical trials before you can spin out as a company, but actually it’s not the case. And what I’ve been told is often the way you get enough money to go through clinical trials is to spin out, that gives you access to the funds. How do you keep stakeholders happy through that process? Because in reality, the revenue from a product comes once it’s been through clinical trials. So just from a practice aspect, how do you keep those stakeholders interested? Is it through showing them the constant progress or as things progress, do they start to take a piece of the property or how do you balance those kinds of individuals?

Matthias Alder:

Well, I think ultimately, it is two observations. One, it takes a lot of capital to develop the drug. And so, trying to do that in a more academic setting I think is inherently challenging because if you’re relying especially on grants, it’s really hard to come by, the money that it takes ultimately to develop the drug. And so, typically the most successful approach to secure the money is to actually go spin that out into a company. And then in a company, you have shareholders and investors and the way to keep them happy and interested is to just progress the program and execute. And there’s risk, right? Nothing is guaranteed in drug discovery, drug development, but showing that progress is ultimately what keeps them happy. And if you have that necessary piece of luck that is always required to be successful, just executing and focusing on progressing the program and not get diluted and distracted I think is key.

Dr Sam Moxon:

The more you bring positive data, the more investors will see that as being de-risked further and further and further and the point where once you get into clinical trials, it’s seen as a much safer prospect, I guess.

Matthias Alder:

Yeah, I mean, there’s risks throughout and there’s companies who take a product all the way through phase three and then don’t get approved, but that’s at every step of the way. In some ways, it’s actually helpful to have quite a highly regulated development process because you can always point to the next step. And once you’ve achieved that, obviously you’ve delivered and then you point to the next step and the next step as you’re engaging with shareholders and investors. The more boxes and steps you take and complete along the way, the greater the confidence. And I think that’s the reality of drug development these days.

Dr Sam Moxon:

So before we come back to the Parkinson’s therapy itself, to finish, I also want to ask if there’s anybody listening to this who’s interested in looking at going down a more industrial commercial avenue and particularly someone who’s thinking, I’ve got an idea here, this could form actually something viable and I want to know how to spin out, but I don’t know where to start. Have you got any advice for somebody like that, about the kind of conversations you should be looking to have?

Matthias Alder:

Obviously, we’re not the first company to have been created and there’s a lot of success stories and failures from which people can learn. And if you are thinking about spinning out from an academic setting into a company, I can guarantee you that there’s many predecessors examples in that academic organization who have done that before. And so, a lot of it is about really reaching out and creating and having the conversations and establishing that network of people who have done it before, who then every conversation leads to something else. First, you need to figure out is what I have already enough in terms of the stage, that type of data that I have, the things I’m thinking about, what the commercial value ultimately is, is that enough to create a company? And once that has been sussed out and then developed as a concept, then starting to connect with potential funding sources, venture capitalists.

And there’s a lot of connections that as every conversation will lead to another conversation, ultimately it all comes together into a successful spin out. And so, I think the starting point is the will and the interest in taking something and spinning it out and then start working it. And a lot of it is, and it’s not everybody’s nature to be networking and reaching out and talking. But that’s I think one of the key ingredients is really building out the network of contacts that you can bridge to really make it a successful process for spinning out the company from an academic group.

Dr Sam Moxon:

The more conversations, the better. So I’ve got two questions to finish with then. The first one is obviously, if I said where do you want to be in five years, the first thing you would say is you want this to be in clinics. So I think the better question is, what’s next after this? What’s the next therapy, the next big thing that you’ve got coming through that you’re excited about?

Matthias Alder:

The next thing for us as a company, other than progressing our lead program is really what we’re started to focus on is oncology, which is interesting because of the nature of the platform, which is entirely agnostic as to therapeutic area. Our interest now focuses in our ability is to develop these binders that are allosteric binders. So we’re able to find allosteric sites on the protein surface. That’s essentially any place on the protein that’s involved in the disease that is not the known active binding site of the protein. And having that ability allows us out of the gate to create very differentiated therapies. And so, from our perspective in oncology, there’s a lot of pre-established models that we can quickly run through and test our molecules and see if they work. And creating that broadening of the application of the platform is going to be important.

The other is to further characterize our lead program and going back to the core interest of the audience here in terms of dementia research, is to further develop and characterize our lead product that we’re initially developing in GPA1 Parkinson’s disease in other neurodegenerative diseases. So we just actually had a poster at ADPD that conference on Alzheimer’s and Parkinson’s research where we’ve shown that our molecule also impacts amyloid beta and phosphor related. So we have a path because it’s a very fundamental mechanism of action with restoring GCase function that translates into other indications including Alzheimer’s disease. And further exploring that continuing to develop the program pre-clinically in other indications including Alzheimer’s will be a key focus for us going forward.

Dr Sam Moxon:

This is all really exciting to hear, and I’m sure there’s a lot of other people listening who are excited by this. I wrote a blog last year called: Are We Entering the Golden Age of Dementia Research? And I think stuff like this reassures me that yes, we are, things are getting closer to the clinic. So for anybody who’s listened to this, who is interested and excited and wants to track your progress, how can they keep up to date on how things are going, not just with the trial, but with the research in general at your company?

Matthias Alder:

Because we’re a public company, our interest is to be very public with our progress. And so, we provide at least quarterly updates on the corporate progress. We also come out with press releases and data announcements all along. We’re going to have another one coming out in August where we’re going to have exciting data coming out. So there is a way to sign up actually on our website for getting updates on the company on an automatic basis whenever we have some news coming out. And then that way you can keep tabs on what we’re doing here at Gain and we look forward to seeing you reaching out to us at Gain.

Dr Sam Moxon:

And so, what we’ll do is we’ll put the link to the website in the show notes so people can follow that and they can subscribe to the updates. Well, Matthias, thank you for joining us. It’s been a really fascinating discussion, really exciting to hear what you guys are up to. So thank you very much for your time today.

Matthias Alder:

Thank you, Sam, thanks for having me. I really enjoyed the conversation here as well.

Dr Sam Moxon:

And we hope you guys enjoy listening as well. So please do tell us on YouTube, on Twitter or whatever social media platform you want to use. But in the meantime, thank you all for listening and we’ll see you all soon.

Voice Over:

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