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Business Of Biotech
Biotech Product Partnership with Coya Therapeutics' Arun Swaminathan, Ph.D. and Dr. Reddy's Milan Kalawadia
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On this week's episode, Milan Kalawadia, CEO, North America, Dr. Reddy's Laboratories, and Arun Swaminathan, Ph.D., CEO, Coya Therapeutics discuss their unique partnership to develop COYA 302, a novel dual-mechanism immunotherapy for the treatment of ALS. The partnership pairs Coya's scientific expertise with Dr. Reddy's manufacturing and commercialization capabilities, putting Coya in a financial position to advance development activities and commercialize COYA 302 upon FDA approval, and providing Dr. Reddy's -- a generics, biosimilars, API, and OTC manufacturer -- with an opportunity to pivot into innovative branded products. Kalawadia and Swaminathan discuss their pathways to the CEO role at each company, respectively, how the partnership came together, ongoing FDA engagement, and what COYA 302 could mean for patients with ALS.
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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 speaking with Milan Kalawadia, ceo North America at Dr Reddy's Laboratories, and Arun Swaminathan, phd, ceo at Koya Therapeutics, about their unique partnership to develop and commercialize Koya 302, a dual-mechanism investigational biologic combination immunotherapy. It's a mouthful for patients with ALS. We'll learn about how and why this collaboration came together, what it means for each of the two companies respectively, and what's next on the pathway toward FDA approval and commercialization. Thanks so much for being here, milan and Arun.
Arun Swaminathan, Ph.D.:Thank you.
Arun Swaminathan, Ph.D.:Ben, thanks for having us.
Ben Comer:And that's Milan, not Milan. I'm going to get that right before this conversation is over.
Milan Kalawadia:It's quite all right, quite all right.
Ben Comer:Thank you. I thought that we could start off with a little bit of background on both of you, as we do on the business of biotech. You've both risen to the very top of your respective organizations and I wonder if you could just take a couple of minutes to reflect on your past experiences and maybe the specific circumstances that got you to this point. What previous jobs prepared you for leading Dr Reddy's and Koya, respectively, and Millen, maybe we'll start with you, if that's okay.
Milan Kalawadia:Yeah, sure so appreciate the opportunity to be here with Arun and yourself, ben. Yeah, sure so appreciate the opportunity to be here with Arun and yourself, ben, very excited for today's conversation. But to get into the crux of it in your first question, so I'll start backwards. So, yes, I'm North America CEO of Dr Reddy's. I've been with the company for over 19 years now. But if I go back to the beginning, I was an undergrad out of Rutgers University. I got a degree out of the business school that essentially set me up for consulting, and I did consulting for a couple of years Deloitte Consulting on the system side it was during the era of which dot-coms were the big buzz was then decided to join a few startup companies with the hopes of retiring early. Didn't quite work out, ended up going back to grad school, got my MBA from Carnegie Mellon and then worked at Merck Pharmaceuticals for a couple of years in the finance capacity, joined Dr Reddy's in 2006 in a role in our finance department, and then my journey from there has been tremendous.
Milan Kalawadia:Was in North America at a time when the company was probably about 45, 50 employees, about 60 million in revenues, and we had just entered the US market back in 2003. So a few years before I joined. So I joined at a time where there was tremendous opportunity and growth. We entered as a retail generics business. I was able to move from finance into many different roles. As I stated, I got the opportunity to spend about four or five years in business development where I started to get exposure to many of our businesses, ultimately moved into an operating role where I was running our marketing group for our private label OTC and then started to add responsibilities related to some of our other commercial entities. Our hospital institution business took over P&L responsibilities for both the private label OTC hospital institution and then ultimately the RxGenerics. And along the way I had the opportunity to do many other things as well.
Milan Kalawadia:I spent time in running North America IR when we were at the early stages of doing US IR, investor relations, took over customer service portfolio, and so when you ask the question about how did my career set me up for the role I'm in, I would say predominantly twofold.
Milan Kalawadia:One early stage of my career was the mindset around being entrepreneurial, strategic, trying to find opportunities, doing what it takes to win. The Dr Reddy's experience helped groom me to get through different roles and responsibilities that ultimately set the stage for me to have this opportunity, which I've been in for a little over a year now, which is responsible for North America, a business that's now 1.7 billion plus in revenues, about 300-ish employees within North America, which includes US and Canada, and looking forward to driving future growth in a couple of our other additional areas beyond the base businesses of private label OTC, hospital institution and retail generics. And those growth businesses are our self-care wellness division and our biosimilars division, and we'll get into more details, I'm sure, through this discussion around how the partnership with COIA is a really good intersection of where Dr Reddy is headed and how we got to that partnership. But that's a bit about my background and appreciate you giving me that opportunity.
Ben Comer:Yeah, that's perfect, Milan. Thank you so much for that, and we'll definitely get into the partnership. And also, you know, I have a question or two, maybe just about the evolving biosimilars landscape too, that I might try to sneak in. But, Arun, let's talk about your background. And oh, last thing, Milan, this is your first CEO role, is that right? That's correct, okay, all right, excellent, all right, Arun, take it away.
Arun Swaminathan, Ph.D.:Yeah, no, thank you, Ben. It's a pleasure to be here on your show with Milan and you Appreciate the opportunity. I'm currently the CEO of Coya Therapeutics and what excites me and I think that has defined my career is the intersection of science and business, and you'll see that, both serendipitous and through my own planned approaches, that's exactly what I've gravitated towards throughout my career. Going backwards, I'm a pharmacist by training and I also got a PhD from the University of Pittsburgh in transplant immunology. So that's kind of my academic background. That led me to places like Bristol-Myers Squibb and I say this quite a bit.
Arun Swaminathan, Ph.D.:I grew up at Bristol-Myers Squibb and what I mean by that is Bristol-Myers Squibb, because of the size of the company allowed me to get experiences across a spectrum of things. I started by designing and running clinical trials, because I was a clinical pharmacologist by training. So I got to understand how that works. How do you design them, how do you get them going, what does it take to get IND approvals and FDA approvals, et cetera. So I was directly involved in taking one product all the way from IND to an NDA filing from the scientific perspective. But that also got me exposed to the commercial side of the business side of the business, and then I did multiple roles in commercial strategy, marketing, brand lead roles as well as business development roles at BMS. All of that kind of gave me that foundation, a solid foundation to be able to do what I've been doing the last 10 years, which is really making good science come to life, and that's kind of what I'm passionate about Last 10 years.
Arun Swaminathan, Ph.D.:Briefly, I started I got the entrepreneurial bug, co-founded a biotech company about 10 to 11 years ago, so that was the start of my small company journey. Since then I've been in the C-suite of small public biotech companies, koya being my fourth company that I'm at in the last 10 years. I gravitated to Koya because of exactly what I was telling you before, ben, which is that it was a perfect intersection of science and potential and market potential for me. I could see the value of the scientific approach. I could see the elegance and simplicity of our approach, which hopefully we'll talk about, and that's what got me excited. I joined COIA two and a half years ago as a chief business officer and had the responsibility to successfully complete the business development deal and bring Dr Reddy's on as our partner, which we are extremely grateful for, because it's been such a value-creating partnership for us. And then I assumed the role of the CEO about I want to say about nine months ago.
Ben Comer:All right, all right, yeah. So leading small public biotechs is not a job for the faint of heart, as you well know, arun. You know what I'm hearing in common from both of you is that you've both worked across a number of different functions in life sciences companies, which I suspect has set you up quite well for the CEO role, and how multifaceted it is, and we'll maybe talk some more about that. But I want to go back to you, mellon, for a moment here. Dr Reddy's Laboratories is known, I think, primarily for manufacturing generic drugs, biosimilars, api, over-the-counter retail products, as you mentioned. But today we're talking about an innovative combination product that Koya is developing, that Dr Reddy's will commercialize. And before we get into Koya 302, can you kind of talk a little bit, millen, about what this deal means for Dr Reddy's and kind of the thinking behind it?
Milan Kalawadia:Sure, ben, I appreciate the opportunity to address this. For Dr Reddy's, yes, we are an API company moved in to finish formulations and generics In the early 2000s we got into biosimilars and first started developing and selling biosimilars into the emerging markets. But there's always been a high level of interest and effort that has gone behind innovative science and innovative medicine within the company. And if I take it back to our founder, Dr. Anji Reddy, he always had the desire and the passion to launch an innovative asset out of Dr Reddy's, and so that transpired over the years. There were a few efforts that we had gone down the path of, not as successfully as we would have liked. To date, however, there's still a high level of interest and focus on innovative science, and so when I think about the transaction or the partnership I should say with COYA, it was a nice intersection of some of our capabilities with our desires to get into innovative science, but then also tying it back to Dr Reddy's and our purpose and our mission. So one of the areas that Dr Reddy's is really focused on is bringing solutions and products that can help meet unmet medical needs, and the segment that COYA 302 actually helps address is ALS. It's an area that, as we know, has had very few products that have come to market that are able to address the disease state, and so it was a very exciting opportunity to discuss with Arun and team, and as we started to dig into it, started to align more and more with how this is an asset that would be one that Dr Reddy's could actually partner with Coya and help make a huge success. And so when I think about your question and how this is key for Dr Reddy's, I think it's the next evolution of our journey. We are moving from, or continuing to be, a generics player. Moving into biosimilars but novel products and new development efforts is the next wave, and Coya 302 fits in nicely with that.
Ben Comer:Yeah, I definitely want to pick up on this new kind of adventure in innovative medicines with Koya 302.
Ben Comer:I have a quick question though, about the kind of evolution of the biosimilar space which is.
Ben Comer:You know. I've seen a number of different and this is more of a commercial question, I won't spend a lot of time on it, but I've seen different approaches where a company and this is maybe particular to the US market, but companies going in with a biosimilar that is priced at, you know, not much of a discount off of the brand name, and then biosimilars coming in at a pretty steep discount to the brand name. And I think the thinking there is, you know some of the PBMs prefer the higher price biosimilar, which they will. Then you know the companies will then discount and you know the PBMs can make money off of that versus, I would assume, in emerging markets the kind of lower price and maybe in parts of the US or certain health systems or insurance plans, the lower price is more effective. I'm just curious, millen, kind of top level, what you're thinking is in terms of how that is evolving, the landscape for biosimilars pricing, and if there's one strategy that you're finding leads to better patient access to biosimilars.
Milan Kalawadia:So specific for the US market.
Ben Comer:Yeah, sure. Yeah because I think with the high-low, you know playing with the price. I think that's probably specific to the US. Sure, yeah, because I think with the high-low, you know playing with the price. I think that's probably specific to the US.
Milan Kalawadia:Yeah, yeah, so probably be a little bit broad in the response here. But Ultimately with any product launch it's market dynamic dependent, and so in the biosimilar space there are two distinct segments. There's the medical benefit and the pharmacy benefit side. Those two segments operate very differently and so pricing is dictated by the segment within which the products align, and then it's also dependent on the number of competitors that come to market on a given product at a given point in time. So strategies evolve. I don't think there's one cookie cutter response to your question in terms of it's going down a particular pathway. It's product to product, specific and unique to the channel within which the product is placed.
Ben Comer:Okay, all right, thanks for that, Arun. Let's get back to COIA-302. But first I wonder if you could provide a kind of high-level explanation of COIA Therapeutics development, work in multimodal Treg therapies and maybe the kinds of diseases and therapeutic areas that COIA is targeting.
Arun Swaminathan, Ph.D.:Yeah, certainly Ben. So our focus at Coya, our vision, is to make devastating neurodegenerative diseases livable diseases. Today, most of these diseases are a rapidly declining quality of life issue for patients, and with many of these diseases the lifespans are significantly shortened as well. With ALS, for example, the average ALS patient lives three to five years after diagnosis and in that three to five years they are rapidly declining in their physical ability. So that is what we want to transform. We want to bring solutions to the market that hopefully allow these patients to lead a normal life.
Arun Swaminathan, Ph.D.:So our focus is neurodegenerative diseases and what we fundamentally focus on is neuroinflammation. What we know, ben, is that when neuroinflammation is high, it is directly correlated with progression of many neurodegenerative diseases, like ALS, like FTD, alzheimer's, parkinson's, right, and so we believe that slowing down or stopping the neuroinflammation and its source is the way to stop the progression of these diseases. To be clear, we're not talking a cure yet. We are talking about stopping the progression of these diseases, which, by the way, nothing there currently does that and not even remotely close to stopping the progression. So we would love to see that happen. And the way we address neuroinflammation is by addressing the regulatory T cells, as the name implies, they are immune cells that regulate something. They are kind of the brakes of the immune system, right? They basically say to the immune system don't go at 100 miles an hour, you should be going at 20. And when that happens, there's a good the good cells are not being attacked. What happens in neurodegenerative diseases is these Tregs, which are the brakes, are not functional and then the T cells and the rest of the immune system starts attacking healthy neurons or nerve cells. When this happens, basically our internal spark plugs are misfiring, right, which is what the neurons and nerve cells are, and this leads to the progression of neurodegenerative diseases. So we, our whole focus is on making these Tregs functional and keeping them functional in a durable manner, and that's exactly what we do with COYA-302.
Arun Swaminathan, Ph.D.:COYA 302 is a proprietary combination of a low-dose interleukin-2. On its own, interleukin-2 will increase. Low-dose will increase the number and function of Tregs, which is what we want. But the CTLA-4 is a critical combination, because what we do with CTLA-4 is keep the inflammation driven by the myeloid cell, by the macrophages, also low. And that's because the CTLA-4 acts on a different mechanism, by acting on CD8086. Because the CTLA-4 acts on a different mechanism by acting on CD8086. So we're acting on two aspects of the immune system that then keep that balance. One allows for the Tregs numbers to go up and the functions to go up and the other, in combination, allows for it to stay anti-inflammatory, the macroenvironment, thereby keeping the Tregs functional for long, which means it should translate into durable clinical efficacy. And that's what we have seen in small investigator-initiated trial that was conducted, that we are seeing that we're able to keep ALS patients from declining. At six months a small IIT study and at one year there was very minimal decline when normally these patients would have declined pretty dramatically in that same time period.
Ben Comer:Right, and a component of COYA-302 is abatacept, a drug that you know is, I believe, Coya in-licensed from Dr Reddy's. Initially it's a biosimilar of BMS's Orencia. It may also be in development at Dr Reddy's as a biosimilar. I'll check in with Milan on that. But I want to hear how this partnership came together. It sounds well. Well, I'm assuming that it started with the in-licensing of abatacept but, um, Arun, maybe I'll stay with you for a minute and then I'll get um and then I'll uh, I'll ask um uh melon to chime in. But um, how did this come together? And you know how? Who, who had this idea that Dr. Reddy's would ultimately commercialize this product. But let's hear the Coya story first.
Arun Swaminathan, Ph.D.:I'll give you the Coya side of it.
Arun Swaminathan, Ph.D.:I think Milan said it earlier.
Arun Swaminathan, Ph.D.:The intersections that the two companies have was a natural synergy, One you just pointed out abatacept is one of the components of COYA-302, and Dr Reddy's is manufacturing abatacept, so that's just number one, a very natural synergy right there to be in the next wave into more innovative therapies. We were aware of that as well. Dr Ellison has publicly stated that. And the synergy between the two companies in terms of our ability to bring to the table different skill sets, different capabilities, where we felt that one plus one is going to be better than two. And I think we are already seeing that in the one year of our partnership.
Arun Swaminathan, Ph.D.:And that's what brought us to the table together. And so it was kind of a natural progressive conversation that happened between the leadership of Coya and leadership of Dr Reddy's. It kind of made intuitive sense to both sides and it was very clear that both sides are going to create value together and, more importantly, together we can bring this therapy hopefully faster to patients, and that's really what drove all of this. And there's a common mission that we have that we want to bring address unmet needs for patients. I'll let Milan give the DRL side of the story.
Ben Comer:Yeah, and Milan, before I turn it over to you, I just had a quick question about Orencia, arun, kind of from a scientific level. Were you familiar with Orencia? You know kind of as you were thinking about, you know the development of 302, was that something that you had kind of hands-on knowledge of? Was there overlap of that drug with you at BMS?
Arun Swaminathan, Ph.D.:Yes, Ben. I was on the launch team of Orencia way back in 2005 as a junior marketing person on Orencia soon after the launch, I should say and then I was also the worldwide brand head and director for Orencia. So I'm extremely familiar with abatacept, with Orencia. Of course, my focus was on marketing Orencia for patients with rheumatoid arthritis, which is the primary indication Orencia was approved for. I was also involved in Orencia when it transitioned from an IV to sub-Q presentation as well, so I have deep knowledge of Orencia from my Bristol-Myers Squibb days.
Ben Comer:Okay, that makes a lot of sense. Milan, what made Dr Reddy's decide we're going to commercialize this quite novel drug mechanism, an innovative product? It seems like something of a departure. But yeah, how did that? What's the Dr Reddy story?
Milan Kalawadia:Sure, sure, yeah, absolutely does seem like a departure from where we are at today, but not where we're headed. But before I get to that, you know what started as a discussion between Koya and Dr Reddy's around what could have been a simple supply deal to provide a Badasept evolved as we started to engage in dialogue and conversation. As we started to engage in dialogue and conversation, arun and team obviously shared a vision, shared the insights on the project and the work that they were doing with our business development team, and there seemed to be a good opportunity here, which then required deeper diligence, a little bit more understanding of the journey that Koya and team had been on the foundational work that they've done to date to actually start the program, to then now get to the point where, uh, that abitasa was now required as part of the broader landscape, and so it was really exciting for us was a project that we were working on, was potentially going to have an opportunity to serve a bigger purpose, and so so, connecting with Arun and Koya and finding an opportunity to take our Abitacid program, which we were in the process of taking forward for the US market as a biosimilar R&D efforts were underway, commercial go-to-market strategies were being devised, then had the opportunity to now serve yet another purpose and also meet an unmet medical need, like we talked about earlier, which is to treat ALS patients. So when we go back to the intersection of the deep science that Koya worked on, to the development work that we were doing for a biosimilar asset, to then the commercial aspirations and Dr Reddy's desire to get into innovative assets, it was great timing for one, but then also a great opportunity. And so, while it may seem as a departure Ben, we're already going down the path of building capabilities for our biosimilars.
Milan Kalawadia:We're in the process. We were at the early stages when we first signed the deal, but where we sit today, we have a team in place that's working on the infrastructure build-out, that's preparing for a biosimilars launch, that's working towards commercializing an asset in a branded fashion. Now biosimilars, different than generics, are going to require market access teams. They're going to require a field force. We have a in-house marketing department, so we're building out capabilities. That also leads us down the path of being a good strategic partner for Koya and to enter into this relationship to commercialize the asset, because timing will be quite optimal in the sense that we will have launched. Our biosimilars are not generics. You do need a market access team.
Ben Comer:You may need even a sales force to go out and talk to physicians. You may need a kind of key accounts manager for payers. It's a very different experience, right than marketing and selling a small molecule generic drug. Okay, that makes a lot of sense. As far as Arun, next, I have kind of a funding question for you and I remember you know the Ice Bucket Challenge and ALS probably one of like the biggest, most successful fundraisers for any disease state. But you know, here we are still today without a really effective treatment for ALS. It's no surprise to anyone that it's a very difficult environment in the public markets right now. It's not easy to fundraise really for anyone in early stages of development. What kind of I guess, strategic rationale would you give for licensing COIA-302 to Dr Reddy's for commercialization and does that actually help you progress the asset?
Arun Swaminathan, Ph.D.:First, 100%. I think our partnership enables to advance the asset more efficiently and also in a more rigorous manner, because we now have the power of Dr Reddy's thought process and expertise as well. The power of two brains, two corporate brains is better than one any day and we fully leverage that. And I think it's a no-brainer answer for me that, yes, it absolutely creates value. As far as the capital markets, you're right, Ben. I mean it's a tough market for biotechs. It has been a tough market for biotechs the last few years and that was part of our rationale also to enter into a partnership with Dr Reddy's, with ALS.
Arun Swaminathan, Ph.D.:What we have been able to do through that partnership is a couple of things. One is it just made more sense to put this product in the hands of somebody like Dr Reddy's and Millen's team that has the sales force, that has the commercial experience, that has PVM teams and managed care teams that can address a lot of the things that COIA doesn't have the infrastructure to do. So it just made a lot of sense that we don't do that ourselves. I'm a big believer that strategic deals are about leveraging do what you're good at and let somebody else do what they're good at, and I think that's what we're doing here.
Arun Swaminathan, Ph.D.:And then the second thing from a capital market is that I mean, I don't know if the market agrees with me I do think we have removed an overhang that a lot of small biotechs have. When they get approved, when the BLA is good, immediately the market goes okay. Now Koya is going to have to spend millions and millions and millions marketing this, but we have taken that off of the first indication, ALS, because we have a strong financial partner in Dr Reddy's who will be responsible for commercializing. So there is that benefit. Definitely that wasn't the main reason we did this partnership, but I think it is a byproduct of it for sure, and that has helped us with the capital markets. It has helped us stay cash efficient with the support of Dr Reddy's, and we are, for a small biotech company, in a relatively good cash position when you compare us to a lot of our peers, and I think that has partly been possible because of this strategic partnership.
Ben Comer:Yeah, and then on manufacturing, you know obviously Dr Reddy's is more than capable of scaling up Abatacept manufacturing for late stage clinical trials. What about the other component of 302? Are you in the process now of scaling up that manufacturing, and is that actually done by a separate CDMO or by COIA internally? And how does that, I guess, work, just thinking about needing to create more of COIA 302 as the drug progresses into the final stages of clinical trials?
Arun Swaminathan, Ph.D.:So the clinical supply we have lined up and it is from a CDMO that is outside of Dr Reddy's. I'm going to hold from speculating or sharing with you because we haven't publicly done so on our plans for commercialization, but it goes without saying we work very closely with Dr Reddy's on how and when we would do that manufacturing of the low-dose IL-2 as well, but the CTLA-4 obviously already is manufactured by Dr Reddy's. And you brought up a very good point, ben. Among lots of the synergies with Dr Reddy's is also their expertise in manufacturing. It's not the core strength of COIA. We are not a manufacturing company. We are advancing the science of Tregs, understanding neuroscience, understanding clinical trial design company. So the two things come well together when you think about our two companies and I think yeah, I think that's what I can appropriately say at this point, obviously at the right time, what Dr Rennes and us will share in more detail how we are preparing for commercialization.
Ben Comer:Great and Milan, you've talked about how COYA 302, commercializing COYA 302, is complementary to some of your other lines of business, in particular biosimilars and the capabilities that you're already in the process of building there of its innovative drug from you in the very beginning. But do you see this as a jumping off point for potentially future commercialization deals with other innovative companies and other innovative brands? Are you making those plans already, or is that something that you're going to look at in a kind of opportunistic way or no?
Arun Swaminathan, Ph.D.:I think the simple answer is yes, it's an opportunity. As we think about evolving business models. COYA 302 is the focus, however, from a space to play with innovative assets. As I stated earlier, is an area that has been of interest to us, and so we are in early stages of going beyond just a single asset, type of environment and looking strategically on how best to move forward and continue to build and evolve in novel products, and so I'll refrain from maybe sharing much more detail, but it definitely creates an opportunity for us to now continue to evolve this side of the business Right.
Ben Comer:Ok, so you don't have any kind of set product goal. You know we're going to commercialize X number of innovative drugs in 2026 or 27 or 28.
Milan Kalawadia:At this point, yeah, no, we we from sharing forward-looking statements such as that as a company, and we have not stated specific targets on how many products we'd be looking to launch by certain periods of time, but simply stated this is an area of the business that we want to continue to focus on and grow.
Ben Comer:Excellent. We've talked a little bit about Coya 302 and how it's different, Arun. It's a combination of two separate active components coming together. The lead indication is for ALS. Is there anything else I guess you would share about other indications or future plans for 302? Yeah, let me just leave it there. What else is happening in terms of development? Is it in parallel? Will you go for this kind of first approval in ALS before looking at advancing other clinical programs and other indications? Sorry, I put a lot of questions in there at one time for you, Arun.
Arun Swaminathan, Ph.D.:No, that's perfectly fine, ben. Yes, our priority is ALS. So I think we want to first get ALS advanced, which hopefully, once we receive the green light from the FDA, which we anticipate in the next 7 to 10 days, we'll hopefully be able to initiate that potentially pivotal phase 2b study in patients with ALS. So that is our number one priority for 2025. However, as I previously mentioned to you, our mechanism will absolutely work in frontotemporal dementia and other diseases as well. So our second indication of priority, if I can call it in order, is frontotemporal dementia. We fully intend to submit an IND to the FDA on FTD towards the end of this year, once our ALS trial is up and running. That's our current plan and we have publicly disclosed that and then, if all goes well, we will initiate a small phase 2B study that will have been funded, partly at least, by the Alzheimer's Drug Discovery Foundation sometime next year, in the first half of next year.
Arun Swaminathan, Ph.D.:That's kind of our two areas of focus On Alzheimer's and Parkinson's disease. Right now we are focused on also a different acid, coya-303, which is a combination with GLP-1 agonists, the popular weight loss drugs that have the potential in diseases like Alzheimer's disease. Of course, as you may be aware, there's going to be some significantly big readouts coming out of no one, nor this semaglutide towards the end of this year on the two big trials, evok and EVOK+, that they're conducting in patients with mild Alzheimer's disease. So I do think that opens up a lot of value creating potential for COIA in the Alzheimer's disease space. But our immediate priority for COIA-302 is ALS. Number one hopefully get the FDA green light, get that trial started, followed by frontal temporal dementia.
Arun Swaminathan, Ph.D.:We have shown investigator-initiated trial data in a very small group of FTD patients that we do something similar to what we've seen in ALS, which is we stop the cognitive decline in these patients. In the case of FTD it's cognitive function as opposed to physical function more, and we've shown that we're stopping it. And, more importantly, we're seeing that the science plays out. We see Treg numbers and function improve with this combination IL-2 plus CTLA-4, and staying durable. And then that translates to the biomarkers moving the right way and then that is translated by the small study to the stabilization of the disease. And that's what we like to see as a scientific company is that everything lines up. That increases our confidence, one in the outcome, the probability of technical and regulatory success in ALS as well, and in other diseases as we move forward.
Ben Comer:On the combination with the GLP-1, is that one? Are you kind of lining up that clinical program with being able to market maybe semaglutide specifically? Are you looking at other you know active GLP-1 ingredients, I guess how are you thinking about that? You know the potential patent expiry of semaglutide and then how you move that in if that is indeed you know the molecule that you're targeting.
Arun Swaminathan, Ph.D.:So we're keeping our options open on the GLP-1 pen. But what we have generated to date is data with semaglutide and with exenatide and we've shown that semaglutide plus COYA-301, which is her proprietary low-dose IL-2, is synergistic in neuroinflammatory markers. This is all preclinical, non-clinical work, so obviously we'll have to show and demonstrate this at some point in the clinic. But you know we're not and of course we do have IP around it. So we have the patent rights to the combination of flow dosing from looking to with any GLP-1 agonist, not just 7-WP.
Ben Comer:Got it, thank you. Thank you for that. Milan, I want to come back to you on the commercial launch us a lot of information about how you're approaching this, building out sales teams that will have kind of double duty, being able to sell biosimilars as well as Coya 302 once that is approved. But can you talk about how you build up those capabilities and kind of where you're focused on? I mean, are there any key new hires that you're making? Are you thinking about Salesforce size? Are you thinking about, you know, specific regions or even ex-US opportunities at this point?
Milan Kalawadia:Yeah, no great question All of it. So we've been on a journey in the US and we have been fortunate to find some great talent in the market that has joined to help us evolve our commercial infrastructure, internal marketing capabilities to pricing analytics, and then also focusing on market access, and I'll call it field force design and ultimate account management. And so we are being very methodical in our approach. We're looking for, one, the right talent, but two, the right approach to actually go to market and commercialize. We've had discussions around do we build the in-house Salesforce? Do we go contract Salesforce? Are there other partnership models that we can evolve? And so those discussions are at a very mature state At the moment.
Milan Kalawadia:When it comes to hiring, there are probably a few more key talents that we need to bring internally, but we have decided that, from a Salesforce design perspective, we are staffing for the US. We have done our field for sizing, but we're going to do it through a third-party model at the time. At this time, at a future point in time, as the business evolves and grows, chances are we would internalize, but at the moment it's going to be a third-party approach. And so we're constantly looking at the business model, the go-to-market strategy, evolving it to make sure that we're nimble, but setting ourselves up for success, and so I'm very confident at the approach that the team has been undertaking, and we're very excited for our first biosimilar launch, which is should, if all goes well, be next summer, followed by a potential abatacept launch in the year after, and so a lot of work is underway, but we will be ready for those launches, as well as the future launch of COYA 302.
Ben Comer:Okay, and you just answered a question that I had that I had kind of forgotten about, which is you are also developing, you know, in parallel, a kind of a biosimilar, or, you know, pushing abatacept forward as a potential biosimilar to Orencia, at the same time as Coya is developing 302.
Arun Swaminathan, Ph.D.:That's accurate, that is correct, and there is a broader pipeline behind the biosimilars business as well, but abatacin becomes the first major molecule that will launch under that division.
Ben Comer:Great, excellent, Arun, I want to come back to you for a question on IP. Obviously, it's a critically important function of value for a biotech. You've got a unique product on your hands. What can you tell me about Coya 302's intellectual property holdings, and maybe just give me a sense of what those are?
Arun Swaminathan, Ph.D.:Yes, Ben, COYA 302 actually has a very strong IP portfolio. I like to call it like an onion. We have a complex series of IP that protects COYA 302 in a very robust manner, with the average life of the intellectual property going well into the 2040s. So we are well protected. And I'll explain to you why. There's really three key reasons. One we have a proprietary low-dose interleukin-2. The patent was granted and we publicly disclosed that in June.
Arun Swaminathan, Ph.D.:So we have the aqueous low-dose interleukin-2, and the methods around it is part of our intellectual property rights. What that allows you to do is it allows you to administer low-dose IL-2 as a subcutaneous administration. The currently available IL-2, which is used in the oncology indications at a much, much, much higher dose, is a lyophilized, freeze-dried presentation that needs to be then reconstituted and it's administered intravenously. So we have enabled, through our intellectual property, the administration of IL-2 in a self-administered or, in the case of ALS patients, likely caregiver administered, but it can be done at a home setting. So that's IP number one.
Arun Swaminathan, Ph.D.:We also have intellectual property around the combination of any interleukin-2, including mutines, spegulated long actings, with any CTLA-4 inhibitor. So that gives us a powerful protection around COYA 302. And to wrap it around. We have some additional biomarker patents on ALS that also give additional protection for COIA-302. And so there's very strong IP and, assuming that one gets an Orphan Disease designation, these diseases definitely qualify Outside of the IP. The FDA tends to grant a seven-year commercial exclusivity for those types of products as well, so we feel pretty good about the ability to protect COIA-302 commercial.
Ben Comer:Got it. And just to clarify, COYA 302 will ultimately be a sub-Q administration that can be done like, say, by an ALS patient, his or herself or a family member. It doesn't have to be a healthcare practitioner. That's giving it. That's an important, I think an important attribute for the product potentially.
Arun Swaminathan, Ph.D.:Exactly, Ben, and that is key to understand is that the presentations and that's how we are designing the clinical trial. The clinical trial will be done where, after the first administration or so, the patients are trained or their caregivers are trained and they administer it at home. And these injections are no different than the current Orencia injections or GLP-1 injections. They're easy. It's not like complicated, they're not slow infusions or slow sub-Q, it's a single shot administration which makes it very easier for the patient to not have to go to the clinic or that kind of setting to get their dosing done.
Ben Comer:Got it. And then, speaking of clinical trial design, could you describe what kind of engagement Arun that you and Koya have had with the FDA? Have they, you know, have they been instructive and, you know, offering guidance, or, you know, have you had other conversations with them about Tregs? Where does that kind of relationship stand, if I can put it that way?
Arun Swaminathan, Ph.D.:I mean we have had multiple interactions with the FDA and what I can say is the FDA is extremely collaborative.
Arun Swaminathan, Ph.D.:I think the FDA has the same mission we all have, which is to bring better options to patients. Through the last year we have had discussions with them on the data needed for them to say, okay, you can go ahead with your phase 2B trial. We've had good alignment with them. We have submitted that data. We anticipate a response from them in the upcoming week, a week or so. So it's been a pretty good engagement and, from our experience, as part of that, obviously the clinical trial protocol is part of that. So we do get feedback from the FDA on our design. So by the time we get all this started, we are aligned with the FDA and we'll have confirmation that we're aligned, hopefully in a couple of weeks with the FDA. So it's been a very collaborative process and we have not seen anything different in our interactions with the FDA. And I'll add that our regulatory submissions are also strengthened through our partnership with DRL, because we do leverage their regulatory experts as we prepare these documents that we submit to the FDA and other agencies as well.
Ben Comer:Oh, ok, I'm glad you mentioned that. That's an important resource, you know, I would imagine, for any small biotech company to have access to regulatory experts. We are running short on time, but I want to get just a final thought from both of you about key priorities. You know for the rest of this year, and maybe Arun we'll keep it with you and then we'll end with Milan, but you know what's next for COYA-302? You're going to hear something back from the FDA in a couple of weeks, but you know what's the key next step. What's your top priority for the rest of 2025?
Arun Swaminathan, Ph.D.:Well advancing. The clinical trial in ALS is priority number one. Obviously, that's contingent on getting that green light from the FDA, but that is our number one priority for 2025, getting that trial started in 2025.
Ben Comer:And that'll be the Phase 3 trial.
Arun Swaminathan, Ph.D.:It'll be a phase two B, okay, in 2025. And that'll be the phase three trial. It'll be a phase two B, but with ALS, the FDA has precedence of approving products with just one trial because of the high unmet need. Of course, that'll be subject to data and we'll have to have a discussion with the regulatory bodies at the right time about it. But, yeah, there is precedence for it. So that is our number one priority Get the ALS clinical trial off the ground.
Arun Swaminathan, Ph.D.:Number two is file the IND for frontotemporal dementia after that and then get ready to start a small trial in FTD in 2026. And then, in parallel, we'll advance our COIA-303 from a preclinical perspective. We have an ongoing animal study that will hopefully further strengthen our hypothesis around the synergy and we should be able to disclose that publicly we hope in the second half of 2025 as well. So these are some of the things, and we'll continue to generate more data around biomarkers and prediction in these ALS and other diseases as well in the second half of 2025. But our number one priority is getting the ALS clinical trial started.
Ben Comer:Got it and Milan. What are your top priorities at Dr Reddy's, for the rest of 2025?
Milan Kalawadia:Yeah, so specific to the partnership we have with COYA and 302, continuing to help progress the outcome right.
Milan Kalawadia:So waiting for FDA feedback, but partnering from a regulatory standpoint as the product continues to evolve, engaging in manufacturing-related discussions to continue to or continuing to ensure that we are ready for success. So that becomes, and continues to be, a priority as it relates to the partnership, the great partnership we have with Coya, as I think, beyond this conversation and the rest of the business, a few different things that are priorities we need to continue to drive our base business, drive growth out of the base business, which is our generic portfolio here in the US, putting a lot of time and energy behind our growth initiatives, which is the self care wellness space, as well as the biosimilars which we spent some time talking about today. And then another critical component of the overall priority list is we have a portfolio of GLP-1s. We're actually in a position to launch our first GLP-1 in Canada, which is semaglutide, and the preparations to ensure that we are ready for day one. Launch of that product in Canada is probably the top priority at this point.
Ben Comer:So, Arun, you've already got a supplier for your semaglutide product, then Well, yeah, I mean, obviously we'll have those conversations.
Milan Kalawadia:I can't share any details at this point.
Ben Comer:Thank you so much, both of you, for being on the show. We've been speaking with Milan Kalawadia, CEO of North America at Dr Reddy's Laboratories, and Arun Swaminathan, Ph. D., CEO at Coya 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 video casts of these conversations every Monday under the Business of Biotech tab at lifescienceleader. com. We'll see you next week and thanks, as always, for listening.
