Eledon Pharmaceuticals at Leerink’s Global Healthcare Conference: Transplant Innovations

Eledon Pharmaceuticals (NASDAQ: ELDN) presented at Leerink’s Global Healthcare Conference 2025 on Tuesday, 11 March 2025, outlining strategic advancements in transplant medicine. The company highlighted its focus on Tagoprivartin (TEGO), a promising CD40 ligand targeted antibody, aiming to replace the current standard of care, tacrolimus, due to its toxicities. While Eledon is optimistic about its potential, the company faces challenges in demonstrating TEGO’s superiority in ongoing trials.

Key Takeaways

• Eledon is advancing Tagoprivartin (TEGO) in transplant medicine, especially kidney transplants, to replace tacrolimus.
• The Phase II BISTO study, a critical trial for TEGO, aims to show a 9-point eGFR improvement with results expected in Q4.
• Eledon is exploring TEGO’s potential in other organ transplants and autoimmune conditions.
• The company collaborates on xenotransplant studies with eGenesis and United Therapeutics.
• Eledon is developing a subcutaneous formulation of TEGO but prioritizes IV infusion.

Operational Updates

• Phase 1b Study (Renal Transplant):

- Updated data to be presented in August at the World Transplant Conference.

- Mean eGFRs reported in the high 60s, indicating promising graft function.

• Phase II BISTO Study:

- Completed last patient enrollment in September with 120 subjects.

- Topline data expected in Q4, designed to detect a 9-point eGFR difference.

• Islet Cell Study (University of Chicago):

- Funded by JDRF, showing promising early data from three patients.

- Additional enrollments expected this year.

• Xenotransplant Studies:

- Collaboration with eGenesis and United Therapeutics on kidney and heart transplants.

- Initial patient outcomes are positive.

• Subcutaneous Formulation of TEGO:

- Non-human primate data available; next step involves a Phase 1 volunteer study.

Future Outlook

• Phase III Study (Renal Transplant):

- Design to follow Phase II BISTO results, expected to expand in scale and scope.

• iBox Endpoint:

- Awaiting FDA guidance for its potential use in future studies.

• Commercial Opportunity:

- TEGO aims to improve long-term graft function, potentially reducing reliance on tacrolimus.

• Indication Expansion:

- Exploring TEGO for other organ transplants and autoimmune diseases.

Q&A Highlights

• CD40 Ligand vs. CD40 Receptor:

- Blocking CD40 ligand is seen as more effective for preventing rejection.

• aescalumab (Novartis):

- Novartis’ unpublished data suggests potential success in transplant studies.

• iBox as Endpoint:

- FDA’s decision on iBox usage could impact future trial designs.

• Islet Cell Transplant:

- Promising results with patients reducing insulin dependence.

• Xenotransplant:

- Technology translation from animals to humans requires CD40 ligand inhibition.

Eledon Pharmaceuticals’ participation at the conference underscores its commitment to advancing transplant medicine. For more detailed insights, refer to the full transcript below.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Tom Smith, Senior Biotech Analyst, Leerink Partners: All right, great. Let’s go ahead and get started. Thanks for joining us here at the Leerink Partners Global Healthcare Conference. My name’s Tom Smith. I’m one of the senior biotech analysts here at Leerink, and it’s my pleasure to welcome our next company to the stage, Elidon Pharmaceuticals.

And happy to be joined up here by President and CSO Steve Perrin. Steve, thanks for joining us. Steve

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Perrin, Tom, thanks for having us. Of

Tom Smith, Senior Biotech Analyst, Leerink Partners: course. Great. And we are in a really exciting year of data for you with your CD40 ligand targeted antibody, TagoproBART. We’re looking for updates from a Phase 1b study in renal transplant and obviously the highly anticipated Phase 2bSTO data in the second half of the year and we’ll hit on a lot of that in much greater detail. But Steve, why don’t you go ahead and kick us off with a little bit of a brief overview of Eladon and what you guys are working on these days?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Sure. Yes. Like you mentioned, it’s a critical and exciting year for us. We have a lot of progress that we’ve made across our transplant studies. We’ll talk more about the two kidney transplant studies, but we’re also seeing progress in the xenotransplant space.

As we announced recently, we did another patient at Mass General for a xeno kidney transplant study in collaboration with eGenesis. That patient’s doing quite well. And we anticipate, after the announcements of both United Therapeutics and eGenesis up there on the path toward trial, that we’ll see some more activity in xenotransplant this year as well. In addition to that, we announced some early data from three patients in our islet cell study at University of Chicago. That’s a study that Doctor.

Wachowski is being funded by JDRF. We’re supplying TEGO for the prevention of islet cell rejection on that study. We anticipate he’s funded to enroll another handful of patients this year. So we should hopefully have another exciting data update from islet cell transplant. As you mentioned, our next data readout for our kidney transplant studies will be our phase one study that will give an update of our data in August at the World Transplant Conference in Houston.

That’ll be a complete data refresh over what we presented a year ago at ATC. So we’ll present all of the data done on those 13 patients, as well as other subjects that we’ve enrolled since then. And very excitingly, it’s going to be a really busy year to aggregate all the data for our BACEO study. That’s our Phase II study that completed last patient of enrollment last September. So that last patient is now already six months out, and we’re guiding to top line data in Q4 of this year.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Great. And why don’t we start, just kind of high level? I think it’s worth emphasizing the differences here between targeting CD 40 ligand, which you’re doing, and targeting CD 40 receptor. Maybe just highlight why I feel like CD 40 ligand targeting is the right way to go in renal transplant and maybe contrast it versus some of the historical approaches what we’ve seen historically.

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Sure. So it’s a great question. From a biological perspective, these are incredibly different targets, even though they’re a ligand on a receptor pair. They were identified back in the ’80s, where the receptor was identified first being expressed on the cell surface of B cells. Today, we know that CD 40 receptors constitutively on the cell surface of all cells of the monocyte lineage in addition to B cells, dendritic cells, macrophages, and other types of antigen presenting cells.

And it’s always on the cell surface whether the target’s engaged or not. That is very different than CD 40 ligand, which is expressed on the cell surface of T cells primarily. It’s only there transiently after costimulatory activation. And then there’s negative feedback mechanisms that gets it off the cell surface to protect uncontrolled autoimmune responses. After the receptors were initially characterized, there was a lot of preclinical data initially done in rodent models of autoimmunity, showing that blocking this pathway was incredibly robust at slowing down disease progression in animal models of multiple sclerosis, lupus nephritis, psoriasis, rheumatoid arthritis, and a host of others.

And subsequent to that, it was shown that blocking this pathway was very potent at preventing transplant rejection in multiple different species, rats, mice, baboons, rhesus macaques, and cynos. And to this day, blocking CD40 ligand in particular has been the most potent way to prevent transplant rejection in multiple species. Great.

Tom Smith, Senior Biotech Analyst, Leerink Partners: And you alluded to the most recent data update we’ve seen from your Phase 1b experience, maybe just kind of level set us, what you’re seeing in that study versus what you historically see with tacrolimus containing transplant regimens?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Sure. So the whole premise of what we’re trying to do with Tagoprivartin Transplant is to replace C and I’s tacrolimus, which is the current foundation of standard of care. Tacrolimus really revolutionized transplant medicine twenty years ago, but there’s been very little innovation since. And it really changed the ability to do transplant and protect grafts up to a year post transplant. But it also comes with some unfortunate toxicities and side effects, including nephrotoxicity.

It’s actually toxic to the actual kidney that it’s trying to protect. It causes hypertension. It can induce nuance of diabetes in about a third of patients after exposure. And then from a quality of life perspective, it also induces tremors and brain fog, which over time some patients just stop taking the immunosuppressive drugs, which leads to increased risks of subsequent transplant rejection. So the whole premise is to replace CNIs with tegopubart and try to improve longer term outcomes for patients.

There’s over one hundred thousand people on the transplant waiting list at any given time. Half of them won’t get to an organ, and there’s only two ways to solve that problem, either make organs last longer post transplant or find a new source of organs. And hemiceenotransplant is also a very exciting technology platform.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yes, that’s great. And then in the Phase 1b, in those 13 patients, I know we have a lot of encouraging biomarker data. I know we’ve been focused on what you’ve been seeing on eGFR. Maybe you could just describe the experience that you’re seeing there relative to DTAC.

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Yes. So the most exciting data that we’re seeing there is our eGFR. It’s become apparent in the last five plus years that eGFR is one of the best predictors of long term kidney function and survival. And on standard of care, there’s large retrospective studies that suggest that after a year, your eGFR on the current standard of care with TAC is around low 50s. And in our 13 patients that we reported, we’re seeing mean eGFRs in the high 60s, which is a really significant clinical delta on predicting and suggesting longer term graft function and survival.

So that dataset that we presented last year of 13 patients was quite exciting to see eGFR levels as high as that.

Tom Smith, Senior Biotech Analyst, Leerink Partners: And how comparable is that? Are those 13 patients to your sort of typical, renal transplant patient in terms of, you know, prognosis and outlook?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: So that’s an open label study and, you know, we have some of that data that we’ve already presented and published, but we’re not cherry picking the patients. These are pretty tough patients. The HLA mismatching tends to be a little bit higher than normal. We’re excluding perfectly matched individuals by HOA. If you look at the mean age of the donors and recipients, they’re a little bit higher than what we’re typically seeing in standard studies.

About the only thing that might favor a more favorable population in that study is we’re seeing a little bit more living donor transplant than deceased, but that’s kind of the nature of a small centered open labeled study. In the Phase II BOSTOUGH study, those variables are actually balanced between the study groups.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. Yeah, that’s really helpful. And then, what have you seen obviously, you’ve also generated data outside of the renal transplant setting, but in terms of safety tolerability, maybe talk a little bit about what you’ve seen in the Phase 1b, but then also more broadly across the program, what are you

Steve Perrin, President and CSO, Elidon Pharmaceuticals: seeing? So in the Phase 1b study, up to last year’s data cut, which was around this time a year ago that we presented in May, the data cut happened sometime in late March. We had three people that had come out of the study. One, she just withdrew consent on her own and it was completely unrelated to kidney function. Her eGFRs at the time, I think, were in the mid-70s, but she was having some alopecia or hair loss that she didn’t tolerate so well on day 200 and decided to switch over to TAC, which was unfortunate because her eGFRs went down to the 50s, but we couldn’t let her back in the study.

We had a second patient who was, I think, the second patient that enrolled in the study with DURATE fifty four due to BK viremia. And the investigator, because our drug was so new, he didn’t have a lot of experience on how to treat that at the time. And so he decided to switch the patient over to tacrolimus just so that he had a better understanding of how to manage their BK viremia at the time. And then the third patient that dropped out of the study did have a T cell mediated rejection around day two seventeen. And the investigator switched them over to tacrolimus because they wanted to add on some other drugs that we didn’t allow in the protocol.

Other than that, the rest of the subjects have either rolled over into the long term extension study or they continue to be in the study and approaching probably a year. As far as broader safety from not only our drug, but from the drug class as a whole, you know, the typical things that we would look like for blocking this type of an immune receptor would be increases in opportunistic infections and malignancy. And not only are we not seeing that in our other studies where there were monotherapy such as our ALS or IGN study, we didn’t see it in our healthy volunteer study either, but across the entire drug class with Sanofi’s drug Biogen, Amgen. The safety profile of the class so far has looked pretty good.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yeah. Okay, great. And one of the other questions we get from investors quite frequently is to just kind of compare and contrast the experience with Novartis’ CD forty receptor targeted escalumab plus out of renal transplant program versus your program. Obviously, there are important compound differences there. But, maybe you could talk about, I guess, the experience with aescalumab and why, you know, you continue to be quite confident in what you’re seeing with the data generated with TEGO.

Steve Perrin, President and CSO, Elidon Pharmaceuticals: So the aescalumab study at the time Novartis was enrolling multiple indications including transplant as well as Sjogren’s syndrome. They’ve never published the results of their transplant studies, unfortunately, and what you can glean from the data that’s on clinicaltrials.gov would suggest that if they continued the study that they actually would have hit statistical significance. And this is based on their data, their analysis on clinicaltrials.gov. So, it would suggest that they possibly stop their transplant indications to favor other indications where maybe they didn’t want to see the safety profile that you might see in a transplant study because they were at that point in time, enrolling in Sjogren’s syndrome and one other. As far as the premise behind transplant, the non clinical data going back to the ’80s would suggest that blocking the ligand is much more potent than blocking the receptor or preventing transplant rejection.

So, we certainly haven’t lost our conviction that we think that we’re a very differentiated target from CD40 receptor and that we should see better efficacy.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. That makes sense. So you have this major clinical data catalyst coming up with the bestow readout at the end of the year. Q4 is the timing that you’ve laid out. When you think about bar for success, maybe you can just help frame expectations, how you’re thinking about bar for success and what investors can expect out of that readout?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Sure. So this was the first study ever that’s going head to head with an anti CD40 ligand antibody compared to standard of care with TAC. It’s a well designed and robust study, 120 subjects randomized one to one. It has a much bigger global footprint for enrollment than our Phase one study we’re enrolling. We enrolled the BISTO study in The U.

S, Canada, Australia, several countries in Europe, as well as South America. It was designed as a superiority design, which is also quite unique. Most of the transplant studies tend to focus on non inferiority against the composite endpoint of graft function, graft survival, patient survival, but we went after being able to read, do a superiority readout on eGFR. The study is powered to detect a nine point difference with 80% power between the two groups. And we based that on the belatacept and aeskalimab study designs as far as what power we would need to detect that difference.

So this is a really exciting study just as a superiority design. Obviously, we’re collecting all of the other data that one would typically collect for the typical composite endpoint. We’re also reading out secondary endpoints around other parameters of kidney function such as DSA. We’re tracking things that are associated with the toxicities of tacrolimus, including diabetes, tremors, brain fog, etcetera. Great.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yeah. It sounds like that will be quite a robust dataset for you. When you think about subsequent steps, I guess engagement with regulators, What’s sort of your base case for what a Phase three or potentially pivotal study would look like? And then, also some questions around IBox and what could be maybe a bit more of a bull case or, you know, something above a base case, but just walk us through kind of your base case right now?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: I mean, certainly we are going to have to run a Phase three study. We get asked that question a lot. So, we will be designing a Phase three study after we get our Phase two BISTO readout. It’s going to probably look a lot like the BISTO study, but with a bigger footprint, more patients, more sites, probably a bigger global footprint as far as countries go. The key thing that maybe is an unknown until we have some discussions with the health authorities is endpoints.

And you brought up iBox and that’s probably the biggest unknown at this point. IBox was approved as a secondary endpoint in Europe a while back. It’s currently under review at the FDA. It’s unclear until we hear what they’re thinking about, which they’re guiding Q1 of next year, how a company could utilize iBox as an endpoint? Is it a co primary endpoint?

Is it a key secondary endpoint? Do you have the flexibility to pick which one that is? Are they only going to allow a company to use full IBox or can you use abbreviated IBox? Are there pluses and minuses to those two things? So, we have some thinking to do about how we may utilize iBox as an endpoint as we’re going through our Phase II design.

And some of that depends upon what our Phase II data looks like, which we’re blinded to. So, we can’t we don’t have any insight right now into what that data looks like.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Right. That makes sense. For those who are less familiar, maybe you could just elaborate on iBox, you know, what goes into it? And then in terms of this pathway, what sort of visibility do we have do you have into that regulatory path to maybe getting iBox accepted as a surrogate endpoint or as a potential use in either a primary or co primary endpoint type of setting? Is that like a transparent process that we can kind of see the development as it moves along in the regulatory pathway or is there a little bit less transparency around it?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: I don’t think we’ve seen much transparency to this point, so I’m guessing that we will not have a lot until we get our initial sense of what they’re thinking about. So, I don’t think we would hear much until Q1 is what is the guidance that we’re hearing from them.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay. And, yeah, I guess what drives that Q1 confidence on your part?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: They’re in the process of evaluating a massive submission. I mean, it was a huge amount of data that went into the initial consortia’s evaluation of IBox and what the parameters might be that correlate with long time graft survival and function and then they did multiple validation sets across multiple other studies. They negotiated with the agency quite a bit about how one might utilize IBOXX in a clinical trial setting. And so, I don’t know that we’re going to hear a lot about what that process is until Q1, if I had to guess. Okay.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Understood. And the incorporation of that, I guess, if I could just ask you to elaborate a little bit on how that could be that sort of bull case for a Phase three

Steve Perrin, President and CSO, Elidon Pharmaceuticals: program for sure. So, I mean, Eyebox is incredibly exciting. I’m not trying to give the impression. We’re really excited about the possibility of having a new endpoint to utilize for clinical studies and transplant. Again, there’s been little innovation in the current endpoints for twenty plus years.

And I box, depending upon how it’s utilized, could be used for the first time as a superiority design. Right now in Phase III studies, we’re kind of hampered by the fact that in the first year, there’s so few rejections on current standard of care that it’s impossible to do anything except for a non inferiority design, unless you want to put 4,000 patients in each arm, which would be cost prohibitive. So, I box could give you the opportunity to actually think about a superiority design at twelve months or as a key secondary endpoint as well if you end up not doing it as a co primary. It has a lot of different moving parts to it though. It’s based on eight different parameters, which puts a lot of onus on the sponsor to make sure that you do an incredibly robust job with data collection, because the way that the algorithm is utilized, it doesn’t impute missing data.

So you can immediately start to lose lots of data at your endpoint if you’re missing pieces of data. And it’s complicated. It’s a combination of clinical data, such as time to transplant. It’s eGFR is one of the major drivers of IBOXX out of the eight parameters. That’s one of the ones that drives the algorithm quite high.

There’s four components around histology. So you need biopsies from every single patient at twelve months, which was often sometimes not easy to get. Another parameter was DSA. And so you have to make sure that you aggregate all of those collections from every patient in your study, you’re going to lose power at the end of your study for iBox. So how you utilize iBox, since nobody’s done it yet, is also something you really have to think carefully about as part of your design.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yes, that makes sense. Okay. Let’s spend a minute talking about the potential commercial opportunity in renal transplant. You alluded to the donor waiting list being 100,000 in The U. S.

I think when most investors kind of think about kind of analogs or presidents in renal transplant, you have TAC, which huge commercial success, I think unequivocal commercial success. You also have Bristol’s belatedcept on perhaps the other end of the spectrum. Maybe you could just high level outline how you’re thinking about the commercial opportunity here and sort of within the realm of those two analogs like where is TEGO going to really fit in there?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: I mean, I think you have a frame transplant as a significant unmet need. There’s around twenty five thousand, twenty seven thousand transplants done per year in The U. S. In equal number in Europe, around two hundred and fifty thousand people with a transplant that’s currently on CNIs, whereas we’ve alluded to that the long term effects of tacrolimus on kidney function is not great. Beltacept has shown that even with not a greatly supported launch, they have about a 6% of the market share right now.

We’re estimating they do about $600,000,000 in the context of transplant rejection. TAC has been a generic drug for a long, long period of time and yet sales are still at $1,600,000,000 There’s clearly an unmet need for innovation in transplant medicines and we think TEGO can improve on both of those. We think certainly we’re going to eliminate all of the C and I toxicities we’ve talked about. We think it’s going to improve long term graft function and survival. And our eGFR data right now is suggesting that we’re actually doing a little bit better than BELLA.

Tom Smith, Senior Biotech Analyst, Leerink Partners: That’s great. Okay. And just one other on commercial, in terms of like reimbursement environment and I guess like ability to kind of price a drug within this regimen when we do have things like generic TAC that’s available but maybe not being used? I guess, how should we be thinking about and it’s too early for you guys obviously to comment specifically on TEGO pricing, but just getting a drug, getting access there and getting a drug paid for. Can you just talk through some of those dynamics?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Yeah. We haven’t really guided that much on the topic, but you know, you could envision that with the annual cost of Bella being $40 K to $50 K per year, patients are on the drug chronically for the rest of their life that, you know, this should be covered by insurance. All transplant medicines are now covered in the context of insurance providers. So if Taygo gets approved for transplant prevention or de novo transplant, rejection should be covered by insurance.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. Okay. Yeah, let’s switch gears and talk a little bit about some of the data that’s coming out of University of Chicago on the islet cell side. Maybe just talk about what you’re seeing there. I think quite impressive results in the first three patients.

But talk about what you’ve seen coming out of that study and I guess potential read through to other transplant settings as well.

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Sure. The data coming out of Chicago is absolutely fantastic and it’s built on, again, a couple of decades of work. Some of the most amazing data that was originally discovered back in the 90s with the first generation anti CD40 ligand antibodies is the ability to induce tolerance in non human primates. So you could basically take non human primate models of islet cell transplant, transplant in donor islets from another animal, treat them with an anti CD40 ligand antibody for six months to a year and then you could wean them slowly off drug and they’d never reject their islets again. And we saw that in a couple of our animals about ten years ago with this particular drug TEGO in our non human primate islet cell transplant study.

So, collaborating with Peter, so this is not a trial sponsored by Eladon, it’s an investigator initiated study funded by the JDRF. He launched the study about a year ago when he got his first three patients in. He got two of them off exogenous insulin with a single transplant. These are tough patients. They were fairly large body mass.

They had had diabetes for decades on really high amounts of exogenous insulin and completely got their HbA1c’s normalized within ninety days post transplant and off exogenous insulin. It’s pretty much a functional cure. And to see that replicated from many years of animal data is absolutely amazing. It’s a significant unmet need, albeit in a small percentage of the T1D population that have really uncontrolled hypoglycemic unawareness events. But with additional safety and efficacy, it’d be interesting to see how that population expands a little bit outside that box.

So, Peter’s data is very, very encouraging.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yes, that’s great. And you, I know this is not an Eladon sponsored study. You’re supplying the drug product, but you don’t necessarily control the timelines, you don’t control the enrollment. Do we have a sense for other expectations, I guess, for updated data from the three patients plus or minus some new patients in 2025?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: We would anticipate that he’ll present some data by the end of the year in one of the transplant conferences in the fall.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay, that’s great. And the total size of that co I think you mentioned is nine.

Steve Perrin, President and CSO, Elidon Pharmaceuticals: He has support from J. D. Ayeroff to enroll up to nine.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay. Okay. That’s great. Let’s talk a little bit about Zeno. And this is another one.

It feels like periodically, but certainly more frequently. We’ve seen some very exciting headlines coming out from a number of programs. And TEGO, you mentioned eGenesis. Maybe you could talk a little bit about your collaborative partners in this space and their choice of using TEGO as their CD40 ligand of choice in these really groundbreaking xenotransplant settings?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Yes. So xenotransplant is just it’s just an amazing technology platform, right? If you’d asked most scientists ten years ago, would you be able to induce 70 genetic mutations into an animal as a potential source for organs, we might have all kind of raised an eyebrow. So to be where we are, even though it seems like a long time, it’s actually in the context of science, really not that long. I think we saw a significant amount of progress in xenotransplant in a couple of ways this year.

One is we obviously got compassionate use to do a few human subjects across multiple different types of organs. We did the cardiac transplant at University of Maryland. We’ve done a couple of kidney transplants at Master General Hospital. As a company, we’re agnostic about the technology around the pigs. We work with both United Therapeutics animals with the heart transplant as well as eGenesis with the kidney transplant.

And we’re trying to be collaborative because there is some consensus that translating the technology from non human primates into humans is going to require inhibition of CD40 ligand signaling. That seems to be one of the key immunosuppressive drugs that needs to be part of that cocktail. The other piece that I think was exciting that we saw in the second half of last year was that they’re kind of transitioning from these compassionate use one off studies to approved clinical studies for both companies. And that really needs to happen with like a really truly designed protocol where there’s some consistency and we can get some better idea about what are the best methodologies to protect these organs post transplant because they’re very different than what we see for allograft transplant.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yeah. That’s great. And I want to also ask you about it and maybe in a similar vein because we now have, as you alluded to, multi organ experience on the xeno side. So, we think about potentially scaling TEGO use beyond renal transplant into other solid organ transplant settings. Like how are you guys as a company thinking about that and approaching that?

Like what would be required? What data do you have to generate?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: I mean, kidney transplant was our initial focus. It’s the biggest market. It’s where most transplants are done. There’s more kidney transplants done than any other organ. In theory, based on just the process of the prevention of rejection, the processes are the kind of the same.

So, one can envision expanding into other organs, be it cardiac, be it liver. You could also envision going after other unmet needs where the mechanism of action of blocking CD40 Ligand makes sense. So, you could think about antibody immediate rejection where there’s a significant unmet need in treating that and blocking CD40 ligand prevents B cell maturation, prevents the formation of mature IgGs and could be a very good solution or at least potential treatment for antibody mediated rejection. Much like belly use has really picked up in the concept of conversion off of C and I’s, especially in cases where people have C and I intolerability, that could be a really great indication once we get further along to test tegopirat as well.

Tom Smith, Senior Biotech Analyst, Leerink Partners: That’s great. And I wanted to ask you also about potentially use CD40 ligand outside of transplant setting because there’s another I feel like the news flow over the last twelve months has been quite strong for other compounds, thinking, you know, UCB Biogen, stapirolimab and lupus, I’m thinking for Exelimab and multiple sclerosis. How are you guys thinking about potential indication expansion and I guess strategic value and read through from what you’re seeing from some of these other large autoimmune indications?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: I mean, I have a personal bias with the answer to that question because I was at Biogen in the 90s when the first anti CD40 ligand antibodies ended up getting halted during clinical development due to platelet activation. It’s really great as a scientist thirty years later to see all of these assets doing well in multiple different indications. You know, the world is your oyster with this particular target as far as where you want to go. The preclinical data is really exciting and I think companies are picking the right indications. The preclinical data in lupus animal models was absolutely fantastic.

It was great to see Biogen’s positive readout. The data in animal models of rheumatoid arthritis was very, very good back in the ’80s, so it’s great to see people focusing there. Some of the other exciting ones that people maybe are just starting to think about probing the biology is of the related kidney diseases. So the IgA nephropathy, so these FSGSs, glomerulonephritis, things like that. I think there’s an opportunity there based on the animal data.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yeah. Okay. And just maybe in the last thirty seconds or so that we have, I think you guys are working on a subcutaneous formulation of TEGO. What’s the latest on that? And then I guess like I can envision a world in which that becomes a very interesting life cycle management strategy and other strategy for maybe getting into some of these large autoimmune indications?

What’s the latest on the subQ?

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Yes. So we have non human primate data from a subQ, we have GMP manufactured product. The next step would be a healthy Phase one volunteer type study before we go into a patient population. We haven’t really prioritized it at this point because we kind of like the IV infusion and our clinical trials support that. This patient population has been on dialysis for long periods of time going to clinics every couple of days.

So having to go every three weeks for one hour infusion, not really that problematic from a lifestyle perspective from them. The doctors know they’re getting their meds, which also gives them some comfort. And so we haven’t really prioritized it at this point as far as a need to get into the clinic, even possibly during Phase III, but we are poised to do so should we want to.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. All right. Well, unfortunately, we’re up against time, but thank you, Steve, for joining us. And exciting year for Eladon. We’ll stay tuned for the data.

Steve Perrin, President and CSO, Elidon Pharmaceuticals: Thanks, Tom. Appreciate it. Thank you.

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