Iovance Biotherapeutics at Goldman Sachs Conference: Strategic Growth and Challenges

On Wednesday, 11 June 2025, Iovance Biotherapeutics (NASDAQ:IOVA) presented at the Goldman Sachs 46th Annual Global Healthcare Conference 2025. The discussion, led by key executives, revolved around the commercialization of AMTAGVI, a cell therapy for metastatic melanoma, and its expansion into other cancer indications. While Iovance highlighted its strategic advancements and confidence in long-term growth, challenges in patient referral and access were also acknowledged.

Key Takeaways

• Iovance is focusing on improving early patient referrals to its ATCs to enhance AMTAGVI’s reach.
• The company revised its 2025 revenue guidance to $250-$300 million, citing referral delays.
• Upcoming data for lung and endometrial cancer trials are expected by year-end.
• Expansion efforts include increasing ATC networks in the US and Europe.
• Iovance is positioning AMTAGVI as a frontline or second-line therapy with a focus on its one-time treatment potential.

AMTAGVI Launch and Market Dynamics

• Learning and Challenges: Initial success was noted in centers receptive to cell therapy. The primary challenge is early patient identification and referral, prompting a shift in focus to engage community oncologists.
• 5-Year Data Presentation at ASCO: Demonstrated AMTAGVI’s durability with 20% of patients alive at five years and a third maintaining response. This underscores the significance of long-term patient outcomes.
• Revised Revenue Guidance: Adjusted to $250-$300 million due to referral timing issues. Iovance plans to grow existing ATCs and onboard new ones to drive earlier referrals.
• Education and Outreach: Campaigns focus on cell therapy’s curative intent and expanding field force to engage oncologists and establish referral pathways.

ATC Network and Patient Access

• ATC Status: Iovance’s network includes 80 ATCs, with most ready and treating patients. Newer ATCs are testing insurance and surgeon proficiency.
• White Glove Service for Surgeons: Provides support for tissue procurement, reducing dose-related issues, and aims to develop self-sufficient surgeons.
• ATC Performance Metrics: Regular reviews and interventions ensure optimal performance and patient outcomes.
• Patient Identification and Referral: Emphasis on early referral to prevent treatment ineligibility, with a goal to move AMTAGVI into earlier treatment settings.

Manufacturing and Commercial Realities

• Manufacturing Consistency: Aligns with clinical trial experiences, aiming to treat more patients in real-world settings.
• ATC Nomination Criteria: Focus on referral patterns and community presence to ensure patient access from day one.

Competitive Landscape

• Competitive Impact: New competitors increase awareness of metastatic melanoma treatment needs. Iovance remains confident in AMTAGVI’s long-term data and one-time treatment approach.

International Expansion

• European Launch Strategy: Iovance aims to enhance infrastructure and coordination, selecting ATCs based on network mapping and patient proximity.
• Treatment Paradigms: Aims for seamless transitions between community and academic settings in Europe.

Pipeline and Future Outlook

• Tillvance (Frontline Trial): Phase III trial in Europe aims to confirm AMTAGVI’s efficacy and promote early patient access.
• Lung Cancer Program: Positive data expected by year-end, addressing unmet needs in the treatment landscape.
• Endometrial Cancer Program: Signal-finding cohort results expected, targeting patients not well-served by current treatments.

In conclusion, Iovance Biotherapeutics is strategically navigating challenges and opportunities in the cell therapy market, with a focus on expanding its reach and enhancing patient access. For more details, refer to the full transcript below.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference 2025:

Wissam Soubra: Good afternoon everyone. Thanks so much for joining us. I’m really pleased to be joined by Brian Gasman, EVP of Medical Affairs, and Dan Kirby, CCO of Iovance. Thank you both for joining us.

Dan Kirby, CCO, Iovance: Thank you.

Wissam Soubra: Dan, maybe I can start with you here. Given Amtagni has been on the market now for over a year, what have been the biggest learnings from this launch? And what has been maybe easier in some ways, or what has been more difficult than maybe the prelaunch expectations? And Brian, I’ll pull you in here since you have been here for the entirety of this launch to date.

Dan Kirby, CCO, Iovance: So it’s a great question. I joined in February. And looking at the year of launch for Emtaglif, a lot of success was had following the CAR T launches. And really, the centers being so receptive to the time that a cell therapy was there for solid tumor and treating patients was a great experience. And you saw that in the year of launch.

As we get to the learnings from the year, and where we go as we expand past that, is really the identification of patients that can be referred in earlier in their treatment journey. And looking at, in metastatic melanoma, the number of patients and just the opportunity there to get to them really brings us to the point of going earlier with the patients into the community to be able to get a better capture of more patients early in their journey to be able to treat. So that’s really where our focus is in the year. So in short, great launch, the next wave will bring even better success for patients.

Brian Gasman, EVP of Medical Affairs, Iovance: Yes. I’ll just say add quickly that the enthusiasm as you see these ATCs mature has just increased. The number of feel good stories of patients getting complete responses with nothing else as an option. We just hear about it all the time. Sometimes we hear about it on the news, but many times it’s the centers themselves and that drives enthusiasm not just in their hospitals but also internally in our company.

Wissam Soubra: Maybe to that point about the feel good stories, the evidence of AMTAGV’s benefit in patients. You did recently present at ASCO five year data. Maybe speak to what you saw, what you presented, and just how meaningful is that for this patient population?

Brian Gasman, EVP of Medical Affairs, Iovance: It’s huge because of all, I like to call it rare error. There’s never been a study in the post PD-one setting that’s prospective, that was a registrational trial, that has ever even come close to this. Remember, this is a one time therapy. The overall survival was based on that therapy alone without salvage therapies to raise that number up. To be a five year final analysis, that’s like a seven year interim analysis of a ten year study.

Twenty percent of patients were alive at the five years, a third of the responders were still at the five year mark to be analyzed. This is huge because when you get these kind of responses, you know you’ll be able to treat your patients and be with them for years on end, maybe even decades. So I think for both the referring physicians as well as the authorized treatment centers themselves, this is a big shift for them to really think that this is something that’s not just about responses, but about durabilities of those responses.

Wissam Soubra: And you guys hosted a panel. One of the things that I was struck by was one of the physicians talking about the meaningfulness of mTagvi and being able to essentially bring patients to a cure for nearly sixty percent. When you combine it, when you think about checkpoint inhibitors and then mTagV following thereafter, a majority of patients being able to reach a cure. How much has that been appreciated by the broader prescribing behavior or prescriber community?

Brian Gasman, EVP of Medical Affairs, Iovance: It’s certainly growing. Number one, it started off that KOL panel that with Dan Olson saying he’s treated over two dozen patients with a forty percent, at least forty percent response rate. One of his main refers is Bruce Brockstein is the one who mentioned that. And this idea that the ideal sequence is you have your frontline followed by IMTAGVY gives you those incredibly high numbers that you mentioned. I think doing anything other than that sequence in their minds is no longer standard.

This is the right way to go. And then if that majority is not that person’s journey, they still have the myriad of other options to choose from. I think this is as centers have these feel good stories, as it gets out in the community, this message is getting stronger and it’s getting louder. And one thing just

Dan Kirby, CCO, Iovance: to add to that is from a cell therapy perspective at the ATCs, it’s to be expected. They’ve had cell therapies starting with allotransplant fifty years ago. So to give a one time therapy and have a durable response, it’s less surprising to them. But when you get into the med onc community and the refers in, that’s something that we have an educational opportunity because they haven’t seen this before. When the patient’s done literally after they’re infused between the lymphodepletion to the actual finishing of the regimen, it’s a couple weeks, and there’s no need for ongoing treatment with it to see these types of responses.

That’s something that’s been eye opening in the community and something that we’re working to continue to educate on.

Wissam Soubra: Maybe one other point that one of the KOLs mentioned is that what they’re seeing in the real world setting is exceeding what your clinical trials would suggest on a response rate. Maybe how broadly applicable are many of your other physicians also seeing such high success rates? Maybe talk to us about what you’re hearing from the ATCs.

Brian Gasman, EVP of Medical Affairs, Iovance: Well, I think it’s key to note that in our LN124 trial, the average patient had at least three prior lines of therapy. They really exhausted everything and then many of them had those same therapies doubled and tripled compounded. What we’re trying to educate the community is that this is a truly line therapy. And as they move toward earlier intervention, not only does it cover the vast majority of all melanoma patients in the setting, but also gives these kind of outcomes and maybe even better. Because we’ve had data in the frontline setting which had even higher response rates.

So I think the earlier you get to them is driving those numbers. The other thing that Dan Olson said as well is that patients that maybe traditionally we thought were harder to treat and we’re resetting what is a hard to treat patient. So altogether you’re seeing those kind of numbers. And we are hearing from other centers, not every center, and again, this is just word-of-mouth at this point. We’re working toward with consortiums to get actual data to present.

But we’re hearing numbers like this and even in some cases higher than that.

Wissam Soubra: Fantastic. Maybe we can talk here about your 2025 guidance recently reset on your last earnings call. Just remind us what led to that revised guidance. And then what gives you the conviction that the reset number now is truly achievable?

Dan Kirby, CCO, Iovance: So great question was that we did reset guidance between 02/5300 on the last earnings call. What we did was we looked at the numbers of patients coming in. And so there’s good and bad to the story with it. The good is the patients are there. The bad is they’re not getting referred to the ATCs in time.

So we’re seeing a lot of patients go to hospice or death as they go in. So when we started looking at that and calculating out to 2025, we wanted to reset guidance with the plan of addressing the current ATCs and growth in the current ATC, while we are going to onboard new ATCs within community networks. So again, we’re looking at the speed to which to do that. So in 2025, that guidance is reflective of our current ATCs plus the new ones coming on and us driving referrals in there earlier from the community. As we look for long term, we’re also simultaneously building out ATCs within community networks and different approaches there so we can bring the product closer to the patient.

Wissam Soubra: What can Iovance do, to your point, to help drive that referring behavior, to try to ensure that patients really do experience the benefits of AMTAGI versus unfortunately maybe being ineligible?

Dan Kirby, CCO, Iovance: Absolutely, so the step is education. So right now we’re working on a disease education campaign that’s all about cell therapy. Because IMTAG is the only cell therapy for metastatic melanoma, we want to educate on cell therapy and one time treatment with curative intent to the med oncs out there that would refer in. So you educate them Secondly, we have a field for expanding that calls on the community. And that is something that we’re working now, giving them the messaging and having them go out.

And again, as we get new ATCs up, putting them out in the community that are gonna refer in, and then having that push come in along with the education. The step here is really to talk to the leadership directly at community organizations and community networks. And form a partnership with them To be able to not only have them refer in, in some cases we have ATC stood up in their area that they can refer into very easily. Having that happen in the short term. But also aligning with them on which ATC’s we need to stand up, or hospitals inside of their networks that are already referral patterns existing that we can maximize.

And that’s, there are three things that we’re doing right now to try to get that education and action out there.

Wissam Soubra: Great. You mentioned, if you think about the number of infusions that you reported for the first quarter, eighty five infusions, some of that being impacted by reduced capacity during the scheduled annual maintenance of ICTC. In that context of 85, you’ve then provided the guidance of 100 to 110 infusions in the second quarter. Maybe help us understand how much line of sight do you have to that, just given the timing of when you reported, when you made this, when you provided this guidance, How much line of sight? How much confidence do you have in that number?

Dan Kirby, CCO, Iovance: So we’re very confident in that number, as well as the number for the full year with it. And again, the full year is looking at two fifty to 300. Now, when you look at the journey from a patient when they’re referred in for IMTAG B, they get referred into the center. They get enrolled. After they’re enrolled, we schedule out a tissue procurement.

We have the tissue procurement, and then we manufacture, and then it’s delivered. And they’re infused with it. So that is a bit of a time lag. So we look at the leading indicators to say that we’re confident that number can take place. But again, you don’t know until the end of the quarter when the infusions actually take place that they’re occurring with it.

But the modeling suggested that that is a viable path forward for it. And again, we want to make sure that we not only meet, but we want to exceed those numbers at the end of the year.

Wissam Soubra: Got it. So the leading indicators all suggesting 100 to 110 is very much.

Dan Kirby, CCO, Iovance: We’re confident in the Great.

Wissam Soubra: Maybe touching on ATCs, I think as of your last disclosure, you noted 80 within your network. Where do these stand in terms of being operationally ready?

Dan Kirby, CCO, Iovance: Most of them are operationally ready and treating patients right now with it. There are a few that have come on recently that are ramping up that journey. Typically when an ATC comes on, they want to test a few patients out from an insurance perspective. So therefore they can, their finance department makes sure that it’s gonna get paid by the payer. And then they start quickening pace after that.

There’s also a learning curve on the surgeon side that Brian’s teams work on to make sure the surgeons are getting a white glove service in the initial phase of it until they can get their legs under them, so to speak. And they can that they know how to do the tissue procurement to give us the best starting possible with it. So most of them are up and treating right now. A few are coming on and ramping up. And then we’ll continue to see that as we bring new on and then newer ones start evolving.

Wissam Soubra: Are all the ATCs receiving the Swagglove treatment?

Brian Gasman, EVP of Medical Affairs, Iovance: Well, of all, we certainly wanted to focus on centers that are new, or older centers that have new surgeons. Mainly we’ve always offered this option for every center. But what we’ve done as a concerted effort is to actually go to the surgeons as well as pre surgery tumor decision making steps of the way and offer them anywhere from there to in the Operating Room and beyond to help them not only get the best tumor, the best preparation of the tumor, but also make sure that the patient gets an infusion and gets through that okay. What’s happening now though is that because they’re letting us in the Operating Room, when we are able to get in there, which is happening more and more, we’re actually seeing a significant drop in dose related out of spec, which is the most common reason for out of spec. And we expect that to continue.

But also as we say, we will let the birdie fly on their own because we do see once we’ve done enough of these and we’ve seen that they’re able to do it on their own, they should be able to. And also should be somewhat infectious that surgeons should be able to treat other surgeons for best practices.

Wissam Soubra: How much of, to that point, let them, once you’re confident in their ability to do this procedure correctly, how much retraining needs to be done or over what frequency would you expect that you would need to maybe go back in, make sure things are still going kind of well there?

Brian Gasman, EVP of Medical Affairs, Iovance: Well, all of our teams, but we each do it a little bit differently. But in my team in particular, we study each ATC individually and we track by time what’s happening there, what happened to each infusion, how much of the dose was in spec, whether it was in spec, out of spec, that type of thing. We have centers now that are doing so well, there really isn’t much more we can teach them, so to speak. They’re doing excellently. In fact, these are the kind of centers that we’d want to go out and teach other centers.

Like again, sort of infectious education. That being said, at that point, it’s really just their communication with Dan’s team and referrals and growth in the program. But the goal is that everyone ends up being like that. And we have centers now that are really already in a sweet spot for that level of quality.

Dan Kirby, CCO, Iovance: Right. And we also, too, we look at the metrics all the time, as you can imagine, with every single ATC. So we have quarterly scheduled business reviews with them, where we go through and we tell them how they’re doing, what their patient’s response was, everything. We have those open discussions with them. But if we see anything blip up, the teams are there right away to work with them and ensure it’s corrected.

Wissam Soubra: And when you’ve reported some metrics as it relates to your ATCs, the proportion that have resected a tumor, have infused one plus patients, have infused 10 plus patients. What does it really take to get an ATC from an infusion in one plus patient to the 10 plus?

Dan Kirby, CCO, Iovance: So actually, it’s a lot of work going on with them and making sure they have the right, mainly they have the surgery, cell therapy, and med onc. That triangle is working very well together. When we get somebody to the expert level of 10 plus, then it really is down to how many patients we can have referred in. So those are when we have the open discussions about who are the large community practices in your area, and how can we help you network them. In some cases we provide, in all cases we offer, but some cases we join in with them on advertising that they do to those sites.

I mentioned the staff that we can send into the sites. But going through there and making sure that once they hit that expert level, we’re sending as many patients to them as possible and putting the pipeline there so they can treat.

Wissam Soubra: I guess right now, out of your 80 ATCs, what proportion are at that? Remind us again, what proportion are at that expert level right now?

Dan Kirby, CCO, Iovance: So we’re about 17% at the last earnings call, we said. And that number continues to grow.

Wissam Soubra: At steady state, any guesses as to where that number can go?

Dan Kirby, CCO, Iovance: Steady state as we look at, not only with the academics, but as the community come on, over half of ours will be that expert going in. Where it’s a relationship on, they’ve mastered the TTP, the process with it, how to infuse. Everything’s going very smoothly with them. We anticipate over half will be at that level. And then the other half will just be ones that we’ll work closer to, to evolve them.

Wissam Soubra: And then to the extent that you’re able to share, but we heard from one of the KOLs, and you mentioned this, that they’ve treated double digit number of patients right now. How many infusions have your top centers done?

Dan Kirby, CCO, Iovance: Anywhere. I think the one that was mentioned was Dance Center at 25. We have 25 plus in the top centers for it. And again, we continue to see that number grow at those centers, plus also the new ones coming up. So that’s where we see them evolving to it.

Wissam Soubra: And when you’ve engaged with the ATCs, and patient identification is such a key part of this process, to your point, what are they telling you with respect to patients that are still available and still likely candidates for Imtagvi?

Dan Kirby, CCO, Iovance: So we see new patient enrollments every single day. And patients going through the channel, as well as getting infusion. So there are a lot of patients out there. I think one of the things that we share with our existing ATCs is the urgency to get patients in there earlier. Because there’s nothing more heartbreaking than getting the announcement.

I have an email feed that happens every time an order or an enrollment is canceled. And if I see patient deaths are hospiced, I know that’s happening before we can even get tissue from them. So we have a joint effort with the ATCs to get patients earlier. But that said, we get enrollments every day. We have TTPs every day.

We have infusions every day. So the patient numbers keep flowing through.

Wissam Soubra: And I guess maybe just remind us here the profile of the patient that is receiving mTaggi right now. Obviously you want to move it to the line. That is the ultimate goal here. But what line setting are they predominantly right now?

Dan Kirby, CCO, Iovance: line plus.

Wissam Soubra: Okay. And that hurdle, I guess maybe how much of a hurdle is it to get it to the line? Is it just the education, it’s the experience of these physicians, it’s the earlier referrals, but anything else you can do to ensure that it becomes a more predominant part of the second line therapy?

Dan Kirby, CCO, Iovance: I think the biggest thing other than what we talked about, and I’ve been talking a little bit about this, is the phenotype of the ATCs that we’re going after. And looking at where we’re headed to the future with it. And going where existing referral patterns are there, versus trying to build them. And that’s something that the CAR Ts talk about all the time, too. I think the famous quote they have is two of ten patients receive treatment.

I think we even have a bigger opportunity in metastatic melanoma by expanding the ATC definition.

Wissam Soubra: And as you think about maybe what you’re seeing commercially and in the real world setting relative to your clinical trial experience, Maybe just put that into context for us, how similar or how different this has been as it relates to manufacturing or patient experience and the like.

Dan Kirby, CCO, Iovance: It’s been consistent on the manufacturing front. I do think that if you look at from the real world experience, we have the ability to treat more patients than clinical trials. So that’s something where we see those patients still going in and going through. But on the other side of this, commercially, there’s so much more opportunity to get those patients in there. And again, we have a lot of later patients inside the clinical trial as well.

But really going after that line patient and going upstream is the huge opportunity.

Wissam Soubra: So much of this really hinges on the ATCs, the quality of the ATCs, and their level of familiarity, their expertise as relates to this process. How do you think about bringing on a new ATC, just given the high bar that you need to be able to make sure that they’re achieving? How do you think about bringing those on? And what is the ideal number if it’s not 80? If you’re expanding, what is the ideal number?

Dan Kirby, CCO, Iovance: And so one thing, I’ll be consistent. I’ve never said the ideal number, because I don’t think it’s a finite number out there. I will say we have changed our criteria. And when we go to nominate an ATC, the teams have to establish with the ATC the referral patterns, what community presence that they have, the fact that they have the ability to get patients from day one. And so that list that I talked about for us is less on day one to get patients in, and more about educating them on how to use.

One instance that just happened recently, we said no to an ATC. And they asked to be on the phone with me. And they were listing out their criteria of clinic affiliations and everything. And they were signing up for commitments for large numbers. And that was a great sign to see that the new process is working for it.

So we can have them work with us and commit. And we can see what their referral patterns are. And the fact that they’re an existing community network center versus an academic center that’s relying on the community to refer in.

Wissam Soubra: So just really reinforcing there, you know, the importance of the referral network that’s really being leveraged to drive into AgB utilization. I guess maybe as you think about the competitive landscape and how it’s evolving here, particularly in the line where you would ideally like mTagV to be positioned, maybe speak to us about what you’re seeing across that landscape and how you think that this might impact mTagV.

Dan Kirby, CCO, Iovance: So I think with new competitors, market always gives attention to metastatic melanoma and the need to treat for patients. And I believe that during our panel at ASCO, this was brought up. And the philosophy that Dan Olson and others said during the panel is the philosophy we keep hearing from the KOLs. When you look at mTagV, it’s a one time treatment. And you look at the long term data now.

What you want to do is you want to offer mTagV Because that’s the best chance for that patient to have a long term response without having to be on chronic therapy for years. Or go through dosing cycles that can last four months, and then two years of chronic therapy. So if you look at the approach they have, it’s really strategic. If you give EMTAGV or evaluate for EMTAGV you allow two shots on goal. You give the EMTAGV.

If you can’t give the EMTAGV, you always have a fallback. If you can give the EMTAG V, which is most cases, you proceed with that. And then you’ll know within a few months, with three weeks of start to finish, they’re done their dosing. And then when they get a response, there’s no need to go somewhere else. If for some reason they don’t get a response, you always have that fallback that’s sitting there for it.

So that’s what we’ve heard. So I think the noise is going be helpful to the market with it. But also too, we’re confident with our KOLs that Entagvia is the option.

Wissam Soubra: Great. I guess maybe as we think about the regulatory path and the expansion into ex US territories, what learnings will you take from The US launch to apply to the European countries?

Dan Kirby, CCO, Iovance: It’s a great question, Wissam. We have our European and UK GM right now. Her and I talk about this about three times a week, about what are the launches. Some of that is infrastructure and how we can approach better. So that’s one of the things that we can do internally to make sure we have a seamless between medical affairs, Brian’s teams, and my teams to ensure that we’re working in sync.

And then also to what we’ve learned in the community. I talked about going to where the patients are and asking them what centers to stand up. We have learned that of going to the government authorities and going to the centers and find out where the patients are right now from the dermocs primarily in Europe. And what centers we need to stand up on that side. And there’s straightforward selection process in some of the countries that we’re going through right now to ensure that we can access those patients.

And it is within their infrastructure to do so.

Wissam Soubra: And remind us here, you’ve noted how many ATCs you’re planning on onboarding to support this launch in Europe.

Dan Kirby, CCO, Iovance: So 15 ex US ATCs is what we’ve committed to. We’re well on our way to accomplishing that. We have over 10 deep in the process right now, halfway through the year.

Wissam Soubra: And what is the coverage, I guess, across those 15 ATCs? How many patients are associated with those ATCs?

Dan Kirby, CCO, Iovance: So it’s hard to give you exact patient number per ATC with it. What I can tell you is that there is a network mapping that we go through in each country. It’s a little bit different. I know The UK, we’re going through that right now, of being able to select the ATCs there. But really making sure that they’re within not only where the patient proximity is, but also to their centers that are authorized.

And typically they’re the cell therapy centers. But they have a good relationship with the dermocs, the surgeons, as well as the cell therapists.

Wissam Soubra: So it would be a fair assumption then for these ATCs, they are already familiar, they’re interested in cell therapies, they’re knowledgeable

Dan Kirby, CCO, Iovance: We received a lot of interest proactively from ATCs outside of The US in countries that we’re pursuing.

Wissam Soubra: How your capacity to offer the white glove service to US ATCs?

Brian Gasman, EVP of Medical Affairs, Iovance: So of all, you should know that most of the ones that we’re standing up outside The United States are ones that we’re already working with on trials. Many of them have large experiences. They have very large infrastructures and some of them you might have seen them on panels already about cell therapy. So these are the high end experts to begin with. In terms of the white glove service or I should say mirroring the services we have in The United States, we’re actually pulling from a lot of our US resources so that we don’t have to completely double everything.

In fact, you’re going to see a very smaller footprint from let’s say a medical affairs perspective to achieve the same thing we have there that we have here. A lot of our strategic leadership will stay here in this side because we have the experience and a lot of things that we did less efficiently at the beginning will not occur. So to speak, the new centers will start with a much higher floor than the ones that started here. And so I think for all those reasons, there are things that will just be part of the norm that had to be changes or amendments in The United States that will just be something baked into the system. So I think there’ll be higher efficiency, less of a need in general and a smaller footprint.

But I do think we will be able to do the same thing there as we have here.

Wissam Soubra: Any notable differences in the treatment paradigm in ex US territories versus US? Or is fairly similar?

Dan Kirby, CCO, Iovance: I think it’s interesting. One of the things that we were not seeing as an obstacle is what we talked about before, the community into the academic. It’s much more seamless. Maybe it’s a single payer structure. The financial incentives aren’t there to keep the patient.

But also too, you have a much more defined treatment algorithm to be able to get them to the centers and evaluate it quicker. That said, we also need to ensure that the cell therapists and the dermocs that usually don’t speak to each other, we’re forming those relationships and going in. In fact, we’ve actually had centers. We’ve had the cell therapists sit through the onboarding discussion with the dermoc there and help the dermoc understand one time cell therapy. And how that is to treat their patients and how they need this.

And we’ve seen great responses doing that.

Wissam Soubra: Great. Maybe one last question here on mTagV. But as it relates to your frontline trials, just any updates you can share there? And particularly on the back of the ASCO data that you did have last year, what has been the receptivity to potentially moving mTagV to the frontline setting?

Brian Gasman, EVP of Medical Affairs, Iovance: Well, Tillvance, as we call it, is still on track. It’s still our confirmatory trial. As you know, it’s a Phase III trial. A lot of it is happening in Europe to be consistent with what I just said before. And that’s also helping us sort of let these centers cut their teeth on the use of cell therapy through our processes.

At a minimum, this is going to not only be confirmatory but it’s also going to promote good practices to try to get these patients as early as possible. And at maximum, it would bring the EMTAGV into the frontline.

Wissam Soubra: And there’s excitement for a therapy like EMTAGV for the frontline?

Brian Gasman, EVP of Medical Affairs, Iovance: Well, when you see CR rates of thirty percent and at least with the Rosenberg’s data, if you hit the CR, you have a ten year, nearly one hundred percent survival. It’s hard to unsee that. Especially for those younger patients who are thinking about long lives with little children, this is really where this could have the most impact.

Wissam Soubra: Great. And then maybe just one more point here. As you think about your revenue guidance of February to 300, obviously a component of that is Prolukin. Prolukin generating revenue not just from Antagvi, but a number of other sources. Help us think through how the Prolukin revenue cadence should look through the remainder of the year.

Dan Kirby, CCO, Iovance: Absolutely, great question. I know in Q4, we had wholesalers that were loading up, one coming on, the major one came on. So what we’ve seen so far this year is the bleeding down of an inventory with it. So I had said in the last earnings call, we expected to reorder this quarter with it, continue that expectation with it, the two will place at least one order from us this quarter with it. As we look through the other channels with AMTAGV, the manufacturing channel, you saw a strong purchase in the first quarter for that.

We continue to put efforts against going to the other manufacturers for cell therapies and having them select Proleukin versus the other IL-2s. Proleukin is the only FDA approved for use in humans. So there are reasons why you’d want to use that in your manufacturing. We do have customers of ours that are other cell therapy companies with commercial products that are using Prolukin in their supply chain with it, and having great success there. So we do see that replicating across and putting efforts towards that.

And of course, the clinical trial pathway for IL-two use as well is a huge opportunity for us. So we look at this, it’s mainly going to be tied to mTag. There are two channels that are pretty decent business to stand up on their own and we’re putting more efforts against that.

Wissam Soubra: Great. Maybe in the last couple minutes that we have here, just your pipeline, you will have two data reads coming later this year. Maybe talk us through both for lung cancer as well as endometrial cancer, just the expectations here.

Brian Gasman, EVP of Medical Affairs, Iovance: Sure. So for lung cancer, we believe that we will have enough response as well as persistent durability that we’ve seen that will be similar to the data that we’ve shown previously in previous press releases. That should be well within the metric that we need to be able to submit that to the FDA. Our plan is to have a large dataset presented by the end of this year. We haven’t stated specifically where we’re going to do that.

It’s still under internal discussion. That being said, generally those kind of large data sets tend to not change much as you add the last bits of data on patients so that you have the full registrational cohort to be able to submit. And that’s the main plan. But the main thing is that since we started this, the landscape really has not improved. And it’s actually been very dour, so to speak, because one would have expected some of these other therapies would have done something in that line.

And the unmet need continues to grow, both for responses as well as durability of responses. In terms of endometrial, we expect to have a sort of signal finding cohort by the end of this year as well that we’re going to present. The key there is that we are looking at both proficient and deficient MMR patients. There’s a need for both, but the fact of the matter is that while lifileucel is an immunotherapy, its mechanism of action is distinct from checkpoint inhibitors. We’ve seen that in our lung cancer data.

We expect to see that also here as well. And this is critical because as you might see a lot of immune based therapies try to get those PD L1 highs or very high hot tumors, so to speak. We don’t necessarily need to fall into that. And that gives us the opportunity not just to go into the line, but also to affect patients where probably the line wasn’t that great either.

Wissam Soubra: Great. As you think about lung cancer, I mean, just mentioned line still very much an unmet need here. How would you anticipate a launch in lung cancer going relative to melanoma? Guess are there parallels there? Is it more difficult?

Is easier in some ways?

Dan Kirby, CCO, Iovance: I think the biggest thing it’ll be very difficult if we didn’t have melanoma out Because what we’ve seen with lung cancer is very fast. And it’s something where the patients are sitting in the community. So getting them to an academic center, a lot of times, even less so than melanoma, that they’ll actually get there. So as we look at what we’re doing in melanoma, success we’re having there, that is setting up lung very well. Because it’s the same community treaters, and we will have already opened up those ATCs within the community network.

So that gives us an opportunity to launch fast and help as many patients as possible, as quickly as possible.

Wissam Soubra: Have you thought or maybe shared the expectations for what could this opportunity represent on a dollar basis? You know, we’ve talked about melanoma. I think Fred has talked about this being a billion plus opportunity in The US alone. How does lung cancer compare to that?

Dan Kirby, CCO, Iovance: It’s multiples of melanoma. It really is. It’s a huge opportunity going forward.

Wissam Soubra: Exciting opportunity ahead then.

Brian Gasman, EVP of Medical Affairs, Iovance: Thank you

Wissam Soubra: guys both for joining us.

Brian Gasman, EVP of Medical Affairs, Iovance: Thank you.

Wissam Soubra: Thank you, everyone.

Brian Gasman, EVP of Medical Affairs, Iovance: Thank you.

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