All right, the team from Genmab up on stage. Thank you for joining us. We really appreciate your time.
We're delighted, and thank you for having us.
Of course. Just need to make a mention of disclosure statements. For all important disclosures, please see Morgan Stanley, www.morganstanley.com/researchdisclosures. My name is Vikram Purohit. I'm one of the biotech analysts with the Morgan Stanley research team. I cover Genmab. Very happy today to have you both on stage with me to discuss some of the key areas of progress with the business, some of the key upcoming milestones, but before we get into specifics, we'd just love to get a quick overview from you on where you've been focused on the business over the past year or so, and then we can go from there.
We are turning the company from an R&D-focused innovation powerhouse into an end-to-end integrated innovation powerhouse with now leading to eight products already on the market based on our science. Two of them, we are co-commercializing and co-developing with our partner, which we're very excited about. EPKINLY and TIVDAK are doing well, and increasingly do better and better and get very good traction in very small markets, but we are expanding the markets as we speak. Then, of course, we did an acquisition of ProfoundBio, the very first acquisition in 25 years of the company, and brought on board a 100% owned late-stage product candidate, Rina-S, which will very soon go into phase III clinical development.
I think the company is doing really, really well. The pipeline is progressing excellently. I think exciting times. In the coming months, we'll have a lot of data, so we are very, very excited about the company.
Great. Great. I mean, on the topic of developing out the proprietary pipeline, you're looking forward five, ten years from now, what do you hope the revenue mix looks like from a partnership revenue basis and then from your wholly owned pipeline basis?
I'm gonna pass it on to Anthony to answer this one.
Yeah. So as everyone knows, we've been focused on building out our capabilities over the last number of years to increase our percentage of value capture. When the company was founded, we were very much focused on what's called a licensing model-
Mm-hmm.
where we'd take our products or make our technologies available, and essentially hand o- those technologies or products over to larger biotech or larger pharma and collect passive income streams. In 2013, we set out a new strategy for the company, which was to forward integrate and increase the value capture for the business. Now, as our pipeline has matured, we've done just that. We've taken, together with our partners, EPKINLY and TIVDAK to market, finished development, taken those products to market in, let's call it, a fifty-fifty type model. The next leg of the story for Genmab is to further increase that value capture and take that percentage up closer to 100%. More recently, we flagged two programs where we do own 100%. That's Rina-S and also GEN1046, or the DuoBody PD-L1/4-1BB.
So moving forward, the base case for us is to take programs further and further and to own closer to that, you know, 100%. What this ultimate revenue mix will look like as we exit this decade between royalty, fifty-fifty, or a hundred percent owned, is probably too early to call, but what we want to leave everybody with is that we've made the investments to have the appropriate capabilities to capture more value as we move forward. And I think the zooming in quickly on some of the performance, particularly around EPKINLY, we're very pleased with the early returns on the commercial performance of EPKINLY in the two markets that we've prioritized, that being the United States and Japan.
And as we move forward and think about progressing to the 100% owned model, that gives us a lot of confidence in our ability to compete and ultimately win as we think about pushing GEN1046 and Rina-S through phase III development, and then pushing those products, if successful, out towards the market.
Understood. On Rina-S, when you were in the marketplace looking for targets, assets that could be interesting, what was your criteria, and how did you come on ProfoundBio and Rina-S as kind of the right asset profile?
All of our products need to be either, having the potential for best-in-class or first-in-class. I mean, that is an absolute requirement for all of the molecules we work on. What happened here is that, I think a year ago, in April 2023, we met with ProfoundBio, and we were very impressed by their linker technology, because the trick here is the linker. They have a very hydrophilic linker, which allows them to attach a few, a lot of hydrophobic payloads to the molecule. And by doing that, not to change the half-life and the PK/PD parameters of that molecule. We already work on ADC for a number of years. As you know, we have actually developed, co-developed together with Seagen, TIVDAK, which is a small molecule, first-generation ADC.
We were very excited about that concept, but there was no clinical data. In November last year at SITC, had the first clinical data in ovarian cancer and endometrial cancer. We were incredibly impressed by the data, and we knew that this was a potential best-in-class technology platform. We approached them after JPMorgan, and of course, they didn't pick up my phone call because they wanted to finish the Series B. My initial plan was to go in there before the Series B, actually, but I was respectful of that process. Immediately afterwards, we actually looked at the complete pipeline. There was not only the lead molecule in the clinic, but there was actually two others moving into the clinic also with their technology.
And a third one, which will move into the clinic imminently, is a bispecific ADC, all with brilliant preclinical data. And we actually realized that, having access to this next generation ADC platform was potentially a very good move for Genmab, because it actually could be complementary to our four platforms in next generation antibody technologies. And we were already very, very deeply involved in ADC developments anyhow. So we thought it was a perfect mix, and also culturally, there seems to be a very good alignment between the teams. So we moved swiftly and very effectively, I think, with the announcement on April the 3rd, for the proposed merger, and then executed it in May. Right now, we're very busy with the integration.
I can also tell you that I got at least two emails from other CEOs from very prominent companies, who are, A, congratulated me on the acquisition of Profound Bio, and B, said, well, we are very disappointed because you snapped it away in front of our face, basically. So I think more companies were looking at the technology platform, and up to now, the integration is going really well, Vikram, most of the team stays on board. At Genmab, we intend to actually expand rather than shrink that, and you will see more and more ADCs coming into our pipeline. Now, we have about 16%-20% ADC products in our pipeline, but that will increase from here. And we think it's a perfect complement.
I think also strategically, on a longer term basis, what we really want to see is combinations of ADCs, which give immunogenic cell death of cancer cells and combine that with immune activating drugs. I believe that we are breaking open a completely new area with the 4-1BB agonistic approaches, which are conditional approaches. Acasunlimab will go into phase III in the coming, literally in the coming months. We have also other 4-1BB targeted programs together with BioNTech, and they're still partnered with also, where we also expect clinical data for GEN1042 in the coming months, basically to dictate a decision to the next step. Ideally, you can actually do a mix and match.
You can actually start combining ADCs with immune activators to get not only very rapid shrinkage of tumors, but also long-lasting responses. So, when you ask me, I've never been more excited about the pipeline. I think this fits like perfect, absolutely perfect with our technology base, and we are super, super excited. I think this will actually open up a completely new era for the company and hopefully for the field.
Great.
Maybe just to add on in terms of the-
Yeah, please.
Thinking about making this investment decision around ProfoundBio, or particularly Rina-S. Another addition to what Jan said, a couple of things that stood out for me was that Rina-S was phase III-ready. So think about allocating the amount of capital we did, there wasn't a lot of additional investment or time that we needed to expend or take to transition this program to phase III. And in conjunction with our Q2 earnings call, we announced that we intend to do just that. We actually brought it forward from 2025 to 2024 in terms of the potential phase III start for Rina-S. And then secondly, I talked about building our capabilities.
Certainly, we can leverage these more broadly, but secondly, we see a lot of benefit and learnings from what we did with TIVDAK in the gynecological oncology space. So I think this was two additional boxes that we could sort of check as we think about making this investment decision.
Got it. Got it. And then, when we think about what the real world differentiation could be from ProfoundBio's linker technology, for Rina-S, how could that differentiate versus competing agents in the field, some of the other ADCs out there, what could that look like from a safety perspective, from an efficacy perspective? What will that mean for patients?
Yeah, very good question. I mean, in two weeks from now at ESMO, we will come with a full data set from the phase one trial, and we already said publicly, Vikram, in April, that we have seen more data at that time that was in the public domain at SITC last year. What it could mean is that we actually go for a much broader population of patients with much wider range of folate receptor alpha overexpression. Like, the first generation, folate receptor alpha targeted ADCs only work in the very highly expressing tumors with folate receptor alpha. We potentially would like to broaden that, not only in ovarian cancer, but also moving into other tumors.
What we already saw in the initial dataset, and I cannot preempt the data at ESMO, but what you will likely also experience while seeing that data is that what Tahamtan, our Chief Medical Officer, already said as well. It seems that actually patients can stay much longer on this molecule, so it's a much cleaner and more clean safety profile, which will actually allow patients to benefit much longer, much more prominently from this type of ADC. So we hope that we actually get much more long-lasting responses, which is many times the problem with ADC.
With ADCs, the good thing about developing an ADC is that when you see rapid shrinkage, you know that you have an active drug there, basically. But what we also know from some of the ADCs now in development and on the market is that they sometimes very rapidly relapse these tumors, and then it's difficult to bring them under control, so when you have a much safer molecule which you can give over a prolonged period of time, you will definitely get further data on duration of responses, et cetera, so from everything we have seen, we become more and more enthusiastic. We are going to broaden the program for Rina-S tremendously. We are not only moving into phase three, but in time, you will see us stacking more and more studies to it.
What Genmab will do more broadly in the coming years, we will actually focus on the top four or five clinical programs, which have created very good data, and then broaden those programs, probably at the expense of doing a bit less in the pipeline and a bit more focused work in the pipeline. We're going to focus the company more on late-stage development from here. What we did in the last three years is we actually expanded the clinical operations and execution teams tremendously. We kept more or less some of the research and preclinical development teams at bay, because we have a very sizable team of scientists already.
So we keep on turning out more and more of these IND candidates, but we are probably going to plateau that development in the coming time and then expand at the clinical development and commercial side. So I think super exciting. I mean, the, you know, twenty-five years young. In February this year, we were celebrating our twenty-fifth anniversary, and the best is yet to come.
Great. Great. What can you tell us about the phase III study starting by the end of this year? The first phase III study for Rina-S. How is that going to be designed? What's the patient population? Any, I guess, initial guidance to kind of keep in mind for how to best interpret that program?
I mean, I cannot give you... I can, but I won't give you any details at this point because of the competitive landscape.
Yeah.
There's a lot of companies now with folate receptor alpha-targeted ADC approaches. But I can say very soon, I think you will see the program appear on ct.gov, and then I'm more than happy to talk about it openly. We think it's a differentiated protocol, a differentiated population versus some of the competitors, and we want to keep it like that and then do very rapid execution, and also move into other trials quite quickly for Rina-S. So more to come in the coming, potentially even weeks, for you to see.
Got it. Got it. Okay, and I know when you announced the transaction, you mentioned blockbuster sales potential for Rina-S. Was that just for the initial phase III indication you're going into now, or was that across all the indications you might be in, or all the studies you might end up stacking on top of this one?
I'm going to ask Anthony to start off and then see whether I can complement that. Anthony?
Yeah, so we talked about that at least initially when we announced the deal back in April. We're talking about the asset or the program. Certainly, as we move forward, you know, we could consider providing additional guidance, but for now, it's talking about the entire asset, number one, and number two, the other guidance we provided was that we're focused on trying to deliver the first launch in the U.S. in 2027. We also said about starting the first phase three, to repeat what I said earlier, we would start that in 2025, and just to highlight, we've brought that forward to 2024. So we're really focused on putting our foot on the gas pedal here in terms of both, you know, speed, in terms of going fast, putting the foot on the gas pedal.
But as Jan highlighted, we think there's a potential to go broad as well, and broad here, broader across ovarian, but potentially in other therapeutic areas as well.
Got it.
We're very excited about this overall, you know, opportunity, even more so here today than when we announced the deal in early April.
Got it. Understood. That's great. So then what are the gating items then for additional studies, for stacking additional programs on Rina-S ? What are the gating items right now? What are the next steps for kind of expanding the team?
I mean, we are already planning those studies in different populations of ovarian cancer and tumors and also other tumors and also different combinations. So we are testing out different combinations very, very soon with Rina-S because we believe that there will be synergies with other molecules. And you will see this as a program which will very rapidly expand and get broader and broader. This will actually materialize over the coming months, for sure.
Okay. Okay, understood. So given the integration work you have right now ongoing for ProfoundBio for Rina-S, is BD a near-term priority, or are you more focused right now on just integrating the company and kind of operationalizing Rina-S and getting it to a kind of a more mature state?
I mean, we have a very active BD team, which is actually looking at the whole competitive landscape and the treatment landscape very, very proactively. So that will remain a priority because we believe that we can potentially add more complementary platforms to the Genmab suite of technologies. And also, we are definitely interested in another late-stage clinical asset with whether it is an antibody-based medicine which could actually fit with our portfolio. On a shorter-term basis, we're really super focused on the execution of Rina-S and moving the other three, now two, but soon three, ADC programs into the clinic and determine the optimal dose and then move further with those programs or stop them, and they are not having good data.
But I would say, don't be surprised when we would execute again, but the priority right now is integration of ProfoundBio, making that team work seamlessly as an integral part of Genmab. We will keep the Suzhou site in near Shanghai, where we do CMC and early-stage clinical development. We potentially expand that site because there's an enormous amount of innovation ongoing in China, which we, I think we can tap in very effectively, also by having a foothold there. We also keep the Seattle site. This is a smaller site for ProfoundBio to give us exposure on the West Coast of the U.S.
So I think integration will be one of the top priorities, but we will at the same time follow the field and also not be willing to shy away from rapid and very swift movements. I mean, we did this very rapidly. As I said, this all culminated in a matter of one and a half months early this year, and then we announced the proposed acquisition with the consent of both boards. And I think we put very rapidly, like sixty, seventy employees from Genmab on due diligence, because as this was our first ever M&A in the history of Genmab, I wanted it to be perfectly well screened and validated before we would actually execute.
I think now, having done that and with the feedback we are seeing up to now, I mean, this is seen universally as strategically a very clever deal. I can tell you that also the emails from the disappointed CEOs also gave me some further at least realization that we did the right thing here. Then another nice surprise was that I discovered actually a few weeks ago that we had actually an agreement with another company which is working on one ADC, but actually compare different platforms side by side, and they took a license from ProfoundBio before we acquired the company. So Genmab is actually now having a pretty good tap into the future royalty income for that molecule.
And this, they actually showed that the ProfoundBio linker and payload technology was absolutely superior to some other very prominent technologies. So I think we did the right thing here at Genmab, and we would not shy away from doing it another time. But the priority right now is integration of ProfoundBio and really make them feel very, very much integrated with the team and progress Rina-S and the other programs.
Great. Related to that, maybe then a question for Anthony then. With two phase three studies starting by the end of the year, and then with indication expansion, program expansion for Rina-S, what could the impact be to operating expenses for R&D in the near term and then SG&A in the long term, as you look to commercialize both therapies?
Yeah, so we've, we've been super clear about what our capital allocation framework is, and, and turning to the P&L, what our investment priorities are and what the direction of travel is. So let me unpack that for you-
Sure
... a little bit. If we think about R&D, over the last number of years, we've materially scaled up research and discovery intentionally. We thought that was an underutilized asset or untapped asset in the company, and as a function of increasing that investment in research and discovery, we can see the number of potential IND candidates have increased over the last number of years. That was an intentional decision we made actually back in twenty seventeen, twenty eighteen, and we can see now that bearing fruit. Now, what that means, where we're at today, that number is increasingly at scale, so any incremental investment there is gonna be more moderate in nature. We really feel as a company and an organization, as we sit here today, that overall level of research and discovery investment is directionally in an okay place.
That's now, I think, equally true for, let's call it, our phase I, phase II-
Mm-hmm
... investment. What this all, the net of this, means is that we're really focused now moving forward in terms of our incremental R&D investment, really focused on registrational trials or phase three trials. These are investments, of course, that, if successful, are gonna generate revenue for us. These are investments we need to make today to ensure the overall financial profile of the company as we exit the decade. We won't shy away from making those investments. What we will do is obviously very clearly articulate the clinical data supporting those decisions and the rationale for making those phase three investment decisions, like we did for acasunlimab and like we're gonna do here for Rina-S with presenting this data at ESMO here shortly.
So long story short, in terms of our R&D, incremental investment will disproportionately be these registration trials or phase three trials. Now, turning to SG&A-
Mm-hmm
again, we had to make a number of important investments over the last number of years to build out our commercialization capability, particularly in the United States and Japan. We've seen the performance in these two markets, particularly around TIVDAK and EPKINLY, and we're pleased with the performance we've seen so far, and these are investments that absolutely we had to make to ensure the performance that we did. We have entered a very competitive market environment with EPKINLY in the DLBCL space or the FL space. These were investments that we had to make to ensure our competitive positioning, not only for today, but over the next number of years, as we think about launches into second line and front line for EPKINLY.
Now, with those investments that we've made, we feel that we're increasingly at scale in the United States and Japan, so any investment moving forward will be more incremental in nature. Now, look, we will have to make investments for Rina-S and for aca, but this is gonna be more, I would say, in the field-facing type, you know, direct costs versus the underlying infrastructure we had to build out for EPKINLY in particular. Now, in terms of G&A, I talked about sales and marketing, and G&A, again, here, this number is increasingly at scale. Again, this was a commitment we made to the market, going back to the beginning of twenty twenty-three, that we are increasingly at scale.
We kind of recommitted to that promise as part of our twenty twenty-four guidance, and now you can see us actually honoring that commitment and looking at the H1 performance, when overall SG&A moderated significantly, was only up 12% year over year, and if you look discreetly at Q2, it was up only 8%. So what I can leave you with is that across our entire business, we'll continue to take a very focused and disciplined approach and scrutinize all of our investments and make sure we're absolutely driving any efficiencies that we can drive. At the same time, we're not gonna shy away from making the investments that we have to make to ensure the long-term health of the business.
Got it. Got it. Very clear. Maybe now it's a good time to switch over to acasunlimab. So, recently, you announced that you're gonna be pursuing that program fully independently. I think there might have been a little bit of confusion around the decision from BioNTech to not progress with you on that molecule. So do you want to just kind of talk us through the decision they came through, your understanding of it, and then your subsequent decision to be motivated to progress that program independently and not seek another partner for the time being?
Absolutely. I'm delighted. I mean, the data's just spectacular, and I think the data is really, really good, the ASCO data, and of course, it needs to hold up because you're talking about the tail of the curve, and it needs to be holding up, and we will follow that in time. I think we share the enthusiasm both with BioNTech for acasunlimab to be a really, really active immune activator, a new principle, a new concept, a completely new concept. It was a purely strategic decision. I mean, you can think about it. I think you need to ask Uğur from BioNTech.
But what I know is that they have at least two competing programs for exactly the same patient population, and these are programs where they obviously owned 100%. And in this case, they owned only 50% of acasunlimab, and Genmab had the dominant commercialization rights in Japan and the US. So not that attractive, basically, from a biotech perspective. So I can easily see that they make a decision to focus on two rather than on three, because to run three phase IIIs in parallel, competing for the same patient population is probably not the smartest thing on earth for any company. But I think you need to ask BioNTech about their exact motivation.
What I can tell you is that what we still share is the enthusiasm for the condition, the concept of conditional activation of 4-1BB, because it has been very challenging, as we know, with 4-1BB-targeted antibodies before. They were either very toxic or not very active. And now we have a super active set of molecules, we believe. And we are still partnering 50-50, GEN1042 program, which is currently being evaluated together with Pembro in front line head and neck cancer, so completely different patient population. And in the coming months, we will get the data, because we're doing different dose iterations and dose frequency iterations to actually make a decision on next steps for that program.
I'm very confident that we share the excitement with BioNTech for that program, and then this is not overlapping with any of the other programs. So I would be surprised if they would make a similar strategic decision, and then there is a third program with brilliant preclinical data that's a combo for 4-1BB. Again, the same concept of conditional activation of T cell and in case of 4-1BB agonism, which is only triggered once both of the arms of the antibodies are bound, and that program is in dose escalation now by BioNTech, and we own 50% of that program. So we're still very, very actively involved in multiple joint programs.
We have a HexaBody OX40 program in the clinic right now, and the dose escalation, which is a very potent immune activator. And we believe that, but I think both companies believe that combining ADC concepts with immune activators is probably the way to go to achieve completely chemo-free treatment paradigms for patients, which are not only give rapid debulking of tumors, but also long-lasting responses. So yeah, I've never been more excited in my life. And I, I'm following this whole antibody therapeutic field for 30 years now, becoming an old man here, I'm afraid. From the early days of Ipilimumab, I still remember the excitement of what we saw there in malignant melanoma.
But it always puzzled me that you only get a very small, relatively small percentage of patients benefiting from these immune activators. And this may be a novel concept. This will let more patients benefit from immune activation. So I think we will open up IO three point zero here with this type of approaches, and I think we share the enthusiasm with BioNTech. So we keep very closely working together. I mean, both companies are very much science-focused and I think rational companies. And this is one of these things that which can happen with acasunlimab, but we are delighted about it, Vikram. I was jumping in the sky, and I couldn't believe it.
The market reaction was a day later about the thing which made me so happy at that point.
Understood. Okay, great. We have a little more than five minutes left. I think maybe we should pivot over to GEN 3014. I know it's a big topic of focus for quite a few people. Starting at the start, I guess, how has GEN 3014 been designed to be potentially differentiated versus Darzalex? Let's start there.
Oh, it's... I mean, this is a completely different antibody to step one. The CD38 antibody targeting CD38 is very different from the antibody in DARZALEX. The DARZALEX has only a very small ability to block the ectoenzymatic activity of CD38. CD38 is an ectoenzyme involved in the generation of adenosine. Adenosine is an immunosuppressive molecule. So the idea is that when you can block the enzymatic activity of CD38, you stimulate the immune system, that's more prominently. The antibody in HexaBody-CD38 or GEN3014 is blocking that for 70-80%. So very, very good blocker of the enzymatic activity. That's one. Then the HexaBody mutation is a single amino acid mutation, so it's not a heavily mutated antibody.
It's one very precisely chosen mutation, which actually allows for much more intense clustering of the antibody once it binds to the tumor cells. And in that way, you actually increase complement-mediated killing 10- to 100-fold, which is like a miracle that you can do that because. But you may remember with daratumumab, and we picked up from a panel, I think, of over 100 CD38 antibodies, it was the only one which gave very good complement activation, and none of the other antibodies had complement activation because of the unique epitope this molecule was targeting in CD38. What we can now do with HexaBody mutations, we can actually turn several of these CD38 antibodies into wonderful complement activator.
There's a completely different mechanism of action than daratumumab preclinically, depending on which assay you're looking at, is between 10- and 100-fold more potent in killing CD38-positive targets. Another effect, Vikram, is that you can kill targets with much lower levels of CD38. And I think we now know that once you kill them more effectively, CD38-positive cells, you get into deeper responses, and deeper responses correlate a much more long-lasting benefit for patients. I think that the preclinical data looks brilliant. This is published now also. The early clinical data from the dose escalation, I think is also looking very, very good. There was a little bit of angst last year at ASH about cardiovascular complications more recently.
Our Chief Medical Officer, Tahamtan Ahmadi, got a question from some analysts, I think, or investor, whether we have seen problems with cardiovascular events, and he said, "No." I think for the rest, we need to wait on the data. So I think it is actually a very tolerable molecule with a much more potent efficacy profile. Yeah, and I think it has the potential to be clinically differentiated. The good thing is, we will see that in the coming months because we are going to have the complete data set, as agreed with J&J, to share with them, and we will flag that up to the market for sure. Next year, we will see the detailed clinical data. Maybe we're gonna give you some top-line data this year.
We have not decided that because we don't have the data in hand right now, but I'm very optimistic that this is a very attractive candidate for J&J potentially to opt into. Also, in the context of IRA, I mean, when you look at the recent CMS list with two molecules from Novo, insulin or insulin plus B3, seen as one molecule, if that is true, and CMS has that kind of broad definition, then Darzalex and Darzalex Faspro should also be seen as one product potentially.
At least I think J&J could potentially take all the risk off the table, and by as soon as possible, buying into a next generation CD38. This is for sure a different antibody and for sure a different mechanism of action, so there will be no debate in the future about whether that's the same molecule or not. I think that is probably a very attractive option. But in the end, J&J needs to decide that, Vikram . So the good thing is we are now coming closer to the agreed data set, and yeah, I think the data looks brilliant.
I mean, when you would have told me ten years ago that it is possible to make a more potent antibody than daratumumab, I would have laughed at it, because I wouldn't have believed it, because daratumumab is a unique antibody. It's one of the best therapeutic antibodies developed over the last decades, I think, in the industry. Three years from now, it's going to be one of the top three biggest cancer drugs on earth. Right now, it's the biggest product for J&J. And then to have a better one, which is differentiated, I think is potentially super exciting. So... And you will get that on top of our own pipeline news, et cetera. This will be extra become. So just think about that.
We don't need it, I think, to really keep this growth path for the company in the coming years, but this is purely on top of it, and our partner would take that over, so I'm very excited about that.
Got it. Got it. So it sounds like you were saying top-line data to the market, maybe this year, but definitely next year.
Definitely next year.
Great.
This year we will have to decide, but we will definitely flag up once we share the data set, because that starts the clock.
Right.
There's a very finite time that J&J can only say yes or no. And yeah, I mean, up to now, everything we have seen looks like it's following the preclinical data, which is very, very nice differentiation.
Understood.
Yeah.
Have you and J&J agreed on a specific threshold for how much of an improvement versus Darzalex would be meaningful or would make them more inclined to opt in, or do you have a completely-
No, we haven't communicated on that, but I think what is important for J&J, potentially, but you need to ask John Reed or one of the colleagues from J&J. I mean, they need probably clinical differentiation, which he can explain to doctors and to the market as being meaningful. Otherwise, they run the risk of it seen as a trick to propagate the income profile, and that will be very challenging for a company like J&J. So I think they want to see a really clear difference, I think, in clinical efficacy. And very likely you will find that in the depth of responses and the duration of responses, because that is what the preclinical data suggests. Because Dara is already a very good antibody, actually. It's a fantastic antibody. It's not only very good, it's fantastic.
But I think to beat that, with more, durable, long-lasting and deeper responses is probably very important. If you communicate, and that is what J&J is doing, that their intention is to actually cure the multiple myeloma patients in the future. They don't know what the magical combination is, but they keep saying that as part of that, combination is a CD38 antibody. And then to have one with a patent life very far beyond the twenty... end of the twenty-thirties, I think could be hugely, hugely attractive for a company like J&J.
Understood. Assuming the opt-in does happen, what do you think a potentially pivotal program could look like for GEN3014?
Ask J&J, but I think what they will likely do is look at the front-runner program, because for multiple myeloma, under the front- new front-runner concept, is that the FDA in the future wants to give conditional approvals based on the molecular endpoint. For all the cancers, I mean, this is almost the clearest for multiple myeloma, where MRD negativity to the ten minus fifth degree is seen as a very validated endpoint correlating with PFS, correlating with survival. So technically, they can do one or two trials, one in front line, combination trial or two arms, having a more molecular endpoint for quick readout, and then following the full trial for overall survival of PFS endpoint. And that's when you do that in front line, it's 50% of the patients.
When you also, on top of that, add one more trial in second line, that's another 30% of the patients. You can actually basically penetrate 80% of the multiple myeloma market, and that's the bulk of the market. The two trials, and I think that is a very smart approach. But I would be J&J, I would do that right away. I would not even think about a second. But they have to, of course, make up their mind, and they're experts in multiple myeloma, and I think they can figure that out. And when they can't figure it out, I will help them.
Understood. We're a little bit past time, but maybe just to close out, I know we weren't able to touch on many parts of the business, but, any closing thoughts on key milestones for people to look forward to, for the assets we discussed and also more broadly for the business?
I mean, data, data, data. I mean, as for data, in two weeks from now, we will have long data on acasunlimab, explaining why we need this every six-week timing, because the market didn't really understand that well. Now you get the translational data, which make it completely clear, that will be reinforced by the SITC data in November, more translational research data. In the coming months, you will see the filing of the package to the J&J. We may have top-line data there. Then EPKINLY, we will get lots of data at ASH. Because we do multiple combinations, we get more and more trials on board. For EPKINLY, the drug is doing really, really well, I can assure you.
So a lot of data, and I will give you for free, also potentially INDs and other entrants into the pipeline. And of course, Rina-S, I forgot probably one of the most impactful ones. I think the acquisition of ProfoundBio at ESMO, you will see the data of the phase one trial, and then a more robust data set and also a longer follow-on, not only in ovarian cancer, but also endometrial cancer. And we're super excited about that data.
Perfect. Perfect. Great place to close out. Thank you, everyone, for joining us. Thank you both for being here. Really appreciate your time.
Thank you.
Thank you.
All right.
Thank you all.