Thank you, everyone, for continuing to join us here at the Stifel Virtual Oncology event. My name is Brad Canino, Senior Analyst here at Stifel. I'm happy to be hosting a public company, Innate Pharma. We've got the CEO, Jonathan Dickinson, and team with us today. They will be presenting an overview of the company through a slide deck, and if time allows, at the end, we'll have a little bit of a fireside Q&A. Thank you so much again for joining us. Jonathan, why don't you take it away?
Thank you, Brad. Very happy to be here this evening, or this afternoon, evening time Europe, to take you through an overview of the company. I'm joined by Yannis Morel, our Chief Operating Officer, and Sonia Quaratino, our Chief Medical Officer. If we can go to the first slide, this basically highlights the strategy which we updated at the J.P. M this year. You can see that we're focusing in on three pillars. These pillars are our ANKET platform, our antibody-drug conjugates, and then our late-stage assets. If we go to the next slide, you can see our extensive differentiated innovative pipeline of products. We currently have eight products in the clinic today, and that's a mix of proprietary products and partnered products, and also a mix of early and late-stage products.
If we go to the next slide, what I'm going to do now is focus in on each of the individual components of the strategy. Starting off with our ANKETs. If we go to the next slide, you can see here an overview of our ANKET platform. This is a proprietary platform. What we're doing with this platform is targeting NKp46 and CD16 on natural killer cells. We basically add a tumor tag to that platform and produce a tri-specific, or in our second generation of antibodies, a tetra-specific antibodies. What we've shown here is the ability to produce superior efficacy. If I refer to our CD20 targeting ANKET versus the historical benchmarks in terms of B- cell depletion, we do that with a very manageable safety profile. The way these antibodies have been engineered, they don't induce pro-inflammatory cytokine markers.
We're avoiding the CRS liability that we see with some T- cell engagers that are out there today. If we go to the next slide, you can see a little more detail on that ANKET platform. Focusing in on the most advanced of those assets, we partnered the first two, IPH 6101 and 6401, with Sanofi, and Sanofi have taken those assets forward. 6101 has completed a phase I dose finding study. At the 1 mg per kg dose, they basically saw five complete responses in a group of 15 patients, so roughly a 33% response rate in treatment refractory AML patients. They were durable responses that lasted in excess of 10 months, with one patient also with MRD negativity.
That, from our perspective, is validation of this platform and the fact that we're producing activity here in a target that's against CD123 in this space, so targeting treatment refractory patients. Off the back of that, Sanofi basically moved into a phase II study in treatment refractory patients and also initiated a phase I study in combination with azacitidine and venetoclax. We're excited to see that continue to move forward. The second asset, IPH 6401, was being pursued in myeloma. It targets BCMA. This has been in a phase I study. Recently, Sanofi announced that they were going to pivot this asset into inflammation and autoimmunity, which is something that we're actually quite excited about. We've not seen data on this from Sanofi, but our assumption is that the data must be pretty robust.
Most importantly, it must be showing a good safety signal to be able to allow that pivot into inflammation and autoimmunity, where toxicity would be much more of a liability. Our most, what we call our most interesting asset, is IPH 6501. This is our asset targeting basically CD20. This is our proprietary asset. If we go on to the next slide, you can see a few more details about this asset. We are targeting the same CD16 and NKp46 on the NK cells, as with the Sanofi partnered assets. Here we have a CD20 tag from a tumor perspective. We engineer a non-alpha IL-2 variant into the antibody. This is a tetra-specific antibody with the idea to basically activate and proliferate natural killer cells and to drive these natural killer cells towards the target, towards the tumor.
If you go to the next slide, you can see how we're advancing this asset. We have been in a phase I study now, dose finding study for about a year. We've gone through a number of dosing cohorts, and we continue to progress well in this particular study. We hope to have some preliminary data establishing safety and efficacy from this particular asset towards the end of this year or at the very latest early next year. Provided that this asset stays clean from a safety perspective, our idea would also be to also explore this asset in inflammation and autoimmunity.
We believe that we would have a very unique proposition here where we would have B- cell depletion in an autoimmune disease, which would be similar or better to CAR T- cell engagers, but without the CRS liability because of the fact that we're targeting natural killer cells. We believe that that would create a unique proposition for the inflammation and autoimmunity field. This is something that we're excited about, and we're advancing this, as I said, through the dose finding study as quickly as possible. If we move on, what I'd like to do now is to take a quick look at our ADC portfolio and share a few details about what we're doing and where we're going here.
If we go to the next slide, you can see here we have the first asset, which is IPH 4502, and this is targeting Nectin-4. The second asset is IPH 43. This is targeting MICA/B . Then we have a number of other ADCs in development targeting non-disclosed targets at this stage that are in the research state. If we go to the next slide, you can see here a few more details about IPH 4502. This particular antibody has been designed to target Nectin-4. It's been designed to target a different epitope versus the other Nectin-4 targeting antibodies out there.
What we've been able to show is by targeting a different epitope on a different domain that we're able to basically show great activity not only in high-expressing tumors, which is what we've seen with other Nectin-4 targeting ADCs, but also in low and moderate Nectin-4 targeting tumors. That really opens up some interesting possibilities in terms of how you could develop this particular asset. It means if we look at some of the low and moderate expressing tumors, there are some big tumors like triple negative breast cancer, prostate, colorectal, non-small cell lung, gastric that have low and moderate expressions of Nectin-4. With this antibody, we have the potential to target those particular tumor types, which is exciting and gives an interesting development perspective. The other element of differentiation is around the payload.
Most of the Nectin-4 targeted ADCs out there are using the payload MMAE. We use an exatecan payload. This is a topoisomerase I inhibitor. What we've been able to demonstrate preclinically with this particular asset is that in a PADCEV resistance model, we can show excellent activity against the tumor and basically clearing of the tumor. This gives us another possibility in terms of how we develop this particular asset. We can go after a PADCEV resistant patient population here where the unmet medical need is very high. There aren't really any standard treatment options for this particular patient group. This would allow us to go with a fast track development program, probably an accelerated review, and a quick-to-market strategy.
That is great because then there are two ways that we can actually take this forward in terms of a tumor type, a large tumor type where there is not so much competition today, and then this particular treatment resistant patient population with a fast approach. In terms of other differentiation, we have differentiation linked to our linker. We have a very hydrophilic linker. This is very stable. We have very small amounts of free circulating payload because it is very tightly bound. We believe that this could also be carried through into the safety profile of the product and some advantages versus some of the other ADCs which are out there today. If we go to the next slide, you can see basically the timelines for moving this forward. We have moved very, very quickly with this particular asset.
The IND cleared at the end of September last year. We were able to initiate the phase one study in January, and we completed the first dosing cohort in less than one week by the end of January. We are now progressing through additional dosing cohorts. We are very excited by the clinical investigator response. We have basically patients lined up ready to go into this phase one study. We hope to be able to continue to progress at the pace we are going today, which is exceptionally rapid. If that continues, we should be able to present some preliminary efficacy and safety data towards the end of this year. That will lead to the next steps from a development perspective. That is our ADC. If we move on to the final pillar of our strategy, this is around our late-stage assets.
The first one of these is lacutamab. If we go to the next slide, you can see a schematic here. We are targeting KIR3DL2 with this antibody. We have completed a phase II study in cutaneous T- cell lymphoma. We have had interactions with FDA and European regulatory authorities. We have fast track designation and PRIME, as well as orphan designation for Europe and U.S.. We have had discussions with FDA at the end of last year about an accelerated path to approval. We have aligned on the high-level elements of that accelerated path to approval and the high-level elements of a confirmatory study, including a single dose that we would take into phase III , which is important in light of Project Optimus. Most recently, we were given a breakthrough designation from FDA for the Sézary Syndrome indication at the end of February.
If you go to the next slide, we're now progressing this asset forward. We believe that we have a business opportunity in excess of $500 million with this asset, potentially up to $700 million with the development program that we have aligned with FDA, which is basically an earlier line of therapy in both Mycosis fungoides and Sézary Syndrome. If we go to the next slide, you can see the timelines that we're working to. We have communicated that we're actively looking for a partner for this particular asset to take it forward. We're in discussions with mid-sized pharma companies. We're also working on a backup plan to fund this ourselves if we can't find the right deal because we have seen through our discussions with partners, we have a de-risked asset here from a development perspective with a very high chance to win in the confirmatory study.
We need a good deal or we will find a way to be able to take this forward. We have long-term follow-up data, which will be presented from the phase II study that I mentioned, the TELLOMAK study at ASCO this year, which continues to get better for this asset. We continue to align with FDA on the phase III confirmatory study. We hope to have that alignment completed by the middle of the year and hopefully a first patient initiated into the phase III confirmatory study by the end of the year or early next year. That will allow us then to progress with the accelerated approval as we move into the end of 2026, 2027.
We also have an ongoing phase II study in PTCL, which is a much bigger indication, about four times the size of cutaneous T- cell lymphoma, where we have the opportunity to further develop the product from a lifecycle management perspective. So that's lacutamab. If we go on to the next slide, this is our other late-stage asset. This is partnered with AstraZeneca. It's being developed in combination with durva. This is a product that is targeting NKG2A. And this particular product is in a phase III study, the PAC-9 study, which is scheduled to read out according to AstraZeneca by May 2026. We're excited to see the turn of this particular card and the analysis. This study was based on three phase II studies. We're very confident about where this is going to be going. We look forward to having the primary readout.
If we go to the next slide, you can see a couple of the elements related to the deal. We have already received over $450 million from AstraZeneca in milestones. We have up to another $825 million in potential commercial, development, or regulatory milestones associated with a positive study. We also have the possibility for a co-promote in Europe, a 50% profit share. We also have double-digit royalties on sales ex-Europe. Again, an inflection point, I think, for our company, which will be coming in the next year or so. If we go to the next slide, I think this is my final slide. You can see we are a clinical stage company with an extensive portfolio of clinical assets at various stages of development. We have the proprietary platform of ANKET with assets underway with partners, but also directly as proprietary with the company.
We have our proprietary ADC targeting Nectin-4, which is progressing rapidly, and lacutamab, which we're progressing forward and hopefully will bring to patients pretty rapidly. From a cash perspective, we have communicated that we have EUR 91 million in cash with an anticipated runway, which would take us to mid-2026. We can stop at that point and open up for questions.
Wonderful. Thank you for the presentation. Definitely a lot to discuss as well. It's a nice and busy portfolio. Maybe just to drill in on the Nectin-4 ADC. If you think about development of that, how would you position it for investors in terms of the differentiation of it? Will that come from a design and construct element in terms of the profile in patients, or will that come from clinical development that is different maybe than what we've seen from the incumbent Nectin-4 ADCs?
I think, I mean, maybe I'll take a first stab at it, and then I think Yannis and Sonia can add to that. I think a lot of this will come from the way we develop this from a clinical perspective. We have the phase I study. It's been designed in a way it's an adaptive design. What we're able to do is to follow the signal and backfill cohorts to be able to further validate any signal that we find in that dose finding study. What we would ideally like to be able to do is to have a cohort of patients that are relapsing on PADCEV .
That would allow us to then pursue this potential accelerated path in a patient group with a very high unmet medical need. I think based on the signals we see in the phase I dose finding study, we'll be able to chase one of the larger tumor types where we'll hopefully see a signal and then be able to further develop it in that specific tumor type where there isn't as much activity in the Nectin-4 space. A lot of the Nectin-4 space activity is basically in urothelial cancer and bladder cancer where PADCEV has validated this particular approach.
I think just one thing to emphasize from a differentiation perspective is because we have the exotican payload, we can go in this treatment resistant patient population where any other Nectin-4 targeting ADCs that are using the MMAE payload, which is most of the antibodies that are being taken forward, will not be able to follow this path because you will have a resistance already in most patients to the MMA payload. I don't know whether Sonia or Yannis, whether you want to add anything to that.
Yeah, maybe just also to start with, the differentiation comes also from the design of the ADC, which is composed of three different components: the antibodies, the linker, and the payload. Like Jonathan has a payload, we are using exotican, which is not sensitive to the same mechanism of resistance as the MMAE. We have also designed a proprietary antibody, which has really interesting properties in terms of epitope, which is not overlapping with enfortumab and very good, having also very good internalization, as well as a linker, which is very hydrophilic and very stable. Altogether, this gives really very differentiated properties to our antibody as we published at previous congress and as we will update at the future meeting at AACR in a couple of weeks.
Now, maybe on the late-stage portfolio, how do you plan to best maximize value of lacutamab and its opportunities?
Yeah, I think we've communicated in an ideal situation. We will find a partner where we're able to establish a deal here where we would have an already established player in the oncology area who would be able to basically take this asset forward. The phase III component, I do not think it is too complicated and too—it is not a big step for us to be able to complete that. I think we have confidence we could run the phase III program ourselves. Ideally, we would like a partner so that we can then actually focus on our ADCs and basically our ANKETs and drive basically IPH 6501 and IPH 4502 forward aggressively and really keep that as the focus for the company. I think getting the best value from this is finding a really good partner who will be able to drive the commercial value of this and will be able to help us to make sure we execute the phase three program very quickly. I think that is the key to maximizing the success. Again, I do not know, Yannis, whether you want to. Yeah.
I think, like Jonathan said, it would be very important to find a partner which is committed to the development of this drug. Obviously, we are really confident in the potential of lacutamab, both in CTCL, but also potentially in PTCL that could at some point also really increase the business case for this product.
Okay. Right. We are running up on time here. Jonathan and the rest of the Innate team, I want to thank you so much for joining our event and going through the presentation with us. We really appreciate it. Thank you, everyone, for joining in.
Thank you, Greg.