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spk06: Continue to stand by, your conference will start very shortly. Please continue to stand by, your conference will start very shortly. good day and thank you for standing by and welcome to the innate farmer 2021 first quarter business update conference call At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. I must advise you that this call is being recorded today, Tuesday, the 11th of May, 2021. If you require any further assistance, please press star 0. I would now like to hand the call over to your first speaker today, Dr. Mondaire Majubi. Please go ahead, sir.
spk00: Thank you. Good morning, good afternoon, and welcome, everyone. This morning, ENAIT issued a press release providing a business update for the first quarter of 2021. I look forward to explaining the progress made during the quarter as well as addressing future goals and milestones. The press release and today's presentation are both available on the IR section of our website. Please move to slide number two. And before we start, I would like to remind you that we will make forward-looking statements regarding the financial outlook in addition to regulatory and product plan development. These statements are subject to risk and uncertainties that may cause actual results to differ from those forecasted. Please move to slide number three. On today's call, I'm delighted to be joined by Dr. Joyson Caraconell, EVP and Chief Medical Officer. I would also like to take this opportunity to welcome our new CFO, Frederic Lombard, who officially started at the company in April and will join the Q&A section of this webcast, which will follow the prepared remarks by myself and Joyce. As you may have noticed, in the past we have only held conference calls marking our half-year and annual results. However, in order to provide more regular updates on our business progress, we have decided to hold conference calls on a quarterly basis it's important to note though that as we do not publish full quarterly financials there will be no formal remarks about our financials during this call or the third quarter call on slide number four you have the uh classic intro slide of innate pharma uh We are a pioneer in the field of innate immunity, as you know, and NK cells, and we follow the science to develop innovative therapeutics for patients, leveraging our know-how and antibody generation platform. We are using this expertise and know-how to develop a robust pipeline of novel medicines for cancers, but also for other life-threatening diseases with high and met medical needs. Slide number five actually depicts our research strategy. And I'm very pleased to see the growing momentum in understanding the important role NK cells play in developing therapeutics to treat cancer. We are the leader in the field of using natural killer cells to activate innate immunity, and this scientific foundation is at our core. As you know, early approaches to immunotherapy were T-cell centric. and have mainly focused on enhancing T cell responses by targeting inhibitory pathways with immune checkpoint inhibitors, for example. These therapies have led to unprecedented successes and transformed the natural history of many cancers. However, the medical need is still high, as only a small fraction of patients respond to T cell therapy, and there remains significant relapse among those who do. Broadly speaking, T cells are not autonomous in their effector function and need help from cells of innate immunity, which we believe represents the second wave or the next generation of immunotherapy. And to us, choosing the right targets to direct the body's immune response is of paramount. We do this by utilizing our fundamental understanding of NK cell biology, tumor microenvironment, and tumor antigens. Please move to slide number six. Our pipeline shows how we have translated this into a robust portfolio of proprietary and partnered assets. It also illustrates how we are executing against our strategy with our lead asset, LACUTA Map, supported by a partnered and earlier stage product. we have a rich pool of preclinical projects which we will carefully select and bring forward to fuel our clinical pipeline. Let me remind you our strategy on slide number seven. Our strategy is centered around three core priorities. First, create a near-term value driven by our lead proprietary product candidate, Lacutamab, which is in development for T-cell lymphoma. Second, fueling our pipeline and creating longer-term value by leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multi-specific NKCL engager delivered from our proprietary platform. And third, we are building a strong and sustainable foundation for our business leveraging the various partnerships across industry and academia, which further validate our science and offer capital that we reinvest to advance our portfolio. And during the first quarter of 2021, we have worked diligently to execute against these three core priorities. Number one, we have continued to advance L'Aquitama as we pursue a broad development strategy across T-cell lymphoma. Earlier this year, in February, we had a virtual IR meeting where we highlighted the advancement of the mycosis fungoridis arm of our Phase II telomex study into Stage II, which occurred earlier than anticipated. In addition, we announced our stepwise approach in developing lecithinib in peripheral T cell lymphoma with two clinical studies for K3DL2 expression patients with relapsed PTCL, including randomized controlled trial in collaboration with our partner at the Lymphoma Study Association, or LISA. We have also worked hard to advance our R&D efforts with our early stage program moving forward. At the start of the year, we were pleased to announce that Sanofi made the decision to progress APS 6101, our lead NKCL engager, into R&D enabling studies. APS 6101 now is This is the first candidate to emerge from our multi-specific NKCL engagement platform, and we are excited by the prospect of this technology, which we believe will fuel our pipeline well into the future. And we look forward to telling you more about our progress here later in this call and in the near future. I would like now to pass the call over to Joyce, who will review the progress made with our portfolio. Jason?
spk02: Thank you, Bondar. On slide eight, let me start with Lakotema, our first-in-class humanized monoclonal antibody that targets the immune receptor KER3-DL2. As you may remember, KER3-DL2 is an inhibitory receptor found in approximately 65% of patients across all cutaneous T-cell lymphoma. and even more in certain aggressive subtypes, but with limited expression in healthy tissue. To date, data from Likudimab have shown promise, demonstrating compelling single-agent activity and offering immense potential in lymphomas historically associated with a poor prognosis for which there are few therapeutic options at advanced stages. On slide nine, as Mondaire mentioned, this past quarter, we hosted a virtual investor event featuring key opinion leaders in cutaneous and peripheral T cell lymphomas. During this event, we highlighted both the unmet need in these populations, as well as the therapeutic rationale for our telemedic study, evaluating lacudamab in subsets of CTCL. Additionally, we introduced a broad development strategy to advance this program initially for Cesare syndrome, a niche CTCL indication with high unmet need into other forms of T cell lymphomas, notably mycosis fungoides and the broader PTCL population. On slide 10, let me first highlight the progress in our ongoing phase two TELEMEC study for cesarean syndrome and mycosis fungoides. We were pleased to share that we had moved the cure 3DL2 expressing mycoses fungoides cohort from stage one to stage two, clearing a predetermined threshold before 50% of the cohort was enrolled. This was very encouraging, and I'm pleased to announce that the preliminary data from the stage one of this cohort will be presented by Dr. Martine Bagot in an oral session on the 22nd of June at the 16th International Conference on Malignant Lymphoma, ICML, Lugano. And this year it is being held virtually. For the sensory syndrome cohort, enrollment is on track. And we expect to be able to report top line data in 2022. Sensory syndrome offers us a potential fast to market opportunity as we received fast track designation in the US and prime designation in the EU last year. On slide 11, Simultaneously, we are working to advance our recently announced clinical development plan for peripheral T cell lymphoma, which will focus initially on the relapse setting, where the unmet medical need is most significant in patients expressing the target, Kir3DL2. We expect to initiate our phase 1B trial evaluating lacudimab as monotherapy by midyear. The study will enroll. approximately 20 patients, and it will evaluate safety and characterize clinical outcomes. First data are expected in 2022. Separately, our partner, Lisa, will initiate an investigator-sponsored Phase II study to evaluate lacudimab in combination with chemotherapy, GemOx, versus GemOx alone. This study will be multicenter, randomized study with approximately 60 relapsed refractory patients outside the US and is expected to be initiated in the second half of 2021. We believe that this stepwise approach will prove efficient in identifying the optimal regimen for lacunamide in the relapsed PTCL setting. Depending upon the data generated in these initial studies, we will consider initiating a separate trial in combination with other standard of care treatments, and eventually, we would look to move lacudimab into earlier lines of treatment, including as potential combination in the CHOP regimen in frontline PTCL, or as a consolidation therapy following standard first-line treatment. On slide 12, turning now to our R&D efforts, we continue to advance multiple programs forward based on our proprietary, multi-specific NK Cell Engager platform, which we believe will be the key to unlocking next-generation clinical molecules in immunotherapy. At the start of the year, we announced that Sanofi had taken the decision to progress IPH6101 or SAR443579 into IND-enabling studies. As you may remember, IPH6101 is an NKP46-based NK cell engager using our proprietary multispecific antibody format. IPH6101 is a part of our ongoing research collaboration with Sanofi to evaluate up to two NK cell engagers and is advancement into the IND-enabling studies milestone pavement 2 and 8. Sanofi is now responsible for all future development, manufacturing, and commercialization of IPH 6101, and we remain eligible for future development and commercial milestones. On slide 13, as you know, our NK Cell Engager platform is at the heart of our research and is a major component of our long-term development strategies. To date, we have developed a robust portfolio of product candidates using our tri-functional NK cell engenders, or NKCE3, which has demonstrated potent NK cell activation, cytotoxicity, and efficient control of tumor growth. Our innovative approach means that we are continually working with our NKCE platform to further develop and expand its capabilities, including the develop development of a next generation tetrafunctional NKCE or NKCE4. Our chief science officer, Eric Vivier, will speak more about these latest innovations in our platform during his plenary talk at the annual meeting of the Federation of Clinical Immunology Societies, also known as FOSIS, on the 10th of June. Additionally, we will hold an investor and analyst event mid-year where we will cover both the next generation NKCE platform and present the lacudimab and mycosis fungoides data that are being presented next month at the ICML Lugano Conference. In addition to our progress with lacudimab and our next generation NKCE antibody, we have also made progress with IPH5301, our CD73 blocking antibody, and a phase one trial is expected to begin later this year. IPH5301 targets the adenosine immunosuppressive pathway and has the potential to promote anti-tumor immune responses across a wide range of tumors. Now I would like to turn the call back over to Mondaire for concluding remarks.
spk00: Thank you, Jolison. As you can see, we are working diligently to execute across all our strategic pillar and believe that we are laying the groundwork to drive near and long-term value for patient and shareholders. Looking at our clinical program, we expect to achieve a number of milestones over the next 18 to 24 months. As you heard from Jolison, our phase two Telomax study for Lakedana continues to progress, and we expect to share preliminary data from stage one of the Q3DL2 excess NMF cohort at the Lugano meeting in June, as well as expecting to report potentially pivotal data in cesarean syndrome in 2022. In addition, we anticipate moving our monotherapy PT-CL program into the clinic by mid-year, with initial data expected in 2022, with the combination study sponsored by ELISA expected also to start in the second half of this year. In parallel, we continue to develop our NKC technology platform, and we are very encouraged by the preclinical results for our next-generation NKC linkages. We believe that this represents a natural evolution of our platform, illustrating the potential of natriurecular cells to be a potent cellular player for the next generation of the shelf cancer immunotherapies. And we look forward to Eric sharing more details on the innovation we have made at the 4C meeting next month. Highlights, as you heard from Jason, of the next generation NKCE platform, together with the LakotaMap NS data presented at Lugano, will also be presented at an online IR event to be held on June 23rd. Details for accessing the event will be posted onto our website in due course and publicized via our usual channels closer to the date of the event. Lastly, we are also very pleased to have such productive collaboration with industry and academic partners to advance Monalizumab and Avdoralimab alongside early stage programs such as APS 6101. In addition, as you have seen, we are well capitalized to deliver on our ambitious development goals and look forward to keeping you updated on our progress throughout 2021 and beyond. That concludes our prepared remarks. We will now open the call to questions. Operators, please can you start with the first question?
spk06: Thank you. Once again, if you have a question for today's call, please press star one on your telephone and wait for your name to be announced. That's star one if you have a question. Our first question comes from the line of Yigal Nukramovich from Citigroup. Your line is open. Please ask your question.
spk03: Hi, thank you very much for taking the questions. I had a question about the positive early signal that you've seen in the KRFD deal to expressing MF cohort. My question is, Can you speak to the durability of these responses that you've seen so far? And was there any correlation between the degree of expression of the target, KR3DL2, and the responses?
spk00: Thank you, Igor. Very important question, indeed, about the quality of the response we achieved with lacrytamab. Before I hand over to Joyce and to give you more details. As you may remember from the Phase 1 study published about now two years ago in Lancet Oncology, the duration of responses and even disease control including progression-free survival in the Phase 1 was quite impressive in the range of 11 to 12 months. So not only lecithinab could have generated a significant tumor shrinkage in the range of 45%, but with a durable response in phase one. And of course, we look forward to sharing with you these data soon in the in the next couple of months. But keep in mind that the stage one was essentially about the tumor shrinkage. That's what basically triggered the move from stage one to stage two. Now I leave it to Joyce to provide more color about this question.
spk02: Thank you, Mondarin. Thanks for the question. So I think, you know, when we look at this, I would look at it similar to what Mondaire was just mentioning. In the phase one study, we talked about the duration of response with the cesarean syndrome, and that, as Mondaire was mentioning, was longer than the benchmark at that time. I think when we look at the mycosis fungoides stage one cohort, the key things to remember here is that the stage one to stage two was dependent upon response. And due to that, we would be showing early data. I think what we are trying to also do is, what we're also trying to do is show you the totality of the data. So I think during Lugano, what you will be able to see is both the QR3DL2 positive as well as the non-expressing QR3DL2 positive. cohort totality. This will be early data, so clearly we may not have as much follow-up as we would like, but that's what we'd be presenting at Lugano.
spk03: Okay, thank you. So, based on the data at Lugano, we will have some sense as to how well the response correlates with the expression of KR3DL2?
spk02: Yeah, I think it will be. So it will be very early data, but yes, I think you will get a sense of that.
spk00: So, Egal, let me maybe rephrase your question to make sure we understand it. There are two cohorts in this MS trial, the Q3DL2 positive or expression and the Q3DL2 negative. The stage one to stage two translation we talked about is in the Q3DL2, so in the patient population that express the tumor antigen. So the level of activity that we will be presenting is in the Q3DL2 positive. We won't be showing data in the Q3DL2 negative so far because it's still ongoing.
spk03: Okay, I understand. Thank you. Thanks.
spk06: Thank you. Our next question comes from the line of Dana Graybosh from SVB Learing. Your line is open. Please ask your question. Thanks for the questions.
spk04: Two from me. First, do you have any data, any updates on when we could see monolizumab data, in particular anything from the ongoing lung cancer trial? And the second question is, whether you guys see a role for NK adoptive cell therapy to be combined with your NK cell engager program. And if you know whether Sanofi has any plans to look at the combination given the recent acquisition of an NK cell therapy company, Kiatis.
spk00: Thank you, Dana. Great questions. The first one, I'm sorry to disappoint you, but as you know, this trial in particular, the COST and NEO-COST trial are trial sponsored by AstraZeneca, and I do not have more information than what they disclosed publicly, which is that they plan to present this data in the second half of 2021. So we are really looking forward to seeing this data in the second half of 2021. For the second question, I'll start and please, Joyce, chime in. I think what we have seen at the last AACR and what also was published, you know, already by the MD Anderson team last year is very encouraging and makes a lot of sense to somehow boost the NK cell engager platform or the NK cell engager antibodies with fresh cells that you infuse in the same time. So it makes a lot of sense. Of course, we cannot speak or speculate on what Sanofi's strategy is in this field. I think the obvious next step is, of course, to move APA 6101 into the clinic and start the phase one. But I can tell you that we are looking at this field very carefully and very excited about the prospect of having this combination that seems, at least in him, to produce a quite, you know, spectacular tumor shrinkage and clinical benefit. Joyce, would you like to complete or add anything on this question as well as on the monolizumab if you know more?
spk02: No, I have to say, you know, the monolizumab, I think you summed it up very well. And also on the second question, I think, you know, that was a great summary and I have nothing more to add.
spk04: Thank you for that. You know, I have to ask about those one trials every time. I mean, you have to.
spk00: I mean, Dana, if you don't ask, I would be surprised.
spk02: Thank you. We'll just predict the question from now on. Thank you.
spk06: Thank you. Our next question comes from the line of Swayam Ramakant from HCW. Your line is open. Please ask your question.
spk01: Thank you. This is RK from HCW. Good afternoon, Mondaire, and good morning, Joyce. In terms of the NCSL Engager program with Sanofi, so we know that the first one is you know, getting into the pre-IND studies. On the second molecule that potentially Sanofi can take into development, would that also be against the same target in the sense NKP46, or it could be against, you know, the other targets that not only you but other folks are also looking at?
spk00: Thank you, RK. Thank you for your question, and great to talk to you as well. I think I believe you know that NKP46 is an activator receptor expressed on NK cells, and it's one of the most specific and stable activator receptors for NK cells. And like, you know, many others, I don't know, to mention NKG2D or CD16, we know that those receptors eventually may get downregulated when the NK cells, you know, are traveling to the tumor microenvironment. Here we are talking about really a very specific and very stable. And I think it's important for us to highlight the fact that our platform is is basically versatile by the fact that you can change to Montagen, but we are extremely delighted, actually, with the proprietary platform we developed around NQP46. So the various partnerships that we will be developing, including the second program that we have with Sanofi, is still used in NQP46. as an activator receptor, but a different tumor antigen that Sanofi did not want to disclose at this point in time. So it's the same technology as for the first one, 6101, but with a different tumor antigen. And beyond Sanofi, again, we are developing both proprietary but also partnered multispecific, again, keeping NKPR46, and changing the tumor antigen depending on, of course, the collaboration and the partner that we are working with. In addition, as you've seen in Joyce's last slide, what Eric Vivier will be presenting next month at the FOSI is basically even the next generation of multispecific NKCE, what we call NKCE4, where we are still, you know, leveraging the NKP46 platform but trying to ensure that we have even a more potent and efficient antibody targeting different tumor antigen. I hope I answered your question.
spk01: Yes, yes, you did. Thank you for that. And then going into the clinical programs, especially the one with leucetamab in PTCO, as you stated, you know, you're initiating the monotherapy and the GEMOX combination is being started by Lisa Group. However, for the combination with the CHOP, do you need to see the data from your monotherapy study before you embark? onto the CHOP combination or you're basically staggering these studies and don't have to wait for all of the data from the monotherapy to come out?
spk00: Again, very, very important question that will give Joyce and the opportunity maybe to remind you a little bit the strategy behind the selection of the monotherapy approach or strategy in relapsed PTCL. Joyce, would you like to take the question?
spk02: Sure. Thanks, Mandir. Thanks for the question. So when we look at the strategy for PTCL, we are targeting, first of all, Kir3DL2 positive patients. And that's going in with the at least early data that we've seen in the mycoses fungoides cohort based on that hypothesis. Now, when we look forward in time, what we would see is that the monotherapy will, there's two approaches that we could take. One is sort of, and I'm specifically talking about an earlier line setting, which would be a CHOP combination. And for that, what we would, what we'd like to do is one, we could, we would be waiting for the totality of the monotherapy data before beginning the first line setting, or to your point, we could stagger it to where what we would do is basically in, as we start to see the data from the monotherapy single arm study, we would begin to if the data is very encouraging, start the earlier line setting at that point. So there's definitely those two approaches that are possible, and we're considering both of those as we start these trials and start looking at the data.
spk01: Thank you both, and talk to you guys soon. Thanks, Hakeem.
spk06: Thank you. Our last telephone question comes from the line of Lisa Baco from Evercore. Your line is open. Please ask your question. Hi, there.
spk05: Just a couple questions for me. First of all, for the PTCL study, do you envision that sort of following the general design of KELOMAC, or can you maybe speak to how you're thinking about the design of that study?
spk00: Thank you, Lisa. Jason? Okay, go ahead.
spk02: Thank you, Ander. Thanks for the question. So, we're considering all approaches at this point in time, but at this point, at least as the data in the mycoses fungoides starts to evolve, as well as we're placing our bets on the KER3 DL2 positive. Now, that's not saying, of course, as we start to see longer term data, especially in the mycoses fungoides, where we may reevaluate our strategy and it starts to look more of like the Telemac where we have an expressors as well as non-expressors. I think it's very early, but we are definitely keeping all those approaches in mind. So one, to look at the monotherapy in the CURE3-DL2 positives and only look at that subset. Number two, continuing to evaluate the mycosis fungoides in the telemax study, especially the longer-term data, and considering putting in a non-expressing cohort into PTCL. And then, you know, also the combination. So not only is LESO running a chemotherapy combination, but we would also be looking at looking at other standard of cares that are available in the U.S. in combination, depending upon the PTCL data. I hope that answered the question. Yeah.
spk05: And can you maybe describe a little bit more kind of the non-expressors? What would be the rationale for activity there?
spk02: So I think when we look at the non-expressors, you know, I think if I understand the question correctly, you're asking if you were to see expression, why would you expect to see expression? in the non-expressors considering the mechanism of action of lacudamab. And what I would say is I think it goes to what we see with a lot of biomarker subsets. And that is tumor heterogeneity, that's number one. And then number two is sampling error. So I think both of these can lead to sort of the, I guess you could say the sensitivity, not only the, not only the sensitivity of the test being able to pick up, which we're confident about that, but more importantly is that are we sampling or is it heterogeneous and that's why we're not picking it up.
spk05: Okay, understood. For 6101, can you maybe talk about what kind of IND enabling work you're doing and when we can expect that to enter the clinic. We're excited to see more about the NK-Engager platform.
spk00: So, Elisa, as you know, the 6101 program is fully under the responsibility of Sanofi. They are conducting the classic, you know, IND-enabled studies with the ambition and goal to start the clinic as soon as possible. So we do not have any data or comments to disclose at this point in time about what Sanofi is doing to move this drug into the clinic.
spk05: So it's kind of really, it's on their hands and whatever. Yeah, yeah. I mean, they're probably not going to disclose that much preclinical stuff. They don't normally do that. Okay. Do you have any sense of when that will start clinical development?
spk00: I mean, the announcement early this year is, I would say, a testimony for their interest to move this to the clinic as quickly as possible. And you know the usual process and what type of IND enables studies. So the plan is to go as fast as possible. But they did not disclose specific dates.
spk05: Okay, fine. Thanks a lot.
spk06: I'd now like to hand the call back to you, sir, for your webcast questions.
spk00: Thank you. Actually, I have one question from the webcast. It's an update on the FORCE timeline. FORCE is the randomized phase 2 study that is testing the potential role of afdoralumab in the treatment of COVID-19-driven pneumonia. As you know, this is an investigator-sponsored trial, and it's currently ongoing. I cannot give timelines or further details about the progress on this study, as INATE is not responsible for the running. I can only say that the trial has completed enrollment and is ongoing for patient follow-up and data analysis, and we'll share with you this data as soon as they become available. That's what I see on the webcast so far. Okay. If there are no more questions, I would like to thank you all for joining this call. And I look forward to our next investor relation event in June. to update you on the progress of our portfolio, especially on the NKCell Engager platform as well as the LACUTIMAB data in mycosis from Goethe's patient that will be presented at the Locano meeting. With that, I close the call and thank you very much. Have a good day.
spk06: Thank you. That does conclude today's conference. Thank you to everyone who has participated in today's call. You may now all disconnect.
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