Earnings Call: Q1 2021

May 11, 2021

Good day, and thank you for standing by, and welcome to the Innate Pharma 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. I must advise you that this call is being recorded today, Tuesday, 11th May 2021. I would now like to hand the call over to your first speaker today, Doctor. Mondher Majoubi, please go ahead, sir. Thank you. Good morning, good afternoon, and welcome, everyone. This morning, Innate issued a press release providing a business update for the Q1 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 2. 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 risks and uncertainties that may cause actual results to differ from those forecasted. Please move to Slide number 3. On today's call, I'm delighted to be joined by Doctor. Joyceann Carconnell, 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 and 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 It's important to note though that as we do not publish full quarterly financials, there will be no formal remarks about our financials during this call or the 3rd quarter call. On Slide number 4, you have the classic intro slide of Innate Pharma. We are pioneering the field of innate immunity as you know in NK cells and we follow the science to develop innovative therapeutics for patient, 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 unmet medical need. Slide number 5 actually depicts our reserve 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 transforming the natural history of many cancers. However, the unmet medical need is still high as only a small fraction of patient respond to T cell therapy and there remains significant relapse among those who do. Broadly speaking, T cells are not autonomous in their effective function and need help from sales of in native immunity, which we believe represents the 2nd wave or the next generation of immunotherapy. And to us, choosing the right targets to direct The budget's immune response is of paramount. We do this by utilizing our fundamental understanding of MK cell biology, Tumor Microenvironment and Tumor AntiJ. Please move to Slide number 6. 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, liquitamab, supported by partnered and earlier stage product. Additionally, 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 7. Our strategy is centered around 3 core priorities. 1st, create a near term value driven by our lead proprietary product candidate, lacutamab, which is in development for T Cell Lymphoma. 2nd, fueling our pipeline and creating longer term value by leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multispecific NK cell engager, delivered from our proprietary platform. And third, we are building a strong and sustainable foundation for our business, leveraging the various partnership across industry and academia, which further validate our science and offer capital that we will reinvest to advance our portfolio. And during the Q1 of 2021, we have worked diligently to execute against these three core priorities. Number 1, we have continued to address lequitiamab as we pursue about development strategy across T cell lymphoma. Earlier this year in February, we held a virtual IR meeting where we highlighted the advancement of the Mycosys Vulgarides arm of our Phase 2 TELEMAK study into Stage 2, which occurred earlier than anticipated. In addition, we announced our stepwise approach in developing lecovirab in peripheral T cell lymphoma with 2 clinical studies for Q3 DL2 expression patient with relapsed PTCL, including a randomized controlled trial in collaboration with our partner at the Lymphoma Study Association or Liza. We have also worked hard to advance our R and 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-six thousand one hundred and one, our lead NK cell engager into IND enabling studies. APS-six thousand one hundred and one now is SAR44,357. This is the first candidate to emerge from our multi specific NK cell engagent platform and we are 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 Jason, who will review the progress made with our portfolio. Jason? Thank you, Bandar. On Slide 8, let me start with lepidumab, our 1st in class Humanized monoclonal antibody that target the immune receptor, CURE3 DL2. As you may remember, CURE3DL2 is an inhibitory receptor found in approximately 65% of patients across all cutaneous T cell lymphomas. And even more in certain aggressive subtypes, but with limited expression in healthy tissue. To date, Data from lacutumab have shown promise, demonstrating compelling single agent activity and offering immense potential in lymphomas historically associated with a core prognosis for which there are few therapeutic options at advanced stages. On Slide 9, as Mandir 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 TELEMEX study evaluating lacutumab in subsets of CTCL. Additionally, we introduced a broad development strategy to advance this program initially for Sezary 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 2 TELEMEX study for Caesare syndrome and mycocetes fungoides. We were pleased to share that we had moved the Cure III DL2 expressing mycoesus fungoides cohort from stage 1 to stage 2, 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 1 of this cohort will be presented by Doctor. Martin Bago in an oral session on the 22nd June at 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. SENSORI Syndrome offers us a potential fast to market opportunity as we received Fast Track designation in the U. S. 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 CURE3 DL2. We expect to initiate our Phase 1b trial evaluating lacutumab as monotherapy by mid year. The study will enroll approximately 20 patients and it will evaluate safety and characterize clinical outcome. First, data are expected in 2022. Separately, our partner, Liza, will initiate an investigator sponsored Phase 2 study to evaluate lacudumab in combination with chemotherapy Gemox versus Gemoxolone. This study will be multicenter, randomized study with approximately 60 relapsedrefractory patients outside the U. S. And is expected to be initiated in the second half of twenty twenty one. We believe that this stepwise approach will prove efficient in identifying the optimal regimen for lacunumab 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 lacutumab 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, now turning our turning now to our R and 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 SAR-four thousand four hundred and thirty five seventy nine into IND enabling studies. As you may remember, IPH6,101 is an NKP-forty six based NK cell engager using our proprietary multi specific antibody format. IPH6,101 is a part of our ongoing research collaboration with Sanofi to evaluate up to 2 NK cell engagers and its advancement into the IND enabling studies that triggered a €7,000,000 milestone payment to Innate. Sanofi is now responsible for all future development, manufacturing and commercialization of IPH-six thousand one hundred and one and we remain eligible for future development and commercial milestones. On Slide 13, as you know, our NK cell engager platform is at the is at the heart of our research and is a major component of our long term development strategy. To date, we have developed a robust portfolio of product candidates using our trifunctional NK cell engagers 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 capability, including the development of a next generation Tetrafunctional, NKCE or NKCE IV. Our Chief Science Officer, Eric Vivier, We'll 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 Fosys, on the 10th 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 lacutumab onycosis fungoides data that are being presented next month at the ICML Lugano conference. In addition to our progress with lacutumab and our next generation NKCE antibody, we have also made progress with IPH5,301, our CD73 blocking antibody and a Phase 1 trial is expected to begin later this year. IPH-five thousand three hundred and one 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 Mandir for concluding remarks. Thank you, Jocelyn. As you can see, we are working diligently to execute across all our strategic pillars and believe that we are laying the groundwork to drive near and long term value for patients and shareholders. Looking at our clinical program, we expect to achieve a number of milestones over the next 18 to 24 months. As you've heard from Joyceann, our Phase 2 telomex study for lacunanab continues to progress and we expect to share preliminary data from Stage 1 of the Q3 DL2 expression MF cohort at the Lugano meeting in June as well as expecting to report potentially pivotal data in Sezary Syndrome in 2022. In addition, we anticipate moving Our monotherapy PTCL program into the clinic by mid year with initial data expected in 2022 with the combination Study sponsored by Liza expected also to start in the second half of this year. In parallel, we continue to develop our and KC Technology Platform and we are very encouraged by the preclinical results for our next generation NK cell engagers. We believe that this represents a natural evolution of our platform, illustrating the potential of natural killer cells to be a potent cellular player for the next generation off the shelf cancer immunotherapies. And we look forward to Eric sharing more details on the innovation we have made at the FOCI meeting next month. Highlights, as you heard from Jason, of The next generation NKCE platform together with the lacutamab NF data presented at Lugano will also be presented at an online IR event to be held on June 23. Details for accessing the event will be posted on to our website in due course and publicized via our usual channels and closer to the date of the event. Lastly, we are also very pleased to have The such productive collaboration with industry and academic partners to advance monalizumab and avdrolumab alongside early stage programs such as APS-six thousand one hundred. 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. Operator, please can you start with the first question? Thank Our first question comes from the line of Yigal Nochomovitz from Citigroup. Your line is open. Please ask your question. Hi. Thank you very much for taking the questions. I had a question about the positive early signal that you've seen in the KRF3 DL2 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 KI3DL2 and the responses? Thank you, Yigal. Very important question indeed about the Quality of the response we achieved with lakitamab. Before I hand over to Joyce and to I'll give you more details. As you may remember from the Phase 1 study published About now 2 years ago in Lancet Oncology, the duration of Responses and even disease control, including provision free survival in the Phase I was quite impressive in the range of 11 to 12 months. So Not only lekutumab could have generated a significant tumor shrinkage in the range of 45%, but with Durable responses in Phase 1. And of course, we look forward to sharing with you these data soon In the next couple of months. But keep in mind that the Stage 1 was essentially about the Tumor shrinkage, that's what basically triggered the move from Stage 1 to Stage 2. Now I'll leave it to Joyceann to provide more Thank you, Mandir, and thanks for the question. So I think when we look at this, we I would look at it similar to what Mandehr was just mentioning. In the Phase 1 study, we talked about the duration of With the Sezary Syndrome or the and that as Wanda was mentioning is was longer than the benchmarks at that time. I think when we look at the mycosis fungalides Stage 1 cohort, The key things to remember here is that the stage 1 to stage 2 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 Cure III DL2 positive as well as the Cure III the non expressing Cure III DL2 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're hoping that's what we'd be presenting at LUCATA. Okay. Thank you. So based on the data, Lugano, we will have some sense as to how well Spread the response correlates with the expression of KRX3DL2? Yes, I think it will be So it will be very early data, but yes, I think you will get a sense of that. Yes. So, Ygal, let me maybe rephrase your question to make sure We understand it. There are 2 cohorts in this MS Trial, the K3 DL2 positive or expression and the K3 DL2 negative. The Stage 1 to Stage 2 translation we talked about is in the Q3 DL2, so in the patient population that express the tumor antigen. So the level of activity that we will be presenting is in the K3DL2 positive. We won't be showing data in the Q3 deal to negative so far because we are still it's still ongoing. Okay. I understand. Thank you. Thanks. Thank you. Our next question comes from the line of Dana Graybosch from SVB Leerink. Your line is open. Please ask your question. Thanks for the questions. 2 from me. First, do you have any data any updates on when we could see mornolizumab 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, QIAIDIS? Thank you, Diana. Great questions, in particular the second one. The first one, I'm Sorry to disappoint you, but as you know, this trial in particular, the COST and NEOCOST trial, Trial sponsored by AstraZeneca and I do not have more information that what they disclosed publicly, which is that they plan to present this data in the second half of twenty twenty one. So we are really looking forward to seeing this data in the second half of twenty twenty one. For the second question, I'll start and please, Joyce and chime in. I think what we have seen at the last AACR and what also was published 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 NK cell engager antibodies with Fresh sales that you infusing the same time. So it makes a lot of sense. Of course, we cannot speak I'll speculate on what Sanofi's strategy is in this field. I think the obvious next step is of course to move APS-six thousand one hundred and one into the clinic and start the Phase 1, but I can tell you that we are looking at This feels very careful and very excited about the prospect of having this combination that Seems that listing in hemagglenity to produce a quite spectacular tumor shrinkage and clinical benefit. Jason, would you like to complete or add anything on this question as well as on the monalizumab, if you know more? No, I have to say, the monozumab, I think you summed it up very well. And also on the second question, I think that was a great summary and I have nothing more to add. Thank you for that. You know I have to ask about those one trials every time. I mean, you have to. I mean, Dana, if you don't ask, I would be surprised. Thank you. We'll just predict the question Thank you. Our next question comes from the line of Swayam Ramakanth from HCW. Your line is open. Please ask your question. Thank you. This is RK from H. C. Wainwright. Good afternoon, Mondher, and good morning, Jaeson. In terms of the NK cell Engager program with Sanofi, So we know that the first one is 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 NKP-forty six or it could be against the other targets that not only you, but other folks are also looking at. Thank you, RK. Thank you for your question and great to talk to you as well. I think I believe you know that NQP-forty six is an activator receptor expressed on NK cells and it's one of the most specific And stable activation receptor for NK cells. Unlike many others, I don't know to mention NKG2D or CD16, we know that those receptors Eventually may get down regulated when the NK cells travel into the tumor microenvironment. Here we are talking about really a very And I think it's important for us to highlight the fact that our platform is basically Versatile by the fact that you can change to margin, but we are extremely Delighted actually with the proprietary platform we developed around NQP 46. So the various partnership that we will be developing, including 2nd program that we have with Sanofi is still using AKP-forty six as an activator receptor, but a different tumor antigen that Sanofi did not I want to disclose at this point in time. So it's the same technology as for the first one, 6,101, but with a different tumor antigen. And beyond Sanofi, again, We are developing both proprietary, but also partnered multi specific, again keeping ANKPR46 And change in the tumor antigen depending on, of course, the collaboration and the partner that we are working with. In addition, as you've seen in Joyceann's last slide, what Eric Vidier will be presenting next month at is basically even the next generation of multispecific NKCE, what we call NKCE 4, Well, we are still leveraging the NKP-forty six platform, but trying to ensure that we have even a more I hope I answered your question. Yes, yes, you did. Thank you for that. And then going into the clinical programs, especially the one With lekutumab in PTCL, as you stated, you're initiating the monotherapy and the Gemox Combination is starting being started by Liisa Group. However, for the combination with the CHOP, Do you need to see the data from your monotherapy study before you embark On to 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. Again, very, very important question that will give The opportunity maybe to remind you a little bit the strategy behind the selection of The monotherapy approach or strategy in relapsed PTCL. Jonathan, would you like to take the question? Sure. Thanks, Mandeir. Thanks for the question. So I think so when we look at the strategy for PTCL, We are targeting 1st of all, Tier 3 DL2 positive patient. And that's going in with the at least early Data that we've seen in the mycosis thromboides cohort based on that hypothesis. Now when we look forward in time, What we would see is that the monotherapy will there's 2 approaches that we could take. 1 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 like to do is, 1, 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 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. Thank you, both, and talk to you guys soon. Thanks, Jose. Thank you. Our last telephone question comes from the line of Lisa Bayko from Evercore. Your line is open. Hi, there. Just a couple of questions for me. First of all, for the PTCL study, You envision that sort of following the general design of Chelimak or can you maybe speak to how you're thinking about the design of that study? Thank you, Lisa. So Okay, go ahead. Thank you, Adair. 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 mycosis fungoides starts to evolve, as well as we're placing our bets on the CAR3 DL deposit. Now That's without that's not saying, of course, as we start to see longer term data, especially in the mycocetes fungoides, where we may reevaluate our strategy and it starts to look more of like the Telemaque 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 Cure III DL2 positives and only look at that subset. Number 2, Continuing to evaluate the mycosis fungoides in the telemaque study, especially the longer term data And considering putting in a non expressing cohort into PTCL. And then as also the combination, so not only is Liza running a chemotherapy combination, but we would also be looking at looking other standard of cares that are available in the U. S. In combination depending upon the PTCL data. I hope that answered the question. Yes. And can you maybe describe a little bit more on kind of the non Expresses, what would be the rationale for activity there? So I think, when we look at the non expressors, I think if I understand the correct 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 lucutumab? What I would say is, I think it goes to what we see with a lot of biomarker subset and that is tumor heterogeneity, that's number 1. And then number 2 is Sampling errors. So I think both of these can lead to sort of the I guess you could say the sensitivity, not only the sensitivity of the test being able to pick up, which we're confident about But more importantly, is that are we sampling or is it heterogeneous and that's why we're not picking it up. Okay, understood. For FINTA-one hundred and one, could 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. So, Elisa, as you know, the 6,101 program is Fully under the responsibility of Sanofi. They are conducting the classic IND enabling studies with the Our 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 Synaptis is doing to move this drug into the clinic. Well, it's kind of really it's on their hands and whatever. They Yes. They can disclose that much Do you have any sense of when that will start clinical development? 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 in the health of study. So The plan is to go as fast as possible, but they did not disclose specific dates. Okay, fine. Thanks a lot. I'd now like to hand the call back to you, sir, for your webcast Questions? 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 aldolumab in the treatment of COVID-nineteen driven pneumonia. As you know, this is an investigator sponsored trial and is currently ongoing. I cannot give timelines or further details about the progress On the study, as INATE is not responsible for dorannin, I can only say that the trial has completed enrollment and is ongoing for patient follow-up and data analysis, and we'll I'll share with you these 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 Relations event in June to update you on the progress of our portfolio, especially on the NK cell engager platform as well as the lakutamab data in microcystifangroides patient that will be presented at the LUKANO meeting. With that, I close the call, and thank you very much. Have a good day. Thank you. That does conclude today's conference. Thank you to everyone who's participated in today's call. You may now all disconnect.