g.123: news de 4 jours:
We are highly committed to this program and optimistic about its potential to address unmet needs in oncology and potentially autoimmune diseases. We are thrilled with the progress of our Nectin-4 targeted ADC, IPH45, with the first patients dosed in January 2025, following the IND clearance in September 2024. This is an exciting milestone, and we are confident that this therapy will make a meaningful impact for patients. Our team is dedicated to moving this program forward rapidly and delivering the next generation of treatment for patients in need. Finally, we turn to lacutamab, which has made good progress recently on the path to commercialization. We are incredibly excited about the breakthrough therapy designation granted to lacutamab by the FDA.
This brings lacutamab one step closer to a potential accelerated approval following the productive feedback received from FDA last year. This achievement is based on the strong data we have seen to date and reinforces the potential lacutamab has to significantly help patients in need. As we continue our interactions with the FDA to finalize the confirmatory Phase 3 in the coming months, we also look forward to sharing updated long term follow-up data via publications at key scientific meetings. We also continue to look for the best path forward for lacutamab with partnership discussions advancing well. We also continue to advance our early pipeline with the expectation to discover new ANKETs and ADCs. As we look ahead to 2025, we are confident that we are building momentum across our pipeline with significant achievements in IPH65, IPH45 and lacutamab.
We remain dedicated to delivering breakthrough therapies to patients in need and are excited about the opportunities the next years will bring. As we reflect on our strategic focus for 2025, I want to take a moment to remind you of the updated strategic focus we shared during our presentation at the JPMorgan Healthcare Conference in January, which is illustrated on Slide 6. Our strategy is focused on three key growth pillars that we believe will drive long term value for Innate Pharma, our shareholders and importantly, for patients. The first pillar is our NK cell engagers. The ANKET platform continues to be a critical component of our strategy. We’re advancing three key programs. IPH65, our CD20 ANKET, is currently in Phase 1. We’re excited about IPH65’s potential to address hematological malignancies and potentially autoimmune diseases.
IPH61, our CD123 targeted ANKET, is progressing in Phase 2 with Phase 1 data already presented by our partner Sanofi. Fast track designation was awarded for the treatment of acute myeloid leukemia. We believe that this asset has the potential to significantly impact patients’ lives. IPH64, our BCMA ANKET, is in a Phase 1 trial in myeloma in partnership with Sanofi and will be transitioned into autoimmune diseases. These three assets continue to bolster our leadership in NK cell engager therapies. The second strategic pillar is our antibody drug conjugates. We are particularly enthusiastic about IPH45, our Nectin-4 targeted ADC. The IND cleared last year and the first patients were dosed in January 2025. This differentiated topo-1 ADC targets high, moderate and low overexpressing Nectin-4 tumors.
With Nectin-4 being over-expressed at varying levels in a range of large tumor types, IPH45's ability to bind low, moderate, and high-expressing tumors pre-clinically significantly expands the potential product opportunity. We also have IPH43, our MICA/B targeted ADC program in research, further advancing our capabilities in ADCs. The third pillar is our current late-stage assets. We're committed to advancing our late-stage programs, particularly lacutamab, with positive Phase 2 data and the FDA feedback on next steps. We are actively progressing partnership discussions. Lacutamab has also been awarded US FDA breakthrough therapy designation, which underscores its potential in treating Sezary syndrome patients with high unmet medical need. Additionally, monalizumab continues to progress well with AstraZeneca in the PACIFIC-9 Phase 3 trial.
And we're optimistic about its future potential. Slide 7 highlights our impressive pipeline. We are advancing a robust pipeline with eight innovative assets currently in the clinic. The highlights include our proprietary asset IPH65 for B cell lymphomas. Our Sanofi partner that assets, IPH6101 for AML and IPH6401 now for autoimmune diseases and our proprietary ADC, IPH45, targeting Nectin-4 expressing tumors. In Phase 2, we have our proprietary KIR3DL2 targeted antibodies, lacutamab for CTCL and PTCL. And finally, we have our AZ-partnered asset monalizumab, which is being studied for neoadjuvant non-small cell lung cancer, and in a Phase 3 study for unresectable Stage 3 non-small cell lung cancer. These assets demonstrate the productivity of our R&D organization and our commitment to delivering breakthrough treatments across a range of cancers.
Slide 8 illustrates our Q4 conference activity at SITC and ASH last year. At the SITC meeting, we presented further preclinical data on our next generation CD20 targeting ANKET IPH65, as well as extensive preclinical data on our Nectin-4 targeted ADC IPH45. At ASH last year, we were pleased to present lacutamab quality of life and pruritus data in an oral presentation. This oral presentation showcased the consistency between the clinical and quality of life data and the important impact of lacutamab on patient well-being. There was also a poster presentation of translational data from the TELLOMAK trial. I would like to now pass the call to Yannis who will review the pre-clinical rationale of our key strategic pillars in ANKETs and ADCs. Yannis?
Yannis Morel: Thank you, Jonathan. I will now highlight the two exciting next-generation antibody therapeutic class on which we are focusing, the NK cell engagers, ANKETs, and antibody drug conjugate. On Slide 10, I draw your attention to our portfolio of ANKET. ANKET is our proprietary 13-class NK cell engager platform. It is a multi-specific plug and play technology aiming at engaging NK cells towards tumor cells by triggering the most stable activating receptor effect on NK cells called NKp46. The interesting feature of this platform is that by swapping the tumor binding portion, it can produce multiple drug candidates addressing a variety of targets in oncology, but it can also potentially harness NK cells to eliminate pathogenic cells in other diseases like in autoimmune disease.
In 2024, Sanofi progressed the most advanced ANKET, SAR’579, to Phase 2 on the back of initial efficacy data showing single agent activity with durable complete responses in relapsed/refractory AML patients and started also a new Phase 1/2 trial in frontline AML in combination with venetoclax and azacytidin. For the BCMA targeting ANKET IPH6401, the Phase 1/2 study led by Sanofi for the treatment of patients with relapsed or refractory multiple myeloma will be stopped early and the product will now be pursued in autoimmune indication. As will be covered by Sonia, our lead proprietary ANKET, IPH65, is now in the clinic. It’s a second-generation molecule, which incorporates a variant of IL2 to induce the expansion of patients’ own NK cells and for which we presented new supporting preclinical data at the SITC conference at the end of last year.
On Slide 11, I’d like to highlight the structure of IPH6501, which is our lead proprietary ANKET. It’s a novel CD20 targeted tetra-specific NK cell engager that’s specifically designed to target B cells. The unique design of IPH6501 involves several key components, each of which enhance its therapeutic potential. First, we have [indiscernible] targeting the tumor associated antigen, here CD20, in a monovalent way. Second, like in a regular antibody, we have an Fc portion that activates the NK cell receptor of CD16. Then the third and key component of the molecule is the NKp46 binder. It targets this NKp46 activating receptor, which is the most specific marker of human NK cells and which expression is stable on tumor infiltrating NK cells.
