Q3 2024 Innate Pharma SA Earnings Call
Swayampakula Ramakanth,
Regina: Hello and thank you for standing by. My name is Regina and I will be your conference operator today. At this time, I would like to welcome everyone to the Innate Pharma 3rd Quarter 2024 Business Update and Financial Results Conference Call.
Regina: All lines have been placed on mute to prevent any background noise.
Regina: After the speaker's remarks, there will be a question and answer session.
Regina: If you would like to ask a question during this time, simply press star then the number one on your telephone keypad.
Speaker Change: To withdraw your question, press star 1 again. I would now like to turn the conference over to Henry Wheeler, Vice President, Investor Relations. Please go ahead.
Henry Wheeler: Thank you. Good morning, good afternoon and welcome everyone. This morning Innate issued a press release for IQ3 2024 business update and financial results. We look forward to highlighting the progress majoring the year to date as well as addressing future goals and milestones.
Henry Wheeler: The press release and today's presentation are both available on the IR section of our website.
Henry Wheeler: On slide two, before we start, I'd like to remind you that we'll be making forward-looking statements regarding the financial outlook in addition to regulatory and product plan developments.
Henry Wheeler: These statements are subject to risk and uncertainty that may cause actual results to differ from those forecasted.
Henry Wheeler: Slide three. On today's call we are very pleased to be joined by Jonathan Dickinson, our new Chief Executive Officer. Jonathan is a seasoned health care professional and joins from Insights. He has a strong background in oncology and previous roles include Ariad, BMS, Roche and Novartis.
Thank you for watching!
Henry Wheeler: On the next slide to cover today's agenda, after an introduction from Jonathan, Sonia Quarantino, our Chief Medical Officer, will cover updates on Lecutumab, IPH6501 and 4502.
Henry Wheeler: who will then hand to Yannis Morel, Chief Operating Officer, who will then discuss our ANCET platform, ADC 6E and Monolith Map updates.
Henry Wheeler: Arvind Sood, EVP U.S. Operations will wrap and close, and we'll also have Frederic Lombard at CFO on the line for questions.
Jonathan, and I'll hand the call over to you.
Thank you.
Jonathan Dickinson: Thank you Henry. Good morning and good afternoon to everybody on the call. I'm very excited to join Innate Pharma, a company which is at the forefront of cutting-edge science in oncology.
Jonathan Dickinson: The innovative work being done at INATE is truly inspiring and world-class.
and I'm looking forward to using my extensive oncology experience
Jonathan Dickinson: to shape the Innate portfolio to maximise the future commercial potential and drive the next chapter of Innate's exciting journey. I look forward to meeting with as many of you as possible in the coming weeks.
Speaker Change: Turning to slide six, I would like to remind you of our strategy.
Speaker Change: As a company with proprietary assets in early clinical stages and partnered assets in early to later stages, our strategy involves leveraging our world-class expertise to develop first and best-in-class antibody-based therapies for cancer.
Speaker Change: Our current business model centers around the three priorities highlighted in slide 6.
Speaker Change: where we look to drive value from our proprietary R&D efforts through our well-established late-stage partnerships.
Speaker Change: Our ambition is to take our proprietary assets further along the clinical development pathway and thereby transform cancer care through a strong pipeline of novel differentiated antibodies.
Speaker Change: The first of these priorities is our lead proprietary asset, the Kuta map.
where we look to create near-term value.
Speaker Change: The Kutumab is in development for T-cell lymphoma with the top-line phase 2 CTCL data already presented.
Speaker Change: Based on this data we have had recent interactions with FDA.
Speaker Change: Sonia will cover this feedback later in today's presentation and we're now assessing the best path forward to maximize the potential of LakutaMap including a potential partnership.
Thank you for watching!
Speaker Change: Second, we continue to fuel our pipeline and create longer-term value by leveraging our antibody engineering capabilities.
Speaker Change: to develop innovative molecules with a primary focus on our multi-specific NK cell engager proprietary platform called ANKET.
Speaker Change: We are pleased to see continued progress with CENOTI presenting various updates to the LEAD ANCHOR Program, IPH61-SAR579.
Speaker Change: We're pleased to see our Lead Proprietary Analyst, IP65, continue to progress in Phase 1.
Speaker Change: As we develop antibody targets for our Ancare platform, we recognize that some of these targets may be better suited to an ADC approach.
Speaker Change: We will illustrate further details of our ADC pipeline today, where our lead acid, IPH45, has now received IND clearance from FDA, and will start Phase I trials by Q1 next year.
Speaker Change: Finally, we're building strong and sustainable foundations for our business by developing value-creating partnerships across industry and academia.
Speaker Change: Monalizumab, which is partnered with AZ, is a good example of these partnerships and the product as part of this collaboration is advancing well in Phase 3 trials in lung cancer.
Speaker Change: Turning to slide 7, this shows a summary of our pipeline which highlights how we continue to translate our science into a robust portfolio of proprietary and partnered assets.
Speaker Change: When the IPH 45 Phase 1 study starts by Q1 next year, we will have eight clinical assets.
Speaker Change: The slide also illustrates how we are executing against our strategy with our lead proprietary assets, the Kutumad, Hanket, and emerging ADCs.
Speaker Change: and which is supported by partner products from late to early stage with AstraZeneca and Sinovac.
Speaker Change: We anticipate a series of potential clinical data readouts and catalysts in the short to mid-term as we leverage our R&D engine and scientific know-how to create a sustainable business.
Speaker Change: Moving to slide 8, which highlights our Q4 conference activity at CITSE and ASH.
Speaker Change: At the CITI meeting last week, we presented further clinical data on our next-generation CD20-targeting antigen, IPH65, as well as preclinical data on our Nektin-4-targeting ADC, IPH45.
which will be covered by Yannis later in today's presentation.
Speaker Change: At ASH, we were pleased to see, or we're pleased to see, that Lecutumab data was accepted for an oral presentation highlighting follow-up on the telemark trial in relapsed recurrent cutaneous T-cell lymphoma as well as a poster on translational analysis.
Speaker Change: I would like to now pass the call over to Sonia who will review the progress made with our clinical portfolio. Sonia.
Sonia Quarantino: Thank you, Jonathan. I will now cover the key proprietary clinical programs in the next slide. Lacuta, IPH6501.
Sonia Quarantino: our CD20-targeting NKI Engager, and now also IPH4502, the Nectin-4-ADC that is fast approaching the clinic.
Can you move to the next slide please?
Sonia Quarantino: Thank you. On this slide I will briefly recapitulate where we are with LAKUTAMAP before moving to the feedback from our recent interaction with the FDA.
Sonia Quarantino: We have already presented the primary result of the TELOMAC trial, a Phase II single-arm study that includes both
Cesaree and Mycosis fungoides patients
Sonia Quarantino: The data in cesarean syndrome were presented at ASH last year and the results in mycosis fungoides at ASCO this year.
Sonia Quarantino: Also this year we will have a relevant presence at ASH with an oral presentation on the health-related quality of life in cesarean and translational results from TELOMAC.
Sonia Quarantino: The TELEMACS study is continuing and we collect more follow-up data from the patients.
Sonia Quarantino: And similarly, in peripheral pisal lymphoma, we continue to enroll patients in the KILT trial, a randomized phase 2 where lacutamab is administered in combination with gemcitabine and doxaliplatin, versus gemcitabine and doxaliplatin alone.
Sonia Quarantino: And we believe that this combination may offer additional benefit to patients with PTCL.
Sonia Quarantino: As a reminder, lacutamab is a monoclonal antibody that targets KIRK-3DL2 and was shown to deplete the cells that express the receptor.
Sonia Quarantino: which is expressed in more than 90% of cesarean syndrome patients and approximately in 50% of patients with mycosis fungoides or PTCL.
Thank you. Thank you. Thank you.
Speaker Change: The SDI granted an orphan drug designation for lacutamab for the treatment of CTCL
Speaker Change: and fast-track designation for the treatment of adult patients with refractory relapsed cesarean syndrome who have received at least two prior lines of systemic therapies.
Speaker Change: We submitted the results from the TELOMAR trial and the proposed regulatory pathway to market approval, including the possibility for an accelerated approval for cesarean syndrome, to the FBI and received an encouraging feedback.
Speaker Change: and the company will continue to align with the FDI around the necessary confirmatory phase three trial.
Speaker Change: We are currently evaluating the next steps for the program, including potential licensing with a partner to deliver the confirmatory phase 3 trial in CTCL.
Swayampakula Ramakanth, Swayampakula Ramakanth,
Now, where do we stand in terms of business case?
Speaker Change: On this slide, the data generated from the TELOMAC trial confirm clinical benefits not only in SS, but also in mycosis fungoides.
Speaker Change: regardless of the expression of the target KIR3DL2, highlighting an opportunity for the CTCL space without a companion diagnostic.
Swayampakula Ramakanth
Speaker Change: With the strong cesarean syndrome and mycosis fungoides data we presented at ASH last year and ASCO this year, there is increased confidence in the potential of Lakuta mothers.
Speaker Change: And our aim is to ensure that La Cuta Map gets to patients who need it as quickly as possible and to maximise the value via an accelerated approval.
Speaker Change: On slide 13, we now switch gear to our most advanced proprietary ANCET asset, IVH-65, a tetraspecific antibody-based N-Kai cell-engager therapeutic, or ANCET in short.
Speaker Change: which is a first-in-class NKI engager that engages the tumor via a tumor-associated antigen, in this case CD20.
Speaker Change: and the NK cells via two activating receptors, NKP46 and CV16, as well as the interleukin-2 receptor via an IL-2 variant, or IL-2V.
Speaker Change: The IL-2 variant is the characteristic of this second-generation tetraspecific anchor aimed to induce activation and proliferation of endogenous NK cells in the tumor microenvironment.
Speaker Change: We were pleased to announce earlier this year that IPH65 entered the clinic and the first in human has started with the first patient being dosed in March.
Speaker Change: The trial is currently recruiting patients with relapsed refractory B-cell non-Hodgkin lymphoma.
We presented proclinical data at ASCO meeting this year.
Speaker Change: showing that IPH-6501 effectively and preferentially stimulated NK cell proliferation from PBNC
Speaker Change: of NHL patients and depleted autologous CD20-positive B-cells from healthy donors with greater efficacy than a CD20-PCL engager and been using lower level of pro-inflammatory cytokines.
which is often a limiting use of this language.
Speaker Change: The current Phase I-II study has been presented as trial in progress at ASCO this year and the European Hematology Association Congress.
Speaker Change: and more recently at the FIDC annual meeting which Yannis will cover shortly.
Speaker Change: Thank you for watching. I'm your host, Sonia Quaratino. And I'll see you next time.
in the next slide.
Speaker Change: I'll give you an overview of the timeline for IPH 6501.
Speaker Change: And throughout the year, we plan, and next year, we plan to complete the dose escalation and look forward for initial safety data, PK and pharmacodynamics readouts, as well as preliminary efficacy signals.
Speaker Change: Throughout 2025 and beyond, we will open the dose optimization part of the study to select the optimal dose for subsequent studies and then open expansion cohorts in non-HRK-lymphoma subtypes.
Thank you. Thank you. Thank you.
Speaker Change: On slide 15, I will summarize the next step of our LEAD-ADC, IPh4502, following the IND clearance at the end of September.
Speaker Change: We are actively working to progress towards Phase I, and we are looking forward to generating preliminary Phase I safety data in 2025, and then establishing anti-tumor activity in tumor types.
with both low and high expression of Nectin-4.
Speaker Change: IPH4502 is a top-of-one ADC targeting Nectin-4, and the proclinical characterization was presented at ACR and CITC this year, highlighting the key differentiation features of this product.
including Unfortunate Baratheon.
Speaker Change: I will now hand over to Yannis to cover the earlier pipeline of Anchored and ADCs, as well as Partnered Assets, Monalizumab.
Thank you for watching!
Yannis Morel: Thank you, Sonia. I will now highlight the two classes of exciting next-generation antibody therapeutics on which we are focusing all our research activities.
in French and English
[inaudible]
Yannis Morel: On slide 17, I draw your attention to our portfolio of armchairs.
Enquete is our proprietary first-class MQTEL engager platform.
Speaker Change: It is a multi-specific, plug-and-play technology aiming at engaging NK cells towards tumor cells by triggering the most stable activating receptor expressed on NK cells called NKP46.
Speaker Change: The interesting feature of this platform is that, by swapping the tumor-binding portion of the AMCET molecule, it can produce multiple drug candidates, addressing a variety of targets in oncology.
Speaker Change: But it can also potentially harvest NK cells to eliminate pathogenic cells in other diseases like in autoimmune diseases.
Speaker Change: Earlier this year, Sanofi provided the most advanced SARS-579 to Phase II on the back of initial efficacy data showing single-agent activity with durable complete responses in relapsed refractory IML patients.
Speaker Change: and started also a new phase 1-2 trial in front-line IML in combination with Venetoplax and Azacitabine.
Speaker Change: As mentioned by Sonia, our lead proprietary on-kit, IPL-65, is now in the clinic.
Speaker Change: It is a second-generation molecule which incorporates a variant of IL-2 to induce expansion of patients' own NK cells.
Speaker Change: The first patient was in March and we recently presented new supporting preclinical data at the CICI conference.
Thank you.
Speaker Change: I will now cover the key updates represented at CICSI for both ITH-65 ONCAT programs and the NICQ4-ADC ITH-45.
Thank you for watching!
Swayampakula Ramakanth, Swayampakula Ramakanth
Speaker Change: The IPH 65 poster presented at the conference summarized the rationale to target the various subtypes of relapsed or refractory DNHL patients.
Speaker Change: Warial CD16, the receptor for the FC portion of antibodies to mediate ADCTC, is strongly downregulated on NK cells in the mid-node of patients. NKP46 expression is maintained, providing a stable anchor for the NK.
Thank you.
by assessing the function of NK cells for multiple patients.
Speaker Change: We have shown also that IPH-65 was able to induce efficient killing by disease NK cells across B-NHL subtypes, including diffuse large B-cell lymphoma, follicular lymphoma, or mental cell lymphoma.
Speaker Change: Finally, we made the interesting observation that post-CAR T patients had an increased NK T cell ratio and, as shown here on the right, an increased NKP46 expression level, further supporting the rationale to evaluate ITA65 in these patients.
Thank you. Thank you.
Speaker Change: On the next slide, the IPH 45 poster summarizes the key differentiating features of our drug candidates.
Speaker Change: As shown earlier in the year at ACR, IPh45O2 is a novel TAR-8 hexapican-based lectin-4-ADC that has the ability to target lectin-4-low-expressing tumors where PADCEL does not work.
Speaker Change: In the CIDC poster, we further demonstrated that ICH45 has also the ability to target tumors having a heterogeneous expression of the Nectin-4.
Speaker Change: Indeed, by mixing at a one-to-one ratio Nectin-4-expressing cell line with the same cell line transferred out for Nectin-4 in order to mimic a heterogeneous tumor showing only 50% of positivity, ICH45 induced complete tumor regression of the mix.
Speaker Change: This effect is completely a lectin-4 dependent and is not related to a non-toxic effect since IPH45 has no effect in the lectin-4 non-express hormone.
© The Ultimate Parody Site!
We also generated a PDX model of PADSAFE acquired registers.
Speaker Change: We obtained it by making 5 injections of PADCELL, resulting in a PDX model that is eventually relapsing under PADCELL, but is completely sensitive to IPH45, highlighting the ability of IPH45 to address patients pre-exposed to PADCELL.
These two posters are available on our website.
Thank you for watching!
Speaker Change: On slide 20, I would like to remind you of Monali Dumab, the anti-NKJ2A that we have licensed to AstraZeneca for oncology.
Speaker Change: On this slide, you can see another view of the late stage development of monalizumab in lung cancer.
Speaker Change: Based on the Phase II COST data, AstraZeneca started in May 2022 the Phase III trial called Pacific Nine.
Speaker Change: evaluating the addition of either monalizumab or olecumab to curvalumab in unrespectable stage 3 non-procellular cancer patients who have not progressed after concurrent chemo-radiation therapy.
Speaker Change: We are encouraged that, over the summer, the Independent Data Monitoring Committee recommends the continuation of the Phase III-PACIFIC-9 trial based on a pre-planned analysis.
Thank you for watching!
Speaker Change: Together with the COST and the NEOCOST data, the NEOCOST-2 data presented at the World Lung Congress in September provided a third proof point in a controlled phase 2 study that monalizumab provides additional anti-tumor activity on top of toralumab in early lungs.
I will now hand over to Arvind.
Arvind Sood: Thank you, Yannis. Good morning, good afternoon, everybody. So, we have several upcoming R&D catalysts that can be meaningful to our long-term growth.
Arvind Sood: I would draw your attention particularly, this I believe is slide 23, I would draw your attention particularly to the ones that are bolded on this slide.
Arvind Sood: Near term, we are looking forward to the next steps for leucutumab, now that we have the positive FDA feedback.
Arvind Sood: Programs coming out of our ANCET platform continue to advance as IPA 6101, targeting CD123 and hematologic malignancies, and partnered with Sanofi, progressed to Phase II earlier this year.
Arvind Sood: Our proprietary tetraspecific ANCIT that goes by IPA6501 is now in clinical development.
Arvind Sood: And our ABC targeting Nectin 4 has cleared IMD and is due to start Phase 1 soon.
Thank you. Thank you.
Speaker Change: I would like to conclude our prepared comments with a few thoughts outlined on slide 24. We have a differentiated pipeline with several first-in-class opportunities.
Speaker Change: Excuse me. We now have seven products in clinical development, with three that are proprietary and four that are partnered.
Speaker Change: Our cash position of around 96.4 million euros through the end of September will enable us to fund operations through the end of 2025.
Speaker Change: So, with that, I would like to open the call for Q&A. Regina, perhaps you can review the process for asking questions for our listeners.
Speaker Change: At this time, I'd like to remind everyone in order to ask a question, simply press star followed by the number one on your telephone keypad. Our first question will come from the line of Lisa Bacow with Evercore ISI. Please go ahead.
Swayampakula Ramakanth,
Speaker Change: Hi, this is Jamie. I'm for Lisa. Thanks for taking our questions
Speaker Change: So, I'm just wondering, could you please provide some color on LakutaMap data to be presented at AASH, especially what does the translational data entail? Also, it would be nice if you could, you know, give some color to the data that you have.
Speaker Change: Culler regarding the regulatory path for leucotomab. Is FDA supportive of filing with current data in seborrheic syndrome for accelerated approval? And then is the filing predicated on finding a partnership? Thank you.
Speaker Change: Thank you for the question. Sonia, could you take that one, please?
Thank you.
Sonia Quarantino: Absolutely, I'm just unmuted. Regarding the data that are going to be presented at ASH, I'm afraid I cannot add any color. There are some embargoes that need to be respected and so I'm afraid you have to wait until December for that.
Speaker Change: I can provide a bit more, perhaps, colour on the SDI interaction that we had. We have received this encouraging initial feedback.
Speaker Change: and the FDA endorsed our proposed regulatory pathway, you know, in general lines. The FDA acknowledged that the currently available data from the phase one and the phase two telemedicine studies
Speaker Change: May be sufficient to support a BLA submission paving the path for an accelerated approval for Cesare's syndrome.
Speaker Change: and the company will then align with the FDA around the confirmatory phase three trial to support
Speaker Change: touch, let's say, accelerated approval, and we are working towards this to make it happen.
Speaker Change: If I may follow up really quick, could you provide some color on timing for the next step? Or, like, when should we expect to hear about details for, or, you know, alignment with FDA for the Phase III confirmatory trial? Thank you.
Thank you. Thank you.
Speaker Change: Well, around the timing for the FDA will also depend on our, let's say, business case in the sense that, as you know, we are also looking for partners that can potentially carry out such a phase three trial.
Speaker Change: We will pave the way by producing a regulatory strategy which eventually may also need to be discussed with a potential partner.
Got it. Thank you.
Thank you. Thank you.
Speaker Change: Our next question comes from the line of Adina Greybosch with Lear Inc. Partners. Please go ahead.
Speaker Change: Hi, thanks for the question. I think I understand from the previous one, I'll just follow up on that.
Speaker Change: reviewing that with FDA and having a more concrete path to accelerated filing. Can you confirm that and then talk to us about what you're doing to find that partner and how those conversations have been going?
and Yannis Morel.
Speaker Change: Sonia, do you want to take the first part of that question and then we'll come back to Yannis and myself.
Speaker Change: And of course, this would be nice to be, let's say, aligned with a potential partner before going for another, let's say, type C meeting with the FDA to discuss
Speaker Change: the go-live of such a study and we are looking for
Speaker Change: partners or many other, let's say, options to make this happen.
Thank you. Thank you.
Speaker Change: Thank you, Sonia. So, I mean, I can add something to what Sonia has just said. So, I guess we're keeping our options open at this stage. We are very actively seeking a partner. But we're also exploring other ways.
Speaker Change: that we might be able to take forward a Lecuta Mark 3 study that would meet the FDA requirements here. So I think it's difficult to say any more on that. We're in discussions at this point in time, and I think when we have some information that we can provide that we will share that moving forward.
Thank you. Thank you.
Speaker Change: Can you provide maybe your guiding principles for why you would go with a partner versus these other ways so we can better understand that process?
Thank you. Thank you.
Thank you.
Yannis Morel: Yannis, do you want to take a stab at that? Yeah, hi Dana. So like Jonathan said, we are undertaking several options in parallel. I would say classical partnering is one option and what will guide us is the way to maximize the return of coordinates. So we really want to, we think that here we have potentially a drug that is really active in
and Yannis Morel.
Speaker Change: Our next question will come from the line of Rajan Sharma with Goldman Sachs. Please go ahead.
Speaker Change: Hi, thank you for taking my question. Sorry, just another one on Lakutamab and partnering strategy. I was just wondering, do you kind of have an internal deadline or sort of line in the sand in mind for finding a partner and executing on a potential deal there? Versus, you know, will there be some point in time when you decide that that's not going to happen and you'll start to take this forward?
Speaker Change: And then maybe related to that is just worn on cash so your runways to the end of 205, so you sort of into the last 12 months.
Speaker Change: I guess, is that something that you're comfortable with and what are the options to extend the runway here? And then I've got a follow-up on next in four, which I'll come back to.
Speaker Change: Thank you, Jonathan. Maybe, Yannis, you can take the first part and then we can go to Frederic for the cash runway.
Hi Raja, obviously it will be a...
Thank you.
Speaker Change: , and the FDA feedback was an important milestone to actually resume discussion with several partners, but also for the other type of options we are looking at. So it's clearly something that we can get during the SBA.
next several months of career
Okay, thank you guys.
Speaker Change: including dilutive and non-dilutive options that we are currently working on.
Speaker Change: and we will provide an update when needed and when finalized.
Thank you for watching!
Speaker Change: Do you have a question on the next in four, Edmund?
Speaker Change: Yeah, so just on that one and you know, obviously clear on the slides that you see the potential for the asset in kind of PADSev or EV refractory patients But just thinking about kind of differentiation beyond that Do you think there's an opportunity to differentiate on tolerability or safety and are there any key adverse events for example that you might call out as a as a differentiation?
Yannis Morel: So Yannis, do you want to take that one? Yeah, we think that there are several lines of differentiation, like...
like what we have shown here at CITI that we...
Speaker Change: ITH45 is working on preclinical models that are resistant to Paxil, either through primary resistance or acquired resistance, like I've just shown today.
Speaker Change: We have also, and it's in the poster that you can find on the website, shown that we can target Nektin-4 low-expressor tumor model, and we are now accumulating data in other tumor types, like breast cancer.
Speaker Change: And this is really a differentiating factor compared to PADCEP, which is really working well in bladder where the expression of nephentol is high and homogenous.
Speaker Change: because there are, and it's also in our poster, there are many, many solid tumors that do express Nexin-4. It's not at the same level of DADR, but that could be within the reach of 45, but not that certain.
Thank you.
Speaker Change: And as a reminder, to ask a question, simply press star 1 on your telephone keypad.
Speaker Change: I'll take a question received online from Erika Berrigaud at CEPL. On leucutumab, is the understanding correct from your initial interactions with the FDA that the agency would not be against a filing with the drug for Sessory Syndrome and maybe even CTCL, with potential in the second case to get a conditional approval based on a complimentary phase 3 trial?
If this understanding is correct.
Speaker Change: Is it what a partner is waiting for, to move on and sign up for a collaboration with you on the asset, or is it more the PTCR data dependent?
Thank you.
Speaker Change: I'll stop there. Sonia, probably a question for you. Henry, I'm not sure I understood the first part of the question. Would you mind to repeat that?
Speaker Change: Is the understanding correct from the initial interactions with the FDA that the agency would not be against a filing with the drug for Cesarean Syndrome and maybe even CTCL, with the potential in the second case to get a conditional approval based on a confirmatory phase 2 trial? Correct. Right. Yes. Sorry. It was the negative that escaped my understanding before. Yes.
Speaker Change: will be looking for the accelerated approval because, of course, the accelerated approval can only be given to indication with a high unmet medical need and surgery would qualify for such an indication.
Speaker Change: would be given based on the Phase 2 and Phase 1 data. But, of course, any accelerated approval can only be obtained when the
Speaker Change: The confirmatory trial is up and running and depending on the recruitment rate it must be quite advanced on that.
Speaker Change: and you know this approval is completely independent from the PDCL which is a very different indication in that respect.
Speaker Change: And with regard to the question on the partnership, I would not say that the FDA feedback was a way to sign a deal, but it was more an important milestone to progress this question.
And that's where we are today.
Speaker Change: And then the second part of Eric's question, what would you consider as the most likely next step for Lakuta-Malibu? Formal filing with the FDA or a partnership with a third party, and what are the reasonable timelines for this to happen?
Thank you for watching!
Thank you. Bye.
Thank you.
and Yannis Morel.
Thank you. Thank you. Thank you.
Speaker Change: taken up by a partner and or eventually finding either option to fund the study and
make it in a different way.
Speaker Change: Okay, thank you. Another offline question from Jingming at Evercore ISI. Could you please remind us why Sanofi decided to return Type H67 anchor? Is it due to activity signals, safety or other reasons, e.g. strategic prioritization?
Speaker Change: Sanofi did not provide any specific reason for the termination, I just remind you that ITH 67 was a very early stage research program, so not even at the candidate selection, it was even before.
Thank you very much.
Speaker Change: And I also remind you that the rest of the agreement is untouched. We are having the CD123 and the BCMA in Phase II and Phase I, and having the B7H3 ONCAD program progressing well in the preclinical development.
Thank you for watching!
Speaker Change: We'll take our next question from the line of Arthur He with HCW. Please go ahead.
Arthur He: Hi, good morning. This is Arthur on 4RK. Thanks for taking my question. So, I have two questions on the NCAT. So, one is for the 52, your own 5001, 50, I mean,
Arthur He: 6201, you are on, 6201, sorry, you said you are currently in the, already in the clinical trial, so could you give us some guidance on the timing for the data update from this, your own program?
Thank you.
Sonia Quarantino: Sonia, can you take that one please? Of course. I think you are referring to IPH6501, which is the second generation anchored in the B-cell non-orthogonal lymphoma.
Sonia Quarantino: We opened the phase one of the dose escalation that goes according to the usual times of a dose escalation with, you know, DLT windows, etc.
Sonia Quarantino: And we believe that we will complete the DOTAS escalation by 2025.
and then open a Dose Optimization.
Sonia Quarantino: And so we will have by 2025 data around safety, pharmacokinetics, pharmacodynamics, and early clinical antitumor efficacy.
Sonia Quarantino: Even though the number of patients tested in each dose level are very limited, classic of any dose escalation.
Sonia Quarantino: But this is what we expect by, let's say, 2025, and in 2026, let's say, more clinical efficacy data, of course.
Speaker Change: Thanks, Sonia. And so another question is just one to follow up on the IPH.
Speaker Change: 67. Are you able to disclose which target they are these assets targeted for or it's still kind of the status of status mode?
and Yannis Morel.
Speaker Change: I can answer that one, that's a target that we're not currently disclosing.
Thank you for watching!
Okay. No problem. Thanks. Thanks. Thanks for the excellent question.
Speaker Change: We have no further questions at this time. Ladies and gentlemen, that will conclude today's meeting. Thank you all for joining. You may now disconnect.
Speaker Change: Please wait. The conference will begin shortly. Thank you for watching.