Innate Pharma SA

PAR:IPH

Earnings Call Analysis

Innate Pharma's Progress on Key Oncology Therapeutics and FDA Interactions

Innate Pharma reported promising advancements in its oncology pipeline during the Q3 2024 call. CEO Jonathan Dickinson highlighted their lead asset, lacutamab, in development for T-cell lymphoma, which has received encouraging FDA feedback suggesting potential accelerated approval pathways. The pipeline includes the ANKET platform, with Phase I trials ongoing for IPH65 and an anticipated IND-cleared ADC, IPH45, set to begin trials Q1 next year. The company maintains a strong cash position of €96.4 million, ensuring funding through 2025. They aim for value-driving partnerships while preparing for a confirmatory Phase III trial for lacutamab.

A Transformative Leadership

The earnings call for Innate Pharma kicked off with a notable transition in leadership, introducing Jonathan Dickinson as the new CEO. His extensive background in oncology promises a strategic shift that aims to maximize the potential within the company’s pipeline. Dickinson emphasized the company's commitment to developing innovative, first- and best-in-class antibody-based therapies, shining a light on their promising pipeline in oncology.

Lacutamab: A Beacon of Potential

Central to Innate's strategy is lacutamab, a monoclonal antibody currently in clinical development for T-cell lymphoma. The latest Phase II data from the TELLOMAK trial has garnered positive feedback from the FDA, suggesting possible pathways towards accelerated approval. Encouragingly, if the confirmatory Phase III trial proceeds as envisioned, lacutamab could address an expanded pool of patients—from 1,500 to potentially 5,000—highlighting its significant therapeutic potential.

Navigating FDA Interactions and Strategic Partnerships

Regarding regulatory strategies, the FDA appears to support a filing for lacutamab based on current data for Sezary syndrome. However, the successful execution of this plan hinges on aligning with a partner to assist with the necessary Phase III study. Discussions with potential partners are ongoing, but the timeline remains fluid, as both partnerships and milestone executions evolve.

Advancements in Antibody Design: ANKET and ADC Platforms

Innate Pharma is not resting on its laurels with lacutamab alone. Their proprietary ANKET platform is generating second-generation molecules, such as IPH65, currently undergoing Phase I trials. This innovation is complemented by the ADC program; specifically, IPH4502 targeting Nectin-4 is poised to start its Phase I trial following IND clearance. These developments illustrate the company’s solid commitment to broadening its oncology portfolio.

Upcoming Catalysts and Financial Outlook

Looking ahead, analysts can expect several key data readouts in the near future, particularly relating to lacutamab and the ANKET platform. Innate Pharma positions itself for growth in 2025 and beyond, projecting a cash runway of approximately EUR 96.4 million, expected to fund operations into 2025. This financial cushion is crucial as the company anticipates pivotal trials and regulatory milestones.

Conclusion: A Company with Significant Potential

In summary, Innate Pharma stands at a strategic juncture with promise in its pipeline, particularly with leading assets like lacutamab and the advancements in their antibody platforms. As they navigate the complexities of regulatory requirements and potential partnerships, investors may find value in the company's innovative approaches to cancer therapy and its overall growth trajectory.

Earnings Call Transcript 2024-Q3

[Operator]

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 Third Quarter 2024 Business Update and Financial Results Conference Call. [Operator Instructions]

I would now like to turn the conference over to Henry Wheeler, Vice President, Investor Relations. Please go ahead.

[Henry Wheeler, executive]

Thank you. Good morning, good afternoon, and welcome, everyone. This morning, Innate issued a press release for our Q3 2024 business update and financial results. We look forward to highlighting the progress made during the year-to-date 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.

On Slide 2, before we start, I would like to remind you that we'll be making 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 forecasts.

Slide 3. On today's call, we are very pleased to be joined by Jonathan Dickinson, our new Chief Executive Officer. Jonathan is a seasoned healthcare professional and joins from Incyte. He has a strong background in oncology and previous roles include ARIAD, BMS, Roche and Novartis.

On the next slide, to cover today's agenda, after an introduction from Jonathan, Sonia Quaratino, our Chief Medical Officer, will cover updates on lacutamab, IPH6501 and 4502, who will then hand to Yannis Morel, Chief Operating Officer, who will then discuss our ANKET platform, ADC SITC and monalizumab updates. Arvind Sood, EVP, U.S. Operations, will wrap and close, and we'll also have Frederic Lombard, our CFO, on the line for questions.

Jonathan, I now hand the call over to you.

[Jonathan Dickinson, executive]

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. The innovative work being done at Innate is truly inspiring and world-class, and I'm looking forward to using my extensive oncology experience to shape the Innate portfolio to maximize 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.

Turning to Slide 6. I would like to remind you of our strategy. 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.

Our current business model centers around the 3 priorities highlighted in Slide 6, where we look to drive value from our proprietary R&D efforts through our well-established late-stage partnerships. 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.

The first of these priorities is our lead proprietary asset, lacutamab, where we look to create near-term value. Lacutamab is in development for T-cell lymphoma with the top line Phase II CTCL data already presented. Based on this data, we have had recent interactions with FDA. Sonia will cover this feedback later in today's presentation, and we're now assessing the best path forward to maximize the potential of lacutamab, including a potential partnership.

Second, we continue to fuel our pipeline and create longer-term value by leveraging our antibody engineering capabilities to develop innovative molecules with a primary focus on our multi-specific NK cell engager proprietary platform called ANKET. We are pleased to see continued progress with Sanofi presenting various updates for the lead ANKET program, [ IPH61/SAR'579 ]. We're pleased to see our lead proprietary ANKET IPH65 continue to progress in Phase I.

As we develop antibody targets for our ANKET platform, we recognize that some of these targets may be better suited to an ADC approach. We will illustrate further details of our ADC pipeline today, where our lead asset, IPH45, has now received IND clearance from FDA and will start Phase I trials by Q1 next year.

Finally, we're building strong and sustainable foundations for our business by developing value-creating partnerships across industry and academia. 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 III trials in lung cancer.

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. When the IPH45 Phase I study starts by Q1 next year, we will have 8 clinical assets. The slide also illustrates how we are executing against our strategy with our lead proprietary assets, lacutamab, ANKET and emerging ADCs, and which is supported by partnered products from late to early stage with AstraZeneca and Sanofi.

We anticipate a series of potential clinical data readouts and catalysts in the short to midterm as we leverage our R&D engine and scientific know-how to create a sustainable business.

Moving to Slide 8, which highlights our Q4 conference activity at SITC and ASH. At the SITC meeting last week, we presented further clinical data on our next-generation CD20-targeting ANKET, IPH65, as well as preclinical data on our Nectin-4 targeting ADC, IPH45, which will be covered by Yannis later in today's presentation.

At ASH, we were pleased to see -- or we're pleased to see that lacutamab data was accepted for an oral presentation, highlighting follow-up on the TELLOMAK trial in relapsed recurrent cutaneous T-cell lymphoma as well as a poster on translational analysis.

I would like to now pass the call over to Sonia, who will review the progress made with our clinical portfolio. Sonia?

[Sonia Quaratino, executive]

Thank you, Jonathan. I will now cover the key proprietary clinical programs in the next slide, lacutamab, IPH6501, our CD20-targeting NK engager and now also IPH4502, the Nectin-4 ADC that is fast approaching the clinic. Can you move to the next slide, please?

Thank you. On this slide, I will briefly recapitulate where we are with lacutamab before moving to the feedback from our recent interaction with the FDA. We have already presented the primary result of the TELLOMAK trial, a Phase II single-arm study that includes both Sezary and mycosis fungoides patients. The data in Sezary syndrome were presented at ASH last year and the results in mycosis fungoides at ASCO this year.

Also this year, we will have a relevant presence at ASH with an oral presentation on the health-related quality of life in Sezary and translational results from TELLOMAK. The TELLOMAK study is continuing, and we collect more follow-up data from these patients. And similarly, in peripheral T-cell lymphoma, we continue to enroll patients in the KILT trial, a randomized Phase II where lacutamab is administered in combination with gemcitabine and oxaliplatin versus gemcitabine and oxaliplatin alone. And we believe that this combination may offer additional benefit to patients with PTCL.

As a reminder, lacutamab is a monoclonal antibody that targets KIR3DL2 and was shown to deplete the cells that express the receptor, which is expressed in more than 90% of Sezary syndrome patients and approximately in 50% of patients with mycosis fungoides or PTCL. The FDA granted an Orphan Drug designation for lacutamab for the treatment of CTCL and Fast Track designation for the treatment of adult patients with refractory/relapsed Sezary syndrome who have received at least 2 prior lines of systemic therapies.

We submitted the results from the TELLOMAK trial and the proposed regulatory pathway to market approval, including the possibility for an accelerated approval for Sezary syndrome to the FDA and received an encouraging feedback, and the company will continue to align with the FDA around the necessary confirmatory Phase III trial. We are currently evaluating the next step for the program, including potential licensing with a partner to deliver the confirmatory Phase III trial in CTCL.

Now where do we stand in terms of business case? On this slide, the data generated from the TELLOMAK trial confirm clinical benefit, not only in SS, but also in mycosis fungoides, regardless of the expression of the target KIR3DL2, highlighting an opportunity for the CTCL space without a companion diagnostic. Therefore, the number of CTCL patients that could potentially benefit from lacutamab expands from 1,500 to 3,500 in the 2-plus line of therapy and to 5,000 patients should we move to an earlier line setting.

With the strong Sezary syndrome and mycosis fungoides data we presented at ASH last year and ASCO this year, there is increased confidence in the potential of lacutamab. And our aim is to ensure that lacutamab gets to patients who need it as quickly as possible and to maximize the value via an accelerated approval.

On Slide 13, we now switch gear to our most advanced proprietary ANKET asset, IPH65, a tetra-specific antibody-based NK cell engager therapeutic or ANKET in short, which is a first-in-class NK engager that engage the tumor via a tumor-associated antigen, in this case, CD20, and the NK cells via 2 activating receptors, NKp46 and CD16, as well as the interleukin-2 receptor via an IL-2 variant or IL-2v. The IL-2 variant is the characteristic of the second-generation tetra-specific ANKET aimed to induce activation and proliferation of endogenous NK cells in the tumor microenvironment.

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. The trial is currently recruiting patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

We presented preclinical data at ASCO meeting this year showing that IPH6501 effectively and preferentially stimulated NK cell proliferation from PBMC of NHL patients and depleted autologous CD20-positive B cells from healthy donors with greater efficacy than a CD20 T-cell engager and inducing lower level of pro-inflammatory cytokines, which is often a limiting use of T cell engagers.

The current Phase I/II study has been presented as trial in progress at ASCO this year and the European Hematology Association Congress and more recently, at the SITC Annual Meeting, which Yannis will cover shortly.

In the next slide, I'll give you an overview of timeline for IPH6501. 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 pharmacodynamic readouts as well as preliminary efficacy signals. 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-Hodgkin lymphoma subtypes.

On Slide 15, I will summarize the next step of our lead ADC, IPH4502, following the IND clearance at the end of September. 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 antitumor activity in tumor types with both low and high expression of Nectin-4.

IPH4502 is a Topo I ADC targeting Nectin-4, and the preclinical characterization was presented at AACR and CITC this year, highlighting the key differentiation features of this product. And based on this data, we feel that we have a novel and differentiated ADC to target Nectin-4 in a broad panel of tumor indications beyond bladder cancer by overcoming the challenges associated with Nectin-4 MMAE-based ADCs, including enfortumab vedotin.

I will now hand over to Yannis to cover the earlier pipeline of ANKET and ADCs, as well as partnered asset, monalizumab.

[Yannis Morel, executive]

Thank you, Sonia. I will now highlight the 2 class of exciting next-generation antibody therapeutics on which we are focusing all our research activities, the NK cell engagers, ANKET and the ADCs.

On Slide 17, I draw your attention to our portfolio of ANKET. ANKET is our proprietary first-in-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 expressed on NK cells called NKp46. The interesting feature of this platform is that by swapping the tumor binding portion of the ANKET molecule, it can produce multiple drug candidates, addressing a variety of targets in oncology, but it can also potentially harvest NK cells to eliminate pathogenic cells in other disease like in autoimmune disease.

Earlier this year, Sanofi provided the most advanced ANKET SAR'579 to Phase II 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 I/II trial in frontline AML in combination with venetoclax and azacytidin.

As mentioned by Sonia, our lead proprietary ANKET, IPH65, is now in the clinic. It is a second-generation molecule, which incorporates a variant of IL-2 to induce expansion of patients' own NK cells. The first patient was dosed in March, and we recently presented new supporting preclinical data at the SITC conference.

I will now cover the key updates we presented at SITC for both IPH65 ANKET program and the Nectin-4 ADC IPH45. The IPH65 poster presented at the conference summarized the rationale to target the various subtypes of relapsed or refractory B-NHL patients.

First of all, on the left, you can see what we think is the key advantage for ANKET over existing CD20-targeting antibodies like rituximab, whereas CD16, the receptor for the Fc portion of antibodies to mediate ADCC, is strongly [ down modulated ] on NK cells in the lymph node of patients. NKp46 expression is maintained, providing a stable anchor for the ANKET. By assessing the function of NK cells for multiple patients, we have shown also that IPH65 was able to induce efficient killing by diseased NK cell across B-NHL subtypes, including diffuse large B cell lymphoma, follicular lymphoma or mantle cell lymphoma.

Finally, we made an 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 IPH65 in these patients.

On the next slide, the IPH45 poster summarized the key differentiating features of our drug candidates. As shown earlier in the year at AACR, IPH4502 is a novel DAR8 exatecan-based Nectin-4 ADC that has the ability to target Nectin-4 low expressing tumors where PADCEV does not work.

In the SITC poster, we further demonstrated that IPH45 has also the ability to target tumors having a heterogeneous expression of the Nectin-4. Indeed, by mixing at a 1:1 ratio Nectin-4 expressing cell line with the same cell line [ crispered ] out for Nectin-4 in order to mimic a heterogeneous tumor showing only 50% of positivity, IPH45 induced complete tumor regression of the mix. This effect is completely Nectin-4 dependent and is not related to a nontoxic effect since IPH45 had no effect in the Nectin-4 non-expressor model.

We also generated a PDX model of PADCEV acquired resistance. We obtained it by making 5 injection of PADCEV, resulting in a PDX model that is eventually relapsing under PADCEV, but is completely sensitive to IPH45, highlighting the ability of IPH45 to address patients pre-exposed to PADCEV. These 2 posters are available on our website.

On Slide 20, I would like to remind you of monalizumab, the anti-NKG2A that we have licensed to AstraZeneca for oncology. On this slide, you can see an overview of the late-stage development of monalizumab in lung cancer. Based on the Phase II COAST data, AstraZeneca started in May '22, the Phase III trial called PACIFIC-9, evaluating the addition of either monalizumab or oleclumab to durvalumab in unresectable Stage III non-small cell lung cancer patients who have not progressed after concurrent chemoradiation therapy.

We were encouraged that over the summer, the Independent Data Monitoring Committee recommended the continuation of the Phase III PACIFIC-9 trial based on a preplanned analysis. Together with the COAST and the NeoCOAST data, the NeoCOAST-2 data presented at the World Lung Congress in September provided a third proof point in a controlled Phase II study that monalizumab provides additional antitumor activity on top of durvalumab in early lung.

I will now hand over to Arvind.

[Arvind Sood, executive]

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. 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.

Near term, we are looking forward to the next steps for lacutamab now that we have the positive FDA feedback. Programs coming out of our ANKET platform continue to advance as IPH6101, targeting CD123 in hematologic malignancies and partnered with Sanofi, progressed to Phase II earlier this year. Our proprietary tetra-specific ANKET that goes by IPH6501 is now in clinical development. And our ADC-targeting Nectin-4 has cleared IND and is due to start Phase I soon.

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. We now have 7 products in clinical development, with 3 that are proprietary and 4 that are partnered. Our cash position of around EUR 96.4 million through the end of September will enable us to fund operations through the end of 2025.

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.

[Operator]

[Operator Instructions] Our first question will come from the line of Liisa Bayko with Evercore ISI.

[Jingming Chen, analyst]

This is Jingming on for Liisa. So I'm just wondering, could you please provide some color on lacutamab to be presented -- lacutamab data to be presented at ASH, especially what does the translational data entail? Also, it would be nice if you could give some color regarding the regulatory path for lacutamab. Is FDA supportive of filing with current data in Sezary syndrome for accelerated approval? Or is the -- and then is the filing predicated on finding a partnership?

[Jonathan Dickinson, executive]

Thank you for the question. Sonia, could you take that one, please?

[Sonia Quaratino, executive]

Absolutely. 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. I can provide a bit more perhaps color on the FDA interaction that we had. We have received this encouraging initial feedback and the FDA endorsed our proposed regulatory pathway in general lines.

The FDA acknowledged that the currently available data from the Phase I and the Phase II TELLOMAK studies may be sufficient to support the BLA submission, paving the path for an accelerated approval for Sezary syndrome. And the company will then align with the FDA around the confirmatory Phase III trial to support such, let's say, accelerated approval, and we are working towards this to make it happen.

[Jingming Chen, analyst]

Got it. 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 alignment with the FDA for the Phase III confirmatory trial?

[Sonia Quaratino, executive]

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 Phase III trial. We will pave the way by producing a regulatory strategy, which eventually may also need to be discussed with the potential partner.

[Operator]

Our next question comes from the line of Daina Graybosch with Leerink Partners.

[Daina Graybosch, analyst]

I think I understand from the previous one, I'll just follow up on that you really need to find a partner to do a confirmation study and that will gate 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?

[Jonathan Dickinson, executive]

Sonia, do you want to take the first part of that question? And then we'll come back to Yannis and myself.

[Sonia Quaratino, executive]

Certainly. As I just briefly mentioned, we are working towards this confirmatory Phase III study for the CTCL indication in more general terms. 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 the go-live of this -- of such a study. And we are looking for partners or many other options to make this happen.

[Jonathan Dickinson, executive]

Thank you, Sonia. So I mean, I can add something to what Sonia has just said. So what -- 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 that we might be able to take forward a lacutamab Phase III 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.

[Daina Graybosch, analyst]

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?

[Jonathan Dickinson, executive]

Yannis, do you want to take a stab at that one?

[Yannis Morel, executive]

Yes. Daina, so like Jonathan said, we are entertaining several options in parallel. I would say classical partnering is one option. And what will guide us is the way to maximize the return for Innate. So we really want to -- we think that here, we have potentially a drug that is really active in CTCL. And we really want to execute swiftly the registrational part of the development, and anything that will maximize the return for the company and the shareholder will be prioritized.

[Operator]

Our next question will come from the line of Rajan Sharma with Goldman Sachs.

[Rajan Sharma, analyst]

Sorry, just another one on lacutamab 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 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 alone?

And then maybe related to that is just one on cash. So, your runway to the end of '25, so you're sort of into the last 12 months. 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 Nectin-4, which I'll come back to.

[Jonathan Dickinson, executive]

Thanks, Rajan. Maybe Yannis, you can take the first part, and then we can go to Frederic for the cash runway.

[Yannis Morel, executive]

Rajan, yes, obviously, it will be busy during the next few months. Obviously, the FDA feedback was an important milestone to actually resume discussion with several partners, but also for the other type of option we are looking at. So it's clearly something that we can get during the next several months hopefully, yes.

[Jonathan Dickinson, executive]

Okay. Thank you, Yannis. Frederic?

[Frederic Lombard, executive]

Yes. On the cash runway, just one thing first is that we -- when we communicate on this cash runway, there is no options that is not fully guaranteed. So we are comfortable with the cash runway that we are publishing first. And second, we are, as usual, constantly monitoring financing needs, including dilutive and non-dilutive options that we are currently working on. And we will provide an update when needed and when finalized.

[Jonathan Dickinson, executive]

And you had a question on Nectin-4, Rajan?

[Rajan Sharma, analyst]

Yes. So just on that one, and obviously clear on the slide that you see the potential for the asset in kind of PADCEV 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 differentiation?

[Jonathan Dickinson, executive]

So Yannis, do you want to take that?

[Yannis Morel, executive]

Yes. We think that there are several lines of differentiation like what we have shown here at SITC that we -- IPH45 is working in preclinical models that are resistant to PADCEV either through primary resistance or acquired resistance like I've just shown today. We have also -- and it's in the poster that you can find on the website shown that it can target Nectin-4 low expressor tumor model, and we are now accumulating data in other tumor type like breast cancer.

And this is really a differentiating factor compared to PADCEV, which is really working well in bladder where the expression of Nectin-4 is high and homogeneous. In terms of tolerability, as we are using an exatecan, we do not expect the same kind of toxicity as with MMAE. And yes, that's basically the different possibility that make the potential business case for this Nectin-4 exatecan IPH45 broader than PADCEV because there are -- and it's also in our poster, there are many, many solid tumors that do express Nectin-4, if not at the same level of bladder, that could be within the reach of 45, but not PADCEV.

[Operator]

[Operator Instructions]

[Henry Wheeler, executive]

I'll take the question received online from Eric Le Berrigaud at Stifel. On lacutamab, is the understanding correct from your initial interactions with the FDA that the agency would not be against the filing with the drug for Sezary syndrome and maybe even CTCL with potential in the second case to get a conditional approval based on a confirmatory Phase III trial? If this understanding is correct, is it what a partner was waiting for to move on and sign up for a collaboration with you on the asset? Or is it more the PTCL data dependent?

I'll stop there. Sonia, probably a question for you.

[Sonia Quaratino, executive]

Henry, I'm not sure I understood the first part of the question. Would you mind to repeat that?

[Henry Wheeler, executive]

Is the understanding correct from the initial interactions with the FDA that the agency would not be against a filing with the drug for Sezary syndrome and maybe even CTCL with the potential in the second case to get conditional approval based on the confirmatory Phase III trial?

[Sonia Quaratino, executive]

Correct. Right. Yes. Sorry. It was the negative that keep my understanding before. Yes. Basically, the data in Sezary where we would be looking for the accelerated approval because, of course, accelerated approval can only be given to indication with a high unmet medical need and Sezary would qualify for such an indication would be given based on the Phase II and Phase I data. But of course, any accelerated approval can only be obtained when the confirmatory trial is up and running and depending on the recruitment rate, it must be quite advanced on that.

And this approval is completely independent from the PTCL, which is a very different indication in that respect.

[Jonathan Dickinson, executive]

Yannis, do you want to take the...

[Yannis Morel, executive]

Yes. And with regard to the question on the partnership, I would not say that the FDA feedback was awaited to sign a deal, but it was more an important milestone to progress discussions, and that's where we are today.

[Henry Wheeler, executive]

And then the second part of Eric's question, what would you consider as the most likely next step for lacutamab, a formal filing with the FDA or a partnership with a third party? And what are the reasonable timelines for this to happen?

[Jonathan Dickinson, executive]

Maybe Sonia?

[Sonia Quaratino, executive]

Okay. The most likely timelines is really to go ahead and prepare a Phase III that can be then taken up by a partner and -- or eventually finding either option to fund the study and make it in a different way.

[Henry Wheeler, executive]

Okay. Thank you. Another offline question from Jingming at Evercore ISI. Could you please remind us why Sanofi decided to return IPH67 ANKET? Is it due to activity signal, safety or other reasons, e.g. strategic prioritization?

[Yannis Morel, executive]

Yes. Hi, Jingming. Sanofi did not provide any specific reason for the termination. I just remind you that IPH67 was a very early-stage research program. So not even at the candidate selection, it was even years away from candidate selection. So there is no specific technical or scientific reason behind that decision. It's really up to Sanofi to comment on that. 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 B7-H3 ANKET program progressing well in the preclinical development.

[Operator]

We'll take our next question from the line of Arthur He with HCW.

[Yu He, analyst]

This is Arthur on for RK. So I have 2 questions on the ANKET. So one is for the 52, your own 5201 -- your own 6501, 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 your own program?

[Jonathan Dickinson, executive]

Sonia, can you take that one, please?

[Sonia Quaratino, executive]

Of course. I think you are referring to IPH6501, which is the second-generation ANKET in the B cell non-Hodgkin lymphoma. We opened the Phase I, the dose escalation that goes according to the usual times of a dose escalation with DLT windows, et cetera. And we believe that we will complete the dose escalation by 2025 and then open a dose optimization. And so we will have by 2025, data around safety, pharmacokinetics, pharmacodynamic and early clinical antitumor efficacy, even though the number of patients tested in each dose level are very limited, classic of any dose escalation. But this is what we expect by, let's say, 2025 and in 2026, let's say, more clinical efficacy data, of course.

[Yu He, analyst]

And so another question is I just want to follow up on the IPH67. Are you able to disclose which targeted -- these assets are targeted for? Or it's still kind of the [ status load ]?

[Jonathan Dickinson, executive]

I can answer that one. That's a target that we're not currently disclosing at this point in time.

[Operator]

[Operator Instructions] 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.