Innate Pharma SA (IPHA) 2025 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Thank you for standing by, and welcome to the Innate Pharma first-half 2025 business update and financial results conference call. (Operator Instructions)

    感謝您的耐心等待,歡迎參加 Innate Pharma 2025 年上半年業務更新和財務業績電話會議。(操作說明)

  • I'd now like to turn the call over to Stephanie Cornen, Vice President, Investor Relations and Communications. You may begin.

    現在我想把電話交給投資者關係和傳播副總裁史蒂芬妮·科寧。你可以開始了。

  • Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

    Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

  • Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma H1 2025 business update and financial results conference call. The press release and today's presentation are both available on the IR section of our website.

    各位早安/下午好。感謝您參加 Innate Pharma 2025 年上半年業務更新與財務績效電話會議。新聞稿和今天的簡報均可在我們網站的投資者關係版塊中找到。

  • Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectation. These statements involve risks and uncertainties that could cause actual results to differ materially.

    在開始之前,我想提醒大家,今天的演講包含基於當前預期的前瞻性陳述。這些聲明涉及風險和不確定性,可能導致實際結果與預期結果有重大差異。

  • I'll briefly cover today's agenda. Our CEO, Jonathan Dickinson, will discuss our strategic overview fast-forward and commercial opportunity. Our COO, Yannis Morel, will provide an update on the scientific differentiation of our lead ADC. He will then hand over to our CMO, Sonia Quaratino, who will present clinical pipeline updates on IPH4502, lacutamab and monalizumab. Afterward, our CFO, Frederic Lombard, will review the financial. Then Jonathan will return with closing remarks and we'll open the call for Q&A.

    我將簡要介紹一下今天的議程。我們的執行長喬納森·迪金森將討論我們的策略概覽、快速發展和商業機會。我們的營運長 Yannis Morel 將介紹我們領先的 ADC 的科學差異化的最新進展。然後他將把發言權交給我們的首席醫療官 Sonia Quaratino,她將介紹 IPH4502、lacutamab 和 monalizumab 的臨床研發進展。之後,我們的財務長弗雷德里克·隆巴德將審核財務報表。然後喬納森將作總結發言,之後我們將開放問答環節。

  • With that, I'll now hand it over to Jonathan.

    這樣,我現在就把它交給喬納森。

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • Thank you, Stephanie, and good morning to those joining from the US, and good afternoon to our participants in Europe.

    謝謝史蒂芬妮,向來自美國的各位問好,向來自歐洲的各位問好,向歐洲的各位問好。

  • Moving to slide 5, Innate Pharma's foundation is in leveraging our deep scientific expertise to advance life-enhancing cancer therapies. Through our years of pioneering work in antibody engineering, we have built a differentiated, high-value, clinical pipeline supported by compelling data, and this positions us to deliver truly transformative treatments.

    翻到第 5 張投影片,Innate Pharma 的基礎是利用我們深厚的科學專業知識來推動改善生命的癌症療法。多年來,我們在抗體工程領域進行了開創性工作,建立了一條差異化、高價值的臨床研發管線,並有令人信服的數據支持,這使我們能夠提供真正具有變革意義的療法。

  • Turning to slide 6, during the first half of the year, we've made significant progress across our portfolio. And today marks an important new chapter for Innate. As you may have read in the press release for our half yearly update that we issued earlier today, we have made the strategic decision to focus our investment where we believe we can deliver the greatest impact for both patients and our shareholders.

    翻到第 6 張投影片,在今年上半年,我們在各個業務領域都取得了顯著進展。今天標誌著 Innate 開啟了重要的新篇章。正如您可能在我們今天早些時候發布的半年報新聞稿中讀到的那樣,我們已經做出了策略決策,將投資重點放在我們認為能夠為患者和股東帶來最大影響的領域。

  • Therefore, going forward, our main investments will be centered on three high-value clinical assets: IPH4502, lacutamab, and monalizumab. These programs represent the strongest opportunities to transform care and create meaningful value, and they will form the focus of today's discussion.

    因此,展望未來,我們的主要投資將集中在三個高價值的臨床資產:IPH4502、lacutamab 和 monalizumab。這些項目代表著改變醫療保健和創造有意義價值的最佳機會,它們將成為今天討論的重點。

  • At the same time, we will concentrate on selecting and advancing our next ADCs towards clinical development. As a consequence of this prioritization and sharpened focus, we intend to streamline our organization to deliver on our strategic objectives and key near-term milestones. This is a pivotal moment for Innate. We are aligning our strategy, our science, our organization, and our investment to drive forward the programs that can truly make the biggest difference.

    同時,我們將集中精力選擇和推進我們的下一代抗體藥物偶聯物(ADC)進入臨床開發階段。由於這種優先事項的確定和重點的明確,我們打算精簡組織架構,以實現我們的策略目標和近期關鍵里程碑。這對Innate來說是一個關鍵時刻。我們正在調整策略、科學、組織和投資,以推進那些真正能產生最大影響力的項目。

  • I could not be more confident in the path we are taking, and I'm excited to share with you how we will execute on this vision in the coming presentation. As you will also have seen in this morning's announcement, our CSO, Eric Vivier, has decided to return to full-time academic research. Eric has been a true driver of the scientific agenda within Innate. So we are extremely pleased that he will continue to support the company's innovation in the important role as an adviser to the R&D Committee of the Board of Directors.

    我對我們目前所走的道路充滿信心,我很高興在接下來的演講中與大家分享我們將如何實現這個願景。正如您在今天早上的公告中看到的那樣,我們的首席科學官埃里克·維維爾決定重返全職學術研究職位。Eric一直是Innate公司科學議程的真正推動者。因此,我們非常高興他將繼續擔任董事會研發委員會顧問這一重要角色,以支持公司的創新。

  • Our Chief Operating Officer, Yannis Morel, has always had responsibilities for preclinical research and development. And he will now also assume the Chief Scientific Officer responsibilities.

    我們的營運長 Yannis Morel 一直負責臨床前研究和開發工作。他也將繼續承擔首席科學官的職責。

  • With that, I will now hand it over to Yannis for a closer look at our lead ADCs and the potential. Yannis?

    接下來,我將把鏡頭交給 Yannis,讓他更仔細地看看我們的主力 ADC 以及他們的潛力。揚尼斯?

  • Yannis Morel - Chief Operating Officer, Executive Vice President, Member of the Executive Board, Member of the Leadership Team

    Yannis Morel - Chief Operating Officer, Executive Vice President, Member of the Executive Board, Member of the Leadership Team

  • Thank you, Jonathan. First, on slide 8, let me share with you why we think Nectin-4 is an attractive target for a next-generation ADC and why our highly differentiated Nectin-4 ADC has more potential across many solid tumors. Even though Nectin-4 is a validated ADC target, PADCEV or enfortumab vedotin carries some challenges and has several limitations. It is approved solely for patients with urothelial cancer where Nectin-4 expression is the highest.

    謝謝你,喬納森。首先,在第 8 張投影片中,讓我和大家分享為什麼我們認為 Nectin-4 是下一代 ADC 的一個有吸引力的靶點,以及為什麼我們高度差異化的 Nectin-4 ADC 在許多實體瘤中具有更大的潛力。儘管 Nectin-4 是一個經過驗證的 ADC 靶點,但 PADCEV 或 enfortumab vedotin 仍存在一些挑戰和限制。該藥物僅獲準用於 Nectin-4 表達最高的尿路上皮癌患者。

  • In addition, PADCEV-related toxicity often leads to treatment continuations and relapse are frequency observed, creating a growing medical need in the post PADCEV setting. Finally, even though Nectin-4 is expressed at moderate to high level in several other tumor types, there is limited evidence showing that PADCEV is active beyond urothelial cancer.

    此外,PADCEV 相關毒性通常會導致治療持續進行,並且經常觀察到復發,從而在 PADCEV 後環境中產生了日益增長的醫療需求。最後,儘管 Nectin-4 在其他幾種腫瘤類型中以中等至高水平表達,但有限的證據表明 PADCEV 在尿路上皮癌之外也具有活性。

  • On the next slide, slide 9, I want to show you why we are so excited by our next-generation Nectin-4 ADC program called IPH4502. As I said previously, this is a differentiated ADC that leverages a novel design to improve both safety and efficacy.

    在下一張投影片(第 9 張投影片)中,我想向大家展示為什麼我們對名為 IPH4502 的下一代 Nectin-4 ADC 計畫如此興奮。正如我之前所說,這是一種差異化的ADC,它利用新穎的設計來提高安全性和有效性。

  • IPH4502 is based on a proprietary humanized antibody that binds a unique epitope on the Nectin-4 molecule. The linker used is stable, cleavable and hydrophilic ensuring high [ADC] exposure and low systemic release of exatecan, which minimize potential side effects.

    IPH4502 是基於專有的人源化抗體,可與 Nectin-4 分子上的獨特抗原決定位結合。所用連接子穩定、可裂解且親水,可確保高[ADC]暴露量和低依沙替康全身釋放,從而最大限度地減少潛在的副作用。

  • The payload itself, exatecan, is important to topoisomerase I inhibitor. It shows what's called bystander activity, which means it impacts number in tumor cells that do not express high level of Nectin-4 and can therefore address tumors with heterogenous expression of Nectin-4. In addition, it remains highly active in enfortumab vedotin or MMAE-resistant models, allowing it to target tumors that have or became resistant to EV.

    有效載荷本身,即依沙替康,對於拓樸異構酶 I 抑制劑而言非常重要。它顯示出所謂的旁觀者活性,這意味著它會影響不表達高水平 Nectin-4 的腫瘤細胞的數量,因此可以治療 Nectin-4 表達異質性的腫瘤。此外,它在對恩福妥單抗或MMAE抗藥性的模型中仍然具有很高的活性,使其能夠針對已或對EV產生抗藥性的腫瘤。

  • In summary, the design of IPH4502 is purpose-built to overcome the limitations seen with existing therapies such as enfortumab vedotin.

    總而言之,IPH4502 的設計旨在克服現有療法(如 enfortumab vedotin)的限制。

  • On the next slide, slide 10, turning to preclinical data. During the period, we were also pleased to present at the AACR Annual Meeting, our filings that highlights the differentiated potential of IPH4502.

    下一張投影片,第 10 張投影片,將轉向臨床前數據。在此期間,我們也很高興在 AACR 年會上展示了我們的文件,該文件突出了 IPH4502 的差異化潛力。

  • Starting from a PDX model of urothelial cancer, we generated a model of acquired resistance by exposing tumors to repeated cycle of enfortumab vedotin. As anticipated, tumors that were initially sensitive became resistant to EV, while keeping expression of Nectin-4. But what is remarkable is that in the same model, IPH4502 maintained its activity. While EV lost efficacy, IPH4502 continued to control tumor growth, underscoring its differentiated profile and the opportunity to address patients who no longer respond to EV.

    從尿路上皮癌的 PDX 模型出發,我們透過重複將腫瘤暴露於 enfortumab vedotin 治療,建立了獲得性抗藥性模型。正如預期的那樣,最初對 EV 敏感的腫瘤變得對 EV 具有抗藥性,同時保持了 Nectin-4 的表達。但令人驚訝的是,在同一模型中,IPH4502 保持了其活性。儘管 EV 失去了療效,但 IPH4502 繼續控制腫瘤生長,這凸顯了其差異化特性,以及為不再對 EV 有反應的患者提供治療的機會。

  • On the next slide, slide 11, our preclinical data also demonstrated antitumor activity in PDX model with low or heterogenous Nectin-4 expression from various tumor types including, for example, triple-negative breast, esophageal, and head and neck cancers. These results highlight the potential of IPH4502 to extend the reach of Nectin-4 targeting beyond urothelial cancer into tumor types with significant unmet medical needs.

    在下一張幻燈片(第 11 張幻燈片)中,我們的臨床前數據還表明,在 Nectin-4 表達低或異質性的各種腫瘤類型(例如三陰性乳腺癌、食道癌和頭頸癌)的 PDX 模型中,該藥物具有抗腫瘤活性。這些結果凸顯了 IPH4502 的潛力,它將 Nectin-4 標靶治療的範圍從尿路上皮癌擴展到具有重大未滿足醫療需求的腫瘤類型。

  • IPH4502 is currently in Phase I development, and we are very excited about the potential of this novel and differentiated Nectin-4 exatecan ADC to address high unmet medical needs, both in bladder cancer post EV, but also in solid tumors with low or heterogenous expression of Nectin-4, representing a potentially broad market opportunity.

    IPH4502 目前處於 I 期開發階段,我們對這種新型且差異化的 Nectin-4 依沙替康 ADC 的潛力感到非常興奮,它能夠滿足膀胱癌 EV 術後以及 Nectin-4 表達低或異質性實體瘤中尚未滿足的醫療需求,這代表著一個潛在的廣闊市場機會。

  • I'll now hand over to Sonia, who will discuss the clinical progress of IPH4502 as well as our other clinical programs.

    現在我將把發言權交給索尼婭,她將討論 IPH4502 的臨床進展以及我們的其他臨床項目。

  • Sonia Quaratino - Executive Vice President, Member of the Executive Board, Chief Medical Officer, Member of the Leadership Team

    Sonia Quaratino - Executive Vice President, Member of the Executive Board, Chief Medical Officer, Member of the Leadership Team

  • Thank you, Yannis. Today, I will focus on preclinical assets that represent the potential to create the highest value for Innate, IPH4502, lacutamab, and monalizumab. In the next slide, starting with IPH4502, the ADC directed against Nectin-4. This is a trial that is an asset that is currently investigated in a first-in-human Phase I study. Enrollment in this dose escalation is going very well, and we are now on track to complete enrollment before the end of Q1 2026.

    謝謝你,揚尼斯。今天,我將重點介紹具有最大潛力為 Innate、IPH4502、lacutamab 和 monalizumab 創造價值的臨床前資產。下一張投影片,從 IPH4502 開始,這是針對 Nectin-4 的 ADC。這是一項目前正在進行首次人體 I 期研究的試驗。這次劑量遞增試驗的招募工作進展非常順利,我們目前正按計畫推進,預計在 2026 年第一季末完成招募工作。

  • The objective of the study is to assess the safety, vulnerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4. And we are pleased to present this study in a trial-in-progress poster at ASCO Annual Meeting in Chicago last June.

    研究的目的是評估 IPH4502 在已知表達 Nectin-4 的晚期實體腫瘤中的安全性、脆弱性和初步療效。我們很高興在去年六月於芝加哥舉行的 ASCO 年會上以試驗進展海報的形式展示了這項研究。

  • The dose escalation is guided by an adaptive (inaudible) design to determine the maximum tolerated dose. And once this is established, patients in one or two selected indications will be randomized across two dose levels to define the recommended Phase II dose as per FDA guidelines.

    劑量遞增採用自適應(聽不清楚)設計,以確定最大耐受劑量。一旦確定了這一點,將對一到兩種選定適應症的患者進行隨機分組,分配到兩個劑量水平,以根據 FDA 指南確定建議的 II 期劑量。

  • The antitumor activity of IPH45 as a single agent will be further explored at RP2D in an expansion phase in selected indications in which signs of activities have been detected in the dose escalation. As well as confirming that the drug has a favorable safety profile and tolerability, the goal of this Phase I trial is to generate efficacy data that will guide the path forward for IPH4502, such as a basket trial in combination with standard of care or expansion phase to help maximize its value for both patients and shareholders.

    在劑量遞增試驗中已發現 IPH45 具有活性的適應症中,將在 RP2D 階段進一步探討其作為單一藥物的抗腫瘤活性。除了確認該藥物具有良好的安全性和耐受性外,這項 I 期試驗的目標是產生療效數據,以指導 IPH4502 的未來發展方向,例如與標準療法聯合進行的籃子試驗或擴展階段,以幫助最大限度地提高其對患者和股東的價值。

  • In slide 14, we have the key milestones ahead for IPH4502. With enrollment progressing well, we expect to report preliminary safety and activity data in the first half of 2026. The preclinical data presented earlier by Yannis are guiding us towards two key hypotheses to be explored in the clinic.

    第 14 張投影片列出了 IPH4502 未來的關鍵里程碑。由於招募工作進展順利,我們預計將於 2026 年上半年公佈初步的安全性和活動數據。Yannis 先前提出的臨床前數據正在引導我們得出兩個需要在臨床上探索的關鍵假設。

  • The first, it's an urothelial carcinoma in the post EV setting, where IPH4502 may overcome resistance to EV. This represents an area of high unmet need with no approved drugs, and the potential to move rapidly into late-stage development is large. The second is to look for signals in other tumor types where a Nectin-4 expression may be low or heterogenous, which could open an even broader opportunity. With this hypothesis, the clinical data will guide us towards the indication where IPH4502 can make the greatest impact.

    第一種情況是 EV 治療後的尿路上皮癌,在這種情況下,IPH4502 可能克服對 EV 的抗藥性。這代表著一個需求尚未充分滿足、目前尚無核准藥物的領域,並且有很大的潛力迅速進入後期開發階段。第二點是尋找其他腫瘤類型中的訊號,在這些腫瘤類型中,Nectin-4 的表達可能較低或存在異質性,這可能會帶來更廣泛的機會。基於這個假設,臨床數據將引導我們找到 IPH4502 能發揮最大作用的適應症。

  • Now turning on next slide on lacutamab. We are close to completion of the Phase III protocol following alignment with the FDA and EMA. To recap, lacutamab is a first-in-class anti-KIR3DL2 antibody in development for the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma.

    現在開始播放下一張關於拉庫單抗的幻燈片。在與FDA和EMA達成一致後,我們即將完成III期臨床試驗方案。綜上所述,lacutamab 是一種首創的抗 KIR3DL2 抗體,目前正在開發用於治療皮膚 T 細胞淋巴瘤和周邊 T 細胞淋巴瘤。

  • In CTCL, lacutamab has already generated strong, long-term, follow-up data, which we presented at ASCO this year and which we will summarize in the next slide. Importantly, the regulatory pathway is clear, supported by key designations that position lacutamab for potential accelerated approval in Sézary syndrome.

    在 CTCL 中,lacutamab 已經產生了強有力的長期追蹤數據,我們在今年的 ASCO 會議上展示了這些數據,我們將在下一張投影片中進行總結。重要的是,監管途徑很明確,關鍵認定為 lacutamab 在 Sézary 症候群治療中具有潛在的加速批准條件。

  • Our confidence in the program was further strengthened earlier this year when the FDA granted breakthrough therapy designation for relapsed or refractory Sézary syndrome based on the TELLOMAK Phase II results. This designation is intended to accelerate both development and regulatory review of drugs that address serious conditions.

    今年早些時候,FDA 根據 TELLOMAK II 期試驗結果授予復發性或難治性 Sézary 症候群突破性療法認定,這進一步增強了我們對該療法的信心。該認定旨在加速治療嚴重疾病藥物的研發和監管審查。

  • Beyond CTCL, PTCL, peripheral T-cell lymphoma, represents a second indication. It's a group of aggressive lymphomas with poor prognosis and a significant life cycle management opportunity for lacutamab. Importantly, KIR3DL2 correlates with worse clinical outcome and is expressed in approximately 40% of PTCL patients.

    除了 CTCL 之外,PTCL(週邊 T 細胞淋巴瘤)是第二個適應症。這是一組侵襲性淋巴瘤,預後不良,而 lacutamab 為該類淋巴瘤的生命週期管理提供了重要的機會。重要的是,KIR3DL2 與較差的臨床結果相關,並且在約 40% 的 PTCL 患者中表達。

  • In PTCL, lacutamab has previously demonstrated some objective responses as a single agent, reinforcing the relevance of the target and providing the rationale to pursue development in combination with chemotherapy. Building on these findings, lacutamab is now being investigated in the KILT trial, a randomized Phase II in combination with gemcitabine and oxaliplatin, versus gemcitabine -- oxaliplatin in relapsed/refractory KIR3DL2 positive PTCL patients.

    在 PTCL 中,lacutamab 先前已作為單一藥物顯示出一些客觀療效,這強化了該標靶的相關性,並為與化療聯合開發提供了理論基礎。基於這些發現,目前正在 KILT 試驗中研究 lacutamab,這是一項隨機 II 期試驗,旨在比較 lacutamab 與吉西他濱和奧沙利鉑聯合用藥與吉西他濱-奧沙利鉑單藥治療復發/難治性 KIR3DL2 陽性 PTCL 患者的療效。

  • When we move to next slide and to recap the data in CTCL that we presented at ASCO 2025, the long-term follow-up data from the TELLOMAK Phase II trial, here, we see the results in Sézary syndrome, which is an aggressive subtype of CTCL and post mogamulizumab, where there are no approved drug, we have shown clinical efficacy. In heavily pretreated patients, all pretreated with Moga, lacutamab demonstrated a global overall response rate of 42.9%, and the medium progression-free survival of 8.3 months.

    當我們進入下一張投影片,回顧我們在 2025 年 ASCO 會議上展示的 CTCL 數據,以及 TELLOMAK II 期試驗的長期追蹤數據時,我們可以看到 Sézary 綜合徵(一種侵襲性 CTCL 亞型)的結果,以及在接受 mogamulizumab 治療後(目前尚無獲批藥物批次)的臨床療效。在接受過大量預處理的患者中(所有患者均接受過 Moga 治療),lacutamab 顯示 42.9% 的整體緩解率和 8.3 個月的中位無惡化存活期。

  • Of note, the median duration of response was 25.6 months, underscoring lacutamab's potential to deliver durable clinical benefit in this very aggressive and difficult-to-treat population.

    值得注意的是,中位緩解持續時間為 25.6 個月,這凸顯了 lacutamab 有可能為這種侵襲性強且難以治療的人群帶來持久的臨床益處。

  • Turning in the next slide to mycosis fungoides. The long-term follow-up data from the TELLOMAK Phase II trial showed that lacutamab achieved a global overall response rate of 19.6%, with consistent activity observed regardless of KIR3DL2 expression level. The median duration of response was 13.8 months, and median progression-free survival was 10.2 months with no difference between the two subgroups.

    下一張投影片將介紹蕈樣肉芽腫。TELLOMAK II 期試驗的長期追蹤數據顯示,lacutamab 的整體緩解率為 19.6%,無論 KIR3DL2 表現量如何,均觀察到一致的活性。中位緩解持續時間為 13.8 個月,中位無惡化存活期為 10.2 個月,兩個亞組之間沒有差異。

  • Importantly, in both Sézary syndrome and mycosis fungoides, every patient who achieved a complete response remained in response at the time of the data cutoff, once again, highlighting lacutamab ability to deliver durable benefit even in heavily pretreated patients. In both indications, Sézary and mycosis fungoides, lacutamab was well tolerated with an excellent safety profile that supports its potential use for long systemic therapy.

    重要的是,在 Sézary 症候群和蕈樣肉芽腫中,所有達到完全緩解的患者在數據截止時仍保持緩解狀態,再次凸顯了 lacutamab 即使在接受過大量預治療的患者中也能帶來持久療效的能力。在 Sézary 和蕈樣肉芽腫這兩個適應症中,lacutamab 的耐受性良好,安全性極佳,支持其用於長期全身性治療的潛力。

  • Now in the next slide, let's look at the potential positioning of lacutamab in CTCL. The challenges in CTCL care are well known. The disease has a profound impact on quality of life with patients suffering from itching, fatigue, and cutaneous lesions with important psychosocial implications. Preventing progression to advanced stages is critical as outcome in Stage IIb and beyond are poor.

    接下來,讓我們在下一張幻燈片中看看 lacutamab 在 CTCL 中的潛在定位。CTCL治療所面臨的挑戰是眾所周知的。此疾病對患者的生活品質有深遠的影響,患者會遭受搔癢、疲勞和皮膚損傷等症狀,並伴隨重要的社會心理影響。防止病情發展到晚期至關重要,因為 IIb 期及以後的預後較差。

  • Yet very few tolerable systemic options are currently available for early-stage patients. And this is where lacutamab can make a real difference. Our data have shown deep antitumor activity, durable responses, and meaningful progression-free survival.

    然而,目前早期患者可耐受的全身性治療方案非常少。而這正是拉庫單抗能夠真正發揮作用的地方。我們的數據顯示,該藥物具有深遠的抗腫瘤活性、持久的療效和顯著的無惡化存活期。

  • Equally important, lacutamab has shown an excellent safety profile overcoming the tolerability concern of other systemic therapies in earlier stages of disease. Furthermore, lacutamab address the symptoms that matter most to patients with a positive impact on the quality of life.

    同樣重要的是,lacutamab 已顯示出極佳的安全性,克服了其他全身療法在疾病早期階段的耐受性問題。此外,拉庫單抗能夠有效緩解患者最關心的症狀,進而對患者的生活品質產生正面影響。

  • In the next slide, we see that the combination of strong efficacy with excellent safety makes lacutamab a unique candidate for earlier use of systemic therapy in CTCL. And this becomes particularly important in mycosis fungoides, where survival estimates deteriorate once patients progress to more advanced stages.

    在下一張投影片中,我們可以看到,拉庫單抗兼具強大的療效和極佳的安全性,使其成為 CTCL 早期系統治療的獨特候選藥物。這點在蕈樣肉芽腫中尤其重要,因為一旦患者病情發展到更晚期,存活率就會下降。

  • As you can see, in Stage IIb and beyond, the five-year survival is lower than 50%. Poor survival in late-stage MF highlights the need for systemic therapies that can be used earlier to change the course of the disease. And here is where lacutamab could fill a critical gap, offering a tolerable systemic option that can be introduced at an earlier time point with the potential to delay progression and improve patient outcomes.

    如您所見,在 IIb 期及以後,五年存活率低於 50%。晚期 MF 患者的存活率低,凸顯了早期使用全身性療法改變疾病進程的必要性。而 lacutamab 正是在這裡可以填補一個關鍵空白,它提供了一種耐受性良好的全身治療方案,可以在更早的時間點引入,有可能延緩疾病進展並改善患者的治療效果。

  • So altogether, we are on track to advance lacutamab towards Phase III in CTCL. As discussed, we are close to finalize the Phase III protocol following interaction with the FDA and EMA. And once financing is secured, we will be positioning to initiate the confirmatory Phase III trial next year, with the potential for accelerated approval in the following year, as enrollment advances in Sézary syndrome targeting approximately 2027.

    綜上所述,我們正按計劃推進 lacutamab 在 CTCL 治療中的 III 期臨床試驗。如同先前討論的,在與FDA和EMA進行溝通後,我們即將完成III期臨床試驗方案。一旦資金到位,我們將做好準備,明年啟動確證性 III 期試驗,並預計在來年獲得加速批准,因為 Sézary 綜合徵的招募工作正在推進,目標是在 2027 年左右完成。

  • The key next step will be to determine the optimal path forward, whether through partnering or additional investor support, always with the goal of maximizing value for both patients and shareholders. In parallel, in PTCL, the LYSA-sponsored KILT trial continues to enroll patients. And we look forward to data from this study in 2026, which could further validate lacutamab potential across additional T-cell lymphoma.

    下一步的關鍵是確定最佳前進路徑,無論是透過合作還是額外的投資者支持,始終以最大限度地為患者和股東創造價值為目標。同時,在 PTCL 領域,LYSA 贊助的 KILT 試驗仍在繼續招募患者。我們期待在 2026 年獲得這項研究的數據,這可能會進一步驗證 lacutamab 在其他 T 細胞淋巴瘤中的潛力。

  • Now switching gear in the next slide. We discussed another late-stage program, monalizumab, with a great potential value creation for the company. As a reminder, monalizumab is a first-in-class, anti-NKG2A checkpoint inhibitor currently evaluated in Phase III clinical trial in lung cancer by our partner, AstraZeneca, in combination with durvalumab. Three Phase II trial, COAST, NeoCOAST, and NeoCOAST-2, demonstrated a strong rationale for this combination in unresectable non-small cell lung cancer and in the neoadjuvant setting.

    接下來,我們將在下一張投影片中轉換主題。我們也討論了另一個後期研發專案monalizumab,該專案對該公司具有巨大的潛在價值創造潛力。再次提醒大家,monalizumab 是一種首創的抗 NKG2A 檢查點抑制劑,目前正由我們的合作夥伴阿斯特捷利康進行 III 期臨床試驗,用於治療肺癌,並與 durvalumab 聯合使用。三個 II 期試驗 COAST、NeoCOAST 和 NeoCOAST-2 證明了這種聯合療法在不可切除的非小細胞肺癌和新輔助治療中具有強大的合理性。

  • Now the Phase III PACIFIC-9 trial aims to demonstrate efficacy of durvalumab in combination with either monalizumab or the AstraZeneca anti-CD73 antibody, oleclumab in patients with unresectable Stage III non-small cell lung cancer who have not progressed following classic platinum-based concurrent chemoradiation therapy. The study is now fully recruited, and it remains on track for primary completion at the end of the first half of 2026. And this is an important catalyst for the program with data expected in the second half of 2026.

    現在,III 期 PACIFIC-9 試驗旨在證明度伐利尤單抗與莫那珠單抗或阿斯特捷利康抗 CD73 抗體奧萊克魯單抗聯合治療對不可切除的 III 期非小細胞肺癌患者(這些患者在接受經典的鉑類同步放化療後病情未進展)的療效。該研究目前已完成全部受試者招募,預計在 2026 年上半年末完成主要研究工作。這對該項目來說是一個重要的催化劑,預計將於 2026 年下半年公佈數據。

  • Now I'm going to hand over to Jonathan again, who will walk through the commercial opportunity of these two late-stage assets, lacutamab and monalizumab.

    現在我將再次把麥克風交給喬納森,他將詳細介紹這兩個後期資產 lacutamab 和 monalizumab 的商業機會。

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • Thank you, Sonia, for showing how lacutamab has the potential to fundamentally reshape the care of CTCL patients.

    謝謝 Sonia,你向我們展示了 lacutamab 如何有可能從根本上改變 CTCL 患者的治療方式。

  • As you can see on slide 23, the opportunity for lacutamab starts with Sézary syndrome, where following a potential accelerated approval in 2027, we see a clear launch pathway. In the past months, by assessing US claims data, we have identified a significantly greater opportunity in Sézary syndrome than previously anticipated. It's been established that there are around 1,000 Sézary syndrome patients in the US with approximately 300 new cases each year and a large pool of post-mogamulizumab treated patients. This represents a meaningful and derisked first market opportunity for lacutamab following an accelerated approval.

    正如您在第 23 張幻燈片中看到的那樣,lacutamab 的機會始於 Sézary 綜合徵,在 2027 年獲得加速批准後,我們看到了一條清晰的上市途徑。在過去的幾個月裡,透過評估美國的索賠數據,我們發現塞札裡症候群的治療機會比之前預期的要大得多。已確定美國約有 1,000 名 Sézary 症候群患者,每年約有 300 例新病例,並且有大量接受過 mogamulizumab 治療的患者。這對 lacutamab 而言,是加速審批後一個意義重大且風險較低的首次市場機會。

  • After accelerated approval in Sézary syndrome, the opportunity expands into second-line plus setting for mycosis fungoides and ultimately, into earlier stages of CTCL patients, where a tolerable systemic option that are currently lacking and where lacutamab has the potential to create a new market opportunity and change the course of the disease for patients through early intervention to stop or delay disease progression beyond Stage IIa.

    在 Sézary 綜合徵獲得加速批准後,該療法的機會擴展到蕈樣肉芽腫的二線治療,並最終擴展到 CTCL 患者的早期階段,目前尚缺乏耐受性良好的全身治療方案,而 lacutamab 有可能創造新的市場機會,並通過早期幹預來阻止或延緩疾病進展到 IIa 期之後,從而改變患者的疾病進程。

  • It's been established through the same US claims data that there are approximately 20,000 CTCL patients in the US with an incidence of approximately 5,000 patients, suggesting a larger population than previously estimated based on publicly available data. These new dynamics, combined with the additional potential in PTCL, have led us to reconsider our strategy and the value we assign to lacutamab. To maximize the opportunity for lacutamab, we are currently planning to bring the product into Phase III and submit a BLA in Sézary syndrome, either with the support of investors or with a partner but with improved deal terms.

    透過同樣的美國索賠數據已經確定,美國大約有 20,000 名 CTCL 患者,發病率約為 5,000 例,這表明患者人數比先前根據公開數據估計的要多。這些新的動態,加上 PTCL 的額外潛力,促使我們重新考慮我們的策略以及我們賦予 lacutamab 的價值。為了最大限度地發揮 lacutamab 的潛力,我們目前計劃將該產品推進到 III 期臨床試驗,並提交 Sézary 綜合徵的生物製品許可申請 (BLA),我們將尋求投資者的支持,或者與合作夥伴合作,但要改善交易條款。

  • Already at launch, lacutamab has the potential to reach a substantial patient population, making it an interesting, profitable, and value-creating opportunity for Innate Pharma. We are actively collecting additional CTCL market data and conducting further analysis, leveraging claims data and market research to further define the market opportunity. We plan to share the new data and market insights at the lacutamab-focused investor event by the end of the year.

    lacutamab 上市後,預計將惠及大量患者,這對 Innate Pharma 來說是一個有趣、有利可圖且能創造價值的機會。我們正在積極收集更多 CTCL 市場數據並進行進一步分析,利用索賠數據和市場研究來進一步明確市場機會。我們計劃在今年年底前舉辦的以 lacutamab 為主題的投資者活動上分享新的數據和市場見解。

  • Turning now to slide 24 and to monalizumab, our partnership with AstraZeneca for monalizumab continues to represent a significant value driver for Innate. The total agreement is worth up to $1.275 billion, and we have already received $450 million in upfront and milestone payments to date under this partnership.

    現在來看看第 24 張幻燈片和莫那珠單抗,我們與阿斯特捷利康在莫那珠單抗方面的合作繼續為 Innate 帶來重要的價值驅動力。該協議總價值高達 12.75 億美元,迄今為止,我們已根據該合作關係收到 4.5 億美元的預付款和里程碑付款。

  • Moving forward, Innate is eligible to up to an additional $825 million in development and commercial milestones. Outside of Europe, AstraZeneca records all sales and Innate will receive double-digit royalties upon commercialization.

    展望未來,Innate 有資格獲得高達 8.25 億美元的額外開發和商業里程碑獎勵。在歐洲以外,阿斯特捷利康會記錄所有銷售額,Innate 將在產品商業化後獲得兩位數的版稅。

  • In Europe, we retained co-promotion rights, along with a 50% profit share while contributing to a portion of the Phase III costs with a predefined cap. This structure ensures that Innate remains well positioned to benefit from monalizumab's future success globally.

    在歐洲,我們保留了共同推廣權,以及 50% 的利潤分成,同時在預先設定的上限內承擔一部分 III 期成本。這種結構確保 Innate 能夠繼續保持良好的發展地位,從而受益於 monalizumab 未來在全球範圍內的成功。

  • That concludes the pipeline update for this presentation. I will now turn the floor to Frederic Lombard, our Chief Financial Officer, to discuss the financials for the first half of the year. Frederic?

    本次報告中的管道更新部分到此結束。現在我將把發言權交給我們的財務長弗雷德里克·隆巴德,讓他來談談今年上半年的財務狀況。弗雷德里克?

  • Frederic Lombard - Chief Financial Officer, Member of the Leadership Team

    Frederic Lombard - Chief Financial Officer, Member of the Leadership Team

  • Thank you, Jonathan. So for the first half of 2025, we've reported total revenue of EUR4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi as well as governmental funding for research expenditures.

    謝謝你,喬納森。因此,在 2025 年上半年,我們報告的總收入為 490 萬歐元,主要得益於與阿斯特捷利康和賽諾菲的合作以及政府對研發支出的資助。

  • Operating expenses were reaching EUR30.3 million with EUR20.5 million in R&D and EUR9.8 million in G&A expenses. And R&D expenses decreased by 29% compared to the prior year, reflecting the phasing of certain clinical programs, while G&A expenses remained stable at EUR9.8 million. At June 30, 2025, we had EUR70.4 million in cash, cash equivalents and financial assets, providing a cash runway until the end of the third quarter of 2026.

    營運支出達 3,030 萬歐元,其中研發支出 2,050 萬歐元,一般及行政費用 980 萬歐元。研發費用較上年下降 29%,反映了某些臨床項目的分階段進行,而一般及行政費用保持穩定,為 980 萬歐元。截至 2025 年 6 月 30 日,我們擁有 7,040 萬歐元的現金、現金等價物和金融資產,足以支撐到 2026 年第三季末。

  • With that, I'm turning it back to Jonathan for closing remarks.

    接下來,我將把發言權交還給喬納森,請他作總結發言。

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • Thank you, Frederic. Turning to slide 28, you can see our news flow for the near and midterm, which is fully aligned with the strategic refocus I outlined at the beginning of today's call. For IPH4502, our novel Nectin-4 ADC, the Phase I trial is progressing well and we expect data in the first half of 2026, while our preclinical R&D continues to build a strong ADC pipeline to fuel our next wave of candidates as shown by Yannis.

    謝謝你,弗雷德里克。翻到第 28 張投影片,您可以看到我們近期和中期的新聞動態,這與我在今天電話會議開始時概述的策略調整完全一致。對於我們新型的 Nectin-4 ADC 藥物 IPH4502,I 期試驗進展順利,我們預計將在 2026 年上半年獲得數據,同時,我們的臨床前研發正在繼續建立強大的 ADC 產品線,以推動我們下一波候選藥物的研發,正如 Yannis 所展示的那樣。

  • Lacutamab has secured FDA breakthrough therapy designation, supported by long-term follow-up data presented at ASCO. And we are preparing the Phase III protocol submission following our discussion with regulators as indicated by Sonia. And for monalizumab, AstraZeneca's Phase III PACIFIC-9 trial is fully recruited and remains on track for primary completion in the first half of 2026, with data expected in the second half of 2026.

    Lacutamab 已獲得 FDA 突破性療法認定,並在 ASCO 上公佈了長期追蹤數據。正如 Sonia 所指出的,在與監管機構討論之後,我們正在準備提交 III 期臨床試驗方案。至於莫那珠單抗,阿斯特捷利康的 III 期 PACIFIC-9 試驗已完成全部受試者招募,並預計在 2026 年上半年完成主要試驗,預計將在 2026 年下半年獲得數據。

  • Turning to slide 29. In summary, we are excited about the opportunities ahead and confident in our ability to deliver value for patients and shareholders. We are concentrating our investment on what we believe are our highest value clinical stage assets, IPH4502, lacutamab, and monalizumab, where we have multiple near-term catalysts. And we will rightsize our organization to deliver on these strategic priorities.

    翻到第29張幻燈片。總之,我們對未來的機會感到興奮,並有信心為病人和股東創造價值。我們將投資重點放在我們認為最有價值的臨床階段資產上,即 IPH4502、lacutamab 和 monalizumab,這些資產近期有多個催化劑。我們將調整組織規模,以實現這些策略重點。

  • With EUR70.4 million in cash at the end of June, we are funded to the end of the third quarter of 2026, providing Innate the ability to execute on our focused strategic priorities.

    截至 6 月底,我們擁有 7,040 萬歐元現金,資金足以支撐到 2026 年第三季末,使 Innate 能夠執行我們重點關注的策略優先事項。

  • Thank you for your attention. And with that, operator, please open the line for questions.

    感謝您的關注。接線員,現在可以開始接受提問了。

  • Operator

    Operator

  • (Operator Instructions) Daina Graybosch, Leerink Partners.

    (操作說明)Daina Graybosch,Leerink Partners。

  • Unidentified Participant

    Unidentified Participant

  • You got Bill on for Daina. So I guess, what should we take away on the potential of targeting NK cells now that ANKET's are not included in your prioritization today as well as Eric Vivier sort of leaving the company? Thank you.

    你讓比爾代替戴娜上場。所以我想,既然 ANKET 目前不在您的優先考慮範圍內,而且 Eric Vivier 也離開了公司,那麼我們應該如何看待靶向 NK 細胞的潛力呢?謝謝。

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • So takeaways from -- I would like to say from Eric leaving the company, maybe that's the place to start off. Eric is leaving the company, but he will still play an important role with the company moving forward. He will be an adviser to the R&D Committee of our Board of Directors. And we have an extended research collaboration with his lab. So we basically will continue to benefit from any innovation, which Eric can bring to the table.

    所以,我想說,艾瑞克離開公司這件事,或許可以從這裡開始說起。艾瑞克即將離開公司,但他未來仍將在公司發展中扮演重要角色。他將擔任我們董事會研發委員會的顧問。我們與他的實驗室有著長期的研究合作關係。因此,我們基本上將繼續受益於艾瑞克所能帶來的任何創新。

  • Moving back to NK cells and the reading, we are still working on NK cells. It's not our main priority today. We're focusing on what we believe are our highest value clinical assets, IPH4502, lacutamab, and monalizumab. We will be basing all future decisions on our NK cell engagers on clinical data and the relevance of that clinical data to markets. And we'll make the appropriate decisions on those assets when we have that clinical data and establish market relevance based on that data. So it's not the end of NK cells, but it's not our priority today anymore.

    回到 NK 細胞和讀數,我們仍在研究 NK 細胞。這不是我們今天的首要任務。我們專注於我們認為最有價值的臨床資產:IPH4502、lacutamab 和 monalizumab。我們將根據臨床數據以及該臨床數據與市場的相關性,做出我們未來所有關於 NK 細胞接合器的決策。我們將在獲得臨床數據並根據這些數據確定其市場相關性後,對這些資產做出適當的決定。所以NK細胞並沒有就此終結,但它不再是我們今天的首要任務了。

  • Operator

    Operator

  • Swayampakula Ramakanth, HCW.

    Swayampakula Ramakanth,HCW。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • So now that the ANKET programs are out at least as far as your development is concerned, any commentary on where Sanofi is with the assets that they currently are developing?

    既然 ANKET 計畫至少就你們的研發而言已經結束,那麼對於賽諾菲目前正在開發的資產,你們有什麼看法?

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • Absolutely. So I'd just like to say that it's not the end of the story for NK cells. We're still moving forward and completing the studies with IPH6501. We have a path to explore IPH61 via investigator-initiated research and an interesting way forward. So I wouldn't say it's the end of NK cells. It's just that it's been basically lowered in our current company priorities.

    絕對地。所以我想說的是,NK細胞的故事還沒結束。我們仍在推進並完成 IPH6501 的研究。我們可以透過研究者發起的研究來探索 IPH61,這是一個有趣的前進方向。所以我不會說NK細胞就此終結。只是它在我們公司目前的優先事項中已被降低。

  • From a Sanofi perspective, Sanofi continues to progress the BCMA-targeted ANKET. And as I think we've communicated in the past, that's being explored in autoimmunity, in immunology as part of Sanofi's focus as a company. And we expect to have updates from Sanofi on that BCMA program in the near future.

    從賽諾菲的角度來看,賽諾菲將繼續推進以BCMA為靶點的ANKET的研發。正如我們過去溝通過的那樣,這是賽諾菲公司在自體免疫和免疫學領域關注的重點之一。我們預計賽諾菲將在不久的將來發布有關 BCMA 項目的最新進展。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Thanks for that. And then regarding the Phase III start for lacutamab, should we still assume that unless you have a partner signed up ahead of the start of the study, it will still -- it will be a wait and watch until you get a partner or do you have enough commitment from investors to go ahead and start that study?

    謝謝。至於 lacutamab 的 III 期臨床試驗啟動,我們是否仍然應該假設,除非在研究開始前找到合作夥伴,否則仍然需要等待觀望,直到找到合作夥伴,或者獲得足夠的投資者承諾才能啟動這項研究?

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • So we are actively working with investors at the moment to basically keep options open. So we're continuing discussions with partners, but we also have some very advanced discussions with investors who are very interested in lacutamab, now that we effectively have a derisked development program to move forward into Phase III.

    因此,我們目前正在積極與投資者合作,以保持選擇的靈活性。因此,我們正在繼續與合作夥伴進行討論,同時我們也與一些對 lacutamab 非常感興趣的投資者進行了非常深入的討論,因為我們現在實際上已經有一個風險降低的開發計劃可以推進到 III 期。

  • And we also see interest based now on the increased potential commercial opportunity. This also will reinvigorate discussions with partners. And we are also expecting next steps with respect to the finalization of the protocol for the confirmatory Phase III study, which is also an important step for partners.

    我們也看到,人們現在對這種潛在商業機會的興趣日益濃厚。這也將重新激發與合作夥伴的討論。我們也期待著確定確認性 III 期研究方案的後續步驟,這對合作夥伴來說也是一個重要的步驟。

  • So we continue the discussions with partners. But at this stage, we see it as very important to keep our future options open to either go down the partner route, but with improved deal terms based on the significantly larger potential market opportunity, particularly with the first accelerated approval launch in Sézary syndrome. And so yes, we're keeping the options open with both -- for both moving forward with investors and with potential partners.

    因此,我們將繼續與合作夥伴進行磋商。但就目前而言,我們認為保持未來選擇的開放性非常重要,我們可以選擇走合作夥伴路線,但會根據更大的潛在市場機會(特別是針對 Sézary 綜合徵的首個加速批准上市)來獲得更好的交易條款。所以,是的,我們對這兩個選項都持開放態度——無論是與投資者合作還是與潛在合作夥伴合作。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • So last question from me, Jonathan. This is on 4502. Based on the preclinical data that you have generated so far, what potential indications do you think 4502 will be effective? And since there are numerous Nectin-4 ADCs in the clinic right now, how differentiated are you is 4502 against those?

    喬納森,我的最後一個問題。這是4502。根據您目前已獲得的臨床前數據,您認為 4502 可能對哪些適應症有效?鑑於目前臨床上已有許多 Nectin-4 ADC,4502 與這些藥物相比有何不同?

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • Yes. So maybe, Sonia, you can take the first part of that question. Sonia?

    是的。所以,索妮婭,或許你可以回答這個問題的第一部分。索尼婭?

  • Sonia Quaratino - Executive Vice President, Member of the Executive Board, Chief Medical Officer, Member of the Leadership Team

    Sonia Quaratino - Executive Vice President, Member of the Executive Board, Chief Medical Officer, Member of the Leadership Team

  • Yes. Can you repeat the question, please?

    是的。請您重複問題好嗎?

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Yeah. Based on the preclinical data that you have generated to date, what indication do you think is where 4502 could be effective?

    是的。根據您目前已獲得的臨床前數據,您認為 4502 可能對哪些適應症有效?

  • Sonia Quaratino - Executive Vice President, Member of the Executive Board, Chief Medical Officer, Member of the Leadership Team

    Sonia Quaratino - Executive Vice President, Member of the Executive Board, Chief Medical Officer, Member of the Leadership Team

  • Right. As I mentioned before, we focus on any indication that express Nectin-4 because we believe that we also can target dose indication with a relatively small Nectin-4 expression, but we also very much focus on the urothelial cancer patients who became refractory or resistant to PADCEV. And for these patients, there are no approved drugs.

    正確的。正如我之前提到的,我們關注任何表達 Nectin-4 的適應症,因為我們相信,即使 Nectin-4 表達量相對較低,我們也可以確定劑量適應症,但我們也非常關注對 PADCEV 產生抗藥性或抗藥性的尿路上皮癌患者。對於這些患者,目前還沒有核准的藥物。

  • And if we have clinical -- good clinical data in this refractory/relapsed patients, we really may have a very fast opportunity for an accelerated market approval in UC post-PADCEV. So we are exploring, let's say, the classic path as well as some more defined area for a potential accelerated approval.

    如果我們有這些難治性/復發性患者的良好臨床數據,我們或許真的有機會在 PADCEV 治療後的 UC 領域獲得加速市場批准。因此,我們正在探索,比如說,傳統的審批途徑,以及一些更明確的領域,以期獲得加速審批。

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • And then in terms of differentiation, RK, I mean, I think we believe that we'll be able to show differentiation here, particularly versus PADCEV or MMAE-based ADCs, due to the payload and the different resistance and toxicity profile, which we believe we'll be able to show meaningful differences between IPH4502 and MMAE-based ADCs.

    至於差異化方面,RK,我的意思是,我認為我們相信我們能夠在這裡展現出差異化,特別是與基於 PADCEV 或 MMAE 的 ADC 相比,因為有效載荷以及不同的抗藥性和毒性特徵,我們相信我們能夠展現出 IPH4502 與基於 MMAE 的 ADC 之間的顯著差異。

  • Operator

    Operator

  • Justin Zelin, BTIG.

    Justin Zelin,BTIG。

  • Justin Zelin - Equity Analyst

    Justin Zelin - Equity Analyst

  • Maybe I'll continue the questioning on 4502. If you can just give us an update on how enrollment has been progressing here. I know you gave an update here on enrollment completion. Just was curious on how you could comment on how enrollment is going today. When we should expect the initial data? If it will be sometime in the first half of next year, how many patients' worth of data we should expect? And any expectations from a safety or efficacy standpoint from that update?

    或許我會繼續詢問 4502 號問題。能否請您向我們報告這裡的招生進度?我知道您在這裡更新了入學完成情況。我只是好奇您能否就目前的招生情況發表一下看法。我們何時可以收到初始資料?如果是在明年上半年,我們應該可以獲得多少患者的數據?從安全性和有效性的角度來看,這次更新有什麼預期嗎?

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • Sonia, do you want to take that one?

    索妮婭,你想選那個嗎?

  • Sonia Quaratino - Executive Vice President, Member of the Executive Board, Chief Medical Officer, Member of the Leadership Team

    Sonia Quaratino - Executive Vice President, Member of the Executive Board, Chief Medical Officer, Member of the Leadership Team

  • Of course, of course. As mentioned, the enrollment with IPH45 is going extremely well. We always have, let's say, a list of patients to go in -- at a different dose level. And also with the [Boeing] design that we have, we also have the possibility to have a parallel enrollment in backfill cohorts. And so we do not have the classic three plus three design with an extremely limited number of patients, but we can expand different to dose levels as we go along.

    當然,當然。如前所述,IPH45 的招生工作進展非常順利。例如,我們總是會有一份患者名單,需要根據不同的劑量等級進行治療。此外,根據我們採用的[波音]設計,我們還有可能同時招募補充隊列成員。因此,我們沒有採用經典的三加三設計,患者數量也極為有限,但我們可以隨著研究的進行,逐步擴展到不同的劑量水平。

  • To your question, of course, we plan to finish the enrollment in the first quarter of 2026. And of course, the data in terms of at least from the first CT scan can only occur as you can understand, eight weeks later from the first dosing. And so it takes another quarter to have the clinical efficacy from the last cohort recruited. Having said that, we are going to have probably a pool of data of 50, 60 patients by then.

    當然,對於您的問題,我們計劃在 2026 年第一季完成招生工作。當然,正如你所理解的,至少從第一次 CT 掃描來看,數據只能在第一次給藥後八週才能獲得。因此,還需要一個季度的時間才能從最後一批招募的患者中得出臨床療效結果。也就是說,到那時我們可能會收集到 50 到 60 名患者的數據。

  • Operator

    Operator

  • And there are no further phone questions at this time. I will now turn the call back over to management for any written questions.

    目前沒有其他電話諮詢。現在我將把電話轉回給管理層,以便他們回答任何書面問題。

  • Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

    Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

  • Thank you. Yes, we have one question on the line here from Rajan Sharma. So the first question is does the new strategic focus means ANKET assets will not be progressed irrespective of clinical data, given that 6501 data are expected in the near term?

    謝謝。是的,我們這裡有一個來自拉詹·夏爾馬的問題。因此,第一個問題是,鑑於近期預計將獲得 6501 數據,新的策略重點是否意味著無論臨床數據如何,ANKET 資產都不會推進?

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • So I think I answered this earlier, but I'll repeat it again. So from an IPH6501 perspective, the study continues. And we expect to have data, I think, as we've communicated previously, towards the end of this year or very early next year. And we will make any decisions on the next steps for IPH6501 based on that clinical data and the clinical relevance of that data to the marketplace.

    我想我之前已經回答過這個問題了,但我再重複一次。因此,從 IPH6501 的角度來看,這項研究仍在繼續。正如我們之前溝通的那樣,我們預計將在今年年底或明年年初獲得相關數據。我們將根據臨床數據以及該數據對市場的臨床相關性,來決定 IPH6501 的下一步措施。

  • Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

    Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

  • Okay. And so the next question, what is the financial impact of the strategic refocus and head count reduction and what proportion of current R&D expense are directed towards IPH4502 and lacutamab?

    好的。那麼下一個問題是,策略調整和人員縮減的財務影響是什麼?目前的研發支出中有多少比例是 IPH4502 和 lacutamab?

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • So the financial impact, we've not -- and we won't be communicating specific numbers on the impact of the financial reductions. We're in a legal process now, which is a French legal process to reduce the size of the organization, which gives us an obligation not to communicate on certain components. And that would fall under that legal framework that we're operating within. So we can't provide specific guidance there.

    因此,對於財務影響,我們沒有——而且我們也不會公佈有關財務削減影響的具體數字。我們現在正處於一個法律程序中,這是一個法國法律程序,旨在縮減組織規模,這使我們有義務不就某些組成部分進行溝通。這符合我們所處的法律架構。因此,我們無法在這方面提供具體指導。

  • In terms of R&D expenses, maybe Frederic would like to comment on the proportion.

    關於研發費用,弗雷德里克或許想就其中的比例發表一些看法。

  • Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

    Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

  • So the question was what proportion of current R&D expenses are directed towards IPH4502 and lacutamab?

    所以問題是,目前研發支出中有多少比例用於 IPH4502 和 lacutamab?

  • Frederic Lombard - Chief Financial Officer, Member of the Leadership Team

    Frederic Lombard - Chief Financial Officer, Member of the Leadership Team

  • Yeah, we usually never communicate on the investment that we do in those two in the portfolio. But following up on the comment from Jonathan, we have a significant portion of our external expenditure, which are on those assets.

    是的,我們通常不會就投資組合中對這兩隻動物的投資進行溝通。但正如喬納森所說,我們很大一部分外部支出都用於這些資產。

  • Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

    Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

  • Okay. So we have another question from Oussema Denguir. So with regard to financial visibility, does the estimate for the end of the third quarter of 2026 take into account the impact of the restructuring plan?

    好的。我們現在收到另一個來自 Oussema Denguir 的問題。那麼,就財務可見性而言,2026 年第三季末的預測是否考慮了重組計畫的影響?

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • The answer to that is yes. So the restructuring plan is fully embedded into the cash runway, which takes us to the end of Q3 2026.

    答案是肯定的。因此,重組計劃已完全納入現金流保障計劃,該計劃將持續到 2026 年第三季末。

  • Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

    Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

  • And last question, concerning Phase III of lacutamab, can you provide an initial estimate of the investment requirements, if you decide to go to the trial without a partner?

    最後一個問題,關於 lacutamab 的 III 期臨床試驗,如果您決定在沒有合作夥伴的情況下進行試驗,您能否提供投資需求的初步估計?

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • Again, this is something that we would not normally communicate on in terms of the cost. This is a standard Phase III study. So I think you can draw your own conclusions. It's nothing too dissimilar from similar oncology Phase III trials.

    再次強調,這方面我們通常不會透露費用資訊。這是一項標準的III期臨床試驗。所以我想你可以自己下結論。它與類似的腫瘤學III期臨床試驗並無太大差異。

  • Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

    Stephanie Cornen - Vice President, Investor Relations, Communication and Commercial Strategy

  • Thank you, Jonathan. There is no further question.

    謝謝你,喬納森。沒有其他問題了。

  • Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

    Jonathan Dickinson - Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team

  • Okay. So thank you for everybody's time and attention and for your interest in Innate Pharma, and we'll look forward to meeting with you in person in the near future or on one of our next calls. Thank you and good-bye.

    好的。感謝大家抽出寶貴時間關注此事,也感謝大家對 Innate Pharma 的關注。我們期待在不久的將來與您見面,或在下次電話會議上與您交流。謝謝,再見。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for your participation. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。