Adaptimmune Therapeutics PLC (ADAP) 2023 Q1 法說會逐字稿

Hello. Welcome to Adaptimmune's First Quarter Call and Business Update. I would now like to turn the call over to Juli Miller. Juli, please go ahead.

你好。歡迎來到 Adaptimmune 的第一季度電話會議和業務更新。我現在想把電話轉給 Juli Miller。朱莉，請繼續。

Good morning, and welcome to Adaptimmune's conference call to discuss our first quarter 2023 financial results and business updates. I would ask you to review the full text of our forward-looking statements from this morning's press release.

早上好，歡迎參加 Adaptimmune 的電話會議，討論我們 2023 年第一季度的財務業績和業務更新。我想請您閱讀今天上午新聞稿中我們前瞻性聲明的全文。

We anticipate making projections during this call, and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC.

我們預計在本次電話會議期間做出預測，實際結果可能會因多種因素而存在重大差異，包括我們最近提交給美國證券交易委員會的文件中概述的因素。

Adrian Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call. Other members of our management team will be available for Q&A. With that, I'll turn it over to Adrian Rawcliffe. Ad?

我們的首席執行官 Adrian Rawcliffe 和我一起參加電話會議的準備部分。我們管理團隊的其他成員將出席問答環節。有了這個，我會把它交給 Adrian Rawcliffe。廣告？

Thank you, Juli, and thanks to everyone for joining the call. My comments today will be brief, and we can go directly to questions.

謝謝 Juli，也感謝大家加入電話會議。我今天的評論會很簡短，我們可以直接進入問題。

We started 2023 at pace, and it promises to be a year of change for Adaptimmune. We completed the prioritization and restructuring in Q1, cutting costs whilst remaining focused on our priorities with afami-cel BLA, the CD8 program in ovarian, bladder and head and neck cancers, PRAME and our allogeneic platform, a strong pipeline of cell therapies for a wide range of solid tumors.

我們從 2023 年開始，它有望成為 Adaptimmune 發生變化的一年。我們在第一季度完成了優先排序和重組，削減成本，同時繼續專注於我們的優先事項，包括 afami-cel BLA、卵巢癌、膀胱癌和頭頸癌的 CD8 計劃、PRAME 和我們的同種異體平台，這是一個強大的細胞療法管道範圍廣泛的實體瘤。

Adding to that strength, we announced that we entered into a strategic combination with TCR2. We have 2 companies that have spent our entire histories focused on solid tumors with experienced teams, with advanced strong clinical pipelines, with significant value-creating near-term catalyst.

為了增強實力，我們宣布與 TCR2 達成戰略合併。我們有 2 家公司，它們的整個歷史都專注於實體瘤，擁有經驗豐富的團隊、先進的強大臨床管線以及重要的創造價值的近期催化劑。

Add to that, the compatibility of our technology platforms, including an innovative next-generation toolbox and a cash runway into 2026. And taken together, it's clear that this combination will create a preeminent cell therapy company to treat solid tumors.

除此之外，我們技術平台的兼容性，包括創新的下一代工具箱和到 2026 年的現金跑道。顯然，這種組合將創建一家卓越的細胞治療公司來治療實體瘤。

We expect the transaction to close in Q2 2023, subject, of course, to shareholder approval at the end of this month. Both companies are very actively planning for integration, and we will update further once the transaction is closed.

我們預計該交易將在 2023 年第二季度完成，當然，這取決於股東在本月底的批准。兩家公司都在非常積極地規劃整合，一旦交易完成，我們將進一步更新。

We are also on track to have a commercial product afami-cel, which would be the first engineered T-cell product on the market for a treatment of a solid tumor. We announced that we have completed Part 2 of the BLA submission in Q1, and Part 3 is in progress for completion in mid-2023. Afami-cel is an incredibly exciting drug. And the need for new marketed treatments for synovial sarcoma, compelling.

我們也有望推出商業產品 afami-cel，這將是市場上第一個用於治療實體瘤的工程 T 細胞產品。我們宣布我們已在第一季度完成 BLA 提交的第 2 部分，第 3 部分正在進行中，將於 2023 年年中完成。 Afami-cel 是一種非常令人興奮的藥物。以及對滑膜肉瘤新上市治療的需求，令人信服。

Recently, we had the privilege of hosting a young woman, who is surviving synovial sarcoma at an internal meeting. Hearing her personal account of misdiagnosis, harsh treatment and are pleased for new and innovative therapies with inspiration for all of us here and highlights further how important afami-cel is for this patient population.

最近，我們有幸在一次內部會議上接待了一位滑膜肉瘤倖存的年輕女性。聽了她關於誤診、嚴酷治療的個人陳述，並對新的創新療法感到高興，這對我們所有人都有啟發，並進一步強調了 afami-cel 對這一患者群體的重要性。

She also described the loss of young lives from this cancer and the experiences of her peers in the sarcoma community. We hope to share stories like her in the future and continue to raise awareness for synovial sarcoma and high unmet need in this cancer.

她還描述了因這種癌症而失去的年輕生命以及她在肉瘤社區中的同齡人的經歷。我們希望在未來分享像她這樣的故事，並繼續提高人們對滑膜肉瘤和這種癌症的高度未滿足需求的認識。

Continuing with the afami-cel news, we will present updated overall survival analysis for afami-cel in June at ASCO. It's clear that this is a powerful treatment for this rare and deadly cancer. Beyond afami-cel, we remain focused on developing our MAGE-A4 franchise with our next-gen CD8 therapy and progressing more products to market.

繼續 afami-cel 新聞，我們將在 6 月的 ASCO 上展示 afami-cel 的更新總體生存分析。很明顯，對於這種罕見且致命的癌症，這是一種強有力的治療方法。除了 afami-cel 之外，我們仍然專注於通過我們的下一代 CD8 療法開發我們的 MAGE-A4 特許經營權，並將更多產品推向市場。

To that end, we are initiating the Phase II SURPASS-3 trial in combination with nivolumab for platinum-resistant ovarian cancer. This trial has the potential to become registrational and is supported by RMAT designation with the FDA.

為此，我們正在啟動與 nivolumab 聯合治療鉑耐藥卵巢癌的 II 期 SURPASS-3 試驗。該試驗有可能獲得註冊，並得到 FDA 的 RMAT 指定的支持。

We are also initiating additional cohorts in the Phase I SURPASS trial in combination with pembrolizumab to treat patients in earlier-line settings for head and neck and urothelial cancer.

我們還在 I 期 SURPASS 試驗中啟動其他隊列，聯合 pembrolizumab 治療頭頸癌和尿路上皮癌的早期治療患者。

Last year, we announced we have PRAME back from GSK, and we believe this is another powerful target for solid tumors, with increasing validation across the industry. We are progressing PRAME to be IND-ready by the end of this year and plan to initiate trials next year.

去年，我們宣布從 GSK 收回 PRAME，我們相信這是實體瘤的另一個強大目標，並在整個行業得到越來越多的驗證。我們正在推動 PRAME 在今年年底前做好 IND 準備，併計劃明年開始試驗。

We also announced in Q1 that we are in the process of transitioning lete-cel back, and we will receive approximately $37 million from GSK in relation to the transition of the ongoing clinical trial.

我們還在第一季度宣布，我們正在將 lete-cel 轉移回來，我們將從 GSK 獲得大約 3700 萬美元，用於正在進行的臨床試驗的轉移。

We anticipate lete-cel data in synovial sarcoma and MRCLS later this year. And we'll evaluate this opportunity accordingly.

我們預計今年晚些時候滑膜肉瘤和 MRCLS 的 lete-cel 數據。我們將相應地評估這個機會。

In closing, this has been a significant first quarter for us and will undoubtedly prove to be a year of change as we move towards our first BLA and marketed product.

最後，這對我們來說是一個重要的第一季度，並且隨著我們向第一個 BLA 和上市產品邁進，無疑將證明是變化的一年。

Behind that, we have an unparalleled pipeline of cell therapies for solid tumors, and we'll continue to prioritize development in a thoughtful, data-driven fashion. I look forward to reporting out of future progress. And with that, I'll turn the call over to Q&A. Operator?

在這背後，我們擁有無與倫比的實體瘤細胞療法管道，我們將繼續以深思熟慮、數據驅動的方式優先發展。我期待著報告未來的進展。有了這個，我會把電話轉給問答環節。操作員？

(Operator Instructions) Our first question comes from Marc Frahm of TD Cowen.

（操作員說明）我們的第一個問題來自 TD Cowen 的 Marc Frahm。

Adrian, you made the update of Part 2 being in of the BLA. On the Part 3 there, do you now have everything you need in-house? And it's a question of packaging it all appropriately and submitting it? Or is there still a lot of data points that you need to gather for that portion?

Adrian，您更新了 BLA 中的第 2 部分。在第 3 部分，您現在是否擁有內部所需的一切？這是一個適當打包並提交的問題嗎？或者您是否仍然需要為該部分收集大量數據點？

There's still a lot of work going on to complete the BLA on time. I'll ask Dennis, who's leading that program, to comment a bit further.

要按時完成 BLA，還有很多工作要做。我會請負責該計劃的丹尼斯進一步發表評論。

Yes, as Adrian said, I mean, we're in the final stages of method validation and some of the other activities related to the dossier preparation, but we continue to look forward towards our goal. And we're excited to have 2/3 of the application already down with the FDA.

是的，正如 Adrian 所說，我的意思是，我們正處於方法驗證和其他一些與檔案準備相關的活動的最後階段，但我們繼續期待實現我們的目標。我們很高興 2/3 的申請已經通過 FDA。

Okay. That's helpful. And then maybe just on the pipeline, the MAGE-A4 CD8 program, just any data presentations we should be looking forward to maybe in the second half of the year?

好的。這很有幫助。然後也許只是在管道中，MAGE-A4 CD8 程序，我們應該期待下半年的任何數據演示？

We've said that we will provide an update on the monotherapy cohort in late-line patients and the patients that we've dosed in combination with nivolumab at an appropriate congress later on this year.

我們已經說過，我們將在今年晚些時候的適當大會上提供有關晚期患者和我們與 nivolumab 聯合給藥的患者的單藥治療隊列的最新情況。

Our next question comes from Tony Butler of EF Hutton.

我們的下一個問題來自 EF Hutton 的 Tony Butler。

Thanks very much. Adrian, I just wanted to discuss some of the -- some of the trials with checkpoint inhibitors. I want to make sure that is Adaptimmune paying for the checkpoint inhibitor? That's point one.

非常感謝。阿德里安，我只是想討論一些——一些檢查點抑製劑的試驗。我想確定 Adaptimmune 是否為檢查點抑製劑付費？這是第一點。

And number 2 is, the notion here that the combinations -- I mean, let's be clear, the combinations may involve greater activity. But I guess in the absence of a total control arm, how do you actually separate the two when you're simply, if you will, doing a Phase II study or at least a study that's exploring the combination? How do you think through that if you were to move to a regulatory trial?

第二個是，這裡的概念是組合——我的意思是，讓我們明確一點，組合可能涉及更大的活動。但我想在沒有一個完整的控制臂的情況下，當你只是簡單地（如果你願意的話）進行 II 期研究或至少進行一項探索組合的研究時，你如何真正將兩者分開？如果你要進行監管試驗，你如何看待這個問題？

So the short answer on the question of who's paying for the checkpoint inhibitors, the answer is that the Adaptimmune is currently paying for the checkpoint inhibitors. And then on the question of the trial design, I think we focused on the SURPASS-3 trials since that's the one that we are -- that is a Phase II trial progressing particularly towards registration.

因此，關於誰為檢查點抑製劑買單的問題的簡短回答是，Adaptimmune 目前正在為檢查點抑製劑買單。然後關於試驗設計的問題，我認為我們專注於 SURPASS-3 試驗，因為這就是我們的試驗——這是一項特別是在註冊方面取得進展的 II 期試驗。

I'll ask Dennis to comment on that trial design and how we consider that in platinum-resistant ovarian cancer.

我會請 Dennis 評論該試驗設計以及我們如何考慮它在鉑類耐藥卵巢癌中的應用。

So in SURPASS-3, it's a randomized trial, in that there's a monotherapy arm and then there's another combination arm with nivolumab. Both arms are compared against historical response rates for nonplatinum-based chemotherapy in platinum-resistant disease.

所以在 SURPASS-3 中，這是一項隨機試驗，有一個單藥治療組，然後有另一個與 nivolumab 聯合治療的組。將兩組與鉑耐藥疾病中非鉑類化療的歷史反應率進行比較。

Your point is well taken. But in the checkpoint inhibitor space, both as monotherapy and in combination with chemotherapy in platinum-resistant disease, the efficacy is very well described. So for us, it will be very obvious that if the combination arm shows something, it will allow us to compare that against the monotherapy arm to make some inferences that we see perhaps greater depth and durability.

你的觀點很好。但在檢查點抑製劑領域，無論是作為單一療法還是與化療聯合治療鉑耐藥疾病，其療效都得到了很好的描述。因此，對我們來說，很明顯，如果聯合治療組顯示出一些東西，我們就可以將其與單一治療組進行比較，從而得出一些我們可能看到更深入和更持久的推論。

But we certainly will be able to determine that that's not solely due to the checkpoint alone because, as we know, checkpoint alone don't have appreciable activity in that disease. So we feel very confident that we'll be able -- the results of that trial will be quite interpretable.

但我們當然能夠確定這不僅僅是因為檢查點本身，因為正如我們所知，檢查點本身在該疾病中沒有明顯的活性。因此，我們非常有信心我們能夠——該試驗的結果將是完全可以解釋的。

And if I could just ask one follow-up, Dennis, on this topic. Thank you very much for the commentary. But the other is, do you limit the number of previous therapies that a patient may undergo in part because it seems that at least the response rates in a number of tumors were better when it was, I think, 2 or less, at least for monotherapy? So I'm just curious, how you may balance that in combination, also, with a checkpoint inhibitor?

如果我能就這個話題問一個後續問題，丹尼斯。非常感謝您的評論。但另一個問題是，你是否限制了患者可能接受的先前治療的數量，部分原因是似乎至少在許多腫瘤中的反應率更好，我認為，至少為 2 或更少，至少單一療法？所以我很好奇，你如何平衡它與檢查點抑製劑的組合？

Yes. For SURPASS-3, we do limit the number of prior lines of treatment. The data we presented about baseline characteristics and how they relate to response, among them being the number of lines of prior therapy, that's across the basket experience we have in the Phase I SURPASS trial. And of course, some of those prior lines of therapies differs notably, depending on which cancer that patient has.

是的。對於 SURPASS-3，我們確實限制了先前治療線的數量。我們提供的關於基線特徵的數據以及它們與反應的關係，其中包括先前治療的線數，這是我們在 I 期 SURPASS 試驗中的一攬子經驗。當然，根據患者所患的癌症，一些先前的治療方案有顯著差異。

In the platinum resistance space, since platinum-based therapy is quite effective until they become resistant. We do allow a number of prior platinum treatments. We would expect patients to receive bevacizumab unless they were otherwise unable to receive that. And we would also expect patients to have received a prior PARP if that was indicated.

在鉑類耐藥領域，由於以鉑為基礎的治療在它們產生耐藥性之前非常有效。我們確實允許進行一些先前的鉑金治療。我們希望患者接受貝伐珠單抗，除非他們無法接受。如果有指示，我們還希望患者之前接受過 PARP。

But we do intend to have a more homogenous Phase II population and among that to limit the number of prior lines in this trial.

但我們確實打算擁有一個更加同質的 II 期人群，並在其中限制該試驗中先前線路的數量。

Our next question comes from Mara Goldstein of Mizuho.

我們的下一個問題來自瑞穗的 Mara Goldstein。

This is Supawat for Mara. Two small ones first. When are you are going to get that $37 million payment from GSK? And it says on the release that there will be the vote on the 30th. Is that TCR's or is that Adaptimmune's vote?

這是 Mara 的 Supawat。先說兩個小的。你什麼時候能從葛蘭素史克那裡拿到 3700 萬美元的付款？它在新聞稿中說，將在 30 日進行投票。那是 TCR 的投票還是 Adaptimmune 的投票？

So I will comment on the vote, and I will ask Helen to comment on the payments received from GSK. The payment -- the votes on the 30th are both the TCR2 and the Adaptimmune votes, happened on the same day. And subject, of course, to that vote, we plan to close the transaction very shortly thereafter. Helen?

所以我將對投票發表評論，我會請海倫對從葛蘭素史克收到的付款發表評論。付款——30 日的投票是 TCR2 和 Adaptimmune 投票，發生在同一天。當然，根據投票結果，我們計劃在此後不久完成交易。海倫？

Yes. Thanks for the question. This is Helen Tayton-Martin. In relation to the money, the income from the GSK transition, the majority of that will be in line with the transition of the programs, which is anticipated, the [lete-cel] program, which is anticipated during the course of 2023.

是的。謝謝你的問題。這是海倫·泰頓-馬丁。關於資金，GSK 過渡帶來的收入，其中大部分將與計劃的過渡一致，這是預期的，[lete-cel] 計劃預計在 2023 年期間進行。

There is some very small amount, which will come in 2024, but we haven't disclosed it. It will come in stages, basically, but the majority of it will be during this year and hence it being [sold] into our runway and protection.

有一些非常小的數量，2024年會到，但是我們沒有透露。基本上，它將分階段進行，但大部分將在今年進行，因此它被 [出售] 到我們的跑道和保護中。

Got it. And then just a follow-up on afami-cel's launch. I was wondering if you can share regarding the payer discussion? How is that going? And any color on the pricing strategy would be helpful.

知道了。然後是 afami-cel 發布的跟進。我想知道您是否可以分享有關付款人的討論？進展如何？定價策略上的任何顏色都會有所幫助。

I think the discussions with payers are going well at this point in time. We are obviously a year or so away from launch, and we will have more to say on pricing strategy as we approach approval.

我認為目前與付款人的討論進展順利。顯然，我們距離發布還有一年左右的時間，隨著我們接近批准，我們將對定價策略有更多的發言權。

Our next question comes from Michael Schmidt of Guggenheim.

我們的下一個問題來自古根海姆的邁克爾施密特。

This is Paul on for Michael. My first one is on PRAME as you look towards a future Phase I. How are you currently thinking about expression thresholds for PRAME and potentially enriching for certain tumors versus sort of a broader signal-finding approach?

這是保羅替邁克爾。當您展望未來的 I 期時，我的第一個是關於 PRAME 的。與更廣泛的信號發現方法相比，您目前如何考慮 PRAME 的表達閾值以及對某些腫瘤的潛在富集？

And then maybe just to read through from the recent PRAME updates across the landscape, it seems like some of the responses have mostly been in particular tumor types in the melanoma ovarian. So as you're moving towards the IND, what gives you confidence in the broader opportunity? And are there any sort of particular indications and focus for you?

然後也許只是從最近的 PRAME 更新中通讀整個領域，似乎一些反應主要針對黑色素瘤卵巢中的特定腫瘤類型。因此，當您朝著 IND 邁進時，是什麼讓您對更廣泛的機會充滿信心？有什麼特別的指示和重點嗎？

So I will ask Jo Brewer to comment on that and our thinking as regards PRAME expression, our TCR and what indications we are considering.

因此，我將請 Jo Brewer 對此以及我們對 PRAME 表達、我們的 TCR 以及我們正在考慮的適應症的想法發表評論。

Thanks, Ad. So it's a great question. And I think we're really excited about having PRAME back in our hands because it's a fantastic target, and we are very excited about the opportunity that this will give us. So you're right, we'll likely look at more than one indication.

謝謝，廣告。所以這是一個很好的問題。我認為我們對 PRAME 重新回到我們手中感到非常興奮，因為它是一個很棒的目標，我們對這將給我們帶來的機會感到非常興奮。所以你是對的，我們可能會研究不止一種跡象。

We are making informed decisions about our clinical strategy at the moment. We're still deciding exactly where we will go. There are obviously synergies in ovarian with our other trials as we're looking -- working with the right people in that area, but there are these great expression profiles in other tumor types as well.

我們目前正在就我們的臨床策略做出明智的決定。我們仍在決定我們要去哪裡。正如我們正在尋找的那樣，卵巢與我們的其他試驗顯然有協同作用——與該領域合適的人一起工作，但在其他腫瘤類型中也有這些很好的表達譜。

And PRAME is a large opportunity for us. So I think we will use some of the -- our learnings from MAGE-A4. Most definitely, we'll look at working with sites that we know well. And we will see -- we're still in the preclinical phase here, getting ready for IND. And obviously, we're discussing those right now.

PRAME 對我們來說是一個巨大的機會。所以我認為我們將使用我們從 MAGE-A4 中學到的一些東西。毫無疑問，我們會考慮與我們熟知的網站合作。我們會看到——我們仍處於臨床前階段，為 IND 做好準備。顯然，我們現在正在討論這些。

But I think in terms of PRAME out there, it's obviously a well-validated target. There's been some great data recently from [Matrix], and we're very mindful of that. Our TCR is engineered as we would expect. So we have a higher-affinity engineered TCR, where we've been optimizing the TCR for binding and function.

但我認為就 PRAME 而言，它顯然是一個經過充分驗證的目標。 [黑客帝國] 最近有一些很棒的數據，我們非常注意這一點。我們的 TCR 按照我們的預期進行設計。所以我們有一個更高親和力的工程 TCR，我們一直在優化 TCR 的結合和功能。

And so we're quite confident that this is going to give an edge with our PRAME products. We're also looking at our next-gen opportunities with PRAME as well, based on work that we've done with the MAGE-A4, we're transferring that across to PRAME. And so we will be looking to make the most of PRAME as a target with products coming forward.

因此，我們非常有信心這將為我們的 PRAME 產品帶來優勢。我們也在尋找下一代 PRAME 的機會，基於我們對 MAGE-A4 所做的工作，我們正在將其轉移到 PRAME。因此，我們將尋求充分利用 PRAME 作為未來產品的目標。

And I think it's still early days for the PRAME space, and we intend to be in there doing the best we can and hopefully bringing forward some great products.

而且我認為 PRAME 空間還處於早期階段，我們打算在那裡盡我們所能，並希望推出一些偉大的產品。

Great. And then maybe just a follow-up on lete-cel. Just wanted to get your updated views on that program. And how you might expect that program transfer in the third quarter to perhaps impact your OpEx? And then for that data later this year, is there a particular response rate threshold you're hoping to see to support a potential commercialization decision?

偉大的。然後也許只是對 lete-cel 的跟進。只是想了解您對該計劃的最新看法。您如何預計第三季度的計劃轉移可能會影響您的運營支出？然後對於今年晚些時候的數據，您是否希望看到一個特定的響應率閾值來支持潛在的商業化決策？

So I think your -- implicit in your question is the correct consideration that we're making, which is, as I've touched on before, we view lete-cel's return as essentially a free option on what has the potential to be quite a late-stage product, given that the [NY-ESO] trial was designed to support, at least in part, registration. So we look forward to getting those data back in-house.

所以我認為你的 - 隱含在你的問題中是我們正在做出的正確考慮，也就是說，正如我之前提到的那樣，我們認為 lete-cel 的回歸本質上是一個免費的選擇，有可能相當考慮到 [NY-ESO] 試驗旨在支持（至少部分支持）註冊，這是一個後期產品。因此，我們期待將這些數據取回內部。

And it will be very much tail end of this year. And we will make rigorous data-driven decisions. And the -- I think the standard for activity in this space has been set by a [afami-cel] with response rate approaching 40%.

這將是今年的尾聲。我們將做出嚴格的數據驅動決策。而且——我認為這個領域的活動標準是由 [afami-cel] 設定的，響應率接近 40%。

But I think if we look historically at what we've said about the required response rates in this space, I think if we're not at still 30-odd percent in the space, I think it will be challenging to think about development. So that's been our historic benchmark that probably ends up being a future benchmark at this point in time for that particular asset, too.

但我認為，如果我們從歷史上看我們所說的這個領域所需的響應率，我認為如果我們在這個領域還沒有達到 30% 以上，我認為考慮發展將是一個挑戰。因此，這是我們的歷史基準，也可能最終成為該特定資產此時的未來基準。

Our next question comes from Jonathan Chang of SVB Securities.

我們的下一個問題來自 SVB 證券的 Jonathan Chang。

Dylan Drakes on for Jonathan. First of all, I just want to ask, how you guys are thinking about strategic priorities for your pipeline programs following the merger, particularly when you think about your approach to ovarian cancer? And how you plan to address any overlapping [MAGE-A4] -- for mesothelin patient populations?

喬納森換下迪倫·德雷克斯。首先，我只想問，你們是如何考慮合併後管道項目的戰略重點的，尤其是當你們考慮治療卵巢癌的方法時？你打算如何解決任何重疊的 [MAGE-A4] - 對於間皮素患者群體？

So let me say, please -- say a little about that. Obviously, we're limited in what we can say because we have yet to complete the transaction. And at the moment, TCR2 and Adaptimmune are continuing as independent companies. And the best way of thinking about our focus at the moment is that we're focused on our priorities for Adaptimmune as a company, which I went through afami-cel BLA, CD8, PRAME and our allogeneic platform.

所以讓我說，請 - 談談這個。顯然，我們能說的有限，因為我們還沒有完成交易。目前，TCR2 和 Adaptimmune 正在繼續作為獨立的公司。目前考慮我們重點的最佳方式是，我們專注於 Adaptimmune 作為一家公司的優先事項，我經歷了 afami-cel BLA、CD8、PRAME 和我們的同種異體平台。

However, clearly, we -- as we bring this pipeline together, we will need to address two angles. One is how do you develop these programs in a synergistic fashion -- a synergistic and efficient fashion. And there's pros to the -- benefits to the fact that we have both assets in ovarian, in terms of execution -- clinical execution and experience in the ovarian space.

然而，很明顯，當我們將這條管道整合在一起時，我們需要解決兩個角度。一個是如何以協同方式開發這些程序——一種協同高效的方式。就執行而言，我們在卵巢方面擁有兩種資產這一事實是有好處的——臨床執行和卵巢空間的經驗。

And there's also considerations like overlap between the antigen that we need to see to think about how [long would deal] with. All of that is driven by data. And I think we are looking forward to the data that has been accumulated by TCR2 of combination with nivolumab. And we look forward to making data-driven decisions on the entire portfolio as we go through this year and into next year.

還有一些考慮因素，例如抗原之間的重疊，我們需要考慮如何 [long would deal] 處理。所有這些都是由數據驅動的。我認為我們期待著 TCR2 與 nivolumab 結合所積累的數據。我們期待在今年和明年的整個投資組合中做出數據驅動的決策。

So we are very clear that we will need to be thoughtful and rigorous about the prioritization across the portfolio in order to develop the best medical out of what is the best pipeline with the broadest range of targets and the deepest base of assets in the cell therapy industry at this point in time.

因此，我們非常清楚，我們需要對整個產品組合的優先順序進行深思熟慮和嚴格的排序，以便從具有最廣泛目標和最深入的細胞治療資產基礎的最佳管道中開發出最好的醫療產品這個時間點的行業。

Follow-up on that, I suppose, how do you see the allogeneic pipeline progressing? And how do you guys think about prioritizing both the allogeneic and autologous programs in the future?

後續，我想，你如何看待同種異體管道的進展？你們如何考慮在未來優先考慮同種異體和自體程序？

So I'm going to touch on that just very briefly, and then I'm going to invite Jo to comment as she is leading the allogeneic platform work.

所以我將非常簡短地談及這一點，然後我將邀請 Jo 發表評論，因為她正在領導同種異體平台工作。

I think one of the things that's become clear in the industry, and in fact, I think this is why there's a resurgence of interest in the autologous space, is that it's been clear to us for a long time that the allogeneic promise is definitely there. The idea of an off-the-shelf cell therapy product is incredibly attractive.

我認為行業中已經清楚的事情之一，事實上，我認為這就是為什麼人們對自體空間重新產生興趣的原因是，很長一段時間以來我們都清楚同種異體的承諾肯定存在.現成的細胞治療產品的想法非常有吸引力。

It's also quite a long way away. And I think the next decade is, particularly in the solid tumor space, the decade of autologous solid cell therapies. And I think you can see in the investments that people are making in the CAR-T space that I think this is becoming an industry perspective.

距離也蠻遠的。我認為下一個十年是自體實體細胞療法的十年，尤其是在實體瘤領域。我認為你可以從人們對 CAR-T 領域的投資中看到，我認為這正在成為一種行業觀點。

Now, it's unfortunate that some of that is because of the inevitable challenges that have arisen as you try to develop a new modality, i.e, allogeneic T-cells.

現在，不幸的是，其中一些是因為在您嘗試開發一種新模式（即同種異體 T 細胞）時出現了不可避免的挑戰。

That means that there's now I think, going to be quite a gap. Autologous is not simply a bridge to allogeneic. There will be different products. And the allogeneic products will be, I think, quite a way behind the autologous products, particularly in the solid tumor space.

這意味著現在我認為會有很大的差距。自體不僅僅是通向同種異體的橋樑。會有不同的產品。我認為，同種異體產品將遠遠落後於自體產品，尤其是在實體瘤領域。

And as such, our focus is on developing our autologous pipeline of products, which have near-term potential -- near- and medium-term potential to benefit thousands of patients who have deadly cancers.

因此，我們的重點是開發我們的自體產品線，這些產品具有近期潛力——近期和中期潛力，可以使成千上萬患有致命癌症的患者受益。

And then I think the evolution of the allogeneic platform will then determine two things: One, the extent to which there is a direct overlap or the extent to which there is complementarity between these platforms in due course. We're very pleased that we have a foot in both camps and in particular, with the allogeneic platform with our partner, Genentech.

然後我認為同種異體平台的進化將決定兩件事：第一，這些平台之間直接重疊的程度或在適當的時候互補的程度。我們很高興能涉足這兩個陣營，特別是與我們的合作夥伴 Genentech 的同種異體平台。

But we see a very, very significant solid business in the autologous space. in solid tumors before there's any allogeneic players out there, including own . Jo, anything that you'd like to add to that?

但我們在自體空間看到了非常非常重要的穩固業務。在實體瘤中，在有任何同種異體玩家之前，包括自己。喬，你還有什麼要補充的嗎？

I think you covered that pretty well. As I said, we are still really committed to the allogeneic platform, and we are making progress there. It's one of those working through unknown [unknown] due to what comes up in these programs. There are new challenges that need to be solved. And the team has been working very hard on this for a long time now, and we've made a huge amount of progress.

我認為你講得很好。正如我所說，我們仍然真正致力於同種異體平台，我們正在那裡取得進展。由於這些程序中出現的內容，它是那些通過未知 [未知] 工作的人之一。有新的挑戰需要解決。很長一段時間以來，團隊一直在努力工作，我們取得了巨大的進步。

But we have to react to the ever-changing landscape around us as well. So the bar -- the regulatory bar for allogeneic program is very different to autologous. And the way that the autologous programs are progressing in terms of business model and ability to supply patients is also making that bar hard enough for allogeneic products as well.

但我們也必須對周圍不斷變化的景觀做出反應。因此，同種異體項目的監管標準與自體項目非常不同。自體項目在商業模式和供應患者能力方面取得進展的方式也使得同種異體產品的門檻也足夠高。

It's becoming -- we're getting better at supplying and treating patients with autologous products, which means that the allogeneic products have to try much harder to be improvements on that.

它正在成為——我們在為患者提供和治療自體產品方面做得越來越好，這意味著同種異體產品必須更加努力地嘗試改進這一點。

We're still completely convinced that, that is the long-term future, and we're keeping all of that in mind. So we're still putting a huge amount of effort into our allogeneic platform because we do see that as our long-term play for the future, and that's why we're very happy to be partnered with Genentech who view it in a similar way to ourselves and that this is a long-term play for good gains at the end of it.

我們仍然完全相信，那是長期的未來，我們將所有這些牢記在心。因此，我們仍在為我們的同種異體平台投入大量精力，因為我們確實將其視為我們未來的長期目標，這就是為什麼我們很高興與以類似方式看待它的基因泰克合作對我們自己來說，這是一場長期的比賽，最終會獲得豐厚的回報。

So I think it's -- we've not been talking about it much recently because we're just carrying on, and it's great. But right now, with transformative data within the autologous space, and we're committed to that as well. We're making a valid business with strong data in treating patients.

所以我認為這是 - 我們最近沒有談論太多，因為我們只是在繼續，這很棒。但是現在，隨著自體空間內的變革性數據，我們也致力於此。我們正在開展一項有效的業務，在治療患者方面擁有強大的數據。

All will come in time, but for now, there's important work to be done in autologous as well and important products that we can bring forward.

一切都會及時到來，但就目前而言，自體以及我們可以推出的重要產品也有重要的工作要做。

Our next question comes from Peter Lawson of Barclays. Please go ahead.

我們的下一個問題來自巴克萊銀行的彼得勞森。請繼續。

Okay. This is Alex on for Peter. Just another question on the PRAME program. I was wondering if you could clarify just the timing of the IND, if that's mid-'23? And then, when would you be in a position to start a Phase I study here?

好的。這是亞歷克斯為彼得。關於 PRAME 程序的另一個問題。我想知道你是否可以澄清 IND 的時間，如果那是 23 年中期？然後，您什麼時候可以在這裡開始第一階段研究？

And then kind of related in terms of manufacturing for the PRAME program, are there any synergies in terms of being able to leverage your current manufacturing footprint or know-how processes for manufacturing for that program?

然後在 PRAME 計劃的製造方面有點相關，在能夠利用您當前的製造足跡或專有技術流程為該計劃製造方面是否存在任何協同效應？

So I will comment briefly, and then I'll ask John Lunger, Chief Patient Supply Officer, to comment on the manufacturing approach for the PRAME program.

因此，我將簡要發表評論，然後請首席患者供應官 John Lunger 對 PRAME 計劃的製造方法發表評論。

I think you might be confusing our BLA timing of mid-2023 with the discussion that we've had on PRAME, where we said we would be IND-ready in 2023, with the clinical trial to follow shortly thereafter. And we anticipate being in the clinic with PRAME in 2024. John, would you like to talk about the manufacturing for PRAME?

我認為您可能會將我們在 2023 年年中的 BLA 時間與我們在 PRAME 上進行的討論混淆了，我們說我們將在 2023 年做好 IND 準備，此後不久將進行臨床試驗。我們預計在 2024 年與 PRAME 一起進入診所。約翰，你想談談 PRAME 的製造嗎？

We're leveraging our capabilities that we've built in manufacturing. It's definitely one of the advantages of building the integrated capabilities that we have. So we -- as soon as PRAME began to come back, we started to look at our network.

我們正在利用我們在製造業中建立的能力。這絕對是構建我們擁有的綜合能力的優勢之一。所以我們——一旦 PRAME 開始回歸，我們就開始關注我們的網絡。

We have the ability to make the lentiviral vector that we would need in our facility that's in the U.K., and we have the capacity for drug product in the Navy Yard. So the flexibility that, that's enabled to react is fantastic, and we'll certainly leverage that.

我們有能力在我們位於英國的設施中製造我們需要的慢病毒載體，並且我們有能力在 Navy Yard 生產藥品。因此，能夠做出反應的靈活性非常棒，我們當然會利用它。

This concludes the question-and-answer session. I would like to turn the conference back over to Adrian Rawcliffe for any closing remarks.

問答環節到此結束。我想將會議轉回 Adrian Rawcliffe 的閉幕詞。

Thanks, everyone, for your time today. We've been very pleased to share our progress with you, and we look forward to updating later on in 2023 after we have concluded our transaction with TCR2. In the meantime, please feel free to reach out with any questions. Thank you again for your time. Bye.

謝謝大家今天的時間。我們很高興與您分享我們的進展，我們期待在 2023 年晚些時候與 TCR2 完成交易後進行更新。同時，如有任何問題，請隨時與我們聯繫。再次感謝您的寶貴時間。再見。

This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.

今天的電話會議到此結束。您可以斷開線路。感謝您的參與，祝您度過愉快的一天。