Oncternal Therapeutics Inc (ONCT) 2023 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Greetings, and welcome to the Oncternal second quarter 2023 financial results call. (Operator Instructions) As a reminder, this conference will be recorded.

    您好,歡迎參加 Oncternal 2023 年第二季度財務業績電話會議。 (操作員說明) 溫馨提示,本次會議將被錄音。

  • And it is now my pleasure to introduce to you Richard Vincent, CFO. Thank you, Richard. You may begin.

    現在我很高興向您介紹首席財務官理查德·文森特。謝謝你,理查德。你可以開始了。

  • Richard Vincent - CFO

    Richard Vincent - CFO

  • Thank you, John. Good afternoon everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Dr. James Breitmeyer and our CMO, Dr. Salim Yazji. Today's call includes the business update and discussion of our second quarter ended June 30, 2023 financial results that were filed earlier today.

    謝謝你,約翰。大家下午好,感謝您今天加入我們。今天下午與我一起參加電話會議的有我們的總裁兼首席執行官 James Breitmeyer 博士和我們的首席營銷官 Salim Yazji 博士。今天的電話會議包括業務更新和討論今天早些時候提交的截至 2023 年 6 月 30 日的第二季度財務業績。

  • Today's press release and a replay of today's call will be available on the Investor Relations section of Oncternal's website for at least the next 30 days. Please note that certain information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act.

    今天的新聞稿和今天電話會議的重播將在至少未來 30 天內在 Oncternal 網站的投資者關係部分提供。請注意,今天電話會議中討論的某些信息受《私人證券訴訟改革法案》的安全港條款管轄。

  • We will be making forward-looking statements during this call about future events such as our business and product development strategies, the timing of initiation of our pre-clinical and clinical studies, the timing of planned interim data updates, the timing of our regulatory filings, and our cash runway. Our actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with our business.

    我們將在本次電話會議期間就未來事件做出前瞻性陳述,例如我們的業務和產品開發戰略、臨床前和臨床研究的啟動時間、計劃的中期數據更新的時間、我們監管備案的時間,以及我們的現金跑道。由於與我們業務相關的風險和不確定性,我們的實際結果可能與這些前瞻性陳述中明示或暗示的結果存在重大差異。

  • These forward-looking statements should be considered in conjunction with and are qualified by, the cautionary statements contained in today's press release and our SEC filings, including our Form 10-Q filed today and our previously filed Form 10-K for full year ended December 31, 2022.

    這些前瞻性陳述應與今天的新聞稿和我們向SEC 提交的文件(包括我們今天提交的10-Q 表格和之前提交的截至12 月全年的10-K 表格)中包含的警示性聲明一起考慮並受到其限制。 2022 年 31 日。

  • This call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 10, 2023. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date of this call.

    本次電話會議包含時間敏感信息,僅截至本次直播之日(2023 年8 月10 日)準確。我們不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後發生的事件或情況的義務。

  • With that, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmeyer. Mute, Jim.

    至此,我很高興將電話轉交給我們的首席執行官 Jim Breitmeyer 博士。靜音,吉姆。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Thank you, Rich and good afternoon everyone.

    謝謝 Rich,大家下午好。

  • At Oncternal, we are now advancing two clinical stage programs targeting cancers for patients with significant unmet medical needs. Last week, Oncternal announced that we received a Study May Proceed letter from the US FDA for the Phase 1/2 dose escalation study of ONCT-534 for patients with advanced prostate cancer.

    在 Oncternal,我們現在正在推進兩個針對癌症的臨床階段計劃,以幫助那些醫療需求未得到滿足的患者。上週,Oncternal 宣布,我們收到了美國 FDA 發出的關於 ONCT-534 針對晚期前列腺癌患者的 1/2 期劑量遞增研究的研究可能進行的信函。

  • FDA's review of the IND application was completed before the standard 30-day review period, and our study startup activities are tracking ahead of schedule. With that, we expect to initiate our study in the third quarter and expect our initial clinical data readout in the first half of 2024. We are very excited to bring ONCT-534 to patients suffering from advanced prostate cancer soon.

    FDA 對 IND 申請的審查在標準的 30 天審查期之前完成,我們的研究啟動活動正在提前進行。因此,我們預計在第三季度啟動我們的研究,並預計在 2024 年上半年讀出我們的初步臨床數據。我們非常高興能夠很快將 ONCT-534 帶給患有晚期前列腺癌的患者。

  • As a reminder, our preclinical study results suggest that ONCT-534 is active against the most common androgen receptor aberrations that drive tumor resistance to currently approved AR signaling inhibitors such as Xtandi or Zytiga. Our CMO, Salim Yazji will provide more details about the study design and ramp up plans in a moment.

    提醒一下,我們的臨床前研究結果表明,ONCT-534 對最常見的雄激素受體畸變具有活性,這些畸變導致腫瘤對目前批准的 AR 信號抑製劑(如 Xtandi 或 Zytiga)產生耐藥性。我們的首席營銷官 Salim Yazji 稍後將提供有關研究設計和提升計劃的更多詳細信息。

  • With respect to our ROR1 targeting autologous CAR T, ONCT-808, we are very pleased to report that the first patients have now been dosed and that enrollment is meeting or surpassing our expectations. We believe ONCT-808 may be a best-in-class ROR1 CAR targeting CAR T as it builds on our extensive clinical experience with zilovertamab, which was found to be safe in several Phase 1 and 2 studies.

    關於我們的 ROR1 靶向自體 CAR T ONCT-808,我們非常高興地報告第一批患者現已接受給藥,入組情況達到或超出了我們的預期。我們相信 ONCT-808 可能是同類最佳的針對 CAR T 的 ROR1 CAR,因為它建立在我們對 zilovertamab 的豐富臨床經驗之上,在多項 1 期和 2 期研究中發現 zilovertamab 是安全的。

  • Preclinical models show robust and specific cytotoxic activity of ONCT-808 against ROR1 expressing cells from multiple tumor types. Clinical manufacturing runs completed to-date continue to support our thesis that our manufacturing process is robust, reproducible, scalable, and shorter than several approved CAR T therapies.

    臨床前模型顯示 ONCT-808 針對多種腫瘤類型的 ROR1 表達細胞具有強大且特異的細胞毒活性。迄今為止完成的臨床生產運行繼續支持我們的論點,即我們的生產過程穩健、可重複、可擴展,並且比幾種已批准的 CAR T 療法更短。

  • We continue to expect to announce some initial clinical data in late 2023, with additional clinical data readouts in 2024.

    我們繼續預計在 2023 年末公佈一些初步臨床數據,並在 2024 年公佈更多臨床數據。

  • Let me now turn the call over to Oncternal's CMO, Salim Yazji, to expand on our clinical plans for ONCT-534 and our progress with ONCT-808. Salim?

    現在讓我將電話轉給 Oncternal 的 CMO Salim Yazji,詳細介紹我們的 ONCT-534 臨床計劃以及 ONCT-808 的進展。薩利姆?

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • Thank you, Jim. Good afternoon, everyone. As Jim mentioned, now we announced that our IND for ONCT-534 is active. We are working diligently to bring ONCT-534 to patients as fast as possible.

    謝謝你,吉姆。大家下午好。正如 Jim 提到的,現在我們宣布 ONCT-534 的 IND 已啟動。我們正在努力工作,盡快將 ONCT-534 帶給患者。

  • Study ONCT-534-101 is a Phase 1/2 dose escalation study that will enroll patients with metastatic castration-resistant prostate cancer with progressive disease that have relapsed or are refractory to next-generation androgen receptor signaling inhibitor, including enzalutamide or abiraterone.

    ONCT-534-101研究是一項1/2期劑量遞增研究,將招募患有進展性疾病的轉移性去勢抵抗性前列腺癌患者,這些患者已復發或對下一代雄激素受體信號抑製劑(包括恩雜魯胺或阿比特龍)耐藥。

  • The dose escalation will use the baseline optimal interval or beyond design, which is an effective statistical method to optimally and quickly identify the maximum tolerated dose or MTD. Once the MTD is identified, the study will roll into a Phase 2 Simon 2-Stage design to evaluate the safety and efficacy of ONCT-534 at two dose levels. The ramp up to the study start is well underway. And we have already selected the clinical sites that will support initial dose finding portion of the study. The potential of ONCT-534 to address a significant unmet need for patients with relapsed refractory metastatic prostate cancer has been appreciated by top KOLs and academic institution in the US and Europe. And we are excited to be working with them to advance the clinical investigation of our novel product candidate.

    劑量遞增將使用基線最佳間隔或超越設計,這是一種有效的統計方法,可以最佳地快速確定最大耐受劑量或MTD。一旦確定了 MTD,該研究將進入 2 期 Simon 2 階段設計,以評估 ONCT-534 在兩個劑量水平下的安全性和有效性。研究開始的準備工作正在順利進行。我們已經選擇了支持研究初始劑量發現部分的臨床地點。 ONCT-534 解決復發難治性轉移性前列腺癌患者未滿足的重大需求的潛力已得到美國和歐洲頂級 KOL 和學術機構的認可。我們很高興與他們合作,推進我們的新型候選產品的臨床研究。

  • Based on this progress, we now expect to initiate the study in the third quarter of 2023, and expect to report initial data in the first half of 2024.

    基於這一進展,我們現在預計在 2023 年第三季度啟動研究,並預計在 2024 年上半年報告初步數據。

  • Now, switching gears into our ROR1 targeting CAR T. We recently treated our first patient in the study, ONCT-808-101, a Phase 1/2 study for patients with relapsed refractory aggressive B-cell lymphoma, including those who have failed previously CD-19 CAR T therapy. As a reminder, patients who have failed CD-19 treatment have extreme unmet medical need with a little likelihood of responding to their next treatment, and very short median progression-free survival and overall survival.

    現在,我們轉向ROR1 靶向CAR T。我們最近治療了ONCT-808-101 研究中的第一位患者,這是一項針對複發難治性侵襲性B 細胞淋巴瘤患者(包括之前失敗的患者)的1/2 期研究CD-19 CAR T療法。提醒一下,CD-19治療失敗的患者的醫療需求極其未得到滿足,對下一次治療產生反應的可能性很小,中位無進展生存期和總生存期也非常短。

  • Overall, we are very pleased with the rate of enrollment and look forward to discussing pulmonary data by the end of this year.

    總的來說,我們對入組率非常滿意,並期待在今年年底之前討論肺部數據。

  • With this, I now turn the call to our CFO, Rich Vincent. Rich?

    現在,我將電話轉給我們的首席財務官 Rich Vincent。富有的?

  • Richard Vincent - CFO

    Richard Vincent - CFO

  • Thank you, Salim. Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $0.1 million for the second quarter ended June 30, 2023. Our total operating expenses for the second quarter were $9.7 million, including $1.7 million in non-cash stock-based compensation expense. That represents a $2.5 million decrease from our total cash operating expenses of approximately $10.5 million for the first quarter of 2023. That represents an efficient wind down of the activities resulting from our reprioritization initiative that we announced on April 3, 2023.

    謝謝你,薩利姆。我們目前的收入來自美國國立衛生研究院 (NIH) 的研發資助。截至 2023 年 6 月 30 日的第二季度,我們的贈款收入為 10 萬美元。第二季度的總運營費用為 970 萬美元,其中包括 170 萬美元的非現金股票補償費用。這比 2023 年第一季度約 1050 萬美元的總現金運營支出減少了 250 萬美元。這意味著我們於 2023 年 4 月 3 日宣布的重新優先順序計劃所產生的活動有效結束。

  • Research and development expenses totaled $6.6 million and general and administrative expenses totaled $3.1 million. Interest income for the quarter was $0.6 million. Net loss for the second quarter was $9 million or a loss of $0.15 per share basic and dilutive. As of June 30, 2023, we had approximately 58.7 million shares of common stock outstanding, 45.5 million in cash and investments and no debt. We believe these funds will be sufficient to fund our operations into 2025.

    研究與開發費用總計 660 萬美元,一般及管理費用總計 310 萬美元。該季度的利息收入為 60 萬美元。第二季度淨虧損為 900 萬美元,即每股基本虧損和攤薄虧損為 0.15 美元。截至 2023 年 6 月 30 日,我們擁有約 5870 萬股已發行普通股,4550 萬股現金和投資,無債務。我們相信這些資金將足以支持我們到 2025 年的運營。

  • With respect to upcoming milestones, we remain on track. For ONCT-808, our ROR1 autologous CAR T, we expect to report initial clinical data by the end of 2023 with additional data readouts in 2024.

    對於即將到來的里程碑,我們仍然走在正軌上。對於 ONCT-808(我們的 ROR1 自體 CAR T),我們預計在 2023 年底前報告初始臨床數據,並在 2024 年公佈更多數據。

  • For ONCT-534, our late DAARI product candidate, we now expect to initiate our Phase 1/2 study in the third quarter 2023, ahead of schedule and to present initial clinical data in the first half of 2024.

    對於我們最新的 DAARI 產品候選產品 ONCT-534,我們現在預計提前於 2023 年第三季度啟動 1/2 期研究,並於 2024 年上半年提供初步臨床數據。

  • Now, I will turn the call back over to Jim.

    現在,我將把電話轉回給吉姆。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Thank you, Rich. We are very pleased with the recent progress as we continue to execute on our plan to achieve significant clinical catalyst for our two lead programs while retaining our cash runway into 2025. With that, I will turn things back to John for the Q&A portion of this afternoon's call.

    謝謝你,里奇。我們對最近取得的進展感到非常高興,因為我們將繼續執行我們的計劃,為我們的兩個主導項目實現顯著的臨床催化劑,同時保留我們的現金跑道到2025 年。這樣,我將把問題轉回給約翰,以進行本問答部分下午的電話。

  • Operator

    Operator

  • Thank you, sir. We will now be conducting a question-and-answer session. (Operator Instructions)

    謝謝你,先生。我們現在將進行問答環節。 (操作員說明)

  • Carl Byrnes, Northland Capital Markets.

    卡爾·伯恩斯,北國資本市場。

  • Carl Byrnes - Analyst

    Carl Byrnes - Analyst

  • Thanks for the question, and congratulations on the progress. With respect to 534, do you see a potential for early PSA reduction signal in the Phase 1 portion of the study? I mean, this is obviously considering the MTDs will determine the incidence -- it will be determined using the incidence of the ELTs with, I think, a timeframe of 28 or so days? And then I have a follow-on question.

    感謝您的提問,並祝賀您取得的進展。關於 534,您是否認為該研究的第一階段部分有可能出現早期 PSA 降低信號?我的意思是,這顯然是考慮到 MTD 將決定發生率——我認為,它將使用 ELT 的發生率來確定,我認為,時間範圍為 28 天左右?然後我有一個後續問題。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • So, Karl, yes. We do think that a PSA signal is possible. And we are -- the eligibility criteria were designed to enrich for patients whose disease remained androgen-dependent -- androgen receptor dependent and the mechanism of action would include inhibiting PSA as an early biomarker.

    所以,卡爾,是的。我們確實認為 PSA 信號是可能的。我們設計的資格標準是為了豐富那些疾病仍然依賴雄激素的患者——雄激素受體依賴,作用機制包括抑制 PSA 作為早期生物標誌物。

  • Carl Byrnes - Analyst

    Carl Byrnes - Analyst

  • Excellent. And similarly, with 808, and considering the dosing there in the study is close to, if not consistent with recommended Phase 2 dosing of other CAR T therapeutics, do you see a potential for early efficacy signal in that initial data?

    出色的。同樣,對於 808,考慮到研究中的劑量接近(如果與其他 CAR T 療法的推薦 2 期劑量不一致),您是否認為初始數據中存在早期療效信號的潛力?

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Salim, do you want to take that one?

    薩利姆,你想拿那個嗎?

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • Yeah, sure. Yeah, I think we would expect to have an early signal as well. As you know, those patients are very hard to treat and after failing -- especially after failing CD-19 -- prior CD-19 CAR T, we would expect actually to have an early signal and also we would like to see a duration of response will be actually something that we are very looking forward to.

    好,當然。是的,我想我們也會期待儘早收到信號。如您所知,這些患者非常難以治療,並且在失敗後 - 特別是在 CD-19 失敗後 - 先前的 CD-19 CAR T,我們期望實際上有一個早期信號,並且我們希望看到持續時間回應實際上是我們非常期待的。

  • Carl Byrnes - Analyst

    Carl Byrnes - Analyst

  • Great. Thanks. Congratulations again.

    偉大的。謝謝。再次恭喜。

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • Thank you.

    謝謝。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Hartaj Singh, Oppenheimer & Company.

    哈塔傑·辛格,奧本海默公司。

  • Hartaj Singh - Analyst

    Hartaj Singh - Analyst

  • Great. Thank you. Thanks for all the updates, and I got a couple of questions. One is just on 808 following on the previous question. If I look on clinicaltrials.gov, you've got B cell NHL patients, MCL and then various types of LBCL patients in there. On your expansion, you're already indicating MCL and I guess, LBCL. zilovertamab, I believe, showed a pretty good -- really good signal with MCL. So, just building on the previous question. You're close to recommended Phase 2 dose starting off. Can you just walk us through what your dose escalation look like? And then I imagine would those be MCL patients would be seeing? And I just got a follow-up question after this.

    偉大的。謝謝。感謝您的所有更新,我有幾個問題。其中一個是在上一個問題之後的 808 上。如果我查看 ClinicalTrials.gov,會看到 B 細胞 NHL 患者、MCL 以及各種類型的 LBCL 患者。在你的擴展中,你已經指出了 MCL,我猜是 LBCL。我相信 zilovertamab 在 MCL 方面表現出了非常好的信號。所以,只是建立在上一個問題的基礎上。您已接近建議的第 2 階段開始劑量。您能否向我們介紹一下您的劑量遞增情況?然後我想這些是 MCL 患者會看到的嗎?此後我收到了一個後續問題。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Salim?

    薩利姆?

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • Yeah. So, Hartaj, I think what we're trying to do, in the beginning, when the dose escalation, we are actually accepting all aggressive lymphoma in the dose escalation. However, in the expansion, I think we would like to have separate MCL, DLBCL and other aggressive lymphoma type. As of now, we're only going with two indications, which is the MCL and DLBCL. What was the other question, Hartaj?

    是的。所以,Hartaj,我認為我們一開始正在嘗試做的事情,當劑量遞增時,我們實際上是在劑量遞增中接受所有侵襲性淋巴瘤。然而,在擴展中,我認為我們希望有單獨的 MCL、DLBCL 和其他侵襲性淋巴瘤類型。到目前為止,我們只提供兩種適應症,即 MCL 和 DLBCL。哈塔傑,另一個問題是什麼?

  • Hartaj Singh - Analyst

    Hartaj Singh - Analyst

  • Yeah. And just a follow-up to that, Salim, which is that -- since this is a CAR T, and you're going in with your knowledge of zilovertamab at a higher dose, in terms of just DLTs, should we just expect something analogous to what we've seen with CAR Ts previously? CRS and other kinds of toxicity?

    是的。 Salim,這只是後續行動,因為這是 CAR T,並且您將了解更高劑量的 zilovertamab,就 DLT 而言,我們是否應該期待一些東西與我們之前看到的 CAR T 類似嗎? CRS 和其他類型的毒性?

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • Well (multiple speakers) -- yeah, go ahead.

    好吧(多個發言者)——是的,繼續。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • I can take that, Salim. So Hartaj, as I'm sure you know, the -- in most CAR T programs, there's not a -- there's not as distinct of a dose response curve as there are with other kinds of molecular entities because the ultimate efficacy has to do with the quality of the CAR T cells and how robustly they expand in the patient and target the tumor. We have -- the type of CAR T construct and process that we're doing is one that would be expected to see some cytokine release syndrome, for example. But our investigators tell us that you need to see some CRS if your CAR T is doing what you want it to.

    我可以接受,薩利姆。 Hartaj,我相信你知道,在大多數 CAR T 項目中,沒有像其他類型的分子實體那樣明顯的劑量反應曲線,因為最終療效必須CAR T 細胞的質量以及它們在患者體內擴增和靶向腫瘤的穩健程度。例如,我們正在做的 CAR T 構建體和過程的類型預計會出現一些細胞因子釋放綜合徵。但我們的調查人員告訴我們,如果您的 CAR T 正在發揮您想要的作用,您需要查看一些 CRS。

  • Hartaj Singh - Analyst

    Hartaj Singh - Analyst

  • Yeah. That makes sense, Jim. Really makes -- I mean, that makes a lot of sense. And then -- the end of the year, the data would be just a safety update or we'd see some clinical potential efficacy data also, potentially?

    是的。這是有道理的,吉姆。真的很有意義——我的意思是,這很有意義。然後 - 到今年年底,這些數據將只是安全更新,或者我們還會看到一些臨床潛在功效數據,有可能嗎?

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Salim?

    薩利姆?

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • Yeah. So, Hartaj, we would expect to see pulmonary data, even including some efficacy data by the end of the year, yes.

    是的。所以,Hartaj,我們預計會在年底看到肺部數據,甚至包括一些療效數據,是的。

  • Hartaj Singh - Analyst

    Hartaj Singh - Analyst

  • Great. Thank you. Thanks for all the questions.

    偉大的。謝謝。感謝您提出所有問題。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Li Watsek, Cantor Fitzgerald.

    李·沃塞克,坎托·菲茨杰拉德。

  • Rosemary Li - Analyst

    Rosemary Li - Analyst

  • Hi there. This is Rosemary on for Li. Thanks so much for taking our questions. Just a general one first about 534. Can you talk a bit about the change in landscape in prostate cancer treatment and how you think 534 could eventually fit in?

    你好呀。這是李的迷迭香。非常感謝您回答我們的問題。首先簡單介紹一下 534。您能談談前列腺癌治療領域的變化以及您認為 534 最終將如何融入其中嗎?

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Happy to, Rosemary. And thank you for standing in today. So, we believe that the part of the landscape where we're sitting is one that has very significant unmet medical need. The androgen receptor signaling inhibitors, enzalutamide, darolutamide, apalutamide, and abiraterone are core therapy and standard-of-care for virtually every patient in the early portion of treating metastatic disease.

    很高興,羅斯瑪麗。感謝您今天站出來。因此,我們相信我們所在的地區有非常重要的未滿足的醫療需求。雄激素受體信號抑製劑、恩雜魯胺、達洛魯胺、阿帕魯胺和阿比特龍是幾乎每個患者在治療轉移性疾病早期階段的核心療法和護理標準。

  • And at the time that patients become resistant to those agents, some of them become androgen receptor independent. And that's not who we're targeting, but a very large proportion of them remain androgen receptor dependent, but resistant to standard AR signaling inhibitors. And so that's a large population, and it's in that space between hormone therapies and chemotherapy or radiotherapy, which have much more toxicity. So, we think it fits perfectly there to begin with.

    當患者對這些藥物產生耐藥性時,其中一些患者就會變得不依賴雄激素受體。這不是我們的目標人群,但其中很大一部分仍然依賴於雄激素受體,但對標準 AR 信號抑製劑有抵抗力。因此,這是一個很大的人群,而且處於激素療法和化療或放療之間的空間,而化療或放療的毒性更大。所以,我們認為它一開始就非常適合。

  • However, we're also showing -- 534 also has very robust activity with patients who have a native or unmutated androgen receptor; and interestingly, have very strong activity in rodent models where the animals were not castrated. And so that is an unusually strong type of activity in the presence of normal testosterone levels that suggest that once we've shown activity in late-stage disease, that there is a clear pathway to move forward into earlier-stage advanced prostate cancer.

    然而,我們還表明——534 對於具有天然或未突變雄激素受體的患者也具有非常強的活性;有趣的是,在未閹割的囓齒動物模型中具有非常強的活性。因此,在睾酮水平正常的情況下,這是一種異常強烈的活性,這表明一旦我們在晚期疾病中表現出活性,就有一條明確的途徑可以進入早期晚期前列腺癌。

  • Rosemary Li - Analyst

    Rosemary Li - Analyst

  • Got it. Great. Thank you. That was really helpful. And maybe just one quick one on 808. So, do you have an estimation for maybe how many patients you could be presented by your data update? I know it's going to be really soon after first patient in, but --

    知道了。偉大的。謝謝。這真的很有幫助。也許只是通過 808 快速了解一下。那麼,您是否估計過您的數據更新可能會為您提供多少患者?我知道第一個病人入院後很快就會發生,但是——

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Salim?

    薩利姆?

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • Yeah. So you're talking about when we're going to present it by the end of the year? Is that what you talk about?

    是的。所以你是說我們什麼時候在年底前推出它?這就是你所說的嗎?

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Yeah, how many 808 patients?

    是啊,808病人有多少?

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • Yeah. So, probably would be at least three patients with a different time to follow-up.

    是的。因此,可能至少有三名患者的隨訪時間不同。

  • Rosemary Li - Analyst

    Rosemary Li - Analyst

  • Great. Thank you so much.

    偉大的。太感謝了。

  • Salim Yazji - Chief Medical Officer

    Salim Yazji - Chief Medical Officer

  • You're welcome.

    不客氣。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Thank you, Rosemary.

    謝謝你,羅斯瑪麗。

  • Operator

    Operator

  • Kemp Dolliver, Brookline Capital Markets.

    Kemp Dolliver,布魯克萊恩資本市場。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Hi, thank you. Just quickly to be -- sure I understand the landscape with 534. Jim, are you saying that you're thinking this would come in between -- after first-line therapy, but before chemotherapy?

    嗨,謝謝你。很快——我當然了解 534 的情況。吉姆,你是說你認為這會發生在一線治療之後、化療之前嗎?

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Exactly, Kemp.

    沒錯,坎普。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Okay.

    好的。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Now, as you know, there are -- some people are using, say, enzalutamide plus docetaxel as the first treatment for metastatic disease, but this agent would still be suitable after that regimen as well.

    現在,如您所知,有些人正在使用恩雜魯胺加多西紫杉醇作為轉移性疾病的首選治療方法,但這種藥物在該方案之後仍然適用。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Got it. And what percentage of the patient population do you think would fall into this target that you've set out?

    知道了。您認為有多少比例的患者會落入您設定的目標?

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Well, we're -- that's something that we're going to learn in the clinical trial. And we do think that after failing enzalutamide or abiraterone that somewhere between one-third and two-thirds of the patients remain androgen receptor dependent.

    嗯,這是我們將在臨床試驗中學到的東西。我們確實認為,在恩雜魯胺或阿比特龍失敗後,三分之一到三分之二的患者仍然依賴雄激素受體。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Got it. Thank you.

    知道了。謝謝。

  • Operator

    Operator

  • There are no further questions at this time. And I would like to turn the floor back over to Dr. Breitmeyer for any closing comments.

    目前沒有其他問題。我想將發言權交還給 Breitmeyer 博士以徵求結束語。

  • James Breitmeyer - President & CEO

    James Breitmeyer - President & CEO

  • Thank you, John; and thank you, everybody, who listened, and for the excellent questions and discussions. We now have two active clinical programs both of which are moving well and both of which will have data in the near-term.

    謝謝你,約翰;感謝所有聆聽的人以及提出的精彩問題和討論。我們現在有兩個活躍的臨床項目,兩個項目進展順利,並且都將在短期內獲得數據。

  • The entire team is excited to be bringing new potential therapy to patients with advanced and refractory aggressive lymphoma, and to patients with advanced and refractory prostate cancer. And hopefully, we will be addressing their high unmet medical need.

    整個團隊很高興能為晚期難治性侵襲性淋巴瘤患者以及晚期難治性前列腺癌患者帶來新的潛在療法。希望我們能夠解決他們未得到滿足的醫療需求。

  • With that, thank you for joining us today, and we look forward to updating you during upcoming medical and banking conferences.

    感謝您今天加入我們,我們期待在即將舉行的醫療和銀行會議期間向您通報最新情況。

  • Operator

    Operator

  • Ladies and gentlemen, that does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

    女士們、先生們,今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。