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Operator
Operator
Thank you for standing by. This is the conference operator. Welcome to the Corvus Pharmaceuticals Second Quarter 2023 Conference Call. (Operator Instructions) The conference is being recorded. (Operator Instructions)
謝謝你的支持。這是會議操作員。歡迎參加 Corvus Pharmaceuticals 2023 年第二季電話會議。 (操作員指示)會議正在錄音。 (操作員說明)
I would now like to turn the conference over to Zach Kubow of Real Chemistry. Please go ahead.
我現在想將會議轉交給 Real Chemistry 的 Zach Kubow。請繼續。
Zack Kubow - Group Director
Zack Kubow - Group Director
Thank you, operator. And good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals Second Quarter 2023 Business Update and Financial Results Conference Call.
謝謝你,接線生。大家下午好。感謝您參加 Corvus Pharmaceuticals 2023 年第二季業務更新與財務業績電話會議。
On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer; Leiv Lea, Chief Financial Officer; James Rosenbaum, Senior Vice President of Research; and Ben Jones, Senior Vice President of Regulatory and Pharmaceutical Sciences. The executive team will open the call with some prepared remarks, followed by a question-and-answer period.
執行長理查德·米勒 (Richard Miller) 出席了電話會議,討論業績和業務動態。 Leiv Lea,財務長; James Rosenbaum,研究資深副總裁;以及監管和製藥科學高級副總裁 Ben Jones。執行團隊將以一些準備好的發言開始電話會議,然後是問答時間。
I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements. Forward-looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by those statements, including the risks and uncertainties described in Corvus' quarterly report on Form 10-Q, which was filed today with the SEC, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.
我想提醒大家,管理階層今天發表的評論和問題的回答將包含前瞻性陳述。前瞻性陳述是基於截至目前的估計和假設,並受到風險和不確定性的影響,這些風險和不確定性可能導致實際結果與這些陳述明示或暗示的結果有重大差異,包括Corvus 季度報告中描述的風險和不確定性10-Q(今天向 SEC 提交)以及該公司不時向 SEC 提交的其他文件。除法律要求外,本公司不承擔公開更新或修改任何前瞻性聲明的義務。
With that, I'd like to turn the call over to Leiv.
說到這裡,我想把電話轉給萊夫。
Leiv Lea - CFO
Leiv Lea - CFO
Thank you, Zack. I will begin with a quick overview of our second quarter 2023 financials and then turn the call over to Richard for a business update.
謝謝你,扎克。我將首先快速概述我們 2023 年第二季的財務狀況,然後將電話轉給理查德,以了解業務最新情況。
Research and development expenses in the second quarter 2023 totaled $4 million compared to $4.9 million for the same period in 2022. The decrease of $0.9 million was primarily related to lower clinical trial and manufacturing costs associated with the development of mupadolimab, our anti-CD73 antibody.
2023 年第二季的研發費用總計 400 萬美元,而 2022 年同期為 490 萬美元。減少 90 萬美元主要與開發我們的抗 CD73 抗體 mupadolimab 相關的臨床試驗和製造成本降低有關。
The net loss for the second quarter of 2023 was $6.5 million, including a $1.3 million noncash loss related to Angel Pharmaceuticals, our partner in China. This compares to a net loss of $8.4 million for the same period in 2022, which included a $1.6 million noncash loss related to Angel Pharmaceuticals.
2023年第二季的淨虧損為650萬美元,其中包括與我們在中國的合作夥伴安琪藥業相關的130萬美元非現金虧損。相較之下,2022 年同期淨虧損為 840 萬美元,其中包括與 Angel Pharmaceuticals 相關的 160 萬美元非現金虧損。
Total stock compensation expense for the second quarter of 2023 was $0.5 million compared to $0.7 million for the same period in 2022. As of June 30, 2023, Corvus had cash, cash equivalents and marketable securities totaling $37 million as compared to $42.3 million at December 31, 2022.
2023 年第二季的股票補償費用總額為50 萬美元,而2022 年同期為70 萬美元。截至2023 年6 月30 日,Corvus 的現金、現金等價物及有價證券總額為3,700 萬美元,而12月為4,230 萬美元2022 年 31 日。
During the quarter, the company sold approximately 2.3 million shares of its common stock through its at-the-market program for net proceeds of $7.5 million. Looking forward, we now expect full year 2023 net cash used in operating activities to be between $20 million and $22 million, resulting in a projected cash balance of between $28 million and $30 million as of December 31, 2023.
本季度,該公司透過市場計劃出售了約 230 萬股普通股,淨收益為 750 萬美元。展望未來,我們目前預計 2023 年全年經營活動使用的淨現金將在 2,000 萬美元至 2,200 萬美元之間,截至 2023 年 12 月 31 日預計現金餘額將在 2,800 萬美元至 3,000 萬美元之間。
As stated last quarter, we continue to prudently manage our cash burn rate by focusing on our most promising opportunities and establishing collaborations that help support the development of our product candidates. Based upon this trend and our focus on soquelitinib, formerly CPI-818, we believe our cash will provide runway into the second half of 2024.
如上季所述,我們透過專注於最有前途的機會並建立有助於支持我們候選產品開發的合作,繼續謹慎管理我們的現金消耗率。基於這一趨勢以及我們對 soquelitinib(以前稱為 CPI-818)的關注,我們相信我們的現金將為 2024 年下半年提供跑道。
I will now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and plans.
我現在將把電話轉給理查德,他將討論我們的臨床進展並詳細說明我們的策略和計劃。
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Thank you, Leiv. And good afternoon, everyone. Thank you for joining us today for our business update call. We continue to focus on the significant opportunity to develop soquelitinib, our selective ITK inhibitor, as a potential novel approach for cancer immunotherapy.
謝謝你,萊夫。大家下午好。感謝您今天參加我們的業務更新電話會議。我們繼續關注開發選擇性 ITK 抑制劑索奎替尼(soquelitinib)的重大機遇,將其作為癌症免疫治療的潛在新方法。
Over the last few months, we achieved several key advancements that further increased our confidence and broader interest in soquelitinib including: ongoing enrollment in our Phase I/Ib trial in peripheral T-cell lymphoma and presenting additional data from that trial at a major international lymphoma meeting; second, publication of a very comprehensive article in bioRXiv on the chemical properties, immunologic function and mechanism of action of soquelitinib in preclinical models of hematologic and solid tumors; third, submission of our data package for an upcoming meeting in the third quarter with FDA to discuss our registration strategy and proposed Phase III trial for soquelitinib in relapsed peripheral T-cell lymphoma or PTCL. And we remain on track to initiate our Phase III trial by the end of the year and plan to start a monotherapy solid tumor study within the next several months.
在過去的幾個月裡,我們取得了幾項關鍵進展,進一步增強了我們對soquelitinib 的信心和更廣泛的興趣,包括:正在進行外周T 細胞淋巴瘤I/Ib 期試驗的入組,並提供來自主要國際淋巴瘤試驗的更多數據會議;第二,在bioRXiv上發表了一篇非常全面的文章,介紹了soquelitinib在血液學和實體瘤臨床前模型中的化學性質、免疫功能和作用機制;第三,為即將在第三季與 FDA 舉行的會議提交我們的數據包,以討論我們的註冊策略和提議的索奎替尼治療復發性外周 T 細胞淋巴瘤或 PTCL 的 III 期試驗。我們仍有望在今年底啟動 III 期試驗,並計劃在未來幾個月內啟動單一療法實體腫瘤研究。
In addition, we are accumulating exciting new data with ciforadenant, our adenosine 2a receptor inhibitor. Recent highlights from this program include: completion of the Phase Ib portion of the Phase Ib/II trial conducted by the kidney cancer consortium with advancement into the Phase II portion of the study in frontline therapy of renal cell cancer in combination with ipilimumab and nivolumab. Initial data from this trial is anticipated by the end of the year; second, presentation at the Japan Cancer Association AACR joint meeting on the mechanism of action of ciforadenant and its effects on myeloid T cell interactions.
此外,我們正在累積有關腺苷 2a 受體抑制劑 Ciforadenan 的令人興奮的新數據。該計劃的最新亮點包括:完成腎癌聯盟進行的 Ib/II 期試驗的 Ib 期部分,並進入與 ipilimumab 和 nivolumab 聯合治療腎細胞癌一線治療研究的 II 期部分。該試驗的初步數據預計將於今年底獲得;第二,在日本癌症協會 AACR 聯合會議上介紹 Ciforadenan 的作用機制及其對骨髓 T 細胞交互作用的影響。
Now I will share more of the details on our progress with soquelitinib and with ciforadenant. We continue to strengthen the scientific and clinical foundation for the potential use of soquelitinib in cancer immunotherapy and importantly are progressing towards a potential registration Phase III randomized trial for T-cell lymphoma. Briefly, we feel soquelitinib is a very special medicine because of the following attributes.
現在我將分享更多有關 soquelitinib 和 ciforadenant 進展的詳細資訊。我們繼續加強索奎替尼在癌症免疫治療中潛在用途的科學和臨床基礎,重要的是朝著 T 細胞淋巴瘤的潛在註冊 III 期隨機試驗取得進展。簡而言之,我們認為索奎替尼是一種非常特殊的藥物,因為它具有以下屬性。
Number one, the ability to inhibit a precisely-defined very specific molecular target, the kinase enzyme ITK with no other known significant off-target effects. Two, early clinical data has demonstrated multipronged effects on the immune system through its modulation of T cell differentiation. Three, in the clinic, we have shown monotherapy antitumor activity with durable responses in very sick patients, along with an attractive safety profile with chronic dosing.
第一,能夠抑制精確定義的非常特定的分子標靶,即激酶 ITK,而沒有其他已知的顯著脫靶效應。第二,早期臨床數據已證明透過調節 T 細胞分化對免疫系統產生多方面的影響。第三,在臨床中,我們已經顯示出單藥治療的抗腫瘤活性,對病情嚴重的患者俱有持久的反應,並且長期給藥具有有吸引力的安全性。
We view soquelitinib as a potential novel approach to cancer immunotherapy that is distinct from checkpoint inhibitors and with the potential to complement or synergize with checkpoint blockade. We believe soquelitinib is first in class as it is the most advanced and selective ITK inhibitor in development. It has an initial opportunity to be an important new treatment option for patients with relapsed PTCL and also represents a platform opportunity across a broad range of cancers and immune diseases.
我們認為索奎替尼是一種潛在的癌症免疫治療新方法,它不同於檢查點抑制劑,並且具有與檢查點阻斷相補充或協同的潛力。我們相信 soquelitinib 是同類首創,因為它是正在開發的最先進、最具選擇性的 ITK 抑制劑。它最初有機會成為復發性 PTCL 患者的重要新治療選擇,也代表了廣泛的癌症和免疫疾病的平台機會。
We remain on track to meet with the FDA this quarter to discuss our proposed Phase III study. We anticipate that the study would be a randomized trial of approximately 150 total patients comparing soquelitinib monotherapy to standard-of-care chemotherapy agents. The planned primary endpoint is progression-free survival. The study also will include an interim analysis.
我們仍有望在本季度與 FDA 會面,討論我們擬議的 III 期研究。我們預計該研究將是一項約 150 名患者參與的隨機試驗,將索奎替尼單藥療法與標準化療藥物進行比較。計劃的主要終點是無惡化存活期。該研究還將包括中期分析。
Assuming our meeting with FDA will be successful, we plan to initiate the Phase III trial before the end of the year, and we have begun recruitment of potential trial sites and investigators. We anticipate up to 40 centers internationally. So far, we have enlisted premier academic and private centers that are preeminent leaders in the lymphoma field. Our principle investigator is a leader in the field and has published extensively and conducted Phase III studies in T-cell lymphoma.
假設我們與 FDA 的會議能夠成功,我們計劃在今年年底之前啟動 III 期試驗,並且我們已經開始招募潛在的試驗地點和研究人員。我們預計國際上將設立多達 40 個中心。到目前為止,我們已經招募了頂級學術和私人中心,它們是淋巴瘤領域的傑出領導者。我們的首席研究員是該領域的領導者,發表了大量文章並進行了 T 細胞淋巴瘤的 III 期研究。
The most recent interim data on soquelitinib was presented at the International Conference on malignant lymphoma in June. We reported that as of May 18, 2023, a total of 30 patients were enrolled in the Phase I/Ib clinical trial in patients with relapsed T-cell lymphoma at the optimum 200-milligram 2x a day dose, including 20 patients evaluable for response.
索奎替尼的最新中期數據已在六月的國際惡性淋巴瘤會議上公佈。我們報告稱,截至2023 年5 月18 日,共有30 名患者參加了復發性T 細胞淋巴瘤患者的I/Ib 期臨床試驗,最佳劑量為200 毫克,每天2 次,其中20 名患者可評估療效。
To briefly recap, out of the 20 evaluable patients, there were 3 complete responses and 3 partial responses, with 1 of these partial responses demonstrating continued regression of tumor. The findings showed that for patients with an absolute lymphocyte count, or ALC, above 900 per cubic milliliter of blood, objective responses were seen in 6 of 14 patients, with disease control in 12 of 14 patients. Correlative laboratory studies on blood and tumor tissue confirmed the mechanism of action, showing increased infiltration of tumors with cytotoxic T cells with increased cytolytic capacity and reduction of T cell exhaustion markers.
簡單回顧一下,在 20 名可評估的患者中,有 3 名完全緩解和 3 名部分緩解,其中 1 名部分緩解顯示腫瘤持續消退。研究結果顯示,對於絕對淋巴球數(ALC)高於每立方毫升血液 900 個的患者,14 名患者中有 6 名出現客觀緩解,14 名患者中有 12 名疾病得到控制。血液和腫瘤組織的相關實驗室研究證實了作用機制,顯示細胞毒性 T 細胞對腫瘤的浸潤增加,細胞溶解能力增加,T 細胞耗竭標記物減少。
We are encouraged by the clinical and lab results and continue to enroll patients in the study. We have submitted an abstract for the ASH Annual Meeting in December, where we plan to present additional information on this trial.
我們對臨床和實驗室結果感到鼓舞,並繼續招募患者參與研究。我們已經為 12 月的 ASH 年會提交了一份摘要,我們計劃在會議上提供有關該試驗的更多資訊。
Further interest in our trial has been generated by the recent publication of preclinical data on soquelitinib in bioRXiv, which highlighted the selective inhibition of ITK to enhance antitumor immune response to hematologic and solid tumors through a novel mechanism of action.
最近在bioRXiv中發表的索奎替尼臨床前數據引起了人們對我們試驗的進一步興趣,該數據強調了ITK的選擇性抑制,透過一種新的作用機制增強對血液和實體瘤的抗腫瘤免疫反應。
Key takeaways from the publication are that soquelitinib, one, is a covalent, irreversible inhibitor that selectively binds to and inhibits ITK function while sparing other closely-related kinases, including resting lymphocyte kinase or RLK. Two, it leads to activation of cytotoxic killer cells, increasing infiltration of these cells into tumors. And three, it reduces and reverses T cell exhaustion, resulting in a more potent and prolonged immune response.
該出版物的主要結論是,soquelitinib 是一種共價、不可逆抑制劑,可選擇性結合併抑制 ITK 功能,同時不影響其他密切相關的激酶,包括靜息淋巴細胞激酶或 RLK。第二,它導致細胞毒性殺傷細胞的激活,增加這些細胞對腫瘤的浸潤。第三,它可以減少並逆轉 T 細胞的耗竭,從而產生更有效、更持久的免疫反應。
The effects on T cell exhaustion were unanticipated and address a major limitation of current immune-based therapies. T cell exhaustion often is a major cause of resistance to immune checkpoint therapy as well as CAR T cell therapies. We also found that soquelitinib inhibited Th2 T cell function in the production of Th2 cytokines, leading to Th1-skewing and the production of interferon gamma and tumor necrosis factor, which are important cytokines in tumor rejection.
對 T 細胞耗竭的影響是出乎意料的,並且解決了當前免疫療法的主要限制。 T 細胞耗竭通常是免疫檢查點療法和 CAR T 細胞療法產生抗藥性的主要原因。我們還發現,索奎替尼抑制 Th2 T 細胞產生 Th2 細胞因子的功能,導致 Th1 偏差以及乾擾素 γ 和腫瘤壞死因子的產生,這些是腫瘤排斥中重要的細胞因子。
The publication showed soquelitinib led to in vivo antitumor activity in several mouse tumor models, including colon, renal, melanoma, B and T cell tumors. Given its multipronged effects, we anticipate soquelitinib will have monotherapy activity as well as complement or synergize with other immune therapies such as checkpoint inhibitors.
該出版物表明,索奎替尼在多種小鼠腫瘤模型中具有體內抗腫瘤活性,包括結腸癌、腎癌、黑色素瘤、B 細胞和 T 細胞腫瘤。鑑於其多管齊下的作用,我們預計索奎替尼將具有單一療法活性,並與檢查點抑制劑等其他免疫療法相補充或協同。
We're excited by the mechanism studies and results described in the bioRXiv publication, and we are planning to initiate clinical studies to evaluate the ability of single agent soquelitinib to enhance immune responses to solid tumors. A protocol has now been developed, and our first indication will be in renal cell cancer patients in first or second relapse following frontline checkpoint inhibitor therapy.
我們對 bioRXiv 出版物中描述的機制研究和結果感到興奮,我們計劃啟動臨床研究來評估單藥 soquelitinib 增強實體瘤免疫反應的能力。目前已經制定了一項方案,我們的第一個適應症將是第一線檢查點抑制劑治療後第一次或第二次復發的腎細胞癌患者。
The primary objective of this study will be to evaluate antitumor activity. We have several reasons for starting with renal cell cancer to establish proof of principle, and we are planning for other solid tumors as well. The Kidney Cancer Research Consortium has expressed strong interest in soquelitinib and will lead this trial.
這項研究的主要目的是評估抗腫瘤活性。我們有幾個理由從腎細胞癌入手來建立原理證明,我們也在計劃其他實體瘤。腎癌研究聯盟對 soquelitinib 表達了濃厚的興趣,並將領導這項試驗。
Finally, we continue to develop our ITK inhibitor platform for potential use in autoimmune diseases based on the findings that soquelitinib inhibits Th2 and Th17 function and their secreted cytokines. These cytokines play a crucial role in many inflammatory diseases. So this approach represents a new idea in the treatment of immune diseases such as atopic dermatitis, asthma, fibrosis and many other autoimmune allergic diseases. We plan to publish preclinical data on the activity of soquelitinib in auto-immunoallergic diseases soon.
最後,基於 soquelitinib 抑制 Th2 和 Th17 功能及其分泌的細胞因子的發現,我們繼續開發 ITK 抑制劑平台,以用於自體免疫疾病。這些細胞激素在許多發炎性疾病中發揮著至關重要的作用。因此,這種方法代表了治療異位性皮膚炎、氣喘、纖維化和許多其他自體免疫過敏性疾病等免疫疾病的新想法。我們計劃很快發布索奎替尼在自體免疫過敏性疾病中的活性臨床前數據。
Turning to our partner-led programs, the Kidney Cancer Research Consortium is currently enrolling patients in a Phase Ib/II clinical trial evaluating ciforadenant, our adenosine 2a receptor inhibitor, as a potential first-line therapy for metastatic renal cell cancer in combination with ipilimumab and nivolumab. The Phase Ib safety portion of the trial has been successfully completed, and patients are currently being enrolled in the Phase II portion of the trial with no change in dosing.
至於我們的合作夥伴主導的項目,腎癌研究聯盟目前正在招募患者參加 Ib/II 期臨床試驗,評估我們的腺苷 2a 受體抑製劑 Ciforadenan 與 Ipilimumab 聯合作為轉移性腎細胞癌的潛在一線療法和納武單抗。該試驗的 Ib 期安全部分已成功完成,目前正在招募患者參加該試驗的 II 期部分,劑量沒有變化。
The clinical trial is expected to enroll up to 60 patients. And based on current time lines, we anticipate initial interim data before the end of 2023. You may recall that this study is based on our 2018 publication showing that the anti-CTLA-4 antibody was the best agent to combine with ciforadenant or other A2A antagonist.
該臨床試驗預計將招募多達60名患者。根據目前的時間線,我們預計在 2023 年底之前獲得初步中期數據。您可能還記得,這項研究基於我們 2018 年的出版物,表明抗 CTLA-4 抗體是與 ciforadenant 或其他 A2A 組合的最佳藥物對手。
In June, our team presented new preclinical data for ciforadenant at the Japanese Cancer Association and American Association for Cancer Research Precision Cancer Medicine International Conference. The presentation highlighted data supporting the synergy between ciforadenant and immune checkpoint blockade leading to a pro-inflammatory response. The data demonstrated the involvement of myeloid cells and that the combination of ciforadenant with immune checkpoint blockade leads to production of Th1 helper cells that promoted the production of several pro-inflammatory cytokines.
6月,我們的團隊在日本癌症協會和美國癌症研究協會精準癌症醫學國際會議上展示了ciforadenan的新臨床前數據。該演講強調了支持 Ciforadenan 和免疫檢查點阻斷之間協同作用導致促發炎反應的數據。數據證明了骨髓細胞的參與,而 Ciforadenan 與免疫檢查點阻斷的組合導致了 Th1 輔助細胞的產生,從而促進了幾種促炎細胞因子的產生。
This confirms our published earlier work in human clinical trials that found a myeloid gene expression signature as a biomarker for response. This biomarker called the adenosine gene signature is based on measuring the expression of 8 myeloid genes. We are encouraged by this preclinical data and look forward to sharing updates on our clinical trial by the end of the year.
這證實了我們早期發表的人體臨床試驗工作,即發現骨髓基因表現特徵作為反應的生物標記。這種稱為腺苷基因特徵的生物標記是基於測量 8 個骨髓基因的表達。我們對這些臨床前數據感到鼓舞,並期待在年底前分享我們臨床試驗的最新情況。
For mupadolimab, our partner, Angel Pharmaceuticals, is continuing to enroll patients in a Phase I/Ib clinical trial in China with mupadolimab alone and together with pembrolizumab in patients with non-small cell lung cancer and head and neck squamous cell cancers.
對於穆帕多利單抗,我們的合作夥伴安琪藥業正在中國繼續招募患者進行單一穆帕多利單抗以及與派姆單抗聯合治療非小細胞肺癌和頭頸鱗狀細胞癌患者的I/ Ib 期臨床試驗。
We made significant progress executing on our strategic initiatives in the second quarter of 2023. We remain focused on advancing ITK inhibition as a new approach to immunotherapy and look to extend the opportunity beyond lymphomas to a broad range of solid cancers and immune diseases.
我們在 2023 年第二季度的策略性舉措執行中取得了重大進展。我們仍然專注於推進 ITK 抑製作為一種新的免疫療法方法,並希望將機會從淋巴瘤擴展到廣泛的實體癌症和免疫疾病。
We have a number of key upcoming milestones for our clinical programs, which include continued enrollment in our Phase I/Ib trial of soquelitinib, meeting with the FDA this quarter to discuss a registration Phase III trial, initiation of the Phase I solid tumor monotherapy study of soquelitinib and interim data from the ciforadenant Phase II trial in frontline metastatic renal cell cancer.
我們的臨床計畫即將迎來許多重要的里程碑,其中包括繼續參加 soquelitinib 的 I/Ib 期試驗、本季度與 FDA 會面討論註冊 III 期試驗、啟動 I 期實體瘤單一療法研究soquelitinib 和來自前線轉移性腎細胞癌ciforadenan II 期試驗的中期數據。
Our programs provide us multiple opportunities to address significant patient needs in cancer and immune diseases. The multiple shots on goal give us significant optionality and the potential to efficiently build value for our shareholders. In closing, we look forward to providing updates on our programs in the coming quarters.
我們的計畫為我們提供了多種機會來滿足癌症和免疫疾病患者的重大需求。多次射門為我們帶來了巨大的選擇權和為股東有效創造價值的潛力。最後,我們期待在未來幾季提供我們計劃的最新資訊。
I will now turn the call over to the operator for Q&A. Operator?
我現在將把電話轉給接線員進行問答。操作員?
Operator
Operator
(Operator Instructions) The first question comes from Roger Song with Jefferies.
(操作員說明)第一個問題來自 Jefferies 的 Roger Song。
Roger Song - Equity Associate
Roger Song - Equity Associate
Great. Congrats for the -- on the progress. Maybe a couple of questions from us, Rich. So the first one for the new data from the Phase Ib/a/y, soquelitinib. The -- at ASH. So what should we expect to see in terms of the patient number or follow-up? Or any other new data points you will draw our attention to see at ASH?
偉大的。祝賀您的進展。里奇,也許我們會問幾個問題。第一個是 Ib/a/y 期新數據,soquelitinib。 ——在 ASH。那麼,從患者數量或追蹤情況來看,我們應該期待看到什麼?或者您會在 ASH 上引起我們注意的任何其他新數據點?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
So the ASH abstracts just went in a few days ago, as you know, and ASH meeting is not until December. So that's quite a ways away. I think that we'll update the data that we have at that time, which I would think would be another 10, 20 patients over what we reported on May 18. We're also doing a lot more of the, I would say, the laboratory relative work, which helps us not only for T-cell lymphoma, but for solid tumors as well. We'll likely update the Street before ASH on the progress of our Phase Ib trial, but I just mentioned the ASH meeting as something that most people know about. So we've been giving updates obviously very frequently at meetings and during these calls, so we'll continue to do that. But ASH meeting is a for sure meeting for us.
如您所知,ASH 摘要幾天前才發布,而 ASH 會議要到 12 月才召開。所以那還有很長的路要走。我認為我們將更新當時擁有的數據,我認為這將比我們 5 月 18 日報告的數據增加 10 到 20 名患者。我想說,我們還在做更多的事情,實驗室相關工作不僅對T細胞淋巴瘤有幫助,對實體瘤也有幫助。我們可能會在 ASH 之前向華爾街通報我們 Ib 期試驗的進展情況,但我剛剛提到 ASH 會議是大多數人都知道的事情。因此,我們顯然在會議和電話會議中非常頻繁地提供更新,因此我們將繼續這樣做。但 ASH 會議對我們來說肯定是一次會議。
Roger Song - Equity Associate
Roger Song - Equity Associate
Excellent. And then so in terms of the cifo, at the end of the year, you also will have the Phase II RCC data. A similar question. So what should we expect from there? What particularly -- what will be the potential next step after the data?
出色的。然後就 cifo 而言,到年底,您還將獲得 II 期 RCC 數據。類似的問題。那我們該期待什麼呢?特別是-數據公佈後下一步可能是什麼?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Well, Roger, I'm glad you asked that question because it gives me a chance to remind people that the cifo trial is -- ciforadenant, a small molecule oral A2A antagonist, is being combined with ipi and nivo in first-line renal cell cancer. Now the reason for combining it with ipi/nivo is twofold.
好吧,Roger,我很高興你問了這個問題,因為它讓我有機會提醒人們 cifo 試驗是——ciforadenan,一種小分子口服 A2A 拮抗劑,正在與 ipi 和 nivo 聯合用於一線腎細胞治療癌症。現在將其與 ipi/nivo 結合的原因有兩個。
One is ipi/nivo is showing in renal cell cancer a plateau on the curve, on the PFS curves. Early on, the PD-1 seem to be better. But there seems to be more durable, longer-term remissions with CTLA-4-containing regimens. So we and others are interested to see if we can increase the plateau on those curves. In other words, maybe cure more people. So that's one reason.
其中之一是 ipi/nivo 在腎細胞癌的 PFS 曲線上顯示出平台期。早期,PD-1 似乎更好。但含 CTLA-4 的治療方案似乎可以實現更持久、更長期的緩解。因此,我們和其他人有興趣看看我們是否可以增加這些曲線上的平台。換句話說,也許可以治癒更多的人。這就是原因之一。
The second reason that we're excited about this program is that we showed, and we now have very, very consistent data on this, that the best agent to combine with an adenosine antagonist, an A2A antagonist, is not an anti-PD-1 but an anti-CTLA-4. And I don't have time to go into the science behind that now, but it's pretty straightforward, I would say.
我們對這個計畫感到興奮的第二個原因是,我們表明,並且我們現在對此有非常非常一致的數據,與腺苷拮抗劑(A2A 拮抗劑)結合的最佳藥物不是抗 PD- 1而是抗CTLA-4。我現在沒有時間深入探討背後的科學原理,但我想說,它非常簡單。
CTLA-4 is the best agent scientifically, and our animal data published in 2018 showed that. So the trials that we're doing in frontline, although an open -- it is an open-label study, doesn't have a concomitant control. But we know very well work that's been done from MD Anderson and Vanderbilt in other sites that if you use as a response criteria what's called deep response, which is complete responses, plus partial responses that are more than 50% tumor regression, so-called deep responses correlate really well with PFS. And in a couple of different trials, deep response rate with ipi/nivo is 32%. So that's the number we're looking to beat. And I suspect that by the end of the year, I don't know, we'll probably have 20, 30 patients with some follow-up in that category, who have been treated and followed long enough to make that determination. Makes sense?
CTLA-4 是科學上最好的藥物,我們在 2018 年發布的動物數據表明了這一點。因此,我們在一線進行的試驗雖然是開放式的-開放標籤研究,但沒有伴隨對照。但我們非常清楚MD安德森和范德比爾特在其他網站所做的工作,如果你使用所謂的深度反應作為反應標準,即完全反應,加上腫瘤消退超過50%的部分反應,即所謂的深度反應。深度反應與 PFS 密切相關。在幾個不同的試驗中,ipi/nivo 的深度緩解率為 32%。這就是我們想要打破的數字。我懷疑,到今年年底,我不知道,我們可能會有 20 到 30 名對該類別的患者進行一些隨訪,他們已經接受了足夠長的治療和隨訪,足以做出決定。說得通?
Roger Song - Equity Associate
Roger Song - Equity Associate
Yes, absolutely. That's it.
是的,一點沒錯。就是這樣。
Operator
Operator
The next question comes from Aydin Huseynov with Ladenburg.
下一個問題來自拉登堡的艾丁·胡賽諾夫。
Aydin Huseynov - MD of Biotechnology Equity Research
Aydin Huseynov - MD of Biotechnology Equity Research
Congratulations on the progress this quarter. So a couple of questions for me. So you plan to meet with the FDA this quarter, which is within next several weeks. And the latest Phase Ib data for soquelitinib was May 18, so it's almost 3 months from now. And the kind of data that you're going to share with the FDA at that meeting, is it just the data before cutoff date of May 18? Or there will be something more than that because some time passed over that and you probably have some more responders or nonresponders? So I'm just curious the kind of data you're going to share with the FDA.
恭喜本季取得的進展。問我幾個問題。因此,您計劃在本季度(即接下來的幾週內)與 FDA 會面。而soquelitinib最新的Ib期資料是5月18日,距離現在已經快3個月了。您將在這次會議上與 FDA 分享的數據是 5 月 18 日截止日期之前的數據嗎?或者還會有更多的事情,因為一段時間過去了,您可能有更多的回應者或無回應者?所以我只是好奇你們會與 FDA 分享什麼樣的數據。
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Aydin, the data that's in our package that's been submitted to FDA contains pretty much the data to May 18. I'm not sure exactly. It might go a few days beyond that, but not very much. That package goes insignificantly in advance. But this package contains data at all the dose levels.
Aydin,我們提交給 FDA 的資料包中的資料幾乎包含截至 5 月 18 日的資料。我不太確定。可能會超出這個時間幾天,但不會太多。那個包裹提前了一點。但這個包包含所有劑量水平的數據。
Recall that what we presented at May 18 was the 200-milligram dose, our optimum dose. But we've shared with FDA now the entire study, the safety, efficacy, the follow-up, pharmacokinetics, biomarker data, basically everything, as well as our plans for Phase III, as well as our plans for subsequent studies. There are still some other preclinical studies that we would have to do. So that's what's in that package. I mean that's all pretty standard.
回想一下,我們在 5 月 18 日提供的是 200 毫克劑量,這是我們的最佳劑量。但我們現在已經與 FDA 分享了整個研究,包括安全性、有效性、隨訪、藥物動力學、生物標記數據,基本上所有內容,以及我們的 III 期計劃以及後續研究的計劃。我們還需要做一些其他的臨床前研究。這就是那個包包裡的東西。我的意思是這都是相當標準的。
Aydin Huseynov - MD of Biotechnology Equity Research
Aydin Huseynov - MD of Biotechnology Equity Research
Okay. Understood. Understood. All right. So given soquelitinib mechanism of action and given that this is actually independent of checkpoint inhibition, would you -- how would you evaluate the possibility of future use of soquelitinib ahead of PD-1/PD-L1, so if it's approved and sort of follow-on studies, follow-on sort of use in the future?
好的。明白了。明白了。好的。因此,考慮到 soquelitinib 的作用機制,並且考慮到這實際上獨立於檢查點抑制,您會如何評估未來在 PD-1/PD-L1 之前使用 soquelitinib 的可能性,所以如果它獲得批准並有點遵循-繼續研究,未來的後續使用?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
So our initial intent, of course, is to study it as a single agent, and we're studying it in renal cell cancer patients for a variety of reasons. Number one, renal is typically thought of as an immune responsive tumor, and these patients are all going to get a PD-1 upfront, and then they're going to relapse. So we're going to get a chance to study monotherapy with soquelitinib in patients who have failed the PD-1, who have relapsed. And so we'll be able to look at reasons for their failure to PD-1 and whether or not our monotherapy could rescue that. So we'll learn a lot from that. There'll be a bunch of biopsies incorporated into that.
當然,我們最初的目的是將其作為單一藥物進行研究,出於多種原因,我們正在腎細胞癌患者中研究它。第一,腎臟通常被認為是一種免疫反應性腫瘤,這些患者都會預先接受 PD-1 治療,然後他們就會復發。因此,我們將有機會研究 soquelitinib 單藥治療 PD-1 失敗且復發的患者。因此,我們將能夠研究他們未能接受 PD-1 治療的原因,以及我們的單一療法是否可以挽救這一局面。所以我們會從中學到很多。其中將包含大量活組織檢查。
Now the way our protocol -- the way this protocol I'm discussing is written. If a patient -- when a patient progresses on our monotherapy, we can add a PD-1 to it. Now there's good rationale to use a PD-1 together with soquelitinib, and the rationale is multifold.
現在我們的協議的方式——我正在討論的協議的編寫方式。如果患者—當患者在我們的單一療法中取得進展時,我們可以添加 PD-1。現在有充分的理由將 PD-1 與索奎替尼一起使用,而且理由是多方面的。
Number one, they're independent mechanism of actions. They have different effects on the immune system. Number two, exhaustion seems to be increasingly identified as a major mechanism of resistance to PD-1. So an -- the ITK inhibitor seems to prevent or reverse exhaustion, and we're getting a much better understanding of that. We think that's due to reduction of tonic T cell receptor signaling. And then the third reason is that ITK is actually involved in the PD-1/PD-L1 negative signal, and that is a very good reason for combining PD-1 and ITK inhibitor together.
第一,它們是獨立的行動機制。它們對免疫系統有不同的影響。第二,疲勞似乎越來越被認為是 PD-1 抗藥性的主要機制。因此,ITK 抑制劑似乎可以預防或逆轉疲勞,我們對此有了更好的了解。我們認為這是由於強直性 T 細胞受體訊號傳導的減少所致。第三個原因是ITK實際上參與了PD-1/PD-L1負訊號,這是將PD-1和ITK抑制劑結合在一起的一個很好的理由。
Let me say that again just so it's clear because it gets a little confusing. PD-1/PD-L1, of course, sends a negative signal to a T cell. An anti-PD-1 blocks that. Well, the PD-1/PD-L1 negative signal requires ITK. So if you were to block PD-1 or PD-L1, plus block ITK, you've totally incapacitated that negative signal, okay? So there are a lot of reasons to combine it with checkpoint blockade.
讓我再說一遍,這樣就更清楚了,因為這有點令人困惑。當然,PD-1/PD-L1 會向 T 細胞發送負面訊號。抗 PD-1 抗體可以阻止這種情況。那麼,PD-1/PD-L1 陰性訊號需要 ITK。因此,如果你要阻斷 PD-1 或 PD-L1,再加上阻斷 ITK,你就完全喪失了這個負面訊號的能力,好嗎?所以有很多理由將其與檢查站封鎖結合起來。
But I think that given that we've been studying it in T-cell lymphoma, and in T-cell lymphoma as a monotherapy, we see tumors regress. We see large tumors regress. We see them stay away for a long time. And it's not because ITK is in the tumor, it's because of the effect on the host immune response. So what we're seeing in T-cell lymphoma, we believe, will be directly transferable to our work in solid tumors. Is that clear?
但我認為,鑑於我們一直在 T 細胞淋巴瘤中研究它,並將 T 細胞淋巴瘤作為單一療法,我們看到腫瘤消退。我們看到大腫瘤消退。我們看到他們離開了很長一段時間。這並不是因為 ITK 存在於腫瘤中,而是因為它對宿主免疫反應有影響。因此,我們相信,我們在 T 細胞淋巴瘤中看到的結果將直接轉移到我們在實體腫瘤方面的工作。明白了嗎?
Aydin Huseynov - MD of Biotechnology Equity Research
Aydin Huseynov - MD of Biotechnology Equity Research
Understood. Yes, that's clear. But do you think that it is possible at all that soquelitinib will be used ahead of PD-1 in the future?
明白了。是的,這很清楚。但您認為索奎替尼未來有可能先於PD-1使用嗎?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
I think that's possible. I think that's possible. I mean I could see a scenario where you want to increase the T cells that migrate into the tumor, and then you want to add a PD-1 to perhaps prevent any negative PD-1/PD-L1 interaction. I think that's possible. In terms of the sequence of the drugs, that's something we're now actually testing in animal models.
我認為這是可能的。我認為這是可能的。我的意思是,我可以看到這樣一種情況:您想要增加遷移到腫瘤中的 T 細胞,然後您想要添加 PD-1,以防止任何負面的 PD-1/PD-L1 相互作用。我認為這是可能的。就藥物順序而言,我們現在正在動物模型中進行實際測試。
Aydin Huseynov - MD of Biotechnology Equity Research
Aydin Huseynov - MD of Biotechnology Equity Research
Okay. That's helpful. Are you aware of any other sort of earlier-stage competitors developing ITK inhibitors for either heme or solid tumors?
好的。這很有幫助。您是否知道還有其他類型的早期競爭對手正在開發針對血紅素或實體瘤的 ITK 抑制劑?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
I am not aware of any other ITK inhibitor that's in clinical trials. There have been -- and I'm glad you asked this question because there's a lot of confusion out there. There have been -- shortly after my team developed ibrutinib, which cross reacts with ITK, there were many people who said there's ITK inhibitors and so forth and so on. So a lot of people were claiming that, oh, they got drugs that block ITK.
我不知道有任何其他 ITK 抑制劑正在進行臨床試驗。我很高興你問這個問題,因為那裡有很多困惑。在我的團隊開發出與 ITK 交叉反應的依魯替尼後不久,很多人說有 ITK 抑制劑等等。所以很多人聲稱,哦,他們得到了阻斷 ITK 的藥物。
But that's not the issue or that's not the challenge. The challenge is to make an ITK inhibitor that doesn't hit any of those other kinases that are involved in T cell differentiation, the important one being RLK or resting lymphocyte kinase. To my knowledge, I don't know if any ITK inhibitor that hits only ITK and does not hit RLK or any of the other closely related.
但這不是問題,也不是挑戰。面臨的挑戰是製造一種 ITK 抑制劑,它不會攻擊任何參與 T 細胞分化的其他激酶,其中重要的一個是 RLK 或靜止淋巴細胞激酶。據我所知,我不知道是否有任何 ITK 抑制劑僅作用於 ITK 而不會作用於 RLK 或任何其他密切相關的藥物。
So for example, ibrutinib does hit ITK weekly, but it hits RLK really hard. So that's no good. You don't want that. So bottom line is, I believe, that soquelitinib is unique. And what's unique about it is the specificity for ITK and the sparing of the other kinases, specifically RLK. Now that didn't happen by accident. That's what the Corvus team set out to do when the company was founded. That was the strategy. We wanted to make an ITK inhibitor that was selective, especially with respect to RLK. That's a very challenging chemical problem, but we were successful doing it.
例如,依魯替尼確實每週都會影響 ITK,但它對 RLK 的影響非常嚴重。所以這樣不好。你不要這樣。所以我相信底線是索奎替尼是獨一無二的。它的獨特之處在於對 ITK 的特異性以及對其他激酶(特別是 RLK)的保留。現在這並不是偶然發生的。這就是 Corvus 團隊在公司成立時就打算做的事情。這就是策略。我們想要製造一種具有選擇性的 ITK 抑制劑,尤其是對於 RLK 而言。這是一個非常具有挑戰性的化學問題,但我們成功地做到了。
Now the reason that was our objective is because of genetic studies that were done in mice 20 years ago showing that if you selectively specifically knock out ITK, you get this Th2 blockade and Th1 skewing, which leads to greater antitumor activity. So our objective was a result of very selective genetic studies done a couple of decades ago. We were able to make the selectivity and, of course, now are moving it, advancing it in clinical trials.
我們的目標之所以如此,是因為20 年前在小鼠身上進行的基因研究表明,如果你選擇性地特異性敲除ITK,你就會得到Th2 阻斷和Th1 傾斜,從而產生更強的抗腫瘤活性。因此,我們的目標是幾十年前進行的非常選擇性的遺傳學研究的結果。我們能夠做出選擇性,當然,現在正在移動它,在臨床試驗中推進它。
The reason we started in T-cell lymphoma was because ITK is in T-cell lymphomas. That gave us an easy way to look at occupancy of the target in the tumor and so forth and so on. And also at the time we started, we didn't have as much information about solid tumors.
我們開始研究 T 細胞淋巴瘤的原因是因為 ITK 存在於 T 細胞淋巴瘤中。這為我們提供了一種簡單的方法來查看腫瘤中目標的佔據情況等等。而且在我們開始時,我們沒有那麼多關於實體瘤的資訊。
But really, there is no reason to think that the mechanism of action is restricted to T-cell malignancies. Having said that, T-cell malignancy is a good place to start. It's obviously an unmet need. Endpoints, especially in the relapse setting, occur quickly on the order of months, a few months.
但實際上,沒有理由認為其作用機制僅限於 T 細胞惡性腫瘤。話雖如此,T 細胞惡性腫瘤是一個很好的起點。這顯然是一個未被滿足的需求。終點,特別是在復發情況下,會在幾個月或幾個月內迅速發生。
So for competitive reasons, for clinical trial reasons, it's a good place to start. And we learned a lot about the biology of ITK. We're able to, I believe, get some good intellectual property around not only our drug but methods of use. And I think that we're in a really good position now from a competitive standpoint because we've really staked out a pretty significant territory in this space.
因此,出於競爭原因、臨床試驗原因,這是一個很好的起點。我們了解了很多關於 ITK 的生物學知識。我相信,我們不僅能夠圍繞我們的藥物,而且能夠圍繞使用方法獲得一些良好的智慧財產權。我認為從競爭的角度來看,我們現在處於非常有利的位置,因為我們確實在這個領域佔據了相當重要的領域。
Aydin Huseynov - MD of Biotechnology Equity Research
Aydin Huseynov - MD of Biotechnology Equity Research
This is super helpful. Just one last question for me. This is more like a general question. Would you consider selling your Angel Pharmaceuticals stake just to raise on that of capital and to be able to focus on the U.S. business? And if you do, how much would the value that stake in Angel Pharmaceuticals?
這非常有幫助。我還有最後一個問題。這更像是一個一般性問題。您是否會考慮出售您的 Angel Pharmaceuticals 股份,只是為了籌集資金並能夠專注於美國業務?如果你這樣做,持有天使製藥公司的股份價值多少?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
First of all, I want to start by saying we love Angel Pharmaceuticals. We have a great collaboration, and they're doing some great work over there, and it's certainly been a synergistic relationship.
首先,我想說我們熱愛安琪製藥。我們有很好的合作,他們在那裡做了一些很棒的工作,這當然是一種協同關係。
I mean would we consider it? Yes, of course, we would consider monetizing Angel in some way if that became necessary and if the terms were favorable. In fact, that was one of the strategies for starting Angel way back a couple of years ago when we started it. The reasons we did Angel were to facilitate our global development, to tap into rapidly emerging markets in China, to accelerate clinical development, et cetera, et cetera. But it also gave us another, if you will, financing vehicle, if necessary. So yes, we could do that. By the way, we own 49% of the stock in Angel. And so yes, we would consider that.
我的意思是我們會考慮嗎?是的,當然,如果有必要且條件有利的話,我們會考慮以某種方式將 Angel 貨幣化。事實上,這就是幾年前我們創辦 Angel 時的策略之一。我們做天使的原因是為了促進我們的全球發展,進入中國快速新興的市場,加速臨床開發等等。但如果你願意的話,它也為我們提供了另一種融資工具(如有必要)。所以是的,我們可以這樣做。順便說一下,我們擁有Angel 49%的股份。所以是的,我們會考慮這一點。
But how would we value it? Well, I would value it a lot more than most folks are. But the valuation of Angel when it was started, the company raised $41 million from some Chinese biotech pharma companies as well as some individuals, $41 million and had a post-money valuation of roughly $110 million, and that was 2 years ago. Since that time point, Angel now has 30 employees roughly, a laboratory facility and 2 clinical trials with both our ITK inhibitor and with mupadolimab going on. So we think it's a lot more valuable today than it was 2 years ago.
但我們要如何評價它呢?嗯,我會比大多數人更重視它。但Angel剛成立時的估值是,該公司從一些中國生物技術製藥公司以及一些個人那裡籌集了4100萬美元,4100萬美元,投後估值約為1.1億美元,那是兩年前的事了。自那時起,Angel 現已擁有約 30 名員工、一個實驗室設施和 2 項正在進行的 ITK 抑制劑和 mupadolimab 臨床試驗。所以我們認為今天它比兩年前更有價值。
Aydin Huseynov - MD of Biotechnology Equity Research
Aydin Huseynov - MD of Biotechnology Equity Research
Got it. Congratulations on the progress, and we look forward to the updates.
知道了。祝賀您取得了進展,我們期待著更新。
Operator
Operator
The next question comes from Li Watsek with Cantor Fitzgerald.
下一個問題來自 Li Watsek 和 Cantor Fitzgerald。
Rosemary Li - Research Analyst
Rosemary Li - Research Analyst
This is Rosemarie Li on for Li Watsek. So for soquelitinib and TCL, would you be able to clarify if the meeting with the FDA has been scheduled, if they are gating steps and if you have a plan to communicate feedback to the Street?
我是羅斯瑪麗·李(Rosemary Li),代表李·沃塞克(Li Watsek)發言。那麼對於 soquelitinib 和 TCL 來說,您能否澄清與 FDA 的會議是否已安排,它們是否是限制性步驟,以及您是否有計劃向華爾街傳達回饋?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Rosemarie, the meeting has been scheduled. A data package has been submitted. And yes, we would plan to give feedback to the Street.
羅斯瑪麗,會議已經安排好了。數據包已提交。是的,我們計劃向華爾街提供回饋。
Rosemary Li - Research Analyst
Rosemary Li - Research Analyst
Great. And then very quickly for your plan in solid tumors. Are you going to do any biomarker selection like you're doing for TCL? Or are you going to start off broadly?
偉大的。然後很快就可以製定實體瘤計劃。你們會像為 TCL 一樣進行生物標記選擇嗎?還是你打算從一個廣泛的角度開始?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
I think we'll start off broadly. We don't have ALC built into the protocol as it is currently developed or currently being developed. I don't think that's going to be an issue, though, because most of the patients -- this is a different disease, where the starting disease will be renal cell cancer in first or second relapse. Those patients are pretty immunocompetent. That's a lot different than our lymphoma patients who are incredibly suppressed. It's a very different kind of population, which is a very good point you're making.
我想我們將從一個廣泛的角度開始。我們沒有將 ALC 內建到協定中,因為它目前正在開發或正在開發。不過,我認為這不會成為問題,因為大多數患者 - 這是一種不同的疾病,其起始疾病將是第一次或第二次復發時的腎細胞癌。這些患者的免疫能力相當強。這與我們的淋巴瘤患者有很大不同,他們的病情受到極大的抑制。這是一種非常不同的人群,這是你提出的一個非常好的觀點。
Operator
Operator
(Operator Instructions) The next question comes from Jeff Jones with Oppenheimer.
(操作員說明)下一個問題來自傑夫瓊斯和奧本海默。
Jeffrey Michael Jones - Research Analyst
Jeffrey Michael Jones - Research Analyst
Congratulations on the quarter, guys. Just 2 questions for me. How much cash do you anticipate you'll need to complete the Phase III study as designed? And then can you share your current thinking on additional indications for the ITK program but in autoimmune and allergy and how you're thinking about this?
夥計們,恭喜這個季度。只要問我 2 個問題。您預計需要多少現金才能完成設計的 III 期研究?然後您能否分享一下您目前對 ITK 計劃的其他適應症(但在自身免疫和過敏方面)的想法以及您對此有何看法?
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Thank you, Jeff. Okay. Two questions. Let's start with the financial one. Let me have Leiv, our CFO, answer that.
謝謝你,傑夫。好的。兩個問題。讓我們從財務開始。讓我們的財務長 Leiv 來回答這個問題。
Leiv Lea - CFO
Leiv Lea - CFO
So Jeff, trial designed is about 150 patients randomized trial, and we project it will be conducted in about 40 centers internationally. The total cost of the trial itself, maybe $20 million, take about 2 years to enroll and complete
Jeff 設計的試驗是大約 150 名患者的隨機試驗,我們預計它將在國際上約 40 個中心進行。試驗本身的總成本可能為 2000 萬美元,註冊和完成大約需要 2 年時間
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Richard A. Miller - Co-Founder, President, CEO & Chairman of the Board
Okay. And in terms of autoimmunity and allergy, Jeff, we are very much into that. We are continuing to pursue various animal models. We actually have a protocol for atopic dermatitis that's being lined up. Probably wouldn't start that until early next year. There is an entire second- and third-generation program we have going on, where we're developing other ITK inhibitors with similar selectivity but with more propensity to affect, let's say, Th2 versus Th17 or Th1. We have some ideas that we could make even better compounds for allergy. And of course, we're also trying to deal with the issue of not wanting to have a cancer drug in an allergy or an autoimmune drug. We are aware and concerned about those pricing issues.
好的。在自體免疫和過敏方面,傑夫,我們非常關注這一點。我們正在繼續探索各種動物模型。實際上,我們正在製定針對異位性皮膚炎的治療方案。可能要到明年初才會開始。我們正在進行一個完整的第二代和第三代計劃,我們正在開發其他具有類似選擇性的 ITK 抑制劑,但與 Th17 或 Th1 相比,更傾向於影響 Th2。我們有一些想法可以製造出更好的抗過敏化合物。當然,我們也在努力解決不想使用抗過敏藥物或自體免疫藥物的問題。我們意識到並擔心這些定價問題。
But we think that given the technology and given the chemistry that we've established, that we can make drugs, ITK inhibitors, with more desired features, especially directed towards autoimmunity, particularly directed towards autoimmunity. So that's sort of our strategy. But listen, I mean as you well know, with potential upcoming Phase III trial, our ongoing ciforadenant study, solid tumor study, mupadolimab being done by Angel, we have a lot on our plate right now.
但我們認為,鑑於我們已經建立的技術和化學,我們可以製造具有更多所需功能的藥物、ITK 抑制劑,特別是針對自體免疫,特別是針對自體免疫。這就是我們的策略。但聽著,我的意思是,正如你們所知,隨著可能即將到來的 III 期試驗、我們正在進行的 ciforadenant 研究、實體瘤研究、Angel 正在進行的 mupadolimab,我們現在有很多工作要做。
There's no question that if we had more resources, we'd be in the clinic with allergy right now, allergy and autoimmunity right now. No question about that. But we just think that the cancer indications, especially for us, given that that's our expertise, we feel that that's a better investment for us at this time.
毫無疑問,如果我們有更多的資源,我們現在就會去診所治療過敏、過敏和自體免疫。毫無疑問。但我們只是認為癌症適應症,特別是對我們來說,鑑於這是我們的專業知識,我們認為目前這對我們來說是更好的投資。
No, that's okay. I see we have no more questions. First of all, I thank everyone for participating in this call. We look forward to updating you on future developments in our upcoming calls. Thank you very much, everyone.
不,沒關係。我發現我們沒有更多問題了。首先,我感謝大家參與本次電話會議。我們期待在即將召開的電話會議中向您通報未來的最新進展。非常感謝大家。
Operator
Operator
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,祝您有個愉快的一天。