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
Good afternoon, and welcome to Oncolytics Biotech second-quarter 2024 conference call.
下午好,歡迎參加 Oncolytics Biotech 2024 年第二季電話會議。
(Operator Instructions) Please be advised that this call is being recorded at the company's request.
(操作員說明)請注意,本次通話是應公司要求進行錄音的。
I would now like to turn the call over to Jon Patton, Director of Investor Relations and Communication.
我現在想將電話轉給投資者關係和溝通總監喬恩·帕頓 (Jon Patton)。
Please go ahead.
請繼續。
Jon Patton - Director of Investor Relations and Communication
Jon Patton - Director of Investor Relations and Communication
Thank you, operator.
謝謝你,接線生。
Earlier today, Oncolytics issued a press release providing recent operational highlights and financial results for the second quarter of 2024.
今天早些時候,Oncolytics 發布了一份新聞稿,提供了近期的營運亮點和 2024 年第二季的財務表現。
A replay of today's call will be available on the Events section of the Oncolytics website.
今天電話會議的重播將在 Oncolytics 網站的「活動」部分提供。
And after remarks from company management, we will open the call for Q&A.
在公司管理階層發表演說後,我們將開始問答環節。
As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of pelareorep, including statements regarding the company's mission, strategy, and milestones, the company's belief as of the potential and mechanism of action of pelareorep as a cancer therapeutic, our belief that we are positioned to execute on our key priorities and reach multiple milestones throughout the second half of the year and into 2025, our potential registrational opportunities for pelareorep, anticipated timing of the release of additional data, our cash runway, and other statements related to anticipated developments in the company's business.
謹此提醒,本次電話會議期間發表的各種言論包含與公司業務前景以及pelareorep 的開發和商業化相關的某些前瞻性陳述,包括有關公司使命、戰略和里程碑的陳述、公司對潛力和發展的信念。我們的現金跑道以及與公司業務預期發展相關的其他報表。
These statements are based on management's current expectations and beliefs and are subject to a number of factors, which involve known and unknown risks, delays, uncertainties, and other factors not under the company's control that may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or expectations implied by these forward-looking statements.
這些陳述是基於管理層當前的期望和信念,並受到許多因素的影響,其中涉及已知和未知的風險、延遲、不確定性以及公司無法控制的其他因素,這些因素可能會導致實際結果、績效或成就公司與這些前瞻性陳述所暗示的結果、績效或預期有重大差異。
In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that these statements or expectation or belief will be achieved.
在 Oncolytics 表達對未來結果的期望或信念的任何前瞻性聲明中,此類期望或信念是善意表達的,並被認為具有合理的基礎,但不能保證這些陳述或期望或信念將會實現。
These factors include results of current or pending clinical trials, risks associated with intellectual property production, financial projections, actions of regulatory agencies, and those other factors detailed in the company's filings with SEDAR and the SEC.
這些因素包括目前或即將進行的臨床試驗的結果、與智慧財產權生產相關的風險、財務預測、監管機構的行動以及公司向 SEDAR 和 SEC 提交的文件中詳細說明的其他因素。
Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
除適用法律要求外,Oncolytics 不承擔任何更新這些前瞻性聲明的義務。
Joining me to discuss the substantial progress we made during the second quarter are a few members of the management team, including Chair of Oncolytics Board of Directors and Interim CEO, Wayne Pisano; Chief Medical Officer; Dr. Tom Heineman; Chief Financial Officer, Kirk Look; Vice President, Business Development; Christophe Degois.
與我一起討論我們在第二季度取得的實質進展的是管理團隊的幾位成員,包括 Oncolytics 董事會主席兼臨時執行長 Wayne Pisano;首席醫療官;湯姆·海涅曼博士;首席財務官,Kirk Look;業務發展副總裁;克里斯多福·德古瓦.
And with that, it's my pleasure to turn the call over to Wayne.
至此,我很高興將電話轉給韋恩。
Wayne?
韋恩?
Wayne Pisano - President, CEO, Board Member
Wayne Pisano - President, CEO, Board Member
Thank you, Jon.
謝謝你,喬恩。
Good afternoon.
午安.
I appreciate everyone taking the time to join us today.
我感謝大家今天抽空加入我們。
While I know you are accustomed to our CEO, Matt Coffey, leading these presentations, personally, and on behalf of the Board, I'd like to wish Matt a swift recovery.
雖然我知道您已經習慣了我們的執行長 Matt Coffey 親自並代表董事會主持這些演講,但我還是祝 Matt 早日康復。
In the interim, the Board and I are highly confident in our tenured executive team's ability to continue executing our mission, achieve our strategic priorities and deliver on our long-term goals, and ultimately, bringing pelareorep to patients with cancer.
在此期間,董事會和我對我們的終身執行團隊有能力繼續執行我們的使命、實現我們的策略重點並實現我們的長期目標,並最終為癌症患者帶來 pelareorep 充滿信心。
Following my brief introduction, Tom will provide an update on the clinical advancements.
在我的簡短介紹之後,湯姆將提供有關臨床進展的最新資訊。
Christophe will discuss recent collaborations and partnership opportunities.
Christophe 將討論最近的合作和夥伴關係機會。
Kirk will review the financials.
柯克將審查財務狀況。
And finally, we will end by taking your questions.
最後,我們將回答大家的問題。
In the second quarter of 2024, we continue to make excellent progress in advancing our potentially leading immunotherapeutic agent, pelareorep, or pela, as we often refer to it.
2024 年第二季度,我們在推進我們潛在領先的免疫療法藥物 pelareorep 或我們經常提到的 pela 方面繼續取得出色進展。
We believe we are well positioned to execute on our key priorities and reach multiple milestones for the second half of the year and into 2025.
我們相信,我們有能力執行我們的關鍵優先事項,並在今年下半年和 2025 年實現多個里程碑。
Now before Tom provides a comprehensive update on our progress and our recent activities continue our mission to improve the lives of people with cancer, I would like to highlight a few important investments.
現在,在湯姆全面更新我們的進展以及我們最近的活動繼續我們改善癌症患者生活的使命之前,我想強調一些重要的投資。
Notably, we held an extremely productive Type C meeting with the FDA, and we are able to communicate what we consider to be the optimal path for pela in breast cancer going forward.
值得注意的是,我們與 FDA 舉行了一次非常有成效的 C 型會議,我們能夠傳達我們認為的 Pela 治療乳癌的最佳路徑。
With input from the agency, we were able to align our key elements for the next steps we plan to take and are bolstered by compelling data from two randomized breast cancer studies showing the benefit of pela combined with paclitaxel, compared with paclitaxel monotherapy.
根據該機構的意見,我們能夠調整我們計劃採取的後續步驟的關鍵要素,並得到兩項隨機乳腺癌研究令人信服的數據的支持,這些數據顯示與紫杉醇單一療法相比,pela 聯合紫杉醇的益處。
This gives us confidence in pela's potential to demonstrate a clinically meaningful benefit in a future registration-enabling study.
這讓我們相信 pela 有潛力在未來的註冊研究中證明具有臨床意義的益處。
Importantly, we remain on track to report overall survival results from the BRACELET-1 trial in the second half of 2024.
重要的是,我們仍有望在 2024 年下半年報告 BRACELET-1 試驗的整體存活結果。
Looking at the opportunity in pancreatic cancer, we dosed the first patient in the modified FOLFIRINOX cohort of the GOBLET study.
著眼於胰腺癌的機會,我們對 GOBLET 研究的改良 FOLFIRINOX 隊列中的第一位患者進行了給藥。
This represents an exciting opportunity to evaluate the combination of pela with another first-line pancreatic cancer chemotherapy regimen that could result in a second registration program in this indication.
這是一個令人興奮的機會來評估 pela 與另一種一線胰腺癌化療方案的組合,這可能會導致該適應症的第二個註冊計劃。
As you may recall, this opportunity came about as a result of positive data demonstrating that the combination of pela, atezolizumab, gemcitabine and nab-paclitaxel in pancreatic cancer patients more than double the tumor response rates compared to the response rates for chemotherapy treatment alone.
您可能還記得,這個機會的出現是因為積極的數據表明,與單獨化療治療的反應率相比,在胰腺癌患者中聯合使用pela、atezolizumab、吉西他濱和白蛋白結合型紫杉醇使腫瘤反應率提高了一倍以上。
That data set, not only garnered fast track designation from the FDA, but it also brought us through our collaboration with the Global Coalition for Adaptive Research, or GCAR, where this combination will be evaluated in an adaptive registration-enabling trial.
該資料集不僅獲得了 FDA 的快速通道指定,而且還使我們與全球適應性研究聯盟 (GCAR) 合作,該組合將在一項適應性註冊支援試驗中進行評估。
As we near a critical inflection point in the company's growth trajectory, we are encouraged by the recent regulatory and clinical progress and look forward to building on this momentum.
隨著我們接近公司成長軌蹟的關鍵拐點,我們對最近的監管和臨床進展感到鼓舞,並期待在此勢頭的基礎上再接再厲。
I would now like to turn the call over to Tom to provide a more detailed update.
我現在想將電話轉給湯姆,以提供更詳細的更新。
Tom?
湯姆?
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thank you, Wayne.
謝謝你,韋恩。
As a reminder, pela is an intravenously delivered immunotherapeutic agent that acts systemically, inducing anticancer immune responses and promoting an inflamed tumor phenotype that is turning cold tumors hot.
需要提醒的是,pela 是一種靜脈注射的免疫治療劑,可全身發揮作用,誘導抗癌免疫反應並促進發炎腫瘤表型,使冷腫瘤變熱。
This allows the antitumor immune cells induced by pela to attack the cancer.
這使得 pela 誘導的抗腫瘤免疫細胞能夠攻擊癌症。
As Wayne mentioned, we are currently focused on advancing pela towards registrational studies in breast and pancreatic cancer.
正如 Wayne 所提到的,我們目前的重點是推動 Pela 走向乳癌和胰臟癌的註冊研究。
We have exciting data in other indications like anal cancer that could eventually lead to additional registrational opportunities, but for today, we'll just focus on breast and pancreatic cancer.
我們在肛門癌等其他適應症方面擁有令人興奮的數據,這些數據最終可能會帶來更多的註冊機會,但今天我們將只關注乳腺癌和胰腺癌。
Starting with our breast cancer program, I'd like to touch on two topics: our recent productive Type C meeting with the FDA and the anticipated BRACELET-1 study survival results.
從我們的乳癌計畫開始,我想談談兩個主題:我們最近與 FDA 舉行的富有成效的 C 型會議以及預期的 BRACELET-1 研究生存結果。
In June, we provided a recap of our Type C meeting with the FDA.
6 月,我們回顧了與 FDA 的 C 類會議。
We had a very productive and helpful discussion with the agency that provided valuable guidance on our proposed registration-enabling study.
我們與該機構進行了非常富有成效和有益的討論,為我們擬議的註冊支持研究提供了寶貴的指導。
One perhaps underappreciated takeaway was that the FDA endorsed progression-free survival as the primary endpoint of the study with overall survival as the secondary endpoint.
一個可能被低估的結論是 FDA 認可無惡化存活期作為研究的主要終點,總存活期作為次要終點。
Having progression-free survival as the primary endpoint mirrors the path taken by Pfizer for the initial approval of IBRANCE based on the PALOMA-1 study and could save substantial development time by allowing us to reach the potential registrational endpoint sooner.
將無惡化存活期作為主要終點反映了輝瑞基於 PALOMA-1 研究初步批准 IBRANCE 所採取的路徑,並且可以讓我們更快地達到潛在的註冊終點,從而節省大量的開發時間。
The patient population for the registrational study is anticipated to include patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate therapy.
預計註冊研究的患者群體將包括荷爾蒙治療失敗且接受過不超過一種抗體藥物結合療法的患者。
Our derisked breast cancer program builds on compelling data and key learnings from two prior randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients who are treated with pela and paclitaxel compared to paclitaxel alone.
我們的無風險乳癌計畫建立在先前兩項隨機研究BRACELET-1 和IND-213 的令人信服的數據和關鍵知識的基礎上,這些研究證明,與單獨使用紫杉醇相比,接受pela 和紫杉醇治療的患者俱有臨床意義的益處。
I should also mention that we have translational data from the AWARE-1 study that provided valuable insights into pela's immune-mediated mechanism of action, including its ability to remodel the tumor microenvironment.
我還應該提到,我們有來自 AWARE-1 研究的轉化數據,這些數據為 pela 的免疫介導作用機制提供了寶貴的見解,包括其重塑腫瘤微環境的能力。
Aligning with the FDA on key design elements and objectives of our planned registrational trial marks a critical step toward bringing this innovative treatment to patients.
在我們計劃的註冊試驗的關鍵設計要素和目標上與 FDA 保持一致,標誌著我們向患者提供這種創新療法的關鍵一步。
Next, I'd like to move on to the anticipated BRACELET-1 survival data.
接下來,我想談談預期的 BRACELET-1 存活數據。
As a reminder, BRACELET-1 is a Phase 2 randomized study in patients with HR-positive/HER2-negative metastatic breast cancer.
提醒一下,BRACELET-1 是一項針對 HR 陽性/HER2 陰性轉移性乳癌患者的 2 期隨機研究。
The study enrolled 48 patients into three cohorts.
該研究將 48 名患者納入三個隊列。
Patients in Cohort 1 received paclitaxel, which served as the control arm.
第 1 組患者接受紫杉醇治療,作為對照組。
Patients in Cohort 2 received paclitaxel plus pela and patients in Cohort 3 received paclitaxel, pela and the checkpoint inhibitor, avelumab.
第 2 組患者接受紫杉醇加 pela 治療,第 3 組患者接受紫杉醇、pela 和檢查點抑制劑 avelumab。
We previously reported strong tumor response and progression-free survival results from the BRACELET-1 study.
我們先前報告了 BRACELET-1 研究的強烈腫瘤反應和無惡化存活結果。
These included a near tripling of the confirmed overall response rate, a greater than 50% improvement in median progression-free survival, and a hazard ratio of 0.29 for patients receiving pela and paclitaxel compared to paclitaxel alone.
其中包括確認的整體緩解率接近三倍、中位無惡化存活期提高超過 50%,以及與單獨使用紫杉醇相比,接受 Pela 和紫杉醇治療的患者的風險比為 0.29。
Overall survival results have not yet been reported due to ongoing patient follow-up that are anticipated later this year.
由於預計今年稍後正在進行的患者隨訪,總體生存結果尚未報告。
As noted, the earlier IND-213 study showed a statistically significant survival benefit in HR-positive/HER2-negative metastatic breast cancer patients who received the combination of pela and paclitaxel compared to paclitaxel alone.
如前所述,早期的 IND-213 研究顯示,與單獨使用紫杉醇相比,接受 Pela 和紫杉醇聯合治療的 HR 陽性/HER2 陰性轉移性乳癌患者俱有統計上顯著的生存獲益。
A strong overall survival readout in the pela, paclitaxel arm in the BRACELET-1 study will serve to further validate these earlier findings and support continuing discussions with potential strategic partners and regulators.
BRACELET-1 研究中 pela 紫杉醇組的強大總體生存率讀數將有助於進一步驗證這些早期發現,並支持與潛在戰略合作夥伴和監管機構的持續討論。
Now turning to our pancreatic cancer program.
現在轉向我們的胰臟癌計畫。
I'd like to start by highlighting our new GOBLET study cohort, which is supported by a $5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network, or PanCAN.
首先我想強調一下我們新的 GOBLET 研究隊列,該隊列得到了胰腺癌行動網絡 (PanCAN) 500 萬美元的治療加速器獎的支持。
PanCAN launched the Therapeutic Accelerator Award to speed up pancreatic cancer drug developments and new therapies could be made available to patients sooner.
PanCAN 設立了治療加速器獎,以加速胰臟癌藥物的開發,讓新療法能夠更快地提供給患者。
By way of background, the GOBLET study is a Phase 1/2 signal finding study in advanced or metastatic gastrointestinal cancers.
作為背景,GOBLET 研究是一項針對晚期或轉移性胃腸癌的 1/2 期訊號發現研究。
The study is being conducted across 17 centers in Germany and is being managed by AIO, a medical oncology working group within the German Cancer Society.
該研究在德國 17 個中心進行,並由德國癌症協會 (AIO) 內的腫瘤內科工作小組 AIO 管理。
To date, we have evaluated pela in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC, third-line metastatic colorectal cancer, and second-line or later anal cancer.
迄今為止,我們已經評估了 pela 治療一線轉移性胰腺導管腺癌 (PDAC)、第三線轉移性結直腸癌和二線或更晚的肛門癌的療效。
In each of these indications, the pela-based combination therapy met the prespecified success criteria.
在每一個適應症中,基於 Pela 的聯合療法都滿足了預先指定的成功標準。
Pancreatic cancer has one of the lowest survival rates among all cancers and is the third leading cause of cancer mortality in the US.
胰臟癌是所有癌症中存活率最低的癌症之一,也是美國癌症死亡率的第三大原因。
Despite its growing incidents, efforts to improve upon the standard of care has met with limited success over the past several years.
儘管事件不斷增加,但過去幾年改善護理標準的努力收效甚微。
In June, we announced the dosing of the first patient in our new GOBLET study cohort evaluating pela combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic PDAC patients.
6 月,我們宣布了新 GOBLET 研究隊列中第一位患者的給藥方案,該研究隊列評估了 pela 聯合改良 FOLFIRINOX 聯合或不聯合 atezolizumab 對新診斷的轉移性 PDAC 患者的療效。
This study utilizes a Simon two-stage design and the co-primary endpoints are objective response rate and safety.
本研究採用西蒙兩階段設計,共同主要終點為客觀緩解率與安全性。
If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm would be enrolled.
如果滿足第一階段的成功標準,一個或兩個治療組可能會擴展到第二階段,其中每組將招募 17 名額外的可評估患者。
The chemotherapy regimens of modified FOLFIRINOX and gemcitabine, nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer.
改良 FOLFIRINOX 和吉西他濱、白蛋白結合型紫杉醇的化療方案是轉移性胰臟癌最常見的兩種治療標準。
We previously reported that the combination of pela, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates more than double the historical results.
我們之前曾報道過,pela、吉西他濱、白蛋白結合型紫杉醇和 atezolizumab 的組合產生的腫瘤緩解率是歷史結果的兩倍以上。
Should the combination of pela and modified FOLFIRINOX also produce a positive outcome, it would indicate that an even broader range of metastatic PDAC patients may benefit from pela-based therapy.
如果 pela 和改良 FOLFIRINOX 的組合也能產生積極的結果,則表明更廣泛的轉移性 PDAC 患者可能會從基於 pela 的治療中受益。
Importantly, this treatment regimen could result in another registrational opportunity for pela in this challenging indication.
重要的是,這種治療方案可能會為 pela 在這項具有挑戰性的適應症中帶來另一個註冊機會。
While we believe there's an exciting opportunity for pela, combined with modified FOLFIRINOX, our immediate registrational strategy in PDAC continues to focus on pela combined with atezolizumab, gemcitabine, and nab-paclitaxel based on the very positive results from the GOBLET study.
雖然我們相信 pela 與改良版 FOLFIRINOX 結合存在令人興奮的機會,但基於 GOBLET 研究非常積極的結果,我們在 PDAC 中的直接註冊策略繼續側重於 pela 與 atezolizumab、吉西他濱和白蛋白結合型紫杉醇聯合用藥。
We continue to collaborate with GCAR to design a study utilizing an adaptive approach to evaluate this combination therapy, and we look forward to providing an update as our plans are finalized.
我們繼續與 GCAR 合作設計一項研究,利用適應性方法來評估這種聯合療法,我們期待在我們的計劃最終確定後提供最新資訊。
Before I turn the call over to Christophe, who will discuss our GCAR collaboration in more detail, I would like to briefly mention our two presentations at this year's ASCO meeting.
在我將電話轉接給 Christophe(他將更詳細地討論我們的 GCAR 合作)之前,我想簡要提及我們在今年的 ASCO 會議上的兩場演講。
Details of the trial design for our new GOBLET study pancreatic cancer cohort in which pela's combined with modified FOLFIRINOX were presented.
我們的新 GOBLET 研究胰腺癌隊列的試驗設計的詳細信息,其中 pela 與改良的 FOLFIRINOX 結合。
Additionally, we presented an abstract detailing pela's ability to induce the expansion of tumor-infiltrating lymphocytes, or TILs, across multiple cancers, including breast, pancreatic, and colorectal cancer.
此外,我們還提出了一份摘要,詳細介紹了 pela 在多種癌症(包括乳腺癌、胰腺癌和結直腸癌)中誘導腫瘤浸潤淋巴細胞 (TIL) 擴增的能力。
Pela's ability to expand TIL populations is important because TIL expansion correlates with tumor response.
Pela 擴大 TIL 群體的能力很重要,因為 TIL 擴大與腫瘤反應有關。
These data further highlight pela's immunotherapeutic mechanism of action and its promise as a backbone immunotherapy for multiple cancer indications.
這些數據進一步強調了 pela 的免疫治療作用機制及其作為多種癌症適應症的骨幹免疫療法的前景。
Taken together, we are extremely excited about the advancements across our pipeline and the growing body of clinical data showcasing pela's broad therapeutic potential.
總而言之,我們對整個產品線的進步以及越來越多的臨床數據顯示 pela 廣泛的治療潛力感到非常興奮。
With that, I will turn the call over to Christophe, who is joining us for the first time on a financial results call.
這樣,我將把電話轉給克里斯托夫,他是第一次參加我們的財務業績電話會議。
He will be heading up our business development efforts going forward and is here to discuss our recent collaborations and partnership opportunities.
他將領導我們未來的業務發展工作,並在此討論我們最近的合作和夥伴關係機會。
Christophe?
克里斯托夫?
Christophe Degois - Vice President, Business Development
Christophe Degois - Vice President, Business Development
Thank you, Tom.
謝謝你,湯姆。
I'm excited to join the team and see a real opportunity for pela and Oncolytics to make an impact in the treatment of cancer.
我很高興加入這個團隊,並看到 Pela 和 Oncolytics 在癌症治療方面發揮影響力的真正機會。
So I'm thrilled to be here.
所以我很高興來到這裡。
In the second quarter, we entered into a preliminary collaboration with GCAR, which we believe underscores the strength of the growing pela data set that continues to attract and pique the interest of the clinical oncology committee.
第二季度,我們與 GCAR 建立了初步合作,我們相信這突顯了不斷增長的 Pela 數據集的實力,該數據集繼續吸引並激起臨床腫瘤學委員會的興趣。
GCAR is a nonprofit corporation, uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech pharma companies, health authorities, and other key stakeholders in health care.
GCAR 是一家非營利公司,聯合了醫生、臨床研究人員、倡議和慈善組織、生物技術製藥公司、衛生當局和醫療保健領域的其他主要利益相關者。
GCAR's objective is to expedite the discovery and development of treatment for patients with rare and deadly diseases.
GCAR 的目標是加快罕見和致命疾病患者治療方法的發現和發展。
As a sponsor of innovative trials, including master protocols and adaptive platform trials, GCAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development.
作為創新試驗(包括主方案和適應性平台試驗)的贊助商,GCAR 致力於透過現代化臨床試驗來推動科學進步,支持更有效率、更低成本的藥物開發。
We are pleased to partner with GCAR and are honored that pela has been selected as the first therapeutic for evaluation in their planned adaptive trial in pancreatic cancer patients.
我們很高興與 GCAR 合作,並很榮幸在他們計劃的胰臟癌患者適應性試驗中,pela 被選為第一個進行評估的治療方法。
The selection process was thorough and involved meeting with and presenting our clinical data to multiple pancreatic cancer key opinion leaders.
選擇過程非常徹底,涉及與多位胰腺癌關鍵意見領袖會面並向其展示我們的臨床數據。
We are working together to finalize a Phase 2/3 master protocol design that will evaluate pela and other investigational therapies for the treatment of pancreatic cancer.
我們正在共同努力完成 2/3 期主方案設計,該設計將評估 pela 和其他治療胰腺癌的研究療法。
GCAR's anticipated trial design seeks to cut registrational study time and reduced trial costs, speeding up the journey to potentially deliver effective treatment -- cancer treatment sooner.
GCAR 預期的試驗設計旨在縮短註冊研究時間並降低試驗成本,從而加快可能提供有效治療(即癌症治療)的進程。
This strategy, which includes leveraging GCAR's extensive investigator network offers a cost-effective opportunity to enhance our ability to quickly and effectively advance the development of this pela-based combination therapy for metastatic pancreatic cancer, a disease with a very high unmet medical need and limited treatment options.
這項策略包括利用GCAR 廣泛的研究人員網絡,提供了一個具有成本效益的機會,以增強我們快速有效地推進這種基於Pela 的聯合療法的開發的能力,用於治療轉移性胰腺癌,這是一種醫療需求未被滿足的疾病非常高且有限的疾病。
Beyond GCAR, we intend to continue to seek strategic opportunities to collaborate and maximize the therapeutic and commercial potential of pela.
除了 GCAR 之外,我們打算繼續尋求策略合作機會,並最大限度地發揮 pela 的治療和商業潛力。
We have an ongoing dialogue with current and potential collaborators and believe additional data updates will continue to strengthen our value proposition.
我們與目前和潛在的合作者進行持續對話,並相信更多的數據更新將繼續加強我們的價值主張。
I will now turn the call over to Kirk to review the financial results for the second quarter of 2024.
我現在將電話轉給柯克,以審查 2024 年第二季的財務表現。
Kirk?
柯克?
Kirk Look - Chief Financial Officer
Kirk Look - Chief Financial Officer
Thanks, Christophe, and good afternoon, everyone.
謝謝克里斯托夫,大家下午好。
I'd like to briefly run through our financial results for the second quarter of 2024, which will be provided in Canadian dollars unless otherwise noted.
我想簡要介紹我們 2024 年第二季的財務業績,除非另有說明,否則將以加幣提供。
A full summary of our financial results can be found on the Investors section of our website under filings and reports or in the press release issued earlier this afternoon.
我們的財務表現的完整摘要可以在我們網站的投資者部分的文件和報告下或今天下午早些時候發布的新聞稿中找到。
We continue to be cognizant of our cash resources and make the necessary investments to progress pela's development, while ensuring we have funds needed to reach critical milestones.
我們將繼續關注我們的現金資源,並進行必要的投資以推進 Pela 的發展,同時確保我們擁有實現關鍵里程碑所需的資金。
As of June 30, 2024, the company reported $24.9 million in cash and cash equivalents with a projected cash runway into 2025.
截至 2024 年 6 月 30 日,該公司報告的現金和現金等價物為 2,490 萬美元,預計現金跑道持續到 2025 年。
Net cash used in operating activities for the six months ended June 30, 2024, was $14.3 million compared to $16.3 million for the six months ended June 30, 2023.
截至2024年6月30日止六個月經營活動使用的現金淨額為1,430萬美元,而截至2023年6月30日止六個月為1,630萬美元。
The change reflected non-cash working capital changes, partly offset by higher net operating activities in 2024.
這項變更反映了非現金營運資本變化,但部分被 2024 年淨營運活動增加所抵銷。
Now general and administrative expenses for the second quarter of 2024 were $3.4 million, consistent with $3.5 million for the second quarter of 2023.
目前,2024 年第二季的一般和管理費用為 340 萬美元,與 2023 年第二季的 350 萬美元一致。
Research and development expenses for the second quarter of 2024 were $4.6 million compared to $3.7 million for the second quarter of 2023.
2024 年第二季的研發費用為 460 萬美元,而 2023 年第二季的研發費用為 370 萬美元。
The increase was primarily due to higher clinical trial expenses, including BRACELET-1 data analysis, and the GCAR collaboration and higher share-based compensation expenses.
這一增長主要是由於臨床試驗費用增加,包括 BRACELET-1 數據分析、GCAR 合作以及股權激勵費用增加。
The increase was partly offset by lower production run and process and analytical development activities in manufacturing.
這一增長被製造業生產運作、製程和分析開發活動的減少所部分抵消。
The net loss for the second quarter of 2024 was $7.3 million compared to a net loss of $7.4 million for the second quarter of 2023.
2024 年第二季的淨虧損為 730 萬美元,而 2023 年第二季的淨虧損為 740 萬美元。
The basic and diluted loss per share was $0.10 per share in the second quarter of 2024 compared to a basic and diluted loss per share of $0.12 in the second quarter of 2023.
2024 年第二季的基本和稀釋每股虧損為 0.10 美元,而 2023 年第二季的基本和稀釋每股虧損為 0.12 美元。
Now this is an exciting time for the company.
現在對公司來說是一個令人興奮的時刻。
And as we conclude today's call, I would like to highlight a few critical events that we believe move us closer to our ultimate goal of regulatory approval for pela.
在我們結束今天的電話會議時,我想強調一些關鍵事件,我們認為這些事件使我們更接近監管部門批准 Pela 的最終目標。
In the second quarter of 2024, we continue to propel pela towards registration-enabling studies in breast and pancreatic cancer.
2024 年第二季度,我們將繼續推動 Pela 進行乳癌和胰臟癌的註冊研究。
We established a strategic collaboration with GGCAR and continue to have productive discussions with key opinion leaders, our clinical collaborators, and regulators.
我們與 GGCAR 建立了策略合作,並繼續與關鍵意見領袖、我們的臨床合作夥伴和監管機構進行富有成效的討論。
In summary, we received productive feedback from the Type C meeting with the FDA for our planned registration-enabling trial for pela in HR-positive/HER2-negative metastatic breast cancer and expect to provide further guidance on the path forward in the second half of the year.
總而言之,我們從與 FDA 舉行的 C 類會議中收到了富有成效的回饋,該會議計劃對 Pela 治療 HR 陽性/HER2 陰性轉移性乳癌進行註冊試驗,並期望為下半年的進展提供進一步的指導。那一年。
We continue following patients from the BRACELET-1 breast cancer study and remain on schedule to report overall survival data in the second half of this year.
我們繼續追蹤 BRACELET-1 乳癌研究的患者,並按計劃在今年下半年報告整體存活數據。
We entered into a collaboration with GCAR for inclusion of pela in an adaptive registration-enabling pancreatic cancer trial and expect to finalize the master protocol for pela, gemcitabine, nab-paclitaxel, and atezolizumab in the second half of 2024.
我們與 GCAR 合作,將 pela 納入一項支持適應性註冊的胰腺癌試驗,並預計在 2024 年下半年敲定 pela、吉西他濱、白蛋白結合型紫杉醇和 atezolizumab 的主方案。
With our collaborators, we then plan to initiate the adaptive registration-enabling trial in the first half of 2025.
然後,我們計劃與我們的合作者一起在 2025 年上半年啟動自適應註冊試驗。
We dosed the first patient in the new GOBLET modified FOLFIRINOX pancreatic cancer cohort supported by funding from PanCAN which could result in another registrational opportunity for pela.
我們在 PanCAN 的資助下對新的 GOBLET 改良 FOLFIRINOX 胰腺癌隊列中的第一位患者進行了給藥,這可能為 pela 帶來另一個註冊機會。
We expect to report a safety run-in update in the second half of the year.
我們預計將在今年下半年報告安全磨合更新。
Taken together, we believe our robust positive clinical and translational data support pela's MOA as an immunotherapeutic agent and potential to improve the lives of people with cancer.
總而言之,我們相信我們強大的積極臨床和轉化數據支持 pela 的 MOA 作為免疫治療劑以及改善癌症患者生活的潛力。
Before we conclude today's call, I would like once again to thank the entire Oncolytics team, our investors, and the many people who are supporting us along the way, including our patients and their families.
在結束今天的電話會議之前,我要再次感謝整個 Oncolytics 團隊、我們的投資者以及一路上支持我們的許多人,包括我們的患者及其家人。
With that, we are happy to take questions.
因此,我們很樂意回答問題。
Operator?
操作員?
Operator
Operator
(Operator Instructions) Louise Chen, Cantor.
(操作員說明)Louise Chen,Cantor。
Carvey Leung - Analyst
Carvey Leung - Analyst
Hi.
你好。
Good afternoon, everyone.
大家下午好。
This is Carvey on for Louise from Cantor.
這是卡維為來自康託的路易絲發言。
Thanks for taking our questions.
感謝您回答我們的問題。
First, can you remind us of the size of the commercial opportunity for pela in HR+/HER2- metastatic breast cancer?
首先,您能否提醒我們 pela 在 HR+/HER2- 轉移性乳癌中的商業機會有多大?
And second, what would your registration trial design look like?
其次,您的註冊試驗設計是什麼樣的?
Thank you.
謝謝。
Kirk Look - Chief Financial Officer
Kirk Look - Chief Financial Officer
Thanks for the questions, Carvey.
謝謝你的提問,卡維。
First, I'll turn it over to Christophe to speak to the market.
首先,我將把它交給 Christophe 來對市場發表演講。
Christophe Degois - Vice President, Business Development
Christophe Degois - Vice President, Business Development
Yes.
是的。
Hi.
你好。
Yeah.
是的。
I mean, as you may know, I mean, this is a very challenging environment with obviously some ADCs and HER2, in particular, making some -- obviously, some changing a lot this market and based on recent data.
我的意思是,正如您可能知道的那樣,我的意思是,這是一個非常具有挑戰性的環境,顯然有一些ADC 和HER2,特別是,根據最近的數據,製造了一些——顯然,一些改變了這個市場。
So we're currently in the process of updating the commercial opportunity.
因此,我們目前正在更新商業機會。
And I think in the next call, we'll be able to provide more detail.
我認為在下一次電話會議中,我們將能夠提供更多細節。
There's still a significant commercial opportunity.
仍然存在重大的商業機會。
If you think about the way HER2 is going to be used in these patients, obviously, they are going to -- they are not approved yet, but I think it's very likely that they would come right after the hormonal therapy.
如果你考慮 HER2 將如何用於這些患者,很明顯,他們將會——他們尚未獲得批准,但我認為他們很可能會在激素治療後立即使用。
But unfortunately, as you know, these patients will still relapse and you'll need a subsequent line of treatment.
但不幸的是,如您所知,這些患者仍然會復發,您將需要後續治療。
And we believe there is a significant commercial opportunity in HER2 failures.
我們相信 HER2 失敗蘊藏著巨大的商業機會。
And also, we need to consider the patient will not be eligible to HER2 because of very low HER2 levels or other condition that may prevent the use of an ADC with these patients.
此外,我們還需要考慮患者不符合 HER2 治療條件,因為 HER2 水平非常低或其他可能阻止對這些患者使用 ADC 的情況。
Kirk Look - Chief Financial Officer
Kirk Look - Chief Financial Officer
And I'll ask Tom to respond to that plan.
我會請湯姆對該計劃做出回應。
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Yes.
是的。
So we expect to move forward with our next trial in the form of a registration-enabling large Phase 2 study with a primary endpoint of progression-free survival and in the population that Christophe actually described, which is patients who have either failed antibody-drug conjugate therapy following progression on hormonal therapy, or patients for whom antibody drug conjugate therapy is inappropriate or who cannot tolerate such agents.
因此,我們希望以可註冊的大型 2 期研究的形式推進下一次試驗,其主要終點是無進展生存期,並且在 Christophe 實際描述的人群中進行,即抗體藥物治療失敗的患者激素治療進展後的綴合物療法,或抗體藥物綴合物療法不適合或無法耐受此類藥物的患者。
So we -- and this study would allow us with two opportunities to win if it meets a high level of significance for the investigational arm, it would put us in the position of applying for an accelerated approval.
因此,如果這項研究對研究部門具有高度意義,那麼我們將有兩次獲勝的機會,這將使我們能夠申請加速批准。
And at a very minimum, it would substantially derisk any subsequent trial that we would conduct to confirm the efficacy of the combination therapy.
至少,這將大大降低我們為確認聯合療法的療效而進行的任何後續試驗的風險。
Carvey Leung - Analyst
Carvey Leung - Analyst
Great.
偉大的。
Thank you so much.
太感謝了。
Operator
Operator
John Newman, Canaccord.
約翰紐曼,Canaccord。
John Newman - Analyst
John Newman - Analyst
Hello.
你好。
Thanks for taking my question.
感謝您提出我的問題。
I also had a question about the registration-enabling study for pelareorep in breast cancer.
我還有一個關於 pelareorep 治療乳癌的註冊研究的問題。
I'm assuming that most of the patients, if not all the patients, enrolling in the study will have previously been treated with an ADC.
我假設參加研究的大多數患者(如果不是全部患者)之前都接受過 ADC 治療。
Is there any specificity as to which ADC?
對於哪個 ADC 有任何特殊性嗎?
And then the second question that I had was just in terms of the geography of the study, would this be primarily a US-based study, would you also include patients from Europe?
然後我的第二個問題是關於研究的地理,這是否主要是基於美國的研究,是否也包括來自歐洲的病人?
Thanks.
謝謝。
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Yeah.
是的。
So John, I can -- it's Tom here, I can comment on that.
約翰,我可以——湯姆在這裡,我可以對此發表評論。
So I think the -- as Christophe said, the treatment approach in patients as it relates to the antibody drug conjugates is still evolving, right?
所以我認為——正如克里斯托夫所說,與抗體藥物偶聯物相關的患者治療方法仍在不斷發展,對嗎?
So I don't think anyone can say with precision exactly what proportion of patients in our study would have failed antibody-drug conjugate therapy, but I think it's very reasonable to assume that the majority of them would have received antibody drug conjugate therapy.
因此,我認為沒有人可以準確地說出我們研究中的患者中有多少比例會失敗抗體藥物結合療法,但我認為假設他們中的大多數人會接受抗體藥物結合療法是非常合理的。
There will be patients who are not appropriate for antibody drug conjugate therapy or who take it for a short period of time and cannot tolerate it.
有些患者不適合抗體藥物偶聯物治療,或服用時間較短且無法耐受。
So there will be patients who have -- who come into the study through other pathways.
因此,會有一些患者透過其他途徑進入研究。
But at present, the data that are available in the population we're looking at would suggest that the antibody drug conjugate therapy that would be most in play, that is to say the patient -- the therapy that patients would have failed before coming into our study would be in HER2, right?
但目前,我們正在研究的人群中可獲得的數據表明,抗體藥物結合療法將發揮最大的作用,也就是說,患者——患者在進入治療之前可能會失敗的治療我們的研究將在HER2 中進行,對嗎?
That's the agent for which the data currently exists, suggesting a solid benefit immediately following the failure of hormonal therapy.
這是目前存在數據的藥物,顯示在荷爾蒙治療失敗後立即有明顯的益處。
Oh, in the geography, yes, I'm sorry.
哦,在地理方面,是的,抱歉。
Yeah, this study -- we would anticipate that this study would be -- have a substantial enrollment in North America, of course, and we're currently evaluating possible other geography for enrollment.
是的,這項研究——我們預計這項研究將——在北美有大量的註冊對象,當然,我們目前正在評估其他地區可能的註冊情況。
It seems reasonable to expect that there would be sites in some of the major Western European countries, for example.
例如,預計在一些主要西歐國家將設立站點似乎是合理的。
And beyond that, we need to consider our option.
除此之外,我們還需要考慮我們的選擇。
John Newman - Analyst
John Newman - Analyst
Thank you.
謝謝。
Operator
Operator
Soumit Roy, Jones Research.
蘇米特·羅伊,瓊斯研究中心。
Soumit Roy - Analyst
Soumit Roy - Analyst
Good afternoon, everyone.
大家下午好。
Possibly a question for Tom.
可能是要問湯姆的問題。
BRACELET-1 trial, have you disclosed p-value or was it too small of a cohort size?
BRACELET-1 試驗,您是否揭露了 p 值,或者隊列規模是否太小?
And second question is for the Phase 2/3 registration trial in breast cancer, do you expect potentially a portion of patients being treated with ADC as the only major variable difference between BRACELET-1 and the Phase 2/3?
第二個問題是,對於乳癌 2/3 期註冊試驗,您是否預期一部分接受 ADC 治療的患者可能是 BRACELET-1 和 2/3 期之間唯一的主要變數差異?
Or do you see other changes could be there, differences between BRACELET and the Phase 2/3?
或者您認為 BRACELET 和 Phase 2/3 之間可能有其他變化嗎?
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Yeah.
是的。
So we have disclosed the p-value for the PFS comparison, okay?
所以我們已經揭露了 PFS 比較的 p 值,好嗎?
And the comparison -- the p-value for the comparison between paclitaxel and the paclitaxel plus pelareorep arm was 0.03. So it was less significant at less than the 0.05 level.
比較-紫杉醇和紫杉醇加 pelareorep 組之間的比較 p 值為 0.03。因此,在低於 0.05 的水平下,顯著性較低。
And with regard to the differences in the BRACELET population, yes, I mean, I think you're right, we would be enrolling patients in this study as discussed already who have failed ADC therapy, which were not enrolled in BRACELET because they simply did not exist at that time.
關於BRACELET 人群的差異,是的,我的意思是,我認為你是對的,正如已經討論的那樣,我們將在這項研究中招募ADC 治療失敗的患者,這些患者沒有參加BRACELET,因為他們只是這樣做了那時不存在。
But otherwise, the patient population would be essentially identical to the BRACELET patient population.
但除此之外,患者群體基本上與 BRACELET 患者群體相同。
Soumit Roy - Analyst
Soumit Roy - Analyst
A quick follow-up.
快速跟進。
Do you expect to do any sub-analysis separating out those patients with prior ADC in Phase 2/3 or are you thinking about
您是否希望在 2/3 期中進行任何子分析,將先前患有 ADC 的患者分離出來,或者您是否正在考慮
--
--
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Well, we haven't -- so we haven't formalized our analysis plans to that level, but I'm sure that we would be looking at any distinctions between significant population groups within any randomized study.
嗯,我們還沒有——所以我們還沒有將我們的分析計劃正式化到這個水平,但我確信我們會在任何隨機研究中研究重要人群之間的任何區別。
Soumit Roy - Analyst
Soumit Roy - Analyst
Thank you, again, and congrats on the progress.
再次感謝您,並祝賀您的進展。
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thank you.
謝謝。
Operator
Operator
Michael Okunewitch, Maxim Group.
邁克爾·奧庫內維奇,Maxim 集團。
Michael Okunewitch - Analyst
Michael Okunewitch - Analyst
Hey, guys.
嘿,夥計們。
Thank you for taking my question today.
感謝您今天回答我的問題。
I just want to see if you can help clarify the nature of the additional registrational opportunity that you're saying could emerge from Cohort 5 of the GOBLET study.
我只是想看看您是否可以幫助澄清您所說的 GOBLET 研究第 5 組中可能出現的額外註冊機會的性質。
Is there an expectation here that you could file for accelerated based on that data?
這裡是否期望您可以根據該數據申請加速?
Or are you referring to the ability to launch a second registrational study based on that data?
或者您指的是基於該數據啟動第二項註冊研究的能力?
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Yes.
是的。
So the data that we're generating in Cohort 5 of the GOBLET study, we view that as a kind of signal finding proof-of-concept data.
因此,我們在 GOBLET 研究的第 5 組中產生的數據,我們將其視為一種訊號查找概念驗證數據。
We would not expect that those data would support in and of themselves an accelerated approval.
我們預計這些數據本身不會支援加速批准。
However, as you know, we are planning to move forward with the other combination, the pela plus the gemcitabine, nab-paclitaxel in through the collaboration with GCAR, right, which is a -- which would be a registrational approach.
然而,如您所知,我們計劃透過與 GCAR 合作推進另一種組合,即 pela 加吉西他濱、白蛋白結合型紫杉醇(右),這是一種註冊方法。
And it is certainly possible if the Cohort 5 results look good and turn out the way we hope and expect they will, that combination could be evaluated, for example, in a platform study such as what we're doing with GCAR already or through some other mechanism.
如果第 5 組的結果看起來不錯並且按照我們希望和期望的方式發展,那麼當然有可能對這種組合進行評估,例如,在平台研究中,例如我們已經使用 GCAR 所做的事情或通過一些其他機制。
Michael Okunewitch - Analyst
Michael Okunewitch - Analyst
All right.
好的。
Thank you.
謝謝。
That's very helpful.
這非常有幫助。
And then one other for me, and I'll hop back in the queue.
然後再給我一張,然後我就會跳回隊列。
I wanted to see if you had any expectations on the size of the potential pivotal study in breast cancer that you need based on the prior PFS data that you haven't had for pela in this setting?
我想了解您是否對您需要的乳癌潛在關鍵研究的規模有任何期望,這些數據是基於您在這種情況下尚未獲得的 pela 之前的 PFS 數據?
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Yeah.
是的。
What we're looking at, I mean, the model that we're following is very similar to the approach that was used by Pfizer, for example, for their initial licensure of IBRANCE and then subsequently by Daiichi for the initial licensure of in HER2.
我的意思是,我們所遵循的模型與輝瑞公司使用的方法非常相似,例如,他們最初獲得 IBRANCE 許可,然後由 Daiichi 獲得 HER2 初始許可。
So what we'd be looking at would be a study of sub-200 patients, 180, 200 patients somewhere in that order of magnitude.
因此,我們將關注的是對 200 名以下患者、180 名、200 名類似數量級患者的研究。
Michael Okunewitch - Analyst
Michael Okunewitch - Analyst
All right.
好的。
Thank you very much and wishing for a speedy recovery for Matt.
非常感謝您並祝福馬特早日康復。
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Yeah.
是的。
Thank you.
謝謝。
Wayne Pisano - President, CEO, Board Member
Wayne Pisano - President, CEO, Board Member
Thank you.
謝謝。
Operator
Operator
Rahul Sarugaser, Raymond James.
拉胡爾·薩魯加瑟,雷蒙德·詹姆斯。
Rahul Sarugaser - Analyst
Rahul Sarugaser - Analyst
Good afternoon, gents.
下午好,先生們。
Thanks so much for taking our questions.
非常感謝您回答我們的問題。
And also, I'll just reiterate Jason's point about wishing a speedy recovery for Matt.
另外,我只是重申傑森關於祝福馬特早日康復的觀點。
But also following up from Jason's question, talking about the -- now that you're through the Type C meeting and you're looking at setting up this -- the breast cancer trial, these patients are effectively going to be second, third-line after HER2 hormonal or potentially an ADC.
但接著傑森的問題,談到——既然你已經參加了 C 型會議,並且你正在考慮建立這個——乳腺癌試驗,這些患者實際上將成為第二、第三—— HER2 激素或潛在的ADC 之後的線路。
So perhaps you can let us know, give us your -- give us a sense of your confidence on patient recruitment, the number of sites you'll need to be able to fill the study?
因此,也許您可以讓我們知道,讓我們了解您對患者招募的信心,以及您需要能夠完成研究的站點數量?
And how fast do you think you'll be able to recruit given that we think that that's going to be a relatively competitive patient group?
鑑於我們認為這將是一個相對有競爭力的患者群體,您認為您能夠多快招募?
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Thomas Heineman - Chief Medical Officer of Oncolytics Biotech (U.S.)
Well, I mean, I think that in -- that keep in mind that we are not -- for the breast cancer, the next study in breast cancer, we are not planning to compete within HER2, right?
嗯,我的意思是,我認為——請記住,我們不是——對於乳癌,下一項乳癌研究,我們不打算在 HER2 領域進行競爭,對嗎?
We would be coming in and recruiting patients who can either not receive in HER2, for example, or who have failed in HER2, right?
例如,我們會招募無法接受 HER2 治療或 HER2 治療失敗的患者,對嗎?
And for that -- for those groups, the only options really available are traditional chemotherapy for the large majority of those patients.
為此,對於這些群體來說,真正可用的唯一選擇是對大多數患者進行傳統化療。
And so actually, to the contrary, I suspect that there will be a pretty high demand for patients' participation in a study that offers something with a -- with clear early -- earlier data that improves upon standard of care chemo.
因此,實際上,相反,我懷疑患者參與一項研究的需求將會相當高,該研究提供了一些——有明確的早期——早期數據,可以改善化療的護理標準。
If you see what I'm saying, in other words, I think there will be plenty of patients who would be looking for better options than what would otherwise be available.
換句話說,如果你明白我所說的,我認為會有很多患者會尋找比其他方法更好的選擇。
So I would anticipate that the enrollment into the study would be reasonably straightforward.
因此,我預計該研究的註冊將相當簡單。
Rahul Sarugaser - Analyst
Rahul Sarugaser - Analyst
That's helpful really.
這真的很有幫助。
Thank you very much.
非常感謝。
That's very helpful.
這非常有幫助。
And now just as a follow-on, pivoting to the GOBLET study and PanCAN.
現在作為後續,轉向 GOBLET 研究和 PanCAN。
Could you perhaps give us a little sense for the destination at which point partners might be interested?
您能否讓我們了解一下合作夥伴可能感興趣的目的地?
Is there a set of outcomes or interim readout that you think would engender that interest?
您認為是否有一組結果或臨時報告會引起人們的興趣?
Kirk Look - Chief Financial Officer
Kirk Look - Chief Financial Officer
Yeah, Rahul, thanks for the question.
是的,拉胡爾,謝謝你的提問。
That's a challenging one.
這是一項具有挑戰性的工作。
Our expectation is on the pancreatic cancer side of things is that we will -- as we see the GCAR study, the first part of the adaptive design study readout is that we'll be able to leverage that and go out specifically with that information to speak to potential partners.
我們對胰臟癌的期望是,正如我們所看到的 GCAR 研究,適應性設計研究讀數的第一部分是,我們將能夠利用這一點,並專門利用這些資訊來與潛在的合作夥伴交談。
What we do find interesting on the Cohort 5 on the GOBLET side of things with the modified FOLFIRINOX combination is we think that, that can be quite interesting because if it shows some similar data as to Cohort 1 with the gem/nab-paclitaxel combination, we think that we have an opportunity to capture a large percentage of the pancreatic cancer treatment market in this particular stage.
我們確實對具有改良 FOLFIRINOX 組合的 GOBLET 方面的隊列 5 感興趣的是,我們認為,這可能非常有趣,因為如果它顯示與具有 gem/nab-紫杉醇組合的隊列 1 類似的數據,我們認為,在這個在特定階段,我們有機會佔領胰臟癌治療市場的很大一部分。
So we'll take advantage of that data in those results when they come out, and then we'll start to obviously outreach towards partners at that time.
因此,當這些結果出來時,我們將利用這些數據,然後我們將開始向合作夥伴伸出援手。
That said, though, prior to that data coming out, we will have -- and things are progressing as expected on the BRACELET overall survival analysis.
儘管如此,在數據公佈之前,我們將進行 BRACELET 總體生存分析,並且事情正在按預期進展。
And so that's happening much quicker.
所以這發生得更快。
And so we'll be looking to perform some meaningful outreach with that information in hand, subject to the results earlier than what we see out of the pancreatic cancer cohorts.
因此,我們將尋求利用現有的資訊進行一些有意義的推廣,但結果要早於我們從胰腺癌隊列中看到的結果。
Rahul Sarugaser - Analyst
Rahul Sarugaser - Analyst
Kirk, you answered my other question.
柯克,你回答了我的另一個問題。
So thanks very much, Kirk.
非常感謝,柯克。
Really appreciate it.
真的很感激。
Will get back in the queue and best wishes to Matt.
將回到隊列中並向馬特致以最良好的祝愿。
Kirk Look - Chief Financial Officer
Kirk Look - Chief Financial Officer
Thank you.
謝謝。
Operator
Operator
Thank you.
謝謝。
That concludes our conference -- I mean, the Q&A session for today.
我們的會議到此結束——我的意思是,今天的問答環節。
And I will now hand back the call to Kirk Look.
現在我將把電話交還給柯克·盧克。
Please go ahead, sir.
請繼續,先生。
Kirk Look - Chief Financial Officer
Kirk Look - Chief Financial Officer
Well, thank you, everyone, and for all that are participating in today's call and for your interest in Oncolytics' development.
好的,謝謝大家,感謝所有參加今天電話會議的人以及對 Oncolytics 開發的興趣。
We continue to be passionate about improving cancer treatment options for patients, and we're taking the necessary steps to bring pela to patients by working with our regulators, our clinical collaborators, and the investigators running our studies.
我們繼續熱衷於改善患者的癌症治療選擇,並且我們正在採取必要的措施,透過與監管機構、臨床合作者和進行研究的研究人員合作,將 Pela 帶給患者。
And we really look forward to our next opportunity to provide another update on our progress and sharing our plans for the rest of the year and into 2025.
我們非常期待下一次有機會再次介紹我們的進展情況,並分享我們今年剩餘時間和 2025 年的計劃。
I'll end our prepared remarks by wishing everyone a great evening.
我將透過祝大家有個美好的夜晚來結束我們準備好的演講。
Thanks very much.
非常感謝。
Operator
Operator
Thank you.
謝謝。
This concludes our conference for today.
我們今天的會議到此結束。
Thank you all for participating.
感謝大家的參與。
You may now disconnect your lines.
現在您可以斷開線路。