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Operator
Operator
Good afternoon.
午安.
We will begin the MacroGenics 2024 third-quarter corporate progress and financial results conference call in just a moment.
我們將立即開始 MacroGenics 2024 年第三季公司進展和財務業績電話會議。
(Operator Instructions)
(操作員指令)
At this point, I will turn the call over to Jim Karrels, Senior Vice President and Chief Financial Officer of MacroGenics.
現在,我將電話轉給 MacroGenics 資深副總裁兼財務長 Jim Karrels。
James Karrels - Chief Financial Officer, Senior Vice President, Corporate Secretary
James Karrels - Chief Financial Officer, Senior Vice President, Corporate Secretary
Thank you, operator.
謝謝您,接線生。
Good afternoon, and welcome to MacroGenics' conference call to discuss our third-quarter 2024 financial and operational results.
下午好,歡迎參加 MacroGenics 電話會議,討論我們 2024 年第三季的財務和營運業績。
For anyone who has not had the chance to review these results, we issued a press release this afternoon outlining today's announcements.
對於那些尚未有機會查看這些結果的人,我們今天下午發布了一份新聞稿,概述了今天的公告。
This release is available under the Investors tab on our website at macrogenics.com. You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed.
此新聞稿可在我們網站 macrogenics.com 的「投資者」標籤下找到。您也可以透過我們網站上的網路直播收聽本次電話會議,會議內容將在通話結束後約兩小時起存檔 30 天。
I would like to alert listeners that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995.
我想提醒聽眾,今天的討論將包括有關公司未來預期、計劃和前景的陳述,這些陳述構成 1995 年私人證券訴訟改革法安全港條款規定的前瞻性陳述。
Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our annual, quarterly and current reports filed with the SEC.
由於各種重要因素,包括我們向美國證券交易委員會提交的年度、季度和當前報告中「風險因素」部分中討論的因素,實際結果可能與這些前瞻性陳述所示的結果存在重大差異。
In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.
此外,任何前瞻性陳述僅代表我們截至今天的觀點,不應被視為代表我們在任何後續日期的觀點。
While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change, except to the extent required by applicable law.
雖然我們可能選擇在未來某個時間點更新這些前瞻性陳述,但我們明確表示不承擔任何義務,即使我們的觀點發生變化,除非適用法律要求。
And now I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of MacroGenics.
現在我想將電話轉給 MacroGenics 總裁兼執行長 Scott Koenig 博士。
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thank you, Jim.
謝謝你,吉姆。
I'd like to welcome everyone participating via conference call and webcast today.
我歡迎今天透過電話會議和網路廣播參加的所有人。
I will provide key updates on our clinical programs this afternoon.
今天下午我將提供有關我們臨床項目的重要更新。
But before I do so, let me first turn the call back to Jim, who will review our financial results.
但在此之前,我先把電話轉回給吉姆,他將審查我們的財務結果。
James Karrels - Chief Financial Officer, Senior Vice President, Corporate Secretary
James Karrels - Chief Financial Officer, Senior Vice President, Corporate Secretary
Thank you, Scott.
謝謝你,斯科特。
This afternoon, MacroGenics reported financial results for the quarter ended September 30, 2024, which highlights our financial position.
今天下午,MacroGenics 公佈了截至 2024 年 9 月 30 日的季度財務業績,突顯了我們的財務狀況。
As described in our release this afternoon, MacroGenics' total revenue was $110.7 million for the quarter ended September 30, 2024, compared to total revenue of $10.4 million for the quarter ended September 30, 2023.
正如我們今天下午的新聞稿中所述,MacroGenics 截至 2024 年 9 月 30 日的季度總收入為 1.107 億美元,而截至 2023 年 9 月 30 日的季度總收入為 1,040 萬美元。
The increase was primarily due to $100 million in milestones received from Incyte in August related to retifanlimab.
成長的主要原因是8月份從Incyte收到的與retifanlimab相關的1億美元里程碑付款。
Our research and development expenses were $40.5 million for the quarter ended September 30, 2024, compared to $30.1 million for the quarter ended September 30, 2023.
截至 2024 年 9 月 30 日的季度,我們的研發費用為 4,050 萬美元,而截至 2023 年 9 月 30 日的季度為 3,010 萬美元。
The increase was primarily due to increased research and development costs related to the company's preclinical ADC pipeline of vobra duo and the TAMARACK clinical trial.
成長的主要原因是公司 vobra duo 臨床前 ADC 管線和 TAMARACK 臨床試驗相關的研發成本增加。
Our selling, general and administrative expenses were $14.1 million for the quarter ended September 30, 2024, compared to $12.4 million for the quarter ended September 30, 2023.
截至 2024 年 9 月 30 日的季度,我們的銷售、一般和行政費用為 1,410 萬美元,而截至 2023 年 9 月 30 日的季度為 1,240 萬美元。
The increase was primarily due to increased stock-based compensation expense and professional fees.
成長的主要原因是股票薪酬費用和專業費用的增加。
Our net income was $56.3 million for the quarter ended September 30, 2024, compared to net income of $17.6 million for the quarter ended September 30, 2023.
截至 2024 年 9 月 30 日的季度,我們的淨收入為 5,630 萬美元,而截至 2023 年 9 月 30 日的季度的淨收入為 1,760 萬美元。
Net income for the quarter ended September 30, 2024, included the aforementioned $100 million in milestones from Incyte.
截至 2024 年 9 月 30 日的季度淨收入包括上述來自 Incyte 的 1 億美元里程碑。
Net income for the quarter ended September 30, 2023, included a $50 million milestone payment from Sanofi related to the previously disclosed achievement of a primary endpoint in a TZIELD clinical study, which was recorded in other income.
截至 2023 年 9 月 30 日的季度淨收入包括賽諾菲支付的 5000 萬美元里程碑付款,該付款與先前披露的 TZIELD 臨床研究主要終點的實現有關,該付款記錄在其他收入中。
Our cash, cash equivalents and marketable securities balance as of September 30, 2024, was $200.4 million compared to $229.8 million as of December 31, 2023.
截至 2024 年 9 月 30 日,我們的現金、現金等價物及有價證券餘額為 2.004 億美元,而截至 2023 年 12 月 31 日為 2.298 億美元。
The balance of September 30, 2024, did not include the $40 million upfront payment anticipated from the closing of the MARGENZA transaction or the $8 million amendment fee we plan to pay our current commercialization partner.
2024 年 9 月 30 日的餘額不包括 MARGENZA 交易結束後預計支付的 4000 萬美元預付款或我們計劃向當前商業化合作夥伴支付的 800 萬美元修改費。
Finally, in terms of our cash runway.
最後,就我們的現金流而言。
Consistent with our prior guidance, we anticipate that our cash, cash equivalents and marketable securities balance of $200.4 million as of September 30, 2024, plus the $40 million upfront payment anticipated from TerSera related to the MARGENZA transaction, less an $8 million amendment fee we expect to pay our current commercialization partner, in addition to projected and anticipated future payments from partners should provide a cash runway into 2026.
與我們先前的指引一致,我們預計截至2024 年9 月30 日的現金、現金等價物和有價證券餘額為2.004 億美元,加上TerSera 預計支付的與MARGENZA 交易相關的4000 萬美元預付款,減去我們預計的800 萬美元修改費預計支付給我們目前的商業化合作夥伴,此外,預計和預期的未來合作夥伴的付款應該能為 2026 年提供現金流。
Our anticipated funding requirements reflect expected expenditures related to the ongoing Phase 2 TAMARACK and LORIKEET studies as well as our other ongoing clinical and preclinical studies.
我們預期的資金需求反映了與正在進行的第 2 階段 TAMARACK 和 LORIKEET 研究以及我們正在進行的其他臨床和臨床前研究相關的預期支出。
And now I'll turn the call back to Scott.
現在我將把電話轉回給史考特。
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thank you, Jim.
謝謝你,吉姆。
We continue to believe our proprietary pipeline of product candidates has great promise, and I will walk you through each of our key programs.
我們始終相信,我們專有的候選產品線有著巨大的前景,我將帶您了解我們的每個關鍵項目。
Vobramitamab duocarmazine, or vobra duo, is our ADC designed to deliver a DNA-alkylating duocarmycin cytotoxic payload to tumors expressing B7-H3.
Vobramitamab duocarmazine 或 vobra duo 是我們的 ADC,旨在向表達 B7-H3 的腫瘤提供 DNA 烷基化 duocarmycin 細胞毒性有效載荷。
B7-H3 is a member of the B7 family of molecules involved in immune regulation.
B7-H3 是參與免疫調節的 B7 分子家族成員。
Vobra duo is designed to take advantage of this antigen's broad expression across multiple solid tumor types.
Vobra duo 的設計旨在利用這種抗原在多種實體腫瘤類型中的廣泛表現。
We continue to believe B7-H3 has the attributes of an ideal cancer target.
我們仍然相信 B7-H3 具有理想癌症標靶的屬性。
The TAMARACK Phase 2 study is being conducted in mCRPC patients who have previously received an androgen receptor access targeted agents and up to one prior taxane containing regimen, but no other chemotherapy.
TAMARACK 第 2 期研究正在針對先前接受過雄性激素受體標靶藥物治療和最多一種含紫杉烷方案但未接受過其他化療的 mCRPC 患者進行。
While study participants are no longer being dosed in the trial, participants continue to be monitored for adverse events, disease progression, and survival.
雖然研究參與者在試驗中不再接受劑量控制,但仍會持續監測參與者的不良事件、病情進展和存活。
The study's primary endpoint is radiographic progression-free survival, or rPFS.
研究的主要終點是放射學無惡化存活期(rPFS)。
Given that only 65 PSF events or 35.9% had accrued as of the July 9, 2024, data cutoff, the interim medium rPFS estimates presented at the ESMO Congress in September were immature.
鑑於截至 2024 年 7 月 9 日資料截止時僅發生了 65 起 PSF 事件(佔 35.9%),9 月在 ESMO 大會上提出的中期 rPFS 估計值尚不成熟。
And because these results were immature, we believe they are likely to change as additional events accrue.
由於這些結果尚不成熟,我們相信隨著更多事件的累積,它們可能會改變。
We expect to have mature median rPFS in hand no later than early 2025.
我們預計最遲在 2025 年初就能獲得成熟的中位數 rPFS。
Assessment of future development alternatives for vobra duo will be based on several factors, including the final TAMARACK safety and efficacy data in mCRPC, a review of the competitive treatment landscape for mCRPC, resource allocation across our clinical portfolio, as well as potential partnering opportunities for vobra duo.
對 vobra duo 未來開發替代方案的評估將基於幾個因素,包括 mCRPC 中 TAMARACK 的最終安全性和有效性數據、mCRPC 競爭治療前景的審查、我們臨床組合中的資源分配,以及潛在的合作機會你是二重唱。
Until we complete our assessment of the monotherapy development opportunity in mCRPC, we have paused our other development efforts in alternative tumor types as well as the Phase 1/2 dose combination study of vobra duo plus lorigerlimab.
在我們完成對 mCRPC 單一療法開發機會的評估之前,我們暫停了在其他腫瘤類型的其他開發工作以及 vobra duo 加 lorigerlimab 的 1/2 期劑量組合研究。
Recall that we have two other clinical molecules that target B7-H3.
回想一下,我們還有另外兩種針對 B7-H3 的臨床分子。
The first, MGC026, is an investigational ADC incorporating a novel topoisomerase 1 inhibitor-based linker payload, SYNtecan E, which we licensed from Synaffix.
第一個藥物 MGC026 是一種正在研究 ADC,它包含一種基於新型拓樸異構酶 1 抑制劑的連接體有效載荷 SYNtecan E,這是我們從 Synaffix 獲得的許可。
Our second additional B7-H3 directed molecule is enoblituzumab, the investigational Fc-optimized monoclonal antibody.
我們的第二種額外 B7-H3 定向分子是 enoblituzumab,一種正在研究的 Fc 優化單株抗體。
MGC026 incorporates a linker payload based on exatecan, a clinically validated and potent [camper] beacon that readily combines with Synaffix's hydrospace technology.
MGC026 包含基於 exatecan 的連接體有效載荷,exatecan 是一種經過臨床驗證的強效 [camper] 信標,可輕鬆與 Synaffix 的 hydrospace 技術結合。
We initiated a Phase 1 dose escalation study of MGC026 early this year in patients with advanced solid tumors.
我們今年稍早針對晚期實體瘤患者啟動了 MGC026 的 1 期劑量遞增研究。
The variable domain of the molecule targeting B7-H3 for MGC026 is the same sequence contained in vobra duo.
針對 MGC026 的 B7-H3 分子的可變域與 vobra duo 中所包含的序列相同。
We view the MGC026 as a complementary approach to vobra duo for targeting B7-H3.
我們認為 MGC026 是針對 B7-H3 的 vobra duo 的補充方法。
More specifically, we believe that having distinct mechanisms of action and potentially different safety and efficacy profiles, vobra duo and MGC026 may address different cancers, tumor stages or be used in combination with alternate agents or potentially with one another to enhance their clinical utility.
更具體地說,我們認為,由於具有不同的作用機制和潛在不同的安全性和有效性,vobra duo 和MGC026 可以針對不同的癌症、腫瘤階段,或與其他藥物聯合使用或潛在地相互使用以增強其臨床效用。
We remain confident in the potential of targeting the B7-H3 pathway regardless of the mechanism of action or payload.
無論作用機製或有效載荷如何,我們仍然對針對 B7-H3 通路的潛力充滿信心。
Regarding enoblituzumab, our academic collaborators are enrolling the HEAT study an investigator-sponsored, randomized Phase 2 study of this molecule in up to 219 men with prostate cancer.
關於恩布利珠單抗,我們的學術合作者正在招募 HEAT 研究,這是一項由研究者發起的隨機 II 期研究,對多達 219 名前列腺癌男性患者進行該分子試驗。
Next, I'll update you on lorigerlimab, our bispecific tetravalent PD-1 by CTLA-4 DART molecule.
接下來,我將向您介紹我們的雙特異性四價 PD-1 CTLA-4 DART 分子 lorigerlimab。
We designed lorigerlimab to have preferential blockade on dual PD-1 CTLA-4 expressing cells, such as tumor-infiltrating lymphocytes, or TILs, which are most abundant in the tumor microenvironment.
我們設計了 lorigerlimab 來優先阻斷雙重 PD-1 CTLA-4 表達細胞,例如腫瘤浸潤淋巴細胞或 TIL,這些細胞在腫瘤微環境中最為豐富。
We are enrolling the LORIKEET study, a randomized Phase 2 clinical trial of lorigerlimab, in combination with docetaxel versus docetaxel alone in second-line chemotherapy naïve and CRPC patients.
我們正在進行 LORIKEET 研究,這是一項隨機 2 期臨床試驗,旨在研究 lorigerlimab 聯合多西他賽與單獨使用多西他賽治療二線化療初治患者和 CRPC 患者。
The current study design includes the primary study endpoint of rPFS.
目前的研究設計包括 rPFS 的主要研究終點。
A total of 150 patients are planned to be treated in a 2:1 randomized study with more than 100 study participants enrolled to date.
計劃以 2:1 隨機研究的方式治療共 150 名患者,迄今已有 100 多名研究參與者。
We anticipate completing enrollment of the study late this year or early 2025 and providing a clinical data update on the study in the first half of 2025.
我們預計將於今年底或 2025 年初完成研究招募,並在 2025 年上半年提供該研究的臨床數據更新。
MGD024 is our next-generation bispecific CD123 by CD3 DART molecule that incorporates a CD3 component designed to minimize cytokine release syndrome while maintaining anti-tumor cytolytic activity and permitting intermittent dosing through a longer half-life.
MGD024 是我們下一代雙特異性CD123 CD3 DART 分子,它包含一個CD3 成分,旨在最大限度地減少細胞因子釋放綜合徵,同時保持抗腫瘤細胞溶解活性,並允許透過更長的半衰期進行間歇性給藥。
Our Phase 1 dose escalation study of MGD024 is ongoing in patients with CD123 positive relapsed or refractory hematologic malignancies, including acute myeloid leukemia and monodysplastic syndromes.
我們正在對患有 CD123 陽性復發或難治性血液系統惡性腫瘤(包括急性髓細胞白血病和單核細胞增生異常綜合徵)的患者進行 MGD024 的 1 期劑量遞增研究。
Recall that Gilead has the option to license MGD024 at predefined decision points during the Phase 1 study.
回想一下,吉利德可以選擇在第 1 階段研究期間的預定義決策點授權 MGD024。
MGC028 is our second topoisomerase 1 inhibitor-based ADC incorporating Synaffix's novel linker payload and an ADAM9 targeting antibody.
MGC028 是我們第二個基於拓樸異構酶 1 抑制劑的 ADC,結合了 Synaffix 的新型連接體有效載荷和 ADAM9 標靶抗體。
ADAM9 is a member of the Adams family of multifunctional type 1 transmembrane proteins that play a role in tumor genesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment.
ADAM9 是亞當斯家族多功能 1 型跨膜蛋白的成員,在腫瘤發生和癌症進展中發揮作用,並在多種癌症中過度表達,使其成為癌症治療的一個有吸引力的標靶。
We recently submitted an investigational new drug application for MGC028 to the US FDA.
我們最近向美國FDA提交了MGC028的新藥試驗申請。
Beyond MGC028, we are exploring additional molecules for potential future IND submission.
除了 MGC028 之外,我們還在探索其他分子以供未來提交 IND。
I look forward to telling you more about these additional molecules on future calls.
我期待在未來的電話會議中向您介紹更多有關這些附加分子的資訊。
Finally, after quarter end, we sold global rights to margetuximab, which is marketed as MARGENZA, to TerSera Therapeutics LLC, a privately held biopharmaceutical company, pursuant to an agreement announced a few weeks ago.
最後,根據幾週前宣布的一項協議,在季度末之後,我們向私營生物製藥公司 TerSera Therapeutics LLC 出售了以 MARGENZA 為商品名的 margetuximab 的全球權利。
TerSera is expected to pay us $40 million at closing, and we may receive additional sales milestone payments of up to an aggregate of $35 million.
TerSera 預計將在交易完成時向我們支付 4000 萬美元,我們還可能收到總計高達 3500 萬美元的額外銷售里程碑付款。
The transaction is expected to close in the fourth quarter of 2024, subject to customary closing conditions.
該交易預計將於 2024 年第四季完成,但須遵守慣例成交條件。
We expect to pay an $8 million amendment fee to our current commercialization partner during the fourth quarter of 2024, and will manufacture MARGENZA drug substance on behalf of TerSera going forward.
我們預計將在 2024 年第四季向我們目前的商業化合作夥伴支付 800 萬美元的修改費,並將在未來代表 TerSera 生產 MARGENZA 藥物成分。
The pending margetuximab transaction, as well as the recently received $100 million in milestones from Incyte, further strengthen our financial position, enabling us to sharpen our focus on our key priorities of advancing our clinical stage assets while researching and developing the next wave of early stage product candidates.
待定的 Margetuximab 交易以及最近從 Incyte 獲得的 1 億美元里程碑付款進一步增強了我們的財務狀況,使我們能夠更加專注於推進臨床階段資產的關鍵優先事項,同時研究和開發下一波早期階段產品候選。
Thank you all for joining today.
感謝大家今天的參加。
As you know, we announced last week that I will be stepping down as President and CEO early next year.
正如你們所知,我們上周宣布我將於明年初辭去總裁兼執行長一職。
After nearly 25 years with MacroGenics, it's truly a milestone for me personally and professionally.
在 MacroGenics 工作了近 25 年後,這對我個人和職業生涯來說確實是一個里程碑。
Together, we've transformed ideas into treatments, building a fully integrated biotech company dedicated to helping patients.
我們共同將創意轉化為治療方法,建立了一家致力於幫助患者的全面整合的生物科技公司。
I'm immensely proud of what we've achieved, particularly the advancement of therapeutics like MARGENZA, ZYNYZ, and TZIELD to FDA approval and our robust pipeline of antibody-based treatments.
我為我們所取得的成就感到無比自豪,特別是 MARGENZA、ZYNYZ 和 TZIELD 等療法獲得 FDA 批准,以及我們強大的基於抗體的治療方法。
This transition comes at a time when MacroGenics is strongly positioned with a diverse and promising development portfolio and a solid financial foundation.
此次轉型正值 MacroGenics 憑藉多元化、前景看好的開發組合和堅實的財務基礎而佔據強勢地位之際。
The Board has initiated a thoughtful search for my successor, and I am committed to supporting the company during this period to ensure a seamless transition.
董事會已開始深思熟慮地尋找我的繼任者,我承諾在此期間支持公司,確保順利過渡。
Looking ahead, I am confident in MacroGenics' future.
展望未來,我對 MacroGenics 的未來充滿信心。
Our near-term goals remain unchanged: advancing our pipeline, expanding partnerships, and creating value for patients and shareholders alike.
我們的近期目標保持不變:推進我們的產品線,擴大合作夥伴關係,為病患和股東創造價值。
I want to thank the MacroGenics team, our Board, our shareholders and our partners for their dedication.
我要感謝 MacroGenics 團隊、董事會、股東和合作夥伴的奉獻精神。
I look forward to continuing my support as an adviser and shareholder, and I'm excited to see all that MacroGenics will accomplish in its next chapter.
我期待以顧問和股東的身份繼續提供支持,並很高興看到 MacroGenics 在新篇章中取得的所有成就。
We would now be happy to open the call for questions.
我們現在很高興開始回答問題。
Operator?
操作員?
Operator
Operator
(Operator Instructions) Tara Bancroft, TD Cowen.
(操作員指示)Tara Bancroft,TD Cowen。
Nicholas Lorusso - Analyst
Nicholas Lorusso - Analyst
This is Nick on for Tara.
這是尼克 (Nick) 代替塔拉 (Tara)。
Just one for me, but I understand the parameters factoring into your excision will be multiple for this.
對我來說只有一個,但我知道影響你切除的參數會有多個。
But what do you need to specifically see from the data next year to make a decision about going forward or not for vobra duo?
但是,您需要從明年的數據中具體看到什麼才能決定是否繼續使用 vobra duo?
And do you have any updated thoughts on the potential dose at this point?
現在您對潛在劑量有什麼最新的想法嗎?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thank you very much, Nick.
非常感謝,尼克。
As we said, we are close to getting the final data.
正如我們所說,我們即將獲得最終數據。
As we've noted, we continued the observation of these patients post the last dosing, which occurred in July.
正如我們所注意到的,我們在 7 月最後一次給藥後繼續觀察這些患者。
The patients will be followed no longer than six more months.
對患者的追蹤時間將不會超過六個月。
As I pointed out, the number of parameters to look at, obviously, looking at the final rPFS, looking at the safety profile of the drug, looking at the competitive landscape and assessing this in the context of other things we have in our portfolio.
正如我指出的那樣,需要查看的參數數量顯然包括最終的 rPFS、藥物的安全性、競爭格局,並根據我們產品組合中的其他內容進行評估。
It's just too early at this point to give the specific parameters which will determine next steps forward.
目前給出決定下一步行動的具體參數還為時過早。
So be patient, and we should be able to provide some insights in the coming months.
所以請耐心等待,我們應該能夠在接下來的幾個月內提供一些見解。
Nicholas Lorusso - Analyst
Nicholas Lorusso - Analyst
Thank you very much.
非常感謝。
Operator
Operator
Jonathan Chang, Leerink Partners.
Jonathan Chang,Leerink Partners。
Jonathan Chang - Analyst
Jonathan Chang - Analyst
And of course, best wishes to Scott.
當然,我也向斯科特致以最良好的祝愿。
First question, on that point, can you provide any color around the search process for the next CEO?
第一個問題,關於這一點,您能否詳細介紹下一任執行長的搜尋過程?
And how we should be thinking about timelines for the transition?
我們應該如何考慮過渡的時間表?
And then second question, on MGC026, your second B7-H3 ADC program.
然後是第二個問題,關於 MGC026,您的第二個 B7-H3 ADC 程式。
Can you discuss how the Phase 1 dose escalation is progressing?
能討論一下第一階段劑量遞增的進展嗎?
And when could investors see initial clinical data from that program?
投資者何時可以看到該項目的初步臨床數據?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
First, Jonathan, thank you very much.
首先,喬納森,非常感謝你。
It's always been a pleasure working with you.
與您共事一直是一件愉快的事。
In terms of the search process, as the announcement occurred last week, there is a subgroup of the Board that has been selected to initiate the process while a search committee is going to be working with an outside firm.
就搜索過程而言,正如上周宣布的那樣,董事會已經選出一個小組來啟動這一流程,同時搜索委員會將與外部公司合作。
And that process is just getting started.
而這一進程才剛開始。
The expectations, as I said, is that I will stay on.
正如我所說,我們希望我能繼續留任。
We're going to continue with the strategy we have adopted and move the programs forward until the new CEO is selected.
我們將繼續執行已採取的策略並推進這些項目,直到選出新的執行長。
It's anticipated.
這是預料之中的。
Obviously, these things take a few months.
顯然,這些事情需要幾個月的時間。
I will stay on until the new CEO is selected so there should be a smooth hand off to anyone when that person comes on board.
我會一直留任,直到新任執行長選出,這樣當新人上任時,應該可以順利交接。
With regard to the 026 study, we're in the middle of dose escalation.
關於026研究,我們正處於劑量遞增的過程中。
The study is going quite well.
學習進展順利。
We're getting into ranges right now.
我們現在正進入範圍。
We're -- one might anticipate the beginning of responsiveness.
我們 — — 人們可能預見到反應能力的開始。
The expectation here is that we would begin -- we would complete this study in '25 and be able to report the data out in '25.
我們的預期是,我們將在 25 年開始——我們將在 25 年完成這項研究,並能夠在 25 年報告數據。
Operator
Operator
Yigal Nochomovitz, Citi.
花旗的 Yigal Nochomovitz。
Unidentified Participant
Unidentified Participant
This is [Reena] on for Yigal.
這是 Yigal 的 [Reena]。
I just wanted to ask what kind of triggered the decision to [help] the combo now versus earlier when the decision was seen to stop dosing patients in TAMARACK?
我只是想問一下,是什麼促使您現在做出幫助該組合的決定,而不是之前決定停止為 TAMARACK 的患者用藥?
And if you could provide any more details on the color on pausing the [lorigerlimab] combo with [vobra], how many patients were dosed?
如果您能提供有關暫停 [lorigerlimab] 與 [vobra] 組合治療的更多詳細信息,有多少患者接受了治療?
Were there any [service what we've] seen in the [vobra] monotherapy?
在 [vobra] 單一療法中我們看到了什麼 [服務] 嗎?
Or just any additional color you might have there?
或者只是您可能擁有的任何其他顏色?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thank you very much for the question.
非常感謝您的提問。
As you know, we had proceeded with the combo study to the point where we were very comfortable with the doses that were achieved in the populations we were examining with the individual lorigerlimab and vobra in combination.
如您所知,我們已經進行了組合研究,我們對使用單獨的 lorigerlimab 和 vobra 組合治療所研究的人群中所達到的劑量非常滿意。
However, as we pointed out, is that we are looking at the final data for TAMARACK coming up in the next couple of months.
然而,正如我們所指出的,我們正在查看未來幾個月內即將公佈的 TAMARACK 最終數據。
We would look at the possibility of exploring additional studies in vobra to fine-tune that, if appropriate.
如果合適的話,我們會考慮在 vobra 中探索其他研究來對其進行微調。
And therefore, rather than continue moving forward and expansions with the doses that we had already tested in combination, we wanted to get that final assessment of the appropriate vobra dose before we would then explore combinations going forward.
因此,我們不想繼續推進和擴大已經測試過的組合劑量,而是想在探索進一步的組合之前對適當的 vobra 劑量進行最終評估。
So it's a judgment that we want to ultimately have the best dose going forward if we continue combination studies.
因此,如果我們繼續進行聯合研究,我們希望最終獲得最佳劑量。
Unidentified Participant
Unidentified Participant
Okay.
好的。
That makes sense.
這很有道理。
Operator
Operator
Etzer Darout, BMO Capital Markets.
Etzer Darout,BMO資本市場。
Etzer Darout - Analyst
Etzer Darout - Analyst
Just one question for me on MGC026.
我只想問一個關於 MGC026 的問題。
Just wonder, given now you've evaluated vobra duo preclinically and in the clinic.
只是好奇,鑑於您現在已經在臨床前和臨床上對 vobra duo 進行了評估。
You've gotten a preclinical assessment of MGC026.
您已獲得 MGC026 的臨床前評估。
If you're seeing any notable differences in the profile for those two ADCs from a safety perspective and how that profile could be differentiated from vobra on sort of safety?
如果您從安全角度看到這兩個 ADC 的設定檔有任何顯著差異,那麼該設定檔在安全性方面如何與 vobra 區分開來?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thanks, Etzer.
謝謝,Etzer。
One would expect that, obviously, with vobra being a DNA-alkylating agent and the 026 being a Topo 1 inhibitor, one will see distinct safety profiles.
顯然,我們可以預料到,由於 vobra 是一種 DNA 烷化劑,而 026 是一種 Topo 1 抑制劑,因此我們會看到不同的安全特性。
As I've said, we want to get the final safety.
正如我所說,我們希望獲得最終的安全。
We obviously achieved much with the TAMARACK study with lowering the doses there.
我們在 TAMARACK 研究中顯然取得了很大成果,降低了那裡的劑量。
But at this point, being only in the middle of dose escalation on 026, I can't give you a side-by-side comparison of the two.
但目前,由於 026 的劑量還處於增加階段,我無法將兩者進行並排比較。
There will be a distinct differences in safety, but it's just too early to spell out the specifics at this point.
安全性方面會有明顯的差異,但現在說出具體細節還為時過早。
Operator
Operator
Jon Miller, Evercore ISI.
喬恩·米勒,Evercore ISI。
Jonathan Miller - Analyst
Jonathan Miller - Analyst
And I'll echo my respect for Scott, and as you've heard before, great to work with you for all these years.
我也會表達對斯科特的敬意,正如你之前聽到的,這麼多年來很高興與你共事。
I'd also love to ask about the vobra lori combo that you're pausing.
我還想問一下您暫停的 vobra lori 組合。
How many patients have you dosed there?
您在那裡給多少病人使用藥物?
How much data do you have?
你有多少數據?
And is there any chance we could see that data?
我們有機會看到這些數據嗎?
Maybe around the same time that lori is coming out or in the near term at any rate?
也許和 lori 推出的時間差不多,或至少在近期?
And maybe from a LORIKEET perspective, how do you view the landscape for lori combinations going forward from here, whether it's with vobra duo or with other ADCs in prostate?
也許從 LORIKEET 的角度來看,您如何看待未來 lori 組合的前景,無論是與 vobra duo 還是與前列腺中的其他 ADC?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Yes.
是的。
Thanks so much, Jon.
非常感謝,喬恩。
I really appreciate the personal comments.
我非常感謝您的個人評論。
It is a pleasure to be working with you and your colleagues as well.
我很高興能與您和您的同事一起工作。
With regard to the number of patients, we did many -- and the actual specific numbers, I can't answer to you off the top of my head but is in the double digits.
關於患者的數量,我們治療了許多患者,至於實際的具體數字,我無法立刻回答您,但肯定是兩位數。
In terms of looking at multiple doses, this was a 3 plus 3 assessment at various combinations.
從多劑量角度來看,這是針對不同組合的 3+3 評估。
But of course, because we were enrolling patients with different tumor types, the representation of any particular tumor type was quite small.
但當然,因為我們招募了不同腫瘤類型的患者,所以任何特定腫瘤類型的代表性都非常小。
So at this point, we haven't assessed the form of presenting the data we have there is more likely that, as I said earlier, we want to assess the final results of TAMARACK, make some decisions, whether we need further alterations of the vobra dosing if we continue with the combination studies going forward.
因此,目前我們還沒有評估呈現資料的形式,更有可能的是,正如我之前所說,我們想評估 TAMARACK 的最終結果,做出一些決定,我們是否需要進一步修改如果我們繼續進行組合研究,則vobra 劑量。
With regard to the opportunity with lorigerlimab, as you know, we are doing the LORIKEET study in combination with docetaxel.
關於 lorigerlimab 的機會,如您所知,我們正在進行與多西他賽聯合使用的 LORIKEET 研究。
And as I noted earlier, that study will completely enroll by the end of the year or very early in '25.
正如我之前提到的,這項研究將在今年年底或 25 年初完成全部報名。
So we'll have data on '25 on that.
因此我們將有 25 年的相關數據。
And we are looking at opportunities of combining lorigerlimab and other clinical settings, not only in prostate cancer, with other agents, but it's, again, too early to assess that until we have the final data on the LORIKEET study.
我們正在尋找將 lorigerlimab 與其他臨床環境(不僅在前列腺癌中)以及其他藥物結合的機會,但現在評估還為時過早,直到我們獲得 LORIKEET 研究的最終數據。
James Karrels - Chief Financial Officer, Senior Vice President, Corporate Secretary
James Karrels - Chief Financial Officer, Senior Vice President, Corporate Secretary
Let me just add to that, just in case it wasn't completely clear to listeners.
讓我補充一點,以防聽眾還不太清楚。
So with regard to vobra plus lori, that combination, we've only studied that in dose escalation.
因此,關於 vobra 加 lori 這種組合,我們僅研究了劑量遞增。
We had thought we would move into dose expansion later this year.
我們原本以為會在今年稍後進入劑量擴大階段。
Obviously, we did not do that.
顯然,我們沒有這樣做。
So all of our data comes from dose escalation and the dose expansion study was never actually commenced.
因此,我們所有的數據都來自劑量遞增,而劑量擴展研究實際上從未開始。
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Yes.
是的。
As Jim was pointing out, again, it was a 3 plus 3 design in looking at that.
正如吉姆所指出的,從這個角度來看,這是一個 3 加 3 的設計。
Operator
Operator
Kelsey Goodwin, Guggenheim Partners.
古根漢合夥人公司的凱爾西古德溫 (Kelsey Goodwin)。
Unidentified Participant
Unidentified Participant
(inaudible) on for
(聽不清楚)
[Kelsey].
[凱爾西]。
Just tell me about the [LORIKEET] trial and the update that's coming in the first half of next year.
請告訴我有關 [LORIKEET] 試驗和明年上半年即將推出的更新的資訊。
In terms of the benchmark there and what would be considered?
那裡的基準是什麼以及會考慮什麼?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thanks very much.
非常感謝。
With regard to the LORIKEET study, you were a little soft on the sound here.
關於 LORIKEET 研究,您對這裡的聲音處理得有點太柔和了。
I just want to make sure everybody understood what the question was.
我只是想確保每個人都明白這個問題是什麼。
Clearly, we're looking here at a chemo-naive population.
顯然,我們這裡關注的是未接受化療的族群。
As you know, if you look at the standard of care of docetaxel alone, if you look at the last three studies where docetaxel was tested, it's approximately 8 to 8.6 months of rPFS benefit.
如您所知,如果單獨看多西他賽的標準治療,如果查看最近三項測試多西他賽的研究,其 rPFS 益處約為 8 至 8.6 個月。
Clearly, we would like to see a significant increase, both in rPFS and then ultimately, obviously, have a benefit seen in OS, the actual number.
顯然,我們希望看到 rPFS 和 OS(實際數字)的顯著增加。
We are not in a position to declare at this point, but certainly would be in a -- for rPFS, will be certainly in a double-digit months of improvement.
目前我們還不能宣布,但對於 rPFS 來說,肯定會有兩位數的改善。
Operator
Operator
Silvan Tuerkcan, Citizens JMP.
Silvan Tuerkcan,公民 JMP。
Silvan Tuerkcan - Analyst
Silvan Tuerkcan - Analyst
And Scott, thank you for working with us.
斯科特,感謝您與我們合作。
It was great to work with you.
與您共事非常愉快。
I have a question on MGD024.
我對 MGD024 有疑問。
You've mentioned that Gilead has some opt-in at various points throughout this trial, and it is ongoing and you may or may not get data next year.
您曾提到,吉利德在整個試驗的各個階段都有一些選擇加入,而且試驗仍在進行中,您明年可能會或可能不會獲得數據。
But are any of those points next year -- could we find out next year for the option or not?
但是明年是否存在這些要點——我們明年能否找到選擇?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
It's -- thank you very much, again, to your personal comments.
這是—再次非常感謝您的個人評論。
With regard to the study, it's proceeding well.
關於這項研究,進展順利。
As you know, with an active redirected T-cell killing molecules, the FDA position is that one requires slow dose escalation.
如您所知,對於主動重定向 T 細胞殺傷分子,FDA 的立場是要求緩慢增加劑量。
And we've been through many, many cohorts already, and we are continuing to dose escalate here.
我們已經經歷了很多次治療,我們還在繼續增加劑量。
So I can't, at this point, determine when the study will be completed.
因此目前我無法確定這項研究何時能夠完成。
It is moving forward.
它正在向前發展。
And nor can I determine when Gilead might make the decision with regard to opting in.
我也無法確定吉利德何時會做出加入的決定。
They have the ability to wait until the end of the Phase 1 data.
他們有能力等到第一階段數據結束。
So at this point, though, we have a very good collaboration.
因此,就目前而言,我們的合作非常良好。
We share the data with them, and we expect that the study will continue.
我們與他們分享數據,並希望研究能持續下去。
Operator
Operator
Mayank Mamtani, B. Riley Securities.
Mayank Mamtani,B.Riley Securities。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
And congrats to Scott for a long list of accomplishments, you'll be missed.
祝賀斯科特取得的一系列成就,我們會想念你的。
One big picture question.
一個大問題。
You've tended to focus as an organization on prostate cancer.
作為一個組織,你們傾向於關注前列腺癌。
Could we see a bit of a strategy shift in terms of as you get to this next chapter for MacroGenics?
當 MacroGenics 進入下一個篇章時,我們是否可以看到策略上的一些轉變?
And relatedly, if you're able to give us a precise guidance, kind of when -- and if at all, next year, we could see both CRPC and maybe lung cancer specific data for to assess direct comparability to both your program and the [PRB 73] programs also getting to late-stage development?
與此相關的是,如果你能給我們一個精確的指導,什麼時候——如果有的話,明年,我們可以看到 CRPC 和肺癌的具體數據,以評估你的項目和[PRB 73] 項目也進入後期開發階段嗎?
And then I have a follow-up.
然後我有一個後續問題。
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thank you very much, again, for the personal comments as well.
再次非常感謝您的個人評論。
With regard to the prostate cancer, we are a company that is strongly focused on developing a wide range of treatments for solid tumors.
就前列腺癌而言,我們是一家專注於開發多種實體腫瘤治療方法的公司。
We embarked on prostate cancer a number of years ago because of the opportunities there and the lack of appropriate treatments, particularly for late-stage patients.
幾年前,我們開始研究前列腺癌,因為那裡有治療機會,但缺乏適當的治療方法,尤其是針對晚期患者。
There certainly was a need there, and that obviously led to the development of multiple molecules which we're pursuing.
那裡確實有需求,這顯然導致了我們正在追求的多種分子的開發。
As you know, the B7-H3 programs as well as lorigerlimab.
如您所知,B7-H3 計劃以及 lorigerlimab。
And we will continue with that.
我們將繼續這樣做。
And I've discussed the results that we expect over the course of 2025.
我已經討論了我們預期 2025 年的結果。
With regard to 026, as we've talked about vobra duo.
關於 026,我們已經討論過 vobra duo。
So with 026, we're looking at the use of this drug in a lot of different tumor types.
因此,透過 026,我們正在研究這種藥物在多種不同腫瘤類型中的應用。
The dose escalation is open to a wide range of B7-H3 positive tumors.
劑量遞增適用於多種 B7-H3 陽性腫瘤。
The plan going forward is to determine patients that have responses to 026 in the dose escalation we have built into the Phase 1 study, the ability to do many expansions.
未來的計劃是確定對第一階段研究中建立的劑量遞增中的 026 有反應的患者,以及進行許多擴展的能力。
And so as a result, with regard to responses in prostate for 026, we expect that we should have data in other tumor types as well.
因此,關於 026 在前列腺中的反應,我們預期也應該有其他腫瘤類型的數據。
But at this point, again, as I indicated, we're only in the middle of dose escalation, and it's too early to determine what specific tumor types we might pursue further.
但目前,正如我再次指出的那樣,我們僅處於劑量遞增的中間階段,確定我們可能進一步研究哪些特定腫瘤類型還為時過早。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
Great.
偉大的。
And then one specific question regarding the TAMARACK learnings.
然後是關於 TAMARACK 學習的一個具體問題。
The efficacy of [VDs] generally comparable post taxane.
[VDs] 的療效通常與紫杉醇類藥物相當。
I was wondering if this could be because of B7-H3 expression and it's maintained expression preimposed tumor, which could be different than say, PSMA.
我想知道這是否可能是因為 B7-H3 表達並且它在腫瘤形成前維持表達,這可能與 PSMA 不同。
And is your expectation going forward that remains the case as you intend to report the final TAMARACK data?
當您打算報告最終的 TAMARACK 資料時,您的預期是否仍然如此?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Yes.
是的。
So we are continuing to look at, obviously, both the chemo-naïve and the post-taxane settings for the TAMARACK data.
因此,我們顯然會繼續研究 TAMARACK 數據的化療初治設定和紫杉烷治療後設定。
As we showed at ESMO and indicated, we are having at the landmark timeframe of six months, we're getting very good responses in both the chemo-naive as well as the chemo-experienced population.
正如我們在 ESMO 上所展示和指出的那樣,在六個月的里程碑時間內,我們在未接受過化療的人群和接受過化療的人群中都獲得了非常好的反應。
So at this point, until we have the final data, we haven't assessed if we pursue this further.
因此,目前,在我們獲得最終數據之前,我們還沒有評估是否要進一步推進這項工作。
Again, as I pointed out earlier, there are a lot of things that we will assess when we have the final data.
再次,正如我之前指出的那樣,當我們獲得最終數據時,我們會評估很多事情。
But right now, it's still open to providing a potentially new paradigm for treatment, both in the chemo-experienced as well as the chemo-naïve population.
但現在,它仍然可以為接受過化療的人群和未接受過化療的人群提供一種潛在的新治療模式。
All comes down to the degree of activity, the rPFS, as well as the safety profile.
一切取決於活動程度、rPFS 以及安全性概況。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
Understood.
明白了。
And lastly, for the LORIKEET trial enrollment getting to completion here, Scott.
最後,斯科特,LORIKEET 試用註冊已經完成。
Are you able to comment on how maybe the patient baseline characteristics, prior treatment exposure, [the SMA] status could compare relative to docetaxel trials that have been done in mCRPC previously?
您能否評論一下,與先前在 mCRPC 中進行的多西他賽試驗相比,患者的基線特徵、先前的治療暴露、[SMA] 狀態如何?
And could you just clarify if the OS results will also be available next year?
您能否澄清一下 OS 結果是否明年也會公佈?
Or would that take longer?
或者說會花更久?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
With regard to the characteristics of the LORIKEET, I would say that the population for these chemo-naïve patients was quite similar to what was enrolled in the patients for TAMARACK.
就 LORIKEET 的特徵而言,我想說這些未接受過化療的患者群體與 TAMARACK 的患者群體非常相似。
So they obviously had progression on an androgen receptor targeting agent.
因此他們在雄激素受體標靶藥物方面顯然取得了進展。
And so we think that this will be a population that is very characteristic of what is normally seen there for patients who are on the standard regimen would get docetaxel.
因此我們認為,這個群體的特徵與當地通常採用標準方案治療的患者非常相似,都會得到多西他賽治療。
The fact that we have this as a controlled trial, we will have our own data to see what docetaxel does alone in the 50 patients or so that are treated with that agent alone as compared to historical data.
事實上,我們將此作為一項對照試驗,我們將有自己的數據來觀察與歷史數據相比,多西他賽單獨治療對 50 名左右單獨使用該藥物治療的患者的效果。
So I'm feeling pretty confident that we will have a data set that will be nicely valuable as compared to historical studies.
因此我非常有信心我們將擁有一組與歷史研究相比非常有價值的資料集。
Now with regard to overall survival, I think it will be too early to be able to report that out in '25.
現在關於整體存活率,我認為在 25 年報告結果還為時過早。
But given that, as we said, the study will be completely enrolled by the end of this year or very early in '25, I think we'll be in very good shape to present, obviously, responses, PSA reductions as well as rPFS in '25, but OS, maybe a little early.
但正如我們所說,這項研究將在今年年底或 2025 年初完成招募,我認為我們將能夠很好地展示反應、PSA 減少以及 rPFS在'25年,但OS,可能有點早。
Operator
Operator
Peter Lawson, Barclays.
巴克萊銀行的彼得勞森 (Peter Lawson)。
Peter Lawson - Analyst
Peter Lawson - Analyst
Great.
偉大的。
I guess as we think about your B7-H3 assets, I guess your second-generation molecule, how far behind is that when do we see the initial data?
我想當我們考慮您的 B7-H3 資產時,我想您的第二代分子,我們什麼時候才能看到初始數據?
And kind of what do you want to see in that, I guess, your first generation B7-H3 to kind of understand if that and how that moves forward?
那麼,您想在第一代 B7-H3 中看到什麼?
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thank you very much, Peter.
非常感謝,彼得。
To comment, as you know, there are a number of other molecules that are moving forward.
評論一下,如你所知,還有許多其他分子正在向前發展。
For Topo 1 inhibitors, the data has been presented in a number of different scientific forms.
對於 Topo 1 抑制劑,數據已以多種不同的科學形式呈現。
Again, we see many of the virtues of the way 026 was designed with regard to having a site-specific conjugation of the Synaffix exatecan with the [DAR4] and with other profiles that despite the fact that we may be behind in that particular molecule development as compared to others that we feel that the opportunity here is that this could perform quite well.
再次,我們看到了 026 設計方式的許多優點,包括 Synaffix exatecan 與 [DAR4] 和其他配置文件的位點特異性結合,儘管我們可能在該特定分子開發方面落後與其他人相比,我們覺得這裡的機會是可以表現得相當好。
And then obviously, because of the broad expression of B7-H3 in different tumor types, the data that's been presented to date for competing molecules has been in a limited number of tumor types.
顯然,由於 B7-H3 在不同腫瘤類型中廣泛表達,迄今為止針對競爭分子所提供的數據僅限於有限數量的腫瘤類型。
And so despite the fact there has been data that has been shown particularly in small cell cancer and in some cases, modest data in other lung cancers, we feel that we can be quite competitive with the 026 molecule once we finish dose escalation.
因此,儘管有數據顯示它特別適用於小細胞癌,而且在某些情況下,也適用於其他肺癌,但我們認為,一旦完成劑量遞增,026 分子就可以具有相當的競爭力。
And as I said earlier, we expect that data from the Phase 1 study to be available in '25.
正如我之前所說,我們預計第一階段研究的數據將在25年獲得。
With regard to the vobra duo molecule, again, it's just too early to spell out the opportunity here.
就 vobra duo 分子而言,現在闡述其機會還為時過早。
Clearly, we have the largest data set in prostate cancer with vobra duo, but we will have to assess again what is necessary to achieve a go-forward plan based on the final rPFS data as well as the final safety profile and whether further tweaking will be necessary for the dosing to move forward into a prostate indication.
顯然,我們擁有前列腺癌領域最大的 vobra duo 數據集,但我們必須再次評估,根據最終的 rPFS 數據以及最終的安全性概況,實現前進計劃需要什麼,以及是否需要進一步調整對於將劑量轉移到前列腺指徵是必要的。
So stay tuned.
敬請關注。
We're still very encouraged by the prospects of both of our B7-H3 ADC molecules.
我們對我們的兩種 B7-H3 ADC 分子的前景仍然感到非常鼓舞。
Peter Lawson - Analyst
Peter Lawson - Analyst
Great.
偉大的。
Scott, it's always been a pleasure to talk to you over the year.
斯科特,這麼多年來我一直很榮幸能與您交談。
So having all those conversations.
因此進行所有這些對話。
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Thank you very much.
非常感謝。
And same here.
我也是一樣。
Operator
Operator
(Operator Instructions) Stephen Willey, Stifel.
(操作員指示) Stephen Willey,Stifel。
Stephen Willey - Analyst
Stephen Willey - Analyst
First, I just wanted to say best of luck to you, Scott.
首先,我只想祝你好運,斯科特。
I have certainly enjoyed all the interactions over the years.
我確實很享受這些年來的所有互動。
And then second, just a quick question on MGC028.
第二,關於 MGC028 的一個簡單問題。
Just curious as to whether or not the Phase 1 dose escalation program is going to be prespecifying for specific tumor types?
只是好奇第一階段的劑量遞增計畫是否會針對特定的腫瘤類型預先指定?
If I remember correctly, I think ImmunoGen had outlined a few different tumor types that it was interested in as it ran that Phase 1 development program.
如果我沒記錯的話,我認為 ImmunoGen 在運行第一階段開發專案時已經概述了它感興趣的幾種不同的腫瘤類型。
I know that you were a partner with them, obviously.
我知道你顯然是他們的合作夥伴。
But just wondering if that list of tumor types has changed, just given that you've stopped the payload out, there's obviously an inherent sensitivity of different tumors to different payloads?
但只是想知道,既然您已經停止了有效載荷,那麼腫瘤類型列表是否已經發生了變化,顯然不同腫瘤對不同有效載荷具有固有的敏感性?
And would be curious if you could just give some information as to what tumors you're thinking about.
我很好奇您是否可以提供一些關於您所考慮的腫瘤的資訊。
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Yes.
是的。
Thanks, Steve.
謝謝,史蒂夫。
And again, a real pleasure, always working with you over the years.
再次強調,多年來我一直非常榮幸能與您合作。
The answer is yes, we are going to limit the specific tumor types going forward.
答案是肯定的,我們將進一步限制特定的腫瘤類型。
As you know, in particular, this -- based on our own preclinical data as well as IHC data, we've shown overexpression in a number of tumor types.
如您所知,具體而言,根據我們自己的臨床前數據以及 IHC 數據,我們已經證明了多種腫瘤類型的過度表現。
So one among the tumors that you could expect would be obviously lung cancer and pancreatic cancer and at least another tumor type as well.
因此,您可以預料到的腫瘤顯然是肺癌和胰腺癌,以及至少另一種腫瘤類型。
So we feel that that will give us the best sense as we dose escalate to be able to see activity signals as well as obviously the safety profile of the drug.
因此,我們認為,隨著劑量的增加,這將為我們帶來最佳的感覺,使我們能夠看到活動訊號以及藥物的安全性。
As you know, one of the challenges on the ImmunoGen molecule is that we were never able to achieve the targeted dose because of the high toxicity that was observed.
如您所知,ImmunoGen 分子麵臨的挑戰之一是,由於觀察到的高毒性,我們從未能夠達到目標劑量。
Operator
Operator
And at this time, I see no further questions in the Q&A queue.
目前,我看到問答隊列中沒有其他問題。
I will now turn the call back over to Dr. Koenig for any closing remarks.
現在我將把電話轉回給 Koenig 博士,請他做最後發言。
Scott Koenig - President, Chief Executive Officer, Director
Scott Koenig - President, Chief Executive Officer, Director
Well, again, thank you, everyone, for your kind remarks personally.
好吧,我再次感謝大家對我的善意評價。
And obviously, we look forward to providing updates on our exciting programs and other company-related activity on our next earnings call.
顯然,我們期待在下次財報電話會議上提供有關我們令人興奮的計劃和其他公司相關活動的最新資訊。
And go out and vote if you haven't done it already.
如果你還沒投票的話,就出去投票吧。
James Karrels - Chief Financial Officer, Senior Vice President, Corporate Secretary
James Karrels - Chief Financial Officer, Senior Vice President, Corporate Secretary
Good night, everyone.
大家晚安。
Operator
Operator
Ladies and gentlemen, that does conclude our conference for today.
女士們、先生們,今天的會議到此結束。
Thank you for your participation.
感謝您的參與。
You may now disconnect.
您現在可以斷開連線。