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Erasca to Present Preliminary SEACRAFT-1 Phase 1 Data for Naporafenib Plus Trametinib in RAS Q61X Mutant Solid Tumors as Oral Presentation at 36th EORTC-NCI-AACR Symposium

Erasca to Present Preliminary SEACRAFT-1 Phase 1 Data for Naporafenib Plus Trametinib in RAS Q61X Mutant Solid Tumors as Oral Presentation at 36th EORTC-NCI-AACR Symposium

Erasca將在第36屆EORTC-新華保險-美國癌症研究協會研討會上以口頭報告形式介紹Naporafenib聯合Trametinib治療RAS Q61X突變實體腫瘤的SEACRAFt-1初步1期數據
Erasca ·  09/25 00:00
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Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor

Naporafenib 是一種潛在的同類首創和同類最佳的 pan-RAF 抑制劑

Erasca is also evaluating naporafenib plus trametinib in the ongoing SEACRAFT-2 pivotal Phase 3 trial in NRAS-mutant melanoma where favorable survival was previously demonstrated in pooled analyses

埃拉斯卡還在正在進行的針對NRAS突變黑色素瘤的Seacraft-2關鍵性3期試驗中評估納波拉非尼聯合曲美替尼,該試驗先前在合併分析中顯示出良好的存活率

Erasca to host virtual R&D update for investors on Thursday, October 24, 2024, at 8:30 AM ET

埃拉斯卡將於美國東部時間2024年10月24日星期四上午 8:30 爲投資者舉辦虛擬研發最新情況

SAN DIEGO, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced an oral presentation of preliminary SEACRAFT-1 Phase 1 data for naporafenib plus trametinib (MEKINIST) in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations at the 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics taking place October 23-25 in Barcelona, Spain. Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor.

聖地亞哥,2024年9月25日(GLOBE NEWSWIRE)——Erasca, Inc.(納斯達克股票代碼:ERAS)是一家臨床階段的精準腫瘤學公司,專注於發現、開發和商業化針對RAS/MAPK路徑驅動的癌症患者的療法,今天宣佈口頭介紹納波拉非尼加曲美替尼(MEKINIST)的Seacraft-1第一期初步數據在第36屆EORTC-NCI-AACR(ENA)分子靶標和癌症療法研討會上,用於患有RAS Q61X突變的局部晚期不可切除或轉移性實體瘤惡性腫瘤患者將於10月23日至25日在西班牙巴塞羅那舉行。Naporafenib 是一種潛在的同類首創和同類最佳的 pan-RAF 抑制劑。

Erasca plans to host a virtual investor event to provide a research and development (R&D) update on naporafenib and the RAS targeting franchise on Thursday, October 24, 2024, at 8:30 AM ET in conjunction with the 36th ENA Symposium. A live question and answer session will follow the formal presentation. To register for the event, please click here.

埃拉斯卡計劃在美國東部時間2024年10月24日星期四上午8點30分與第36屆ENA研討會同時舉辦一次虛擬投資者活動,提供有關納波拉非尼和RAS目標特許經營權的最新研發(R&D)。正式演講之後將進行現場問答環節。要註冊該活動,請點擊這裏。

Oral Presentation Details

口頭陳述詳情

Preliminary results from SEACRAFT-1: An open-label study of naporafenib with trametinib in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations

Seacraft-1的初步結果:一項針對具有RAS Q61X突變的局部晚期不可切除或轉移性實體瘤惡性腫瘤患者的納波非尼聯合曲美替尼的開放標籤研究

Presenter: Dr. Elisa Fontana, Sarah Cannon Research Institute, London, UK

主持人:英國倫敦莎拉·坎農研究所艾麗莎·豐塔納博士

Date and Time: Thursday, October 24, 2024, at 10:18 AM CEST

日期和時間:歐洲中部標準時間 2024 年 10 月 24 日星期四上午 10:18

Session: Proffered Papers: Advancing patient care through novel clinical trials; Plenary 3; Catalog 2

會議:提供的論文:通過新型臨床試驗推進患者護理;全體會議3;目錄2

About Erasca
At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team's capabilities and experience, further guided by our scientific advisory board which includes the world's leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.

關於 Erasca
在埃拉斯卡,我們的名字就是我們的使命:消滅癌症。我們是一家臨床階段的精準腫瘤學公司,專注於爲Ras/mapK路徑驅動的癌症患者發現、開發和商業化療法。我們公司由精準腫瘤學和RAS領域的領先先驅共同創立,旨在開發旨在全面關閉癌症治療的ras/MAPK途徑的新療法和聯合方案。我們已經組裝了業內最深的以RAS/MAPK路徑爲重點的管道之一。我們相信,我們的團隊的能力和經驗,再加上包括ras/MAPK途徑領域的世界領先專家在內的科學顧問委員會的進一步指導,爲我們實現消滅癌症的大膽使命奠定了獨特的地位。

Cautionary Note Regarding Forward-Looking Statements
Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates, including naporafenib; the planned advancement of our development pipeline; and our ability to successfully prioritize our pipeline portfolio to focus on existing programs that we believe have the highest probability of success. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; we only have one product candidate in clinical development and all of our other development efforts are in the preclinical or development stage; the analysis of pooled Phase 1 and Phase 2 naporafenib plus trametinib data covers two clinical trials with different designs and inclusion criteria, which cannot be directly compared, and therefore may not be a reliable indicator of survival data; due to differences between trial designs and subject characteristics, comparing data across different trials may not be a reliable indicator of data; preliminary results of clinical trials are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and more patient data become available; our SEACRAFT trials may not support the registration of naporafenib; our assumptions around which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; potential delays in the commencement, enrollment, data readout, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; the inability to realize any benefits from our current licenses, acquisitions, and collaborations, and any future licenses, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; later developments with the FDA or EU health authorities may be inconsistent with the feedback received to date regarding our development plans and trial designs; our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2023, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

關於前瞻性陳述的警示說明
埃拉斯卡提醒您,本新聞稿中有關非歷史事實事項的陳述均爲前瞻性陳述。前瞻性陳述基於我們當前的信念和預期,包括但不限於:我們對包括納波拉非尼在內的候選產品的潛在治療益處的預期;我們開發渠道的計劃進展;以及我們成功確定研發產品組合的優先順序,將重點放在我們認爲成功概率最高的現有項目上的能力。由於我們業務固有的風險和不確定性,實際結果可能與本新聞稿中列出的結果有所不同,包括但不限於:我們發現和開發候選產品的方法以關閉ras/MAPK途徑爲唯一重點,這是一種未經證實的新穎方法;我們在臨床開發中只有一種候選產品,所有其他開發工作都處於臨床前或開發階段;對合並階段1的分析和 Naporafenib 和 trametinib 的 2 期數據涵蓋兩項臨床具有不同設計和納入標準的試驗,無法直接比較,因此可能不是存活數據的可靠指標;由於試驗設計和受試者特徵之間的差異,比較不同試驗的數據可能不是可靠的數據指標;臨床試驗的初步結果不一定代表最終結果,隨着患者入組的繼續,在對數據進行更全面的審查和更多的患者數據之後,一項或多項臨床結果可能會發生重大變化可用;我們的SeaCraft試驗可能不支持納泊非尼的註冊;我們對哪些項目可能更有可能成功的假設可能不準確,我們可能會將有限的資源用於研究特定的候選產品和/或適應症,而未能利用具有更大開發或商業潛力的候選產品或適應症;臨床試驗和臨床前研究的開始、註冊、數據讀取和完成可能出現延遲;我們對第三者的依賴與之相關的各方製造、研究、臨床前和臨床試驗;我們的候選產品出現意想不到的不良副作用或療效不足,可能會限制其開發、監管批准和/或商業化,或可能導致召回或產品責任索賠;臨床前研究或臨床試驗的不利結果;無法從我們當前的許可、收購和合作以及未來的任何許可、收購或合作中獲得任何好處,以及我們在此類安排下履行義務的能力;美國和國外的監管發展;美國食品和藥物管理局或歐盟衛生當局的後期進展可能與迄今爲止收到的有關我們的開發計劃和試驗設計的反饋不一致;我們爲候選產品獲得和維持知識產權保護以及維護知識產權許可下權利的能力;我們用當前的現金、現金等價物和有價證券爲運營計劃提供資金的能力;以及我們先前向證券交易所提交的文件中描述的其他風險交易委員會(SEC),包括我們在截至2023年12月31日止年度的10-k表年度報告中的 「風險因素」 標題下,以及隨後向美國證券交易委員會提交的任何文件。提醒您不要過分依賴這些前瞻性陳述,這些陳述僅代表截至本文發佈之日,我們沒有義務更新此類陳述以反映在本聲明發布之日之後發生的事件或存在的情況。本警示聲明是根據1995年《私人證券訴訟改革法》的安全港條款作出的,對所有前瞻性陳述進行了全面的限定。

MEKINIST is a registered trademark owned by or licensed to Novartis AG, its subsidiaries, or affiliates.

MEKINIST 是諾華股份公司、其子公司或關聯公司擁有或許可的註冊商標。

Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

聯繫人:
喬伊斯·阿萊爾
LifeSci 顧問有限公司
jallaire@lifesciadvisors.com

Source: Erasca, Inc.

資料來源:Erasca, Inc.


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Source: Erasca, Inc.

資料來源:Erasca, Inc.

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