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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将在第36届EORTC-新华保险-美国癌症研究协会研讨会上以口头报告形式介绍Naporafenib联合Trametinib治疗RAS Q61X突变实体肿瘤的SEACRAFt-1初步1期数据
Erasca ·  09/25 00:00
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Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor

Naporafenib 是一种潜在的同类首创和同类最佳的 pan-RAF 抑制剂

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

埃拉斯卡还在正在进行的针对NRAS突变黑色素瘤的Seacraft-2关键性3期试验中评估纳波拉非尼联合曲美替尼,该试验先前在合并分析中显示出良好的存活率

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

埃拉斯卡将于美国东部时间2024年10月24日星期四上午 8:30 为投资者举办虚拟研发最新情况

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.

圣地亚哥,2024年9月25日(GLOBE NEWSWIRE)——Erasca, Inc.(纳斯达克股票代码:ERAS)是一家临床阶段的精准肿瘤学公司,专注于发现、开发和商业化针对RAS/MAPK路径驱动的癌症患者的疗法,今天宣布口头介绍纳波拉非尼加曲美替尼(MEKINIST)的Seacraft-1第一期初步数据在第36届EORTC-NCI-AACR(ENA)分子靶标和癌症疗法研讨会上,用于患有RAS Q61X突变的局部晚期不可切除或转移性实体瘤恶性肿瘤患者将于10月23日至25日在西班牙巴塞罗那举行。Naporafenib 是一种潜在的同类首创和同类最佳的 pan-RAF 抑制剂。

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.

埃拉斯卡计划在美国东部时间2024年10月24日星期四上午8点30分与第36届ENA研讨会同时举办一次虚拟投资者活动,提供有关纳波拉非尼和RAS目标特许经营权的最新研发(R&D)。正式演讲之后将进行现场问答环节。要注册该活动,请点击这里。

Oral Presentation Details

口头陈述详情

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的初步结果:一项针对具有RAS Q61X突变的局部晚期不可切除或转移性实体瘤恶性肿瘤患者的纳波非尼联合曲美替尼的开放标签研究

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

主持人:英国伦敦莎拉·坎农研究所艾丽莎·丰塔纳博士

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

日期和时间:欧洲中部标准时间 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

会议:提供的论文:通过新型临床试验推进患者护理;全体会议3;目录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.

关于 Erasca
在埃拉斯卡,我们的名字就是我们的使命:消灭癌症。我们是一家临床阶段的精准肿瘤学公司,专注于为Ras/mapK路径驱动的癌症患者发现、开发和商业化疗法。我们公司由精准肿瘤学和RAS领域的领先先驱共同创立,旨在开发旨在全面关闭癌症治疗的ras/MAPK途径的新疗法和联合方案。我们已经组装了业内最深的以RAS/MAPK路径为重点的管道之一。我们相信,我们的团队的能力和经验,再加上包括ras/MAPK途径领域的世界领先专家在内的科学顾问委员会的进一步指导,为我们实现消灭癌症的大胆使命奠定了独特的地位。

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.

关于前瞻性陈述的警示说明
埃拉斯卡提醒您,本新闻稿中有关非历史事实事项的陈述均为前瞻性陈述。前瞻性陈述基于我们当前的信念和预期,包括但不限于:我们对包括纳波拉非尼在内的候选产品的潜在治疗益处的预期;我们开发渠道的计划进展;以及我们成功确定研发产品组合的优先顺序,将重点放在我们认为成功概率最高的现有项目上的能力。由于我们业务固有的风险和不确定性,实际结果可能与本新闻稿中列出的结果有所不同,包括但不限于:我们发现和开发候选产品的方法以关闭ras/MAPK途径为唯一重点,这是一种未经证实的新颖方法;我们在临床开发中只有一种候选产品,所有其他开发工作都处于临床前或开发阶段;对合并阶段1的分析和 Naporafenib 和 trametinib 的 2 期数据涵盖两项临床具有不同设计和纳入标准的试验,无法直接比较,因此可能不是存活数据的可靠指标;由于试验设计和受试者特征之间的差异,比较不同试验的数据可能不是可靠的数据指标;临床试验的初步结果不一定代表最终结果,随着患者入组的继续,在对数据进行更全面的审查和更多的患者数据之后,一项或多项临床结果可能会发生重大变化可用;我们的SeaCraft试验可能不支持纳泊非尼的注册;我们对哪些项目可能更有可能成功的假设可能不准确,我们可能会将有限的资源用于研究特定的候选产品和/或适应症,而未能利用具有更大开发或商业潜力的候选产品或适应症;临床试验和临床前研究的开始、注册、数据读取和完成可能出现延迟;我们对第三者的依赖与之相关的各方制造、研究、临床前和临床试验;我们的候选产品出现意想不到的不良副作用或疗效不足,可能会限制其开发、监管批准和/或商业化,或可能导致召回或产品责任索赔;临床前研究或临床试验的不利结果;无法从我们当前的许可、收购和合作以及未来的任何许可、收购或合作中获得任何好处,以及我们在此类安排下履行义务的能力;美国和国外的监管发展;美国食品和药物管理局或欧盟卫生当局的后期进展可能与迄今为止收到的有关我们的开发计划和试验设计的反馈不一致;我们为候选产品获得和维持知识产权保护以及维护知识产权许可下权利的能力;我们用当前的现金、现金等价物和有价证券为运营计划提供资金的能力;以及我们先前向证券交易所提交的文件中描述的其他风险交易委员会(SEC),包括我们在截至2023年12月31日止年度的10-k表年度报告中的 “风险因素” 标题下,以及随后向美国证券交易委员会提交的任何文件。提醒您不要过分依赖这些前瞻性陈述,这些陈述仅代表截至本文发布之日,我们没有义务更新此类陈述以反映在本声明发布之日之后发生的事件或存在的情况。本警示声明是根据1995年《私人证券诉讼改革法》的安全港条款作出的,对所有前瞻性陈述进行了全面的限定。

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

MEKINIST 是诺华股份公司、其子公司或关联公司拥有或许可的注册商标。

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

联系人:
乔伊斯·阿莱尔
LifeSci 顾问有限公司
jallaire@lifesciadvisors.com

Source: Erasca, Inc.

资料来源:Erasca, Inc.


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Source: Erasca, Inc.

资料来源:Erasca, Inc.

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