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CAMBRIDGE, Mass. & MONTREAL--(BUSINESS WIRE)--Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, announced today that, under its worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib, it has earned a $40 million milestone payment from Roche upon dosing of the first patient with camonsertib (RP-3500 or RG6526) in Roche’s TAPISTRY trial (NCT04589845).
马萨诸塞州剑桥市和蒙特利尔市——(商业新闻短讯)——Repare Therapeutics Inc.(“Repare”或“公司”)(纳斯达克:RPTX),一家领先的临床阶段精准肿瘤学公司,今天宣布,根据其与罗氏公司就camonsertib的开发和商业化达成的全球许可和合作协议,在罗氏的TAPISTRY试验(NCT04589845)中,第一名服用卡蒙塞替尼(RP-3500或RG6526)的患者获得了罗氏4000万美元的里程碑式付款。
TAPISTRY is a Phase 2, global, multicenter, open-label, multi-cohort clinical trial designed to evaluate the safety and efficacy of targeted therapies or immunotherapy in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations..
TAPISTRY是一项2期,全球,多中心,开放标签,多队列临床试验,旨在评估靶向治疗或免疫治疗在不可切除,局部晚期或转移性实体瘤患者中的安全性和有效性,这些患者被确定具有特定的致癌基因组改变。。
In October, Roche also enrolled the first patient in a camonsertib-based arm in its Phase 1b/2 clinical trial of multiple immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (Morpheus Lung; NCT03337698). The TAPISTRY and MORPHEUS trials are actively enrolling patients.
10月,罗氏公司还在其转移性非小细胞肺癌(Morpheus lung;NCT03337698)参与者的基于多种免疫疗法的治疗组合的1b/2期临床试验中招募了第一名基于camonsertib的患者。TAPISTRY和MORPHEUS试验正在积极招募患者。
In collaboration with Roche, Repare is continuing to conduct tumor specific expansions in the ATTACC trial to support future clinical development for camonsertib + PARP inhibitor combinations..
Repare与罗氏公司合作,继续在ATTACC试验中进行肿瘤特异性扩增,以支持卡蒙塞替尼+PARP抑制剂组合的未来临床开发。。
“This milestone is a key achievement for us, demonstrating Roche’s commitment to the global clinical development of camonsertib and highlighting their exploration of development opportunities for camonsertib across multiple tumor types and genetic alterations to maximize patient impact,” said Lloyd M.
Lloyd M.说:“这一里程碑是我们取得的一项关键成就,证明了罗氏公司致力于卡蒙塞替尼的全球临床开发,并强调了他们在多种肿瘤类型和基因改变中探索卡蒙塞替尼的发展机会,以最大限度地提高患者的影响。”。
Segal, President and Chief Executive Officer of Repare..
Repare总裁兼首席执行官Segal。。
Under the terms of its collaboration with Roche, Repare received a $125 million upfront payment in July 2022, as well as $13.6 million in additional payments, and is eligible to receive up to $1.2 billion in potential clinical, regulatory, commercial and sales milestone payments, and royalties on global net sales ranging from high-single-digits to high-teens.
根据与罗氏的合作条款,Repare在2022年7月收到了1.25亿美元的预付款,以及1360万美元的额外付款,并且有资格获得高达12亿美元的潜在临床、监管、商业和销售里程碑付款,以及全球净销售额的版税,从高个位数到高十几岁不等。
The collaboration also provides Repare with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval is received. If Repare chooses to exercise its co-development and profit share option, it will continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S.
该合作还使Repare能够选择50/50的美国共同开发和利润分享安排,包括在获得美国监管机构批准的情况下参与美国共同推广。如果Repare选择行使其共同开发和利润分享期权,则除全额ex-U外,它将继续有资格获得某些临床、监管、商业和销售里程碑付款。S。
royalties..
版税。。
About Repare Therapeutics’ SNIPRx® Platform
关于Repare Therapeutics的SNIPRx®平台
Repare’s SNIPRx® platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors.
Repare的SNIPRx®平台是一种基于全基因组CRISPR的筛选方法,它利用专有的同基因细胞系来鉴定新的和已知的合成致死基因对,以及根据其肿瘤的遗传特征最有可能从公司治疗中受益的相应患者。
Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx® screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates..
Repare的平台能够为肿瘤包含通过SNIPRx®筛选鉴定出的一种或多种基因组改变的患者开发精确疗法,以便选择性地针对最有可能从候选产品中获得临床益处的患者。。
About Repare Therapeutics, Inc.
关于Repare Therapeutics,Inc。
Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair.
Repare Therapeutics是一家领先的临床阶段精密肿瘤学公司,通过其专有的合成致死性方法来发现和开发新型疗法。该公司利用其全基因组CRISPR支持的SNIPRx®平台,系统地发现和开发针对基因组不稳定性的高度靶向癌症治疗,包括DNA损伤修复。
The Company’s pipeline includes lunresertib (also known as RP-6306), a PKMYT1 inhibitor currently in Phase 1/2 clinical development; camonsertib (also known as RP-3500 or RG6526), a potential leading ATR inhibitor currently in Phase 1/2 clinical development and partnered with Roche; RP-1664, a preclinical PLK4 inhibitor program; RP-3467, a preclinical Polθ inhibitor program; as well as additional, undisclosed preclinical programs.
该公司的管道包括lunresertib(也称为RP-6306),这是一种PKMYT1抑制剂,目前正在进行1/2期临床开发;camonsertib(也称为RP-3500或RG6526)是一种潜在的领先ATR抑制剂,目前正处于1/2期临床开发阶段,并与罗氏合作;RP-1664,一种临床前PLK4抑制剂程序;RP-3467,一种临床前Polθ抑制剂程序;以及其他未公开的临床前计划。
For more information, please visit reparerx.com..
有关更多信息,请访问reparex.com。。
SNIPRx® is a registered trademark of Repare Therapeutics Inc.
SNIPRx®是Repare Therapeutics Inc.的注册商标。
Forward-Looking Statements
前瞻性声明
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in Canada. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words.
本新闻稿包含《1995年私人证券诉讼改革法案》和加拿大证券法所指的“前瞻性声明”。除历史事实声明外,本新闻稿中的所有声明均为“前瞻性声明”。这些声明可以用“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“预测”、“目标”、“打算”、“可能”、“计划”、“可能”、“潜在”、“寻求”、“意愿”和变体等词来识别尽管并非所有的前瞻性陈述都包含这些词语,但这些词语或类似的表达方式旨在识别前瞻性陈述。
Forward-looking statements in this press release include, but are not limited to, statements regarding: Repare’s collaboration with Roche; the potential of Repare to receive milestone payments and royalties under the strategic collaboration agreement; the Company’s ability to enroll patients in clinical trials, to timely and successfully complete those trials and to receive necessary regulatory approvals; the safety, efficacy and clinical progress of the Company’s clinical programs, including lunresertib (RP-6306) and camonsertib; the clinical and preclinical development of the Company’s pipeline and its research and development programs, including the anticipated timing, anticipated patient enrollment, trial outcomes or associated costs of its clinical trials of lunresertib and camonsertib; and the status of clinical trials and development timelines for the Company’s product candidates.
本新闻稿中的前瞻性声明包括但不限于以下声明:Repare与罗氏的合作;Repare根据战略合作协议获得里程碑付款和版税的潜力;公司招募患者参加临床试验,及时成功完成这些试验并获得必要的监管批准的能力;该公司临床计划的安全性,有效性和临床进展,包括lunresertib(RP-6306)和camonsertib;公司管道及其研发计划的临床和临床前开发,包括lunresertib和camonsertib临床试验的预期时间,预期患者登记,试验结果或相关费用;以及该公司候选产品的临床试验状态和开发时间表。
These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s clinica.
这些前瞻性声明基于截至本新闻稿发布之日公司的预期和假设。这些前瞻性陈述中的每一项都涉及可能导致公司临床医生的风险和不确定性。