A Randomized, Open-Label, Phase 2 Study of a Patient-Specific Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer With Minimal Residual Disease Following Surgical Resection and Standard Adjuvant Chemotherapy

The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus [ChAd] and self-amplifying messenger RNA [samRNA] vectors), in combination with checkpoint inhibitors. Antitumor activity will be based on molecular response in patients with colon cancer who have circulating tumor deoxyribonucleic acid (ctDNA) following surgical resection.

开始日期2022-05-19

申办/合作机构

Gritstone bio, Inc.

NCT05141721 / Active, not recruiting临床2/3期

A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer

The primary objective of the Phase 2 portion of the study is to characterize the clinical activity of maintenance therapy with GRT-C901/GRT-R902 (patient-specific vaccines) in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus a fluoropyrimidine/bevacizumab alone as assessed by molecular response which is based on changes in circulating tumor (ct)DNA. The primary objective of the Phase 3 portion is to demonstrate clinical efficacy of the regimen as assessed by progression-free survival.

开始日期2022-02-12

申办/合作机构

Gritstone bio, Inc.

NCT03639714 / Completed临床1/2期

An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

开始日期2019-02-13

申办/合作机构

Gritstone bio, Inc.

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100 项与 GRANITE-001 相关的临床结果

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100 项与 GRANITE-001 相关的转化医学

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100 项与 GRANITE-001 相关的专利（医药）

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项与 GRANITE-001 相关的文献（医药）

2014-07-01·Anticancer research4区 · 医学

Molecular-targeted therapy for chemotherapy-refractory gastric cancer: a case report and literature review.

4区 · 医学

Article

作者: Yeh, Kun-Huei ; Kuo, Hung-Yang

The prognosis of advanced gastric cancer (AGC) remains poor despite therapeutic advances in recent decades. Several recent positive phase III trials established the efficacy of second-line chemotherapy for metastatic gastric cancer in prolonging overall survival. However, malnutrition and poor performance of AGC in late stages usually preclude such patients from intensive treatment. Many targeted-therapies failed to show a significant survival benefit in AGC, but have regained attention after the positive result of ramucirumab was announced last year. Among all targeted agents, only trastuzumab, a monoclonal antibody against Human epidermal growth factor receptor-2 (HER2) protein, has been proven as having survival benefit by addition to first-line chemotherapy. Herein we reported a patient who benefited from adding trastuzumab to the same second-line combination chemotherapy (paclitaxel, 5-fluorouracil, and leucovorin) upon progression of bulky liver metastases. At least five months of progression-free survival were achieved without any additional toxicity. We also reviewed literature of molecularly-targeted therapy for chemotherapy-refractory gastric cancer, including several large phase III trials (REGARD, GRANITE-1, EXPAND, and REAL-3) published in 2013-2014.

2008-10-01·International Endodontic Journal2区 · 医学

Modification of mineral trioxide aggregate. Physical and mechanical properties

2区 · 医学

Article

作者: Camilleri, J

AbstractAim To evaluate the physical and mechanical properties of two cements with a similar chemical composition to mineral trioxide aggregate and to attempt to improve their properties by producing a composite material.Methodology Two cement types were used: a mixture of calcium sulpho‐aluminate cement and Portland cement (CSA) and calcium fluoro‐aluminate cement (CFA) in conjunction with an admixture to improve the handling characteristics. Cements were mixed with an inert filler to produce cement composite. The setting time of the cements was evaluated using an indentation technique. The flexural and uni‐axial compressive strengths and solubility of the cements and cement composites were evaluated. The properties of the materials were compared with proprietary brand glass–ionomer cement.Results The setting time of the CSA and CFA cements was less than 6 min. The use of an admixture to improve the handling properties tended to retard setting. CSA was stronger then CFA in both compression and flexure (P < 0.001). Addition of granite increased the flexural strength of both cements but reduced the compressive strength (P < 0.01). CFA absorbed more water then CSA. Addition of granite reduced the water uptake of both cements.Conclusions Both CSA and CFA cements had adequate setting times and compressive strength values when compared with proprietary brand glass–ionomer cement. CSA was superior to CFA and had more promise as a prospective dental material.

2005-09-01·Journal of Agricultural and Food Chemistry1区 · 农林科学

Partitioning of Penoxsulam, a New Sulfonamide Herbicide

1区 · 农林科学

Article

作者: Tjeerdema, Ronald S. ; Jabusch, Thomas W.

Penoxsulam (trade name Granite) is a new acetolactate synthase (ALS) inhibitor herbicide for postemergence control of annual grasses, sedges, and broadleaf weeds in rice culture. This study was done to understand the equilibrium phase partitioning of penoxsulam to soil and air under conditions simulating California rice field conditions. Partitioning of penoxsulam was determined between soil and water (Kd) by the batch equilibrium method and between air and water (K(H)) by the gas-purge method. In four representative soils from the Sacramento Valley, the Kd values ranged from 0.14 to 5.05 and displayed a modest increase with soil pH. In soil amended with manure compost, soil sorption increased 4-fold with increasing soil organic matter content, but was still low with a Kd of 0.4 in samples with high organic carbon contents of 15%. Penoxsulam was confirmed to be extremely nonvolatile and did not partition into air at any measurable rate at 20 or 40 degrees C. K(H) (pH 7) was estimated at 4.6 x 10(-15) Pa x L x mol(-1) on the basis of available water solubility and vapor pressure data. The results imply that soil and air partitioning of penoxsulam do not significantly affect its potential for degradation or offsite movement in water.

项与 GRANITE-001 相关的新闻（医药）

2024-10-12

·佰傲谷BioValley

临床数据不佳，公司申请破产

今日，生物技术公司Gritstone bio宣布，已根据《美国破产法》第11章向特拉华地区美国破产法院提交了自愿申请。一旦企业向法院递交第11申请，则视为法院下达了“救济令”（Order for Relief），法院会要求企业在其监督下继续经营业务，并配合法院启动破产重整程序。在财务重组过程中，Gritstone打算按照正常方式继续运营，并继续推动其临床项目，包括其主要候选产品mRNA肿瘤疫苗GRANITE，和其他新抗原肿瘤疫苗和传染病疫苗项目。钱花光了根据Gritstone公司发布的第二季度财报，截止2024年6月30日，现金、现金等价物、有价证券和限制性现金为6170万美元。按照同期的费用支出计算，可能只能支持该公司运营至2024年第四季度。为了节省资金，Gritstone公司曾在2024年3月宣布了一项裁员计划；以及在4月完成了一次承销公开发行，总收益为3250万美元。延伸阅读：临床试验推迟，裁员40% 总之到现在，钱应该是用的差不多，只能申请破产，请求救济了。最新数据还拉胯 Gritstone申请破产的决定，是在其候选产品GRANITE的2期数据发布后做出的。原本，Gritstone公司寄希望于GRANITE上，期待新的临床数据能够提振公司的前景，但是不佳的临床数据终结了这一可能。 9月30日，Gritstone公布了GRANITE针对一线维持治疗转移性微卫星稳定性结直肠癌（MSS-CRC）（MSS-CRC）的2期临床数据，该研究主要评估GRANITE联用免疫检查点抑制剂对比单独使用氟嘧啶/贝伐珠单抗的临床益处。数据显示：GRANITE队列中所有患者均观察到无进展生存期（PFS）的益处。与标准护理（SOC）对照组相比，GRANITE队列的进展或死亡相对风险降低21%（HR=0.79 [95% CI，0.42-1.50]）；低疾病负担患者（定义为研究开始时ctDNA等于或低于试验人群中位数）的临床获益最为显著。但是令人质疑的是，尽管风险比（HR）为0.79显示出对GRANITE组合有利，但是1.50的95%置信区间的上限，意味着对照组的表现要比GRANITE癌症疫苗好。有分析师提出，如果Gritstone能够继续跟踪患者，延长随访可能会得出更有利的数据。但是Gritstone公司的运营情况令人堪忧。也正是如此，Gritstone才向法院递交了第11章申请，以获得救济。Gritstone公司的联合创始人、总裁兼首席执行官Andrew Allen在一份声明中表示，GRANITE的研究数据需要额外的时间才能获取，申请第11章的决定能够使其专注其使命。今年接连临床失利实际上，Gritstone的临床失利不仅仅只是这一个。 2024年3月，Gritstone的Covid-19疫苗2b期临床试验无法按时启动，因为GMP级原材料的供应原因，导致该试验预计将推迟至今年秋季。截至最新季度报告，Gritstone没有提供开始研究的最新时间框架。在2024年4月，Gritstone就公布了GRANITE联合疗法作为一线维持治疗转移性微卫星稳定性结直肠癌（MSS-CRC）的早期2期临床数据，但是市场对于该数据并不看好，原因是在分子缓解率（循环肿瘤DNA），GRANITE联合疗法组未能与对照组显示出差异。延伸阅读：临床试验推迟，裁员40% 肿瘤疫苗喜忧参半，公司股价大跌45% 再加上GRANITE最新数据的披露。接连的临床失利，以及申请破产消息的传来，使得Gritstone公司的股价从今年初的2美元/股下跌至0.06美元/股。运营时长9年 Gritstone bio曾用名Gritstone Oncology，成立于2015年，于2018年在纳斯达克上市，股价最高达35.2美元/股。在2015年成立之初，该公司就致力于开发针对肿瘤新抗原的免疫疗法。后来因为业务扩展到传染性疾病上，便将Oncology更改为了bio。目前公司针对肿瘤和传染病两大疾病领域建立了多条研发管线。但是，肿瘤主要候选药物GRANITE的临床失利和Covid-19疫苗的临床推迟，使得市场对该公司的认可度不高。目前，有报道称，Gritstone已经在与一个潜在的买家进行讨论，该买家可能从作为假马竞拍人，以确保价值最大化交易，使该公司能够继续进行研发工作。参考资料： 1.https://ir.gritstonebio.com/news-releases/news-release-details/gritstone-bio-takes-action-preserve-value-and-strengthen-capital 2.https://www.fiercebiotech.com/biotech/gritstone-files-bankruptcy-hope-keeping-cancer-vaccine-rd-afloat 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

财报疫苗临床2期

2024-10-11

·药事纵横

一家癌症疫苗biotech宣告破产

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 10月10日，临床阶段疫苗开发公司Gritstone bio宣布公司已根据《美国破产法》第11章向特拉华地区美国破产法院提交了自愿申请。截至6月底，公司拥有6170万美元的现金、等价物和有价证券，公司预计到年底资金将会耗尽。 Gritstone 正在就其破产保护案提交惯常的 “首日 ”动议，以确保正常运营。一旦法院批准这些 “首日 ”动议，Gritstone 将最大限度地减少破产程序对公司供应商、员工和其他主要利益相关者的影响。 Gritstone 打算利用由法院管理的重组程序来保值并支持其正在进行的战略选择过程。公司正在与作为跟踪竞标者或计划发起人的一方进行讨论，并打算最早于下周向法院提交一份协议，以便达成价值最大化交易。在财务重组过程中，Gritstone打算按正常程序运作，继续致力于推进其临床项目，包括正在进行的新抗原免疫疗法和传染病项目，并推动免疫疗法和疫苗开发的创新，公司的管线专注于癌症疫苗和传染病疫苗。 2018年9月，Gritstone作为一家成立三年的初创公司以1亿美元的IPO价格上市。当时，它被称为Gritstone Oncology，后来因将业务扩展到传染病领域去掉了后半部分，并希望在大流行病疫苗领域有所作为。该公司还与吉利德公司合作，开发基于疫苗的艾滋病治疗方法。吉利德负责指导这项合作。受此消息影响，Gritstone股价暴跌68%。由于Gritstone在其治疗结直肠癌的个性化新抗原疫苗的第二阶段研究中试验数据不佳，并在启动大规模的Covid-19疫苗试验中陷入困境，年初至今其股价已下跌了约96%。今年4月，Gritstone bio宣布其个性化癌症疫苗GRANITE在一线转移性微卫星稳定结直肠癌（MSS-CRC）中正在进行的II/III期研究的II期部分的数据。总体来说，该癌症疫苗未能触发循环肿瘤DNA（ctDNA）的变化，导致II期试验未达主要终点。今年3月，Gritstone因无法按时启动Covid-19疫苗的2b期试验而裁员40%。Gritstone原计划在2024年第一季度开始一项1万人的研究，并寄希望于美国联邦机构提供高达4.33亿美元的资金来支持这项研发。截至最新季度报告，Gritstone没有提供开始研究的最新时间框架。 Gritstone 联合创始人、总裁兼首席执行官、医学博士Andrew Allen说：“我们的世界级科学和尖端创新使我们处于肿瘤学和医学突破的前沿。我们最近报告了正在进行的 GRANITE 第二阶段中期数据，该数据继续显示出对患者的新益处，但数据的成熟还需要更多的时间。申请破产保护的决定使我们能够继续专注于我们的使命，即为全球患者提供像 GRANITE 这样可能挽救生命的治疗方法。” 参考资料：公司官网 -END- 2025CMC-CHINA药博会 • 展位火热预定中！

疫苗IPO免疫疗法临床2期信使RNA

2024-10-10

·EndPoints

Gritstone files for bankruptcy, says it could forge a transaction as early as this month to keep R&D going

Gritstone bio filed for Chapter 11 bankruptcy on Thursday morning in a bid to keep itself afloat as it seeks a buyer or other transaction to continue running R&D of its cancer and infectious disease vaccines. The California and Massachusetts biotech has seen its share price $GRTS dip about 90% year-to-date after running into hurdles with a Phase 2 of its personalized neoantigen vaccine for colorectal cancer and struggles with launching a large Covid-19 vaccine trial. In March, Gritstone laid off 40% of its staff after being unable to start a Phase 2b of its Covid-19 vaccine on time. The biotech had planned to begin a 10,000-person study in the first quarter of 2024 and was banking on up to $433 million in funding from US federal agencies to help support the development. As of its latest quarterly report , Gritstone did not provide an updated time frame for commencing the study. Gritstone said it is talking with a “party to act as a stalking horse bidder or plan sponsor” and aims to present an agreement to the court overseeing the restructuring process “as early as next week.” The goal is to ink a “value-maximizing transaction” that would allow the company to keep up R&D of its vaccines and immunotherapies, Gritstone said. At the end of June, the company had $61.7 million in cash, equivalents and marketable securities. “The decision to file for Chapter 11 relief allows us to stay focused on our mission of bringing potentially life-saving treatments like GRANITE to patients around the world,” CEO Andrew Allen said in a statement. GRANITE is the name of the company’s personalized vaccine for cancer. The company plans to keep operating “in the ordinary course” during the restructuring, it said. Gritstone went public as a three-year-old startup in a $100 million IPO in September 2018. At the time, it was known as Gritstone Oncology, but later dropped the second half as it expanded to include infectious diseases and had hoped to make a dent in the pandemic vaccine landscape. It is also working with Gilead to create a vaccine-based HIV treatment. Gilead is directing the collaboration.

疫苗IPO

100 项与 GRANITE-001 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性结直肠癌	临床3期	美国	Gritstone bio, Inc.	2022-02-12
晚期恶性实体瘤	临床2期	澳大利亚	Bristol Myers Squibb Co.	2019-02-13
晚期恶性实体瘤	临床2期	美国	Gritstone bio, Inc.	2019-02-13
结直肠癌	临床2期	-	Bristol Myers Squibb Co.	-
食管癌	临床2期	-	Bristol Myers Squibb Co.	-
食管癌	临床2期	-	Gritstone bio, Inc.	-
非小细胞肺癌	临床2期	-	Bristol Myers Squibb Co.	-
非小细胞肺癌	临床2期	-	Gritstone bio, Inc.	-
泌尿生殖系统肿瘤	临床2期	-	Gritstone bio, Inc.	-
泌尿生殖系统肿瘤	临床2期	-	Bristol Myers Squibb Co.	-

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


GlobeNewswire 人工标引	临床2期	转移性微卫星稳定结直肠癌一线	104	GRANITE+ immune checkpoint inhibitors + fluoropyrimidine+bevacizumab	(鬱餘獵醖蓋鏇願網選觸) = 積觸餘簾選鏇鏇範憲襯糧襯製鹽積顧選艱積顧 (廠廠獵築顧鹹鏇鬱顧鑰 ) 更多	积极	2024-09-30
GlobeNewswire 人工标引	临床2期	转移性微卫星稳定结直肠癌一线	104	Fluoropyrimidine+bevacizumab	(鬱餘獵醖蓋鏇願網選觸) = 構淵願鏇艱餘築醖鬱醖糧襯製鹽積顧選艱積顧 (廠廠獵築顧鹹鏇鬱顧鑰 )	积极	2024-09-30
NCT05141721 (Biospace) 人工标引	临床2期	微卫星稳定型结直肠癌一线	104	5-FU + bev+GRANITE + ipilimumab + atezolizumab	(憲構憲製膚鹹淵製獵鹹) = 範憲繭製憲範顧餘顧選鑰積積壓鹽憲選膚選壓 (範淵壓積餘膚襯壓壓餘, 20) 更多	不佳	2024-04-01
NCT05141721 (Biospace) 人工标引	临床2期	微卫星稳定型结直肠癌一线	104	5-FU + bev	(憲構憲製膚鹹淵製獵鹹) = 鬱廠構壓膚鑰夢築艱構鑰積積壓鹽憲選膚選壓 (範淵壓積餘膚襯壓壓餘, 12) 更多	不佳	2024-04-01
NCT03639714 (GO-004｜GO-005, Pubmed \| Nat Med) 人工标引	临床1期	实体瘤	14	Nivolumab+Ipilimumab+GRANITE-001-001	(築鑰廠膚遞鏇繭製範選) = 10^12 VP ChAd68 + 30 µg samRNA 選餘鹹範襯膚簾鹽糧齋 (憲襯壓鏇簾構繭衊膚鹽 ) 更多	积极	2022-08-15
NCT03639714 (GO-004｜GO-005, ESMO2021) 人工标引	临床1/2期	非小细胞肺癌 \| 转移性胃食管腺癌 \| 转移性微卫星稳定结直肠癌 Microsatellite Stable (MSS)	22	ipilimumab+nivolumab+GRANITE-001	(醖夢築鏇鑰鹽願顧鑰願) = 顧選網鹽淵願鏇廠壓觸醖願鹽製構廠壓艱鏇鏇 (構廠憲膚獵壓蓋選製鹹 ) 更多	积极	2021-09-17