A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III) - VaxLung

开始日期2012-09-13

申办/合作机构

VAXON Biotech SA

NCT01935154 / Completed临床2期

Phase II Study of Vx001 Vaccine in HLA-A*0201 Positive Patients With TERT Positive Stage IV or Recurrent Stage I-III NSCLC

Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.
The objective of the trial is survival rate at 12 months.

开始日期2012-08-01

申办/合作机构

VAXON Biotech SA

EUCTR2006-005032-25-GR / Unknown statusN/A

A multi-centre phase II controlled study of Vx-001 in Non Small Cell Lung Cancer (NSCLC)

开始日期2007-05-08

申办/合作机构

VAXON Biotech SA

100 项与 Vx-001 相关的临床结果

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100 项与 Vx-001 相关的转化医学

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100 项与 Vx-001 相关的专利（医药）

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项与 Vx-001 相关的文献（医药）

2020-05-12·British Journal of Cancer1区 · 医学

Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial

1区 · 医学

Article

作者: Kotsakis, Athanasios ; Georgoulias, Vassilis ; Kentepozidis, Nikolaos ; Kosmatopoulos, Kostas ; Gridelli, Cesare ; Correale, Pierpaolo ; Kazarnowisz, Andrzej ; Majem, Margarita ; Domine, Manuel ; Jamet, Jeanne- Menez ; Griesinger, Frank ; Gallou, Catherine ; Zarogoulidis, Konstantinos ; de Las Penas, Ramon ; Sadjadian, Parvis ; Chella, Antonio ; Szczesna, Aleksandra ; Cobo, Manuel ; Korozan, Magdalena ; Bover, Isabel ; Bournakis, Evangelos ; Kalofonos, Charalabos ; Syrigos, Kostantinos N ; Ciuleanu, Tudor ; Chinet, Thierry ; Vetsika, Eleni- Kyriaki

AbstractBackgroundThe cancer vaccine Vx-001, which targets the universal tumour antigen TElomerase Reverse Transcriptase (TERT), can mount specific Vx-001/TERT572 CD8 + cytotoxic T cells; this immune response is associated with improved overall survival (OS) in patients with advanced/metastatic non-small cell lung cancer (NSCLC).MethodsA randomised, double blind, phase 2b trial, in HLA-A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy were randomised to receive either Vx-001 or placebo. The primary endpoint of the trial was OS.ResultsTwo hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the placebo and the Vx-001 arm, respectively) were analysed for efficacy. There was not treatment-related toxicity >grade 2. The study did not meet its primary endpoint (median OS 11.3 and 14.3 months for the placebo and the Vx-001, respectively; p = 0.86) whereas the median Time to Treatment Failure (TTF) was 3.5 and 3.6 months, respectively. Disease control for >6months was observed in 30 (33.7%) and 26 (25.7%) patients treated with Vx-001 and placebo, respectively. There was no documented objective CR or PR. Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).ConclusionVx-001 could induce specific CD8+ immune response but failed to meet its primary endpoint. Subsequent studies have to be focused on the identification and treatment of subgroups of patients able to mount an effective immunological response to Vx-001.Clinical trial registrationNCT01935154

2020-04-13·Current Topics in Medicinal Chemistry4区 · 医学

Telomerase-based Cancer Therapeutics: A Review on their Clinical Trials

4区 · 医学

Review

作者: Gemma, Sandra ; Brogi, Simone ; Brindisi, Margherita ; Zisterer, Daniela ; Khan, Tuhina ; Butini, Stefania ; Saraswati, Akella P. ; Campiani, Giuseppe ; Federico, Stefano ; Relitti, Nicola

Telomeres are protective chromosomal ends that shield the chromosomes from DNA damage, exonucleolytic degradation, recombination, and end-to-end fusion. Telomerase is a ribonucleoprotein that adds TTAGGG tandem repeats to the telomeric ends. It has been observed that 85 to 90% of human tumors express high levels of telomerase, playing a crucial role in the development of cancers. Interestingly, the telomerase activity is generally absent in normal somatic cells. This selective telomerase expression has driven scientists to develop novel anti-cancer therapeutics with high specificity and potency. Several advancements have been made in this area, which is reflected by the enormous success of the anticancer agent Imetelstat. Since the discovery of Imetelstat, several research groups have contributed to enrich the therapeutic arsenal against cancer. Such contributions include the application of new classes of small molecules, peptides, and hTERT-based immunotherapeutic agents (p540, GV1001, GRNVAC1 or combinations of these such as Vx-001). Many of these therapeutic tools are under different stages of clinical trials and have shown promising outcomes. In this review, we highlight the current status of telomerase-based cancer therapeutics and the outcome of these investigations.

2016-07-01·Annals of Translational Medicine4区 · 医学

Optimized tumor cryptic peptides: the basis for universal neo-antigen-like tumor vaccines

4区 · 医学

Review

作者: Kosmatopoulos, Kostas ; Gallou, Catherine ; Menez-Jamet, Jeanne ; Rougeot, Aude

The very impressive clinical results recently obtained in cancer patients treated with immune response checkpoint inhibitors boosted the interest in immunotherapy as a therapeutic choice in cancer treatment. However, these inhibitors require a pre-existing tumor specific immune response and the presence of tumor infiltrating T cells to be efficient. This immune response can be triggered by cancer vaccines. One of the main issues in tumor vaccination is the choice of the right antigen to target. All vaccines tested to date targeted tumor associated antigens (TAA) that are self-antigens and failed to show a clinical efficacy because of the immune self-tolerance to TAA. A new class of tumor antigens has recently been described, the neo-antigens that are created by point mutations of tumor expressing proteins and are recognized by the immune system as non-self. Neo-antigens exhibit two main properties: they are not involved in the immune self-tolerance process and are immunogenic. However, the majority of the neo-antigens are patient specific and their use as cancer vaccines requires their previous identification in each patient individualy that can be done only in highly specialized research centers. It is therefore evident that neo-antigens cannot be used for patient vaccination worldwide. This raises the question of whether we can find neo-antigen like vaccines, which would not be patient specific. In this review we show that optimized cryptic peptides from TAA are neo-antigen like peptides. Optimized cryptic peptides are recognized by the immune system as non-self because they target self-cryptic peptides that escape self-tolerance; in addition they are strongly immunogenic because their sequence is modified in order to enhance their affinity for the HLA molecule. The first vaccine based on the optimized cryptic peptide approach, Vx-001, which targets the widely expressed tumor antigen telomerase reverse transcriptase (TERT), has completed a large phase I clinical study and is currently being tested in a randomized phase II trial in non-small cell lung cancer (NSCLC) patients.

项与 Vx-001 相关的新闻（医药）

2024-05-27

·信狐药迅

新药上市申请1个品规、仿制药申请2个品规、进口申请6个品规发通知件；临床申请品种均默示许可| 新获批（5.20-5.26）

每周药品注册获批数据，分门别类呈现，一目了然。(5.20-5.26）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号TQ-B3525片正大天晴药业集团南京顺欣制药有限公司1CXHS2300050HSK16149胶囊海思科医药集团股份有限公司1CXHS2200058国;CXHS2200058甲磺酸瑞泽替尼胶囊上海倍而达药业有限公司1CXHS2101009国;CXHS2101009阿利沙坦酯氨氯地平片深圳信立泰药业股份有限公司2.3CXHS2200061国;CXHS2200061氟唑帕利胶囊江苏恒瑞医药股份有限公司2.4CXHS2300070温经汤颗粒华润三九医药股份有限公司3.1CXZS2300012新药临床申请药品名称企业注册分类受理号177Lu-LNC1010注射液烟台蓝纳成生物技术有限公司1CXHL2400286F230片北京康蒂尼药业股份有限公司1CXHL2400281F230片北京康蒂尼药业股份有限公司1CXHL2400280F230片北京康蒂尼药业股份有限公司1CXHL2400279INNA1605软膏武汉亿诺药业有限公司1CXHL2400271INNA1605软膏武汉亿诺药业有限公司1CXHL2400270ABP2111Na片上海爱博医药科技有限公司1CXHL2400265ABP2111Na片上海爱博医药科技有限公司1CXHL2400264BPYT-01胶囊百极优棠(广东)医药科技有限公司1CXHL2400269BPYT-01胶囊百极优棠(广东)医药科技有限公司1CXHL2400268MK-1084片默沙东研发(中国)有限公司1CXHL2400267MK-1084片默沙东研发(中国)有限公司1CXHL2400266SPH7450片上海医药集团股份有限公司1CXHL2400260SPH7450片上海医药集团股份有限公司1CXHL2400259SPH7450片上海医药集团股份有限公司1CXHL2400258SPH7450片上海医药集团股份有限公司1CXHL2400257HRS9531片福建盛迪医药有限公司1CXHL2400256HRS9531片福建盛迪医药有限公司1CXHL2400255HRS9531片福建盛迪医药有限公司1CXHL2400254HRS9531片福建盛迪医药有限公司1CXHL2400253HRS9531片福建盛迪医药有限公司1CXHL2400252KX-826酊苏州开禧医药有限公司1CXHL2400246DGPR1008注射液新斗生物科技(苏州)有限公司1CXHL2400243HRS9531片福建盛迪医药有限公司1CXHL2400251HRS9531片福建盛迪医药有限公司1CXHL2400250HRS9531片福建盛迪医药有限公司1CXHL2400249注射用LYSC98浙江医药股份有限公司新昌制药厂1CXHL2400236ARG-Vx-001注射液劲威生物医药科技有限公司1CXHL2400227TYR-Vx-001注射液劲威生物医药科技有限公司1CXHL2400226酒石酸阿福特罗雾化吸入用溶液海南斯达制药有限公司3CYHL2400052盐酸维洛沙秦缓释胶囊江苏恩华药业股份有限公司3CYHL2400050盐酸维洛沙秦缓释胶囊江苏恩华药业股份有限公司3CYHL2400049比拉斯汀口崩片浙江普利药业有限公司3CYHL2400048BAT7104注射液百奥泰生物制药股份有限公司1CXSL2400198注射用BAT8008百奥泰生物制药股份有限公司1CXSL2400197QL1706注射液齐鲁制药有限公司1CXSL2400193注射用QLS31905齐鲁制药有限公司1CXSL2400192注射用YL211苏州宜联生物医药有限公司1CXSL2400191GB08注射液深圳科兴药业有限公司1CXSL2400190BAT6005注射液百奥泰生物制药股份有限公司1CXSL2400189BAT1308注射液百奥泰生物制药股份有限公司1CXSL2400188SHR-4849注射液苏州盛迪亚生物医药有限公司1CXSL2400186注射用YL205苏州宜联生物医药有限公司1CXSL2400185SSGJ-707注射液沈阳三生制药有限责任公司1CXSL2400184金纳单抗注射液长春金赛药业有限责任公司1CXSL2400179SHR-9539注射液苏州盛迪亚生物医药有限公司1CXSL2400178SHR-9539注射液苏州盛迪亚生物医药有限公司1CXSL2400177NK042细胞注射液上海恩凯细胞技术有限公司1CXSL2400163宫血间充质干细胞注射液浙江生创精准医疗科技有限公司1CXSL2400156SCM-181注射液云南舜喜再生医学工程有限公司1CXSL2400157仿制药申请药品名称企业注册分类受理号甘露醇山梨醇注射液北京柏雅联合药物研究所有限公司3CYHS2300551注射用青霉素钠山东如至生物医药科技有限公司3CYHS2300364盐酸去氧肾上腺素注射液南京海融医药科技股份有限公司3CYHS2300323盐酸去氧肾上腺素注射液南京海融医药科技股份有限公司3CYHS2300321依帕司他片成都倍特药业股份有限公司3CYHS2300224琥珀酸美托洛尔缓释胶囊辰欣药业股份有限公司3CYHS2300114琥珀酸美托洛尔缓释胶囊辰欣药业股份有限公司3CYHS2300113硫酸长春新碱注射液海南美康达药业有限公司3CYHS2300105法莫替丁注射液北京布霖生物科技有限公司3CYHS2300014国;CYHS2300014法莫替丁注射液华夏生生药业(北京)有限公司3CYHS2300012国;CYHS2300012重酒石酸间羟胺注射液山西振东泰盛制药有限公司3CYHS2201833国;CYHS2201833盐酸丙卡特罗片海南万玮制药有限公司3CYHS2201781国;CYHS2201781硫酸沙丁胺醇注射液安徽恒星制药有限公司3CYHS2201696国;CYHS2201696吲哚布芬片浙江美迪深生物医药有限公司3CYHS2201574国;CYHS2201574氧柳州西能气体有限公司4CYHS2301496氧(液态)长沙广钢气体有限公司4CYHS2301379氧(液态)液化空气(武汉)高新气体有限公司4CYHS2301355丙戊酸钠缓释片(I)四川科伦药业股份有限公司4CYHS2301072富马酸卢帕他定片江苏万珺医药科技有限公司4CYHS2300772贝前列素钠片成都苑东生物制药股份有限公司4CYHS2300726枸橼酸西地那非口腔崩解片山东华铂凯盛生物科技有限公司4CYHS2300671磷酸奥司他韦胶囊江西药都仁和制药有限公司4CYHS2300632盐酸文拉法辛缓释胶囊吉林天衡药业有限公司4CYHS2300491盐酸文拉法辛缓释胶囊吉林天衡药业有限公司4CYHS2300490吸入用乙酰半胱氨酸溶液温州海鹤药业有限公司4CYHS2300463间苯三酚注射液北京民康百草医药科技有限公司4CYHS2300299雷贝拉唑钠肠溶片丽珠集团丽珠制药厂4CYHS2300208他氟前列素滴眼液扬子江药业集团有限公司4CYHS2300136马来酸氟伏沙明片成都倍特药业股份有限公司4CYHS2300122米拉贝隆缓释片江西山香药业有限公司4CYHS2300087乳果糖口服溶液海南美康达药业有限公司4CYHS2300058乳果糖口服溶液海南美康达药业有限公司4CYHS2300057间苯三酚注射液华润双鹤利民药业(济南)有限公司4CYHS2300008国;CYHS2300008西格列汀二甲双胍片(II)宁波美诺华天康药业有限公司4CYHS2202163国;CYHS2202163西格列汀二甲双胍片(I)宁波美诺华天康药业有限公司4CYHS2202162国;CYHS2202162硝苯地平控释片江西山香药业有限公司4CYHS2202029国;CYHS2202029西格列汀二甲双胍片(Ⅱ)江苏德源药业股份有限公司4CYHS2202025国;CYHS2202025泊沙康唑注射液重庆华邦制药有限公司4CYHS2202001国;CYHS2202001布南色林片湖南省湘中制药有限公司4CYHS2201983国;CYHS2201983盐酸莫西沙星滴眼液中山万汉制药有限公司4CYHS2201968国;CYHS2201968拉考沙胺注射液江苏恩华药业股份有限公司4CYHS2201782国;CYHS2201782艾司奥美拉唑镁肠溶片黑龙江珍宝岛药业股份有限公司4CYHS2201757国;CYHS2201757地氯雷他定片广东怡至药品研究院有限公司4CYHS2201682国;CYHS2201682枸橼酸西地那非口腔崩解片仁合益康集团有限公司4CYHS2201664国;CYHS2201664熊去氧胆酸胶囊福建瑞泰来医药科技有限公司4CYHS2201653阿普米司特片桂林南药股份有限公司4CYHS2200763国;CYHS2200763盐酸莫西沙星滴眼液山东光明药业有限公司4CYHS2201389国;CYHS2201389盐酸莫西沙星滴眼液山东光明药业有限公司4CYHS2201388国;CYHS2201388甲磺酸雷沙吉兰片石家庄四药有限公司4CYHS2201044国;CYHS2201044盐酸舍曲林片桂林南药股份有限公司4CYHS2201011国;CYHS2201011草酸艾司西酞普兰片山东新华制药股份有限公司4CYHS2200872国;CYHS2200872阿普米司特片桂林南药股份有限公司4CYHS2200762国;CYHS2200762阿普米司特片桂林南药股份有限公司4CYHS2200761国;CYHS2200761甲磺酸雷沙吉兰片山东华铂凯盛生物科技有限公司4CYHS2200628国;CYHS2200628盐酸依匹斯汀片兆科药业(广州)有限公司4CYHS2102251国;CYHS2102251溴芬酸钠滴眼液河北创健药业有限公司4CYHS2101763国;CYHS2101763进口申请药品名称企业注册分类受理号注射用舒巴坦钠/注射用度洛巴坦钠组合包装Entasis Therapeutics Inc.1JXHS2300022替尔泊肽注射液Eli Lilly and Company5.1JXHS2200078国;JXHS2200078替尔泊肽注射液Eli Lilly and Company5.1JXHS2200077国;JXHS2200077替尔泊肽注射液Eli Lilly and Company5.1JXHS2200076国;JXHS2200076替尔泊肽注射液Eli Lilly and Company5.1JXHS2200075国;JXHS2200075左甲状腺素钠片Intas Pharmaceuticals. Ltd.5.2JYHS2300089左甲状腺素钠片Intas Pharmaceuticals. Ltd.5.2JYHS2300088左甲状腺素钠片Intas Pharmaceuticals. Ltd.5.2JYHS2300087左甲状腺素钠片Intas Pharmaceuticals. Ltd.5.2JYHS2300086左甲状腺素钠片Intas Pharmaceuticals. Ltd.5.2JYHS2300085他达拉非片M/s Cipla Ltd.5.2JYHS2300064麦考酚钠肠溶片TWi Pharmaceuticals, Inc.5.2JYHS2200062国;JYHS2200062麦考酚钠肠溶片TWi Pharmaceuticals, Inc.5.2JYHS2200061国;JYHS2200061Vorasidenib片Institut de Recherches Internationales Servier1JXHL2400061中药相关申请药品名称企业注册分类受理号FTZ浓缩丸深圳前海吉奥健康科技有限公司1.1CXZL2400014母苏颗粒瑞阳制药股份有限公司1.1CXZL2400013肾炎康复片天津同仁堂集团股份有限公司2.3CXZL2400012注：灰色字体部分结论为不批准或收到通知件；

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100 项与 Vx-001 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性非小细胞肺癌	临床2期	意大利	VAXON Biotech SA	2012-08-01
转移性非小细胞肺癌	临床2期	德国	VAXON Biotech SA	2012-08-01
转移性非小细胞肺癌	临床2期	罗马尼亚	VAXON Biotech SA	2012-08-01
转移性非小细胞肺癌	临床2期	波兰	VAXON Biotech SA	2012-08-01
转移性非小细胞肺癌	临床2期	法国	VAXON Biotech SA	2012-08-01
转移性非小细胞肺癌	临床2期	西班牙	VAXON Biotech SA	2012-08-01
转移性非小细胞肺癌	临床2期	捷克	VAXON Biotech SA	2012-08-01
转移性非小细胞肺癌	临床2期	希腊	VAXON Biotech SA	2012-08-01

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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


ASCO2008	临床1/2期	HR阳性/HER2低表达实体瘤	71	Vx-001	(壓糧選簾衊廠艱廠艱壓) = 衊製蓋餘鏇顧繭顧構鹹壓廠獵夢壓觸簾衊醖廠 (鏇選窪衊膚憲廠鹽衊淵 )	-	2008-05-20
ASCO2007	N/A	晚期非小细胞肺癌	22	Vx-001	(築簾膚積遞觸夢鬱鏇顧) = 衊餘鏇簾製積築壓顧憲餘鬱窪憲製蓋網範範淵 (築築遞觸顧鑰襯餘艱窪 ) 更多	积极	2007-06-20