A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1+ Synovial Sarcoma Participants Following First Line Systemic Anti-cancer Therapy (V943-003, IMDZ-04-1702)

To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

开始日期2018-09-18

申办/合作机构

Immune Design Corp.

NCT02015416 / Completed临床1期

A Phase 1 Open Label, Multicenter, Multiple Ascending Dose Trial Evaluating the Safety, Tolerability and Immunogenicity of Intramuscular Recombinant NY-ESO-1 Protein With GLA-SE Adjuvant in Patients With Unresectable or Metastatic Cancer

This is a Phase I, multi-center, multiple ascending dose study to evaluate the clinical safety and immune response of IDC-G305 when injected intramuscularly in patients with unresectable or metastatic cancer. IDC-G305 is an immunotherapy consisting of recombinant NY-ESO-1 antigen and the adjuvant, GLA-SE. The goal is for IDC-G305 to stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors include the NY-ESO-1 protein. Patients with melanoma, ovarian, renal cell or non-small cell lung cancer may be considered for the trial.

开始日期2013-11-01

申办/合作机构-

100 项与 NY-ESO-1/GLA-SE cancer vaccine(Immune Design Corp.) 相关的临床结果

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100 项与 NY-ESO-1/GLA-SE cancer vaccine(Immune Design Corp.) 相关的转化医学

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100 项与 NY-ESO-1/GLA-SE cancer vaccine(Immune Design Corp.) 相关的专利（医药）

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项与 NY-ESO-1/GLA-SE cancer vaccine(Immune Design Corp.) 相关的文献（医药）

2021-01-01·Oncoimmunology2区 · 医学

A phase 1 study of NY-ESO-1 vaccine + anti-CTLA4 antibody Ipilimumab (IPI) in patients with unresectable or metastatic melanoma

2区 · 医学

ArticleOA

作者: Zarour, Hassane M. ; Ryan, Aileen ; Mauldin, Ileana S. ; Slingluff, Craig L. ; Venhaus, Ralph ; Olson, Walter C. ; Ricciardi, Toni ; Kirkwood, John M. ; Wolchok, Jedd D. ; Friedlander, Philip ; Gaughan, Elizabeth M. ; Macri, Mary J. ; Tawbi, Hussein Abdul-Hassan ; Postow, Michael A. ; Devoe, Craig E. ; Smith, Kelly T.

Ipilimumab (IPI) can enhance immunity to the cancer-testis antigen NY-ESO-1. A clinical trial was designed to assess safety, immunogenicity, and clinical responses with IPI + NY-ESO-1 vaccines and effects on the tumor microenvironment (TME). Patients with measurable NY-ESO-1⁺ tumors were enrolled among three arms: A) IPI + NY-ESO-1 protein + poly-ICLC (pICLC) + incomplete Freund's adjuvant (IFA); B) IPI + NY-ESO-1 overlapping long peptides (OLP) + pICLC + IFA; and C) IPI + NY-ESO-1 OLP + pICLC. Clinical responses were assessed by irRC. T cell and Ab responses were assessed by ex vivo IFN-gamma ELIspot and ELISA. Tumor biopsies pre- and post-treatment were evaluated for immune infiltrates. Eight patients were enrolled: 5, 2, and 1 in Arms A-C, respectively. There were no DLTs. Best clinical responses were SD (4) and PD (4). T-cell and antibody (Ab) responses to NY-ESO-1 were detected in 6 (75%) and 7 (88%) patients, respectively, and were associated with SD. The breadth of Ab responses was greater for patients with SD than PD (p = .036). For five patients evaluable in the TME, treatment was associated with increases in proliferating (Ki67⁺) CD8⁺ T cells and decreases in RORγt⁺ CD4⁺ T cells. T cell densities increased for those with SD. Detection of T cell responses to NY-ESO-1 ex vivo in most patients suggests that IPI may have enhanced those responses. Proliferating intratumoral CD8⁺ T cells increased after vaccination plus IPI suggesting favorable impact of IPI plus NY-ESO-1 vaccines on the TME. List of Abbreviations: Ab = antibody; CTCAE = NCI Common Terminology Criteria for Adverse Events; DHFR/DHRP = dihydrofolate reductase; DLT = Dose-limiting toxicity; ELISA = enzyme-linked immunosorbent assay; IFA = incomplete Freund's adjuvant (Montanide ISA-51); IFNγ = Interferon gamma; IPI = Ipilimumab; irRC = immune-related response criteria; mIFH = multispectral immunofluorescence histology; OLP = NY-ESO-1 overlapping long peptides; PBMC = peripheral blood mononuclear cells; PD = Progressive disease; pICLC = poly-ICLC (Hiltonol), a TLR3/MDA-5 agonist; RLT = Regimen-limiting Toxicity; ROI = regions of interest; RT = room temperature; SAE = serious adverse event; SD = stable disease; TEAE = treatment-emergent adverse events; TLR = toll-like receptor; TME = tumor microenvironment; TRAE = treatment-related adverse events.

2020-07-20·ACS applied bio materials

Cowpea Mosaic Virus (CPMV)-Based Cancer Testis Antigen NY-ESO-1 Vaccine Elicits an Antigen-Specific Cytotoxic T Cell Response

Article

作者: Patel, Bindi K ; Wang, Chao ; Lorens, Braulio ; Levine, Alan D ; Steinmetz, Nicole F ; Shukla, Sourabh

Cancer vaccines are promising adjuvant immunotherapies that can stimulate the immune system to recognize tumor-associated antigens and eliminate the residual or recurring disease. The aberrant and restricted expression of highly immunogenic cancer testis antigen NY-ESO-1 in several malignancies, including triple-negative breast cancer, melanoma, myelomas, and ovarian cancer, makes NY-ESO-1 an attractive antigenic target for cancer vaccines. This study describes a NY-ESO-1 vaccine based on a bio-inspired nanomaterial platform technology, specifically a plant virus nanoparticle. The 30 nm icosahedral plant virus cowpea mosaic virus (CPMV) displaying multiple copies of human HLA-A2 restricted peptide antigen NY-ESO-1_157-165 exhibited enhanced uptake and activation of antigen-presenting cells and stimulated a potent CD8⁺ T cell response in transgenic human HLA-A2 expressing mice. CD8⁺ T cells from immunized mice exhibited antigen-specific proliferation and cancer cell cytotoxicity, highlighting the potential application of a CPMV-NY-ESO-1 vaccine against NY-ESO-1⁺ malignancies.

2020-04-01·Journal for immunotherapy of cancer2区 · 医学

Results of a randomized, double-blind phase II clinical trial of NY-ESO-1 vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in participants with high-risk resected melanoma

2区 · 医学

ArticleOA

作者: Jackson, Heather M ; Cebon, Jonathan S ; Maraskovsky, Eugene ; McArthur, Grant A ; Davis, Ian D ; Williams, Geoff ; Corrie, Pippa G ; Evans, T R Jeffry ; Thompson, John F ; Dalgleish, Angus G ; Haack, Dennis ; Cerundolo, Vincenzo ; Nathan, Paul ; Smithers, Mark ; Chen, Weisan ; Hersey, Peter ; Maria, Marples ; MacGregor, Duncan ; Behren, Andreas ; Walpole, Euan ; Endo-Munoz, Liliana ; Fisher, Cyril ; Dunbar, P Rod ; Marsden, Jeremy ; Winkler, Sintia ; Tutuka, Candani S A ; Brimble, Margaret ; Venhaus, Ralph ; Gore, Martin ; Ottensmeier, Christian Hermann ; Old, Lloyd J ; Findlay, Michael P N ; Millward, Michael

Background:

To compare the clinical efficacy of New York Esophageal squamous cell carcinoma-1 (NY-ESO-1) vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in a randomized, double-blind phase II study in participants with fully resected melanoma at high risk of recurrence.

Methods:

Participants with resected stage IIc, IIIb, IIIc and IV melanoma expressing NY-ESO-1 were randomized to treatment with three doses of NY-ESO-1/ISCOMATRIX or ISCOMATRIX adjuvant administered intramuscularly at 4-week intervals, followed by a further dose at 6 months. Primary endpoint was the proportion free of relapse at 18 months in the intention-to-treat (ITT) population and two per-protocol populations. Secondary endpoints included relapse-free survival (RFS) and overall survival (OS), safety and NY-ESO-1 immunity.

Results:

The ITT population comprised 110 participants, with 56 randomized to NY-ESO-1/ISCOMATRIX and 54 to ISCOMATRIX alone. No significant toxicities were observed. There were no differences between the study arms in relapses at 18 months or for median time to relapse; 139 vs 176 days (p=0.296), or relapse rate, 27 (48.2%) vs 26 (48.1%) (HR 0.913; 95% CI 0.402 to 2.231), respectively. RFS and OS were similar between the study arms. Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4+and CD8+responses. Biopsies following relapse did not demonstrate differences in NY-ESO-1 expression between the study populations although an exploratory study demonstrated reduced (NY-ESO-1)+/Human Leukocyte Antigen (HLA) class I+double-positive cells in biopsies from vaccine recipients performed on relapse in 19 participants.

Conclusions:

The vaccine was well tolerated, however, despite inducing antigen-specific immunity, it did not affect survival endpoints. Immune escape through the downregulation of NY-ESO-1 and/or HLA class I molecules on tumor may have contributed to relapse.

项与 NY-ESO-1/GLA-SE cancer vaccine(Immune Design Corp.) 相关的新闻（医药）

2022-11-15

·药研发

【药研发1116】鸿运华宁ETa单抗获批糖尿病肾病临床 | 石药rt-PA类溶栓药脑梗死适应症报产...

「本文共：15条资讯，阅读时长约：3分钟」今日头条鸿运华宁ETa单抗获批糖尿病肾病临床。鸿运华宁自主研发的ETa特异性单抗GMA131注射液获FDA新药临床许可，拟开发用于治疗糖尿病肾病。GMA131特异靶向ETa，阻断ET-1/ETa信号传导，与ETb无结合。GMA131和正在进行中、美联合肺动脉高压临床试验的GMA301属同一分子。临床前及临床研究显示，该分子具有良好的安全性，有望成为新一代治疗糖尿病肾病的药物。国内药讯1.石药rt-PA类溶栓药脑梗死适应症报产。国家药监局受理石药集团旗下石药明复乐递交的注射用重组人TNK组织型纤溶酶原激活剂（铭复乐，rhTNK-tPA）的新适应症上市申请，推测适应症可能是针对急性缺血性卒中（脑梗死）的治疗。今年8月，铭复乐在用于治疗急性缺血性卒中的III期临床（TRACE II）中达到主要终点，铭复乐与阿替普酶相比，90天mRS评分0-1分的患者比例达到非劣性标准。2.君实PD-1抑制剂在欧洲报产。君实生物PD-1抑制剂特瑞普利单抗向欧洲药品管理局（EMA）提交两项上市申请（MAA），联合顺铂和吉西他滨一线治疗局部复发或转移性鼻咽癌（NPC）；以及联合紫杉醇和顺铂一线治疗不可切除局部晚期/复发或转移性食管鳞癌（ESCC）。今年7月，FDA也受理该新药重新提交的上市申请，联合吉西他滨/顺铂一线治疗晚期复发或转移性NPC患者，以及单药二线及以上治疗复发或转移性NPC，PDUFA日期为今年12月23日。3.恒瑞「吡咯替尼」新适应症拟纳入优先审评。恒瑞医药HER1/HER2/HER4酪氨酸激酶抑制剂马来酸吡咯替尼片的新适应症上市申请获CDE拟纳入优先审评，拟用于一线治疗HER2阳性复发/转移性乳腺癌患者。今年8月，该新药联合曲妥珠单抗和多西他赛一线治疗HER2阳性复发/转移性乳腺癌的III期临床（HR-BLTN-III-MBC-C研究）达到主要终点，吡咯替尼联合治疗显著改善患者的无进展生存期（24.3vs10.4个月，HR=0.41）。4.基石引进三抗实体瘤早期临床积极。基石药业在SITC2022年会上公布从Numab公司引进的PD-L1/4-1BB/HSA多特异性抗体CS2006（NM21-1480）治疗先前已接受过多种方案治疗的晚期实体瘤的I期剂量递增研究结果。在23例可评估患者中，大多数患者能观察到临床获益，有1例患者（晚期结直肠癌）显示部分缓解。24-800mg剂量组患者的8周疾病控制率（DCR）为57%。大多数治疗相关的不良事件（TRAE）的严重程度为轻中度。5.固安鼎泰三靶点DNA肿瘤疫苗报IND。固安鼎泰海规生物公司1类生物制品"NMM肿瘤治疗性DNA疫苗裸质粒注射液"临床试验申请获CDE受理（受理号：CXSL2200571），推测这是一款靶向3个肿瘤抗原靶点的DNA疫苗，拟通过局部注射用于多种实体瘤的治疗。今年4月，该公司获得一项名为《一种抗肿瘤重组NMM融合抗原质粒DNA疫苗》的专利授权（CN109081873B）；该项发明设计和构建了一种融合有3个肿瘤抗原靶点(NY-ESO-1, MUC1,MAGE-A3)的重组质粒DNA(pNMM)疫苗。6.豪森引进一款临床前EGFR/cMet双抗。翰森制药附属公司翰森（上海）健康与普米斯生物就后者一款临床前期EGFR/cMet双抗药物PM1080订立合作许可协议，获得PM1080在中国的开发、注册审批、生产及商业化授权。PM1080具有能够同时阻断EGFR和c-Met的信号传导，抑制肿瘤生长和存活等作用的巨大治疗潜力。根据协议，普米斯将获得5000万人民币首付款，和高达14.18亿人民币的潜在里程碑付款，以及产品的销售分成。‍‍‍国‍‍‍‍‍‍‍‍‍际‍‍‍‍药讯‍‍1.创新ADC治疗难治性卵巢癌获FDA加速批准。ImmunoGen公司靶向FRα的抗体偶联药物Elahere（mirvetuximab soravtansine）获FDA加速批准上市，用于单药治疗FRα高表达、对含铂疗法耐药的晚期卵巢癌经治患者。在关键Ⅲ期临床SORAYA中，该新药经研究者评估的客观缓解率达到31.7%（95% CI：22.9%，41.6%），中位缓解持续时间为6.9个月（95% CI：5.6，8.1）。华东医药拥有该新药在大中华区的独家授权。2.体内CRISPR基因编辑治疗HAE早期临床积极。Intellia Therapeutics公司在ACAAI2022年会上公布CRISPR/Cas9候选疗法NTLA-2002治疗遗传性血管水肿（HAE）的Ⅰ/Ⅱ期临床最新结果。数据显示，25mg和75mg剂量队列患者的激肽水平降幅分别为64%与92%，且持续时间分别达到32与16周；其中25mg剂量组在第1周至第16周平均HAE发病率降低91%，在第5周至第16周平均HAE发病率降低89%，并且在单次给药后5.5～10.6个月无进展。NTLA-2002总体耐受性良好。3.肿瘤反应性CAR-NK疗法临床前研究积极。CytoImmune公司在STIC 2022年会上公布其双机制、工程化CAR-NK细胞疗法CYTO-102的临床前数据。研究结果显示，CYTO-102在体外模型中产生了对淋巴瘤和非小细胞肺癌（NSCLC）的连续杀伤；当与肿瘤抗原导向的单抗联用时，能够有效增强NK细胞的连续杀伤能力并让不敏感NK细胞系在体外转化为敏感细胞系；TRACK-NK细胞能够有效地“循环”表达CD16，并且其连续杀伤能力可在细胞静息或冷冻保存后迅速恢复表达。4.罗氏Aβ单抗两项III期研究失败。罗氏皮下注射Aβ单抗Gantenerumab治疗早期阿尔茨海默病的两项III期GRADUATE研究（GRADUATE I 和II）没有达到主要终点。116周治疗数据显示，两个试验Gantenerumab组痴呆严重程度评分（CDR-SB）较基线分别降低-0.31（p=0.0954）和-0.19（p=0.2998），均无统计学意义。此外，Gantenerumab清除Aβ蛋白水平低于预期。药物的总体耐受性良好。5.内分泌多肽药物公司完成新一轮融资。MBX Biosciences公司宣布完成金额达1.15亿美元的B轮融资，以推动其先导项目MBX 2109治疗甲状旁腺功能减退症的Ⅰ期临床开发，以及用于支持包含MBX 1416在内的临床前管线和其他内分泌疾病项目的发现与开发。MBX 2109是一款长效甲状旁腺内分泌多肽前体，能够以一周一次的剂量，提供长效的甲状旁腺激素（PTH）活性。该药物今年7月已获得FDA的孤儿药资格。‍‍‍‍‍‍‍医‍‍‍‍药‍‍‍‍热‍‍‍‍点‍‍‍‍‍‍‍1.中国高血压临床实践指南发布。11月13日，由国家心血管病中心、中国医师协会等学术机构共同制定的《中国高血压临床实践指南》正式颁布，推荐将我国成人高血压诊断界值由140/90mmHg下调至130/80mmHg，与五年前美国高血压协会/美国心脏病协会发布的标准平齐。以新标准估算，中国高血压患者数将由2.45亿增至近5亿，超1/3国人都将成为高血压病患者。2.新疆防疫一线医务人员可提前申报高级职称。日前，新疆维吾尔自治区人力资源和社会保障厅发布消息称，自治区人社厅结合当前疫情防控工作需要和职称评审工作实际，提早研判、精准施策，采取放宽继续教育学习时间、延长职称申报期限等五项工作举措，稳步有序推进专业技术人员职称评审工作。其中，为关心关爱抗疫一线医护人员，新疆明确在2022年卫生健康系列高级职称评审工作中，疫情防控一线医务人员可提前一年申报职称。 3.全球人口达到80亿。联合国《世界人口展望2022》报告预计，全球人口在2022年11月15日达到80亿。根据此前联合国人口基金会的统计，全球人口在2011年10月31日达到了70亿。世界人口从70亿增长到今天的80亿，用了11年零半个月。根据联合国最新预测，到本世纪80年代，全球人口将达到约104亿的峰值，并保持这个水平到2100年。‍‍‍‍‍‍评‍‍‍审‍‍动态‍‍‍‍‍‍1. CDE新药受理情况（11月15日) 2. FDA新药获批情况（北美11月10日）股市资讯上个交易日 A 股医药板块 +1.12%涨幅前三跌幅前三金石亚药+20.02% 安图生物-6.53%陇神戎发+20.00% 舒泰神 -5.16%亨迪药业+19.99% 新产业 -5.16% 【沃森生物】公司于近日收到广州医科大学附属第一医院医学伦理委员会关于“评价新型冠状病毒变异株mRNA疫苗（S蛋白嵌合体）序贯加强免疫接种的免疫原性和安全性的随机、盲法、阳性对照IIIa期临床试验”的《临床试验快速审查批件》【华东医药】全资子公司中美华东美国合作方ImmunoGen”）对外宣布，其用于治疗铂耐药卵巢癌的全球首创ADC药物ELAHERE获得美国FDA加速批准上市【恒瑞医药】公司子公司瑞石生物治疗特应性皮炎的Ⅲ期临床研究RSJ10333（QUARTZ 3）主要研究终点达到方案预设的有效标准，研究结果显示艾玛昔替尼片疗法的中重度特应性皮炎患者和改善皮肤瘙痒方面显著优于安慰剂。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

临床3期优先审批申请上市临床2期疫苗

100 项与 NY-ESO-1/GLA-SE cancer vaccine(Immune Design Corp.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床2期	美国	Portage Biotech, Inc.	2022-08-24
乳腺癌	临床1期	美国	Immune Design Corp.	2013-11-01
黑色素瘤	临床1期	美国	Immune Design Corp.	2013-11-01
非小细胞肺癌	临床1期	美国	Immune Design Corp.	2013-11-01
卵巢癌	临床1期	美国	Immune Design Corp.	2013-11-01
肉瘤	临床1期	美国	Immune Design Corp.	2013-11-01