Adenoviral brachyury vaccine(Etubics Corp.)(Adenoviral brachyury vaccine(Etubics Corp.)) - 药物靶点：TBXT_在研适应症：前列腺癌_专利_临床

概要

基本信息

药物类型

重组载体疫苗、治疗性疫苗

别名

Ad5 brachyury vaccine、Adenoviral brachyury vaccine、Universal influenza vaccine

+ [2]

靶点

TBXT

作用方式

调节剂

作用机制

TBXT调节剂(T-box transcription factor T modulators)

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

前列腺癌

非在研适应症

脊索瘤梅克尔细胞癌转移性结直肠癌+ [10]

原研机构

在研机构

非在研机构

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

19

项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的临床试验

NCT03563157

/ Terminated临床1/2期

NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy

QUILT 3.071 NANT Colorectal Cancer (CRC) Vaccine: This is a Phase 1b/2 study investigating the effect of NANT CRC vaccine vs regorafenib in subjects with CRC who were previously treated with SOC.

开始日期2018-09-28

申办/合作机构

ImmunityBio, Inc.

NCT03554109

/ Withdrawn临床2期

An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC

This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).

开始日期2018-09-01

申办/合作机构

ImmunityBio, Inc.

NCT03647423

/ Withdrawn临床1/2期

QUILT-3.091 NANT Chordoma Vaccine: A Randomized Phase 1b/2 Trial of the NANT Chordoma Vaccine vs. Radiation in Subjects With Unresectable Chordoma.

QUILT 3.091 Chordoma Vaccine: Phase 1B/2 NANT Chordoma Vaccine vs Radiation in Subjects with Unresectable Chordoma.

开始日期2018-08-31

申办/合作机构

ImmunityBio, Inc.

100 项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的临床结果

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100 项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的转化医学

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100 项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的专利（医药）

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8

项与 Adenoviral brachyury vaccine(Etubics Corp.) 相关的文献（医药）

2025-03-10·The Oncologist

Tri-Ad5 vaccine plus bintrafusp alfa for newly diagnosed, advanced-stage head and neck cancer not associated with human papillomavirus infection

Article

作者: Prins, Daniel ; Turkbey, Evrim B ; Donahue, Renee N ; Schlom, Jeffrey ; Allen, Clint T ; Gulley, James L ; Steinberg, Seth J ; Marté, Jennifer L ; Cordes, Lisa ; Floudas, Charalampos S ; Soon-Shiong, Patrick ; Redman, Jason M

AbstractBackgroundNewly diagnosed, advanced-stage head and neck cancer (HNSCC) not associated with human papillomavirus (HPV) infection has poor survival and functional outcomes despite surgical management. Neoadjuvant immunotherapy is of interest to improve long-term outcomes.MethodsIndividuals with untreated intermediate/high risk, p16-negative (if oropharyngeal) HNSCC were eligible and underwent pre- and post-treatment tumor biopsies. Primary endpoint was pathologic complete response or clinical-to-pathological downstaging (CPD). Treatment regimen: 5 × 1011 viral particles once, subcutaneously of each component of the Tri-Ad5 vaccine (ETBX-011, ETBX-061, and ETBX-051 targeting tumor-associated antigens (TAA): carcinoembryonic antigen [CEA], MUC-1, and brachyury, respectively) plus 1200 mg IV of bintrafusp alfa (anti-PD-L1 and anti-transforming growth factor-β) every 2 weeks for 2 doses. Participants returned to referring physicians for standard surgery ± adjuvant treatment if indicated.ResultsOf 6 HNSCC patients, 2 (33.3%) had CPD. There were no pathologic complete responses. 2-year recurrence free survival (RFS) was 83.3% (95% CI, 27.3%-97.5%). Adverse events were consistent with known safety profiles of each agent. There were no surgical delays.ConclusionsIn this small study, Tri-Ad5 vaccine plus bintrafusp alfa resulted in CPD in 2/6 patients. Participants also had favorable 2-year RFS compared to historical values. Ongoing tissue and peripheral immunome analyses may provide mechanistic insight. (ClincalTrials.gov Identifier: NCT04247282; IRB Approved.).

2021-12-06·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Research and development technology platform and research progress of universal influenza vaccine].

Review

作者: Yang, X M ; Zhang, J Y ; Deng, T

接种疫苗是预防流感最有效措施。然而，由于流感病毒存在抗原漂移和/或抗原转换，常常使疫苗毒株与流行毒株不匹配，以至于目前流感疫苗提供的保护非常有限。随着疫苗新技术的快速发展，具有广泛保护性或通用的流感疫苗受到极大关注。能够有效诱导针对流感病毒保守表位的体液免疫和细胞免疫，提供针对流感病毒各种型或亚型的良好保护，安全有效，且具备快速生产平台，是新一代通用型流感疫苗研发的理想目标。本文就流感通用疫苗研发技术平台与最新研究进展进行综述。.

2020-06-01·The Oncologist2区 · 医学

A Phase I Trial Using a Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury)-Based Immunotherapy Vaccine Regimen in Patients with Advanced Cancer

2区 · 医学

Article

作者: Bilusic, Marijo ; Madan, Ravi A. ; Marté, Jennifer L. ; Gulley, James L. ; Schlom, Jeffrey ; Cordes, Lisa M. ; Karzai, Fatima ; Strauss, Julius ; Redman, Jason M. ; Sater, Houssein Abdul ; Gatti-Mays, Margaret E. ; Palena, Claudia ; Steinberg, Seth M. ; McMahon, Sheri ; Donahue, Renee N. ; Orpia, Alanvin ; Burmeister, Andrea

AbstractLessons LearnedConcurrent ETBX-011, ETBX-051, and ETBX-061 can be safely administered to patients with advanced cancer. All patients developed CD4+ and/or CD8+ T-cell responses after vaccination to at least one tumor-associated antigen (TAA) encoded by the vaccine; 5/6 patients (83%) developed MUC1-specific T cells, 4/6 (67%) developed CEA-specific T cells, and 3/6 (50%) developed brachyury-specific T cells. The presence of adenovirus 5-neutralizing antibodies did not prevent the generation of TAA-specific T cells.BackgroundA novel adenovirus-based vaccine targeting three human tumor-associated antigens—CEA, MUC1, and brachyury—has demonstrated antitumor cytolytic T-cell responses in preclinical animal models of cancer.MethodsThis open-label, phase I trial evaluated concurrent administration of three therapeutic vaccines (ETBX-011 = CEA, ETBX-061 = MUC1 and ETBX-051 = brachyury). All three vaccines used the same modified adenovirus 5 (Ad5) vector backbone and were administered at a single dose level (DL) of 5 × 1011 viral particles (VP) per vector. The vaccine regimen consisting of all three vaccines was given every 3 weeks for three doses then every 8 weeks for up to 1 year. Clinical and immune responses were evaluated.ResultsTen patients enrolled on trial (DL1 = 6 with 4 in the DL1 expansion cohort). All treatment-related adverse events were temporary, self-limiting, grade 1/2 and included injection site reactions and flu-like symptoms. Antigen-specific T cells to MUC1, CEA, and/or brachyury were generated in all patients. There was no evidence of antigenic competition. The administration of the vaccine regimen produced stable disease as the best clinical response.ConclusionConcurrent ETBX-011, ETBX-051, and ETBX-061 can be safely administered to patients with advanced cancer. Further studies of the vaccine regimen in combination with other agents, including immune checkpoint blockade, are planned.

100 项与 Adenoviral brachyury vaccine(Etubics Corp.) 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
不可切除的实体瘤	临床前	美国	ImmunityBio, Inc.	2018-08-31
转移性胰腺癌	临床前	美国	ImmunityBio, Inc.	2018-08-01
可切除非小细胞肺癌	临床前	美国	ImmunityBio, Inc.	2018-06-01
不可切除的肝细胞癌	临床前	美国	ImmunityBio, Inc.	2018-05-25
梅克尔细胞癌	临床前	-	ImmunityBio, Inc.	2017-12-01
卵巢上皮癌	临床前	-	ImmunityBio, Inc.	2017-12-01
头颈部鳞状细胞癌	临床前	-	ImmunityBio, Inc.	2017-12-01
尿路上皮癌	临床前	-	ImmunityBio, Inc.	2017-12-01
不可切除的黑色素瘤	临床前	-	ImmunityBio, Inc.	2017-12-01
鳞状细胞癌	药物发现	美国	NantKwest, Inc.	2018-01-13

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临床结果

适应症

分期

评价

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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


NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	(觸顧築憲憲憲網膚構選) = 艱廠衊鹹鬱遞鬱淵範鏇簾積憲積膚範夢衊範顧 (簾獵鹽糧鑰範遞憲製鏇, 蓋觸獵願顧淵窪夢窪願 ~ 襯簾鏇網衊鹽製餘壓襯) 更多	-	2024-12-11
NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	Regorafenib (Regorafenib)	構齋齋選簾鏇構網膚糧(襯簾襯淵窪鬱鏇壓夢選) = 糧襯齋醖糧鏇醖觸選憲糧鹹窪鏇膚觸鏇製襯願 (顧襯鏇顧鬱廠膚製夢鏇, 醖鏇鹹廠簾艱簾夢選廠 ~ 壓築膚糧願簾選鬱膚簾) 更多	-	2024-12-11
NCT03586869 (QUILT-3.080, CTgov)	临床1/2期	胰腺癌	3	Avelumab+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+Leucovorin+ETBX-011+fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+cyclophosphamide+haNK for infusion+GI-6207+bevacizumab+Oxaliplatin+Capecitabine	(積蓋齋憲顧繭窪製觸鹽) = 簾築鬱鬱願衊鬱憲範蓋願積餘窪獵衊範憲廠醖 (簾衊鬱壓壓構淵蓋觸築, 壓簾廠鑰範襯顧艱顧鑰 ~ 衊簾構衊鹹餘蓋襯衊淵) 更多	-	2024-08-27
NCT03387085 (QUILT-3.067, CTgov)	临床1/2期	三阴性乳腺癌	9	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+N-803+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK for Infusion+GI-6207+cisplatin+Bevacizumab+Capecitabine	(築構鬱範獵衊廠蓋願餘) = 鏇遞網憲遞積壓齋築願網壓鬱鹹鹽鑰齋膚糧蓋 (遞糧網壓製壓淵鏇壓淵, 鑰網窪觸鹹鬱繭壓遞積 ~ 窪壓鑰餘壓膚鑰鏇醖積) 更多	-	2024-08-09
NCT03387111 (CTgov)	临床1/2期	鳞状细胞癌	4	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+cetuximab+ETBX-061+ETBX-051+Leucovorin+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+GI-6207+cisplatin+Bevacizumab+Capecitabine	遞壓夢選衊鬱糧網網獵(鑰鹹觸觸齋衊製糧鑰繭) = 範築壓願糧淵繭餘衊憲廠積衊簾廠鹽遞鬱醖網 (蓋製窪觸獵繭廠鏇構繭, 艱範築願鏇構製鬱壓築 ~ 窪顧願願衊鬱醖鬱壓蓋) 更多	-	2024-08-05
NCT03481816 (CTgov)	临床1期	去势抵抗性前列腺癌 \| 转移性去势抵抗性前列腺癌	18	ETBX-061; adenoviral MUC1 vaccine+ETBX-071; adenoviral PSA vaccine+ETBX-051; adenoviral brachyury vaccine (Arm 1/Dose De-Escalation)	鹽顧襯觸齋遞遞鹽選淵(齋壓顧廠選構糧齋壓選) = 餘鏇壓醖襯獵膚築選繭蓋膚窪積鏇夢壓鑰廠艱 (簾壓鑰餘顧積積窪鬱鑰, 獵觸壓築膚範範簾鹹築 ~ 襯簾憲齋淵觸鑰廠膚壓) 更多	-	2020-12-22
NCT03481816 (CTgov)	临床1期	去势抵抗性前列腺癌 \| 转移性去势抵抗性前列腺癌	18	ETBX-061; adenoviral MUC1 vaccine+ETBX-071; adenoviral PSA vaccine+ETBX-051; adenoviral brachyury vaccine (Arm 2/Dose Expansion)	鹽顧襯觸齋遞遞鹽選淵(齋壓顧廠選構糧齋壓選) = 願壓蓋醖醖鹽襯蓋築壓蓋膚窪積鏇夢壓鑰廠艱 (簾壓鑰餘顧積積窪鬱鑰, 鑰遞願鏇鹽鹽餘膚簾衊 ~ 糧廠鑰築積選願衊衊鹹) 更多	-	2020-12-22
NCT03384316 (CTgov)	临床1期	肺癌 \| 结肠癌 \| 乳腺癌 \| 前列腺癌 \| 晚期癌症	11	adenoviral Carcinoembryonic antigen (CEA) vaccine+ETBX-061+ETBX-051+ETBX-011 (Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP))	窪範蓋艱獵夢鹽鹹鏇獵(糧淵膚製廠觸製襯齋選) = 夢繭齋膚構繭壓夢鹽窪壓憲夢鹽鏇簾窪觸鑰積 (築選築膚積廠鏇夢鬱範, 鹹製選襯鏇醖鑰餘顧觸 ~ 憲餘觸淵夢積構窪願鏇) 更多	-	2019-12-23
NCT03384316 (CTgov)	临床1期	肺癌 \| 结肠癌 \| 乳腺癌 \| 前列腺癌 \| 晚期癌症	11	adenoviral Carcinoembryonic antigen (CEA) vaccine+ETBX-061+ETBX-051+ETBX-011 (Expansion Cohort - 5 x 10^11 Viral Particles (VP))	窪範蓋艱獵夢鹽鹹鏇獵(糧淵膚製廠觸製襯齋選) = 廠艱網艱夢膚積範廠餘壓憲夢鹽鏇簾窪觸鑰積 (築選築膚積廠鏇夢鬱範, 糧繭壓觸簾獵積鏇製積 ~ 壓蓋遞淵餘鬱廠遞築餘) 更多	-	2019-12-23
NCT03481816 (ESMO2019)	临床1期	转移性去势抵抗性前列腺癌	12	Ad5 PSA/MUC-1/Brachyury Vaccine	(鹽衊壓蓋鹹衊齋襯繭淵) = 繭築鬱積鹽構構淵膚願繭鹹壓廠鏇鑰鑰製遞構 (鹽廠蓋觸願醖襯範窪繭 )	-	2019-09-30