pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.)(pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.))

概要

基本信息

药物类型

通用抗原疫苗、DNA疫苗、治疗性疫苗

别名-

靶点

HPV E7

作用机制

E7调节剂(人乳头瘤病毒E7蛋白调节剂)

治疗领域

肿瘤

在研适应症-

非在研适应症

头颈部肿瘤

原研机构

Ichor Medical Systems, Inc.

在研机构-

非在研机构

Ichor Medical Systems, Inc.

最高研发阶段终止临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

2

项与 pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.) 相关的临床试验

NCT01493154 / Terminated临床1期IIT

A Phase I Clinical Trial Assessing the Safety and Feasibility of Administration of pNGVL4a-CRT/E7(Detox) DNA Vaccine Using the Intramuscular TriGridTM Delivery System in Combination With Cyclophosphamide in HPV-16 Associated Head and Neck Cancer Patients

This study will test the safety of an HPV DNA vaccine after it is injected into your muscle using an electroporation device (TriGridTM Delivery System made by Ichor Medical Systems), and will test the ability of the vaccine to help your body's immune system to recognize HPV-infected and associated cancer cells. In addition to giving the vaccine using an electroporation device, we are giving the vaccine in combination with an immunomodulatory agent to further enhance immune responses against HPV-infected and associated cancer cells.

开始日期2012-04-01

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT00988559 / Completed临床1期IIT

A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.

开始日期2009-09-01

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

100 项与 pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.) 相关的临床结果

登录后查看更多信息

100 项与 pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.) 相关的转化医学

登录后查看更多信息

100 项与 pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.) 相关的专利（医药）

登录后查看更多信息

7

项与 pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.) 相关的文献（医药）

2018-12-01·Virology3区 · 医学

Epithelial boost enhances antigen expression by vaccinia virus for the generation of potent CD8+ T cell-mediated antitumor immunity following DNA priming vaccination

3区 · 医学

Article

作者: Hung, Chien-Fu ; Ma, Ying ; Peng, Shiwen ; Cheng, Max A ; Qiu, Jin ; Wu, T-C ; Roden, Richard B S ; Yang, Andrew ; Chang, Yung-Nien ; Farmer, Emily

While both pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine and TA-HPV recombinant vaccinia viral vector-based vaccines have elicited HPV-specific CD8+ T cell responses in HPV16/E7-expressing tumor models, and been used as prime-boost regimen to enhance HPV-specific immune responses in humans (NCT00788164), the optimal route of administration for TA-HPV remains unclear. In a preclinical model, we examined the immunogenicity of priming with intramuscular pNGVL4a-Sig/E7(detox)/HSP70 followed by TA-HPV boost through different administration routes. We observed that priming twice with a pNGVL4a-Sig/E7(detox)/HSP70 followed by a single TA-HPV immunization boost through skin scarification generated the strongest antigen-specific CD8+ T cell response in C57BL/6 mice. These data translate to tumor control and prolonged survival of treated mice. Our results provide rationale for future clinical testing of intramuscular pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine prime, TA-HPV vaccine skin scarification boost immunization regimen for the control of HPV-associated diseases.

2018-03-01·Cancer Immunology Research1区 · 医学

Integration of Oncogenes via Sleeping Beauty as a Mouse Model of HPV16+ Oral Tumors and Immunologic Control

1区 · 医学

Article

作者: Hung, Chien-Fu ; Farmer, Emily ; Peng, Shiwen ; Lin, Yi-Hsin ; Yang, Ming-Chieh ; Chang, Yung-Nien ; Jiang, Rosie ; Henkle, Talia ; Yang, Andrew ; Tseng, Ssu-Hsueh ; Wu, T.-C.

AbstractHuman papillomavirus type 16 (HPV16) is the etiologic factor for cervical cancer and a subset of oropharyngeal cancers. Although several prophylactic HPV vaccines are available, no effective therapeutic strategies to control active HPV diseases exist. Tumor implantation models are traditionally used to study HPV-associated buccal tumors. However, they fail to address precancerous phases of disease progression and display tumor microenvironments distinct from those observed in patients. Previously, K14-E6/E7 transgenic mouse models have been used to generate spontaneous tumors. However, the rate of tumor formation is inconsistent, and the host often develops immune tolerance to the viral oncoproteins. We developed a preclinical, spontaneous, HPV16+ buccal tumor model using submucosal injection of oncogenic plasmids expressing HPV16-E6/E7, NRasG12V, luciferase, and sleeping beauty (SB) transposase, followed by electroporation in the buccal mucosa. We evaluated responses to immunization with a pNGVL4a-CRT/E7(detox) therapeutic HPV DNA vaccine and tumor cell migration to distant locations. Mice transfected with plasmids encoding HPV16-E6/E7, NRasG12V, luciferase, and SB transposase developed tumors within 3 weeks. We also found transient anti-CD3 administration is required to generate tumors in immunocompetent mice. Bioluminescence signals from luciferase correlated strongly with tumor growth, and tumors expressed HPV16-associated markers. We showed that pNGVL4a-CRT/E7(detox) administration resulted in antitumor immunity in tumor-bearing mice. Lastly, we demonstrated that the generated tumor could migrate to tumor-draining lymph nodes. Our model provides an efficient method to induce spontaneous HPV+ tumor formation, which can be used to identify effective therapeutic interventions, analyze tumor migration, and conduct tumor biology research. Cancer Immunol Res; 6(3); 305–19. ©2018 AACR.

2016-02-01·Gynecologic Oncology2区 · 医学

A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16 + cervical intraepithelial neoplasia 2/3 (CIN2/3)

2区 · 医学

Article

作者: Paradis, Mihaela ; Hester, Shirley ; Trimble, Cornelia L ; Jackson, Bradford E ; Adams, Emily A ; Boyer, Jean ; Lamb, Lawrence S ; Bae, Sejong ; Conner, Michael G ; Sauter, Elizabeth ; Wang, Chenguang ; Hung, Chien-Fu ; Alvarez, Ronald D ; Wu, T C ; Huh, Warner K

OBJECTIVEThe purpose of this study was to evaluate the safety, efficacy, and immunogenicity of a plasmid vaccine, pNGVL4a-CRT-E7(detox), administered either intradermally, intramuscularly, or directly into the cervical lesion, in patients with HPV16-associated CIN2/3.METHODSEligible patients with HPV16(+) CIN2/3 were enrolled in treatment cohorts evaluating pNGVL4a-CRT-E7(detox), administered by either particle-mediated epidermal delivery (PMED), intramuscular injection (IM), or cervical intralesional injection, at study weeks 0, 4, and 8. Patients were monitored for local injection site and systemic toxicity. A standard therapeutic resection was performed at week 15. The primary endpoints were safety and tolerability. Secondary endpoints included histologic regression and change in cervical HPV viral load. Exploratory endpoints included immune responses in the blood and in the target tissue.RESULTSThirty-two patients with HPV16(+) CIN2/3 were enrolled onto the treatment phase of the study, and were vaccinated. Twenty-two of 32 patients (69%) experienced vaccine-specific related adverse events. The most frequent vaccine-related events were constitutional and local injection site in nature, and were grade 1 or less in severity. Histologic regression to CIN 1 or less occurred in 8 of 27 (30%) patients who received all vaccinations and underwent LEEP. In subject-matched comparisons, intraepithelial CD8+ T cell infiltrates increased after vaccination in subjects in the intralesional administration cohort.CONCLUSIONpNGVL4a-CRT-E7(detox) was well-tolerated, elicited the most robust immune response when administered intralesionally, and demonstrated preliminary evidence of potential clinical efficacy.

100 项与 pNGVL-4a-CRT/E7 DNA vaccine(Ichor Medical Systems, Inc.) 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
头颈部肿瘤	临床1期	美国	Ichor Medical Systems, Inc.	2012-04-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00988559 (CTgov)	临床1期	宫颈上皮内瘤样病变 \| 人乳头瘤病毒 16 阳性	132	Gene gun vaccine+DNA vaccination (PMED Delivery - Groups 1 and 2)	繭顧餘範膚窪鹹窪壓夢(簾願糧壓遞醖餘廠鑰顧) = 鏇餘觸鹹簾憲憲餘構鬱積構齋醖壓醖範築鑰齋 (選網醖襯醖築製醖築壓, 製襯衊餘鏇獵積壓蓋膚 ~ 鏇齋網簾製鏇構艱餘淵) 更多	-	2018-07-09
				therapeutic resection of the lesion+intramuscular vaccination+DNA vaccination (IM Injections - Groups 5 and 6)	繭顧餘範膚窪鹹窪壓夢(簾願糧壓遞醖餘廠鑰顧) = 膚窪襯鹹衊築積餘選淵積構齋醖壓醖範築鑰齋 (選網醖襯醖築製醖築壓, 選窪築鏇顧夢鏇餘艱構 ~ 願窪選醖願願廠糧憲觸) 更多