NTX-010(NTX-010) - 药物靶点：TEM8_在研适应症：神经内分泌肿瘤，大细胞神经内分泌癌，肿瘤_专利_临床

概要

基本信息

药物类型

溶瘤病毒

别名

Seneca Valley Virus-001、NTX 010、NTX-010

+ [1]

靶点

TEM8

作用方式

抑制剂、刺激剂

作用机制

TEM8 抑制剂(ANTXR cell adhesion molecule 1 inhibitors)、细胞凋亡刺激剂

治疗领域

肿瘤

在研适应症

神经内分泌肿瘤大细胞神经内分泌癌肿瘤+ [1]

非在研适应症

晚期恶性实体瘤类癌小细胞肺癌

原研机构

Novartis Pharma AG

在研机构

Seneca Therapeutics, Inc.初创企业

非在研机构

Neotropix, Inc.Novartis Pharma AG

最高研发阶段临床1/2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

4

项与 NTX-010 相关的临床试验

NCT06889493

/ Not yet recruiting临床1期IIT

A Phase 1 Trial of the Oncolytic Virus SVV-001 in Combination with Nivolumab in Patients with Poorly Differentiated Neuroendocrine Carcinomas and Well-Differentiated Neuroendocrine Tumors

The purpose of this study is to determine:
1. The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
2. The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
3. The highest dose and frequency of dosing of the trial intervention that targets neuroendocrine tumors with at least the same degree of effectiveness and tolerability as currently available (standard of care) treatments for patients with neuroendocrine tumors.

开始日期2025-05-01

申办/合作机构

University of Miami

[+1]

NCT01017601

/ Terminated临床2期IIT

A Randomized Double-Blinded Phase II Study of NTX-010, a Replication-Competent Picornavirus, After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer

RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells without damaging normal cells. It is not yet known whether NTX-010 is more effective than a placebo in treating small cell lung cancer.
PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared with a placebo when given after chemotherapy in treating patients with extensive-stage small cell lung cancer.

开始日期2010-01-01

申办/合作机构

Alliance Foundation Trials LLC

[+1]

NCT01048892

/ Completed临床1期IIT

A Phase 1 Dose Escalation Study of Seneca Valley Virus (NTX-010), A Replication-Competent Picornavirus, in Relapsed/Refractory Pediatric Patients With Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features

RATIONALE: Seneca Valley virus-001 may be able to kill certain kinds of tumor cells without damaging normal cells. Adding low dose cyclophosphamide (in part B of study) may help to kill even more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of Seneca Valley virus-001 in treating young patients with relapsed or refractory neuroblastoma, rhabdomyosarcoma, or rare tumors with neuroendocrine features.

开始日期2009-09-01

申办/合作机构

The Children's Oncology Group Foundation, Inc.

[+1]

100 项与 NTX-010 相关的临床结果

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100 项与 NTX-010 相关的转化医学

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100 项与 NTX-010 相关的专利（医药）

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16

项与 NTX-010 相关的文献（医药）

2022-10-01·VIROLOGY

Characterisation of a Seneca Valley virus thermostable mutant

Article

作者: Burga, Laura N ; Bostina, Mihnea ; Burga, Laura N. ; Jayawardena, Nadishka ; McCarthy, Cormac ; Strauss, Mike ; Waqqar, Shakeel ; Wang, Ivy

Seneca Valley virus (SVV) is a newly discovered picornavirus in the Senecavirus genus. SVV-001 strain has shown promise as an oncolytic virus against tumors with neuroendocrine features. There is a need to use a structure-based approach to develop virus-like particles capable to mimicking the architecture of naturally occurring empty capsids that can be used as vaccines or as carriers for targeted cancer treatment. However, these empty capsids are inherently less stable, and tedious to purify. This warrants investigation into factors which confer the SVV capsid stability and into combining this knowledge to recombinantly express stable SVV VLPs. In this study, we isolated a thermostable mutant of SVV by thermal selection assays and we characterized a single mutation located in a capsid protein. The cryo-EM map of this mutant showed conformational shifts that facilitated the formation of additional hydrogen bonds and aromatic interactions, which could serve as capsid stabilizing factors.

2021-02-01·Veterinary microbiology2区 · 农林科学

Comparison of historical and contemporary isolates of Senecavirus A

2区 · 农林科学

Article

作者: Guo, Baoqing ; Faaberg, Kay S ; Buckley, Alexandra C ; Michael, David D ; Yoon, Kyoung-Jin ; Lager, Kelly M

Senecavirus A (SVA) was discovered as a cell culture contaminant in 2002, and multiple attempts to experimentally reproduce disease were unsuccessful. Field reports of porcine idiopathic vesicular disease (PIVD) cases testing PCR positive for SVA in addition to outbreaks of PIVD in Brazil and the United States in 2015 suggested SVA was a causative agent, which has now been consistently demonstrated experimentally. Ease of experimental reproduction of disease with contemporary strains of SVA raised questions concerning the difficulty of reproducing vesicular disease with historical isolates. The following study was conducted to compare the pathogenicity of SVA between historical and contemporary isolates in growing pigs. Six groups of pigs (n = 8) were intranasally inoculated with the following SVA isolates: SVV001/2002, CAN/2011, HI/2012, IA/2015, NC/2015, SD/2015. All isolates induced vesicular disease in at least half of the inoculated pigs from each group. All pigs replicated virus as demonstrated by serum and/or swab samples positive for SVA by quantitative PCR. Pig sera tested by virus neutralization assay demonstrated cross-neutralizing antibodies against all viruses utilized in the study. Cross-neutralizing antibodies from pigs inoculated with historical isolates were lower than those pigs that were inoculated with contemporary isolates. Phylogenetic analysis revealed two clades with SVV001/2002 being in a separate clade compared to the other five isolates. Although differences in the infection kinetics and sequences of these six isolates were found, clinical presentation of vesicular disease was similar between both historical and contemporary isolates.

2020-01-01·Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer1区 · 医学

A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study

1区 · 医学

Article

作者: Molina, Julian R ; Schild, Steven E ; Dakhil, Shaker R ; Aubry, Marie Christine ; Nieva, Jorge J ; Dy, Grace K ; Tan, Angelina D ; Lee Hann, Christine ; Wadsworth, Troy W ; Mandrekar, Sumithra J ; Bertino, Erin ; Adjei, Alex A ; Schenk, Erin L ; Sachs, Bradley A

INTRODUCTION:

The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy.

METHODS:

Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed.

RESULTS:

From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4-3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4-4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4-1.5 months] versus 1.8 months [95% CI: 1.3-5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4-2.6 months] versus 1.3 months [95% CI: 1.0-5.3 months], respectively [p = 0.04]).

CONCLUSIONS:

Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.

9

项与 NTX-010 相关的新闻（医药）

2023-12-11

·Business Wire

Dr. Paul Hallenbeck, CSO and President of Seneca Therapeutics to Present at Oncolytic Virotherapy Summit 2023 on December 13

PHILADELPHIA--( BUSINESS WIRE )--Seneca Therapeutics, Inc. (STI), announced today that Dr. Paul Hallenbeck will present a talk at the 8th Oncolytic Virotherapy Summit 2023 entitled “ Assessing the Benefits and Challenges of Intravenous Delivery of Oncolytic Viruses” . In his talk, Dr. Hallenbeck will discuss the challenges inherent in doing multiple (IV) intravenous administrations of oncolytic viruses, where the field is meeting these challenges, and present data on the development of multiple IV technology for STI’s oncolytic virus SVV-001, a clinical stage oncology product. “There are several important hurdles to be overcome to develop the capability of performing multiple intravenous delivery of an oncolytic virus,” said Dr. Paul Hallenbeck, President and Chief Scientific Officer at Seneca Therapeutics. “These include cost of goods, high cancer target selectivity, elimination and/or avoidance of existing neutralizing antibodies and obtaining significant replication at the tumor site. SVV-001 has the profile to potentially meet all these multiple challenges.” About Seneca Therapeutics Seneca Therapeutics was founded to capitalize on the profound tumor specificity of SVV and further the development of SVV-001 in several upcoming clinical trials and the creation and testing of armed derivatives selectively expressing gene product(s) that are inserted into the genome of SVV-001 that create additional anti-tumor effects. Forward-Looking Statements This press release contains “forward-looking statements” concerning the development of Seneca Therapeutics products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Seneca Therapeutics undertakes no obligation to update any forward-looking statements for any reason. www.senecatherapeutics.com

临床研究

2023-11-27

·BioSpace

Dr. Paul Hallenbeck, CSO and President of Seneca Therapeutics to Present at World Vaccine Congress November 28, 2023

Dr. Hallenbeck will provide an update on the latest efforts with Multiple IV dosing with SVV-001 PHILADELPHIA--(BUSINESS WIRE)-- Seneca Therapeutics, Inc., announced today Dr. Paul Hallenbeck will present a talk titled “Facilitating multiple deliveries of therapeutic viruses by exploiting natural methods of evading neutralizing immunity”, during the World Vaccine Congress in Santa Clara, CA on November 28, 2023. In his talk, Dr. Hallenbeck will present data on the development of multiple IV technology for SVV-001, a clinical stage oncology product. “Seneca believes that having both multiple intratumoral ('IT') and multiple intravenous ('IV') dosage forms of SVV-001 will be important to clinicians,” said Dr. Paul Hallenbeck, President and Chief Scientific Officer at Seneca Therapeutics. “Unlike many oncolytic viruses, SVV-001 has already been safely delivered systemically as a single dose in humans. SVV-001 has also shown efficacy in relevant murine models as a single IV dose and preliminary evidence of efficacy in humans as a single IV dose. We will present data showing several approaches to deliver SVV-001 systemically in a multiple dose IV regimen.” About Seneca Therapeutics Seneca Therapeutics was founded to capitalize on the profound tumor specificity of SVV and further the development of SVV-001 in several upcoming clinical trials and the creation and testing of armed derivatives selectively expressing gene product(s) that are inserted into the genome of SVV-001 that create additional anti-tumor effects. Forward-Looking Statements This press release contains “forward-looking statements” concerning the development of Seneca Therapeutics products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Seneca Therapeutics undertakes no obligation to update any forward-looking statements for any reason.

疫苗临床研究

2023-06-05

·BioSpace

Seneca Therapeutics, Inc. Appoints Cuong Do to its Board of Directors

Cuong Do, MBA, is President and Chief Executive Officer of BioVie Inc. and has over two decades serving the industry as a senior strategy officer in the biotech and pharmaceutical industries. PHILADELPHIA--(BUSINESS WIRE)-- Seneca Therapeutics, Inc. (STI), today announced the appointment of Cuong Do, MBA to its Board of Directors. "Cuong has successfully financed and led several life science biotech companies across a range of therapeutic areas, and we are extremely excited to welcome him to our Board," said James Hussey, Chief Executive Officer of Seneca Therapeutics, Inc. "Cuong’s extensive executive leadership experience, together with his strategic expertise, will help guide us as we advance our neuroendocrine neoplasm (NEN) cancer programs towards late-stage trials. He will also work to deepen our relationships with leading biopharmaceutical companies. His background is extremely complementary with those of our leadership team and is strategically aligned with the long-term R&D goals of the company. I look forward to working together." Mr. Do added, "The opportunity to join Seneca Therapeutics at this crucial stage in the Company's evolution is compelling. Clinical data has already demonstrated SVV-001’s ability to provide significant patient benefit in many cancer indications. SVV-001’s potential to synergize with checkpoint inhibition and drive objective responses in NEN is especially exciting.” “Seneca Therapeutics’ upcoming clinical trial in patients with NEN cancer will provide valuable opportunities to accelerate SVV-001’s path towards registration in these indications. I am excited to welcome Cuong’s insights to company management and the Board as we work towards these potential catalysts and prepare for anticipated growth," said Chief Scientific Officer and President of Seneca Therapeutics, Paul Hallenbeck, PhD. Mr. Do joins STI’s Board with over two decades of experience in the pharmaceutical and biotechnology industries. He is currently the Chief Executive Officer (CEO) of BioVie where he leads a team focused on the development of treatments for Alzheimer’s Disease. Prior to his appointment with BioVie, Mr. Do was President of Samsung Electronics Co., Ltd. Global Strategy Group where he helped set the strategic direction for Samsung’s diverse business portfolio. He was previously the Chief Strategy Officer for Merck and Company, a leading US pharmaceuticals company. Mr. Do is a former senior partner at McKinsey & Company, where he spent 17 years helping to build the health care, high tech and corporate finance practices. He holds a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth. About Seneca Therapeutics Seneca Therapeutics was founded to capitalize on the profound tumor specificity of SVV and further the development of SVV-001 in several upcoming clinical trials and the creation and testing of armed derivatives selectively expressing gene product(s) that are inserted into the genome of SVV-001 that create additional anti-tumor effects. Forward-Looking Statements This press release contains “forward-looking statements” concerning the development of Seneca Therapeutics products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Seneca Therapeutics undertakes no obligation to update any forward-looking statements for any reason. View source version on businesswire.com: Contacts Paul Hallenbeck CSO and President phallenbeck@senecatherapeutics.com James Hussey CEO jhussey@senecatherapeutics.com Source: Seneca Therapeutics, Inc. View this news release online at:

高管变更

100 项与 NTX-010 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06129

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
神经内分泌肿瘤	临床2期	美国	Seneca Therapeutics, Inc.初创企业	2022-10-03
小细胞肺癌	临床2期	-	Novartis Pharma AG	-
大细胞神经内分泌癌	临床1期	美国	Seneca Therapeutics, Inc.初创企业	2025-05-01
晚期恶性实体瘤	临床1期	美国	Neotropix, Inc.	2006-04-01
类癌	临床1期	美国	Neotropix, Inc.	2006-04-01
肿瘤	临床前	-	Seneca Therapeutics, Inc.初创企业	2022-04-11
实体瘤	临床前	美国	Seneca Therapeutics, Inc.初创企业	2021-04-27

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临床结果

适应症

分期

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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


NCT01017601 (N0923, Pubmed) 人工标引	临床2期	广泛期小细胞肺癌	50	NTX-010	網鹹鹽壓築襯構壓範觸(獵鹹蓋衊獵艱範膚選簾) = 顧鹽獵餘網膚鏇範選膚願築醖構糧蓋構範蓋製 (獵鬱襯餘襯顧鹽願構淵, 1.4 ~ 3.1) 更多	不佳	2020-01-01
				Placebo	網鹹鹽壓築襯構壓範觸(獵鹹蓋衊獵艱範膚選簾) = 積製齋鏇淵窪獵廠艱簾願築醖構糧蓋構範蓋製 (獵鬱襯餘襯顧鹽願構淵, 1.4 ~ 4.3) 更多
NCT01017601 (N0923 \| Alliance (NCCTG) N0923, CTgov)	临床2期	广泛期小细胞肺癌	59	Seneca Valley virus-001 (NTX-010) (Arm I (NTX-010))	壓餘簾鹹淵顧醖蓋觸鬱(壓艱繭鑰構顧衊襯願遞) = 醖願醖選遞製鏇鑰鹹齋襯繭憲鏇糧構鏇觸壓餘 (餘襯窪壓窪願鏇艱觸憲, 襯憲夢餘範憲願構窪艱 ~ 簾艱壓鏇淵齋鑰鑰醖選) 更多	-	2017-05-08
				Placebo (Arm II (Placebo))	壓餘簾鹹淵顧醖蓋觸鬱(壓艱繭鑰構顧衊襯願遞) = 膚遞蓋衊範糧遞鑰襯鹽襯繭憲鏇糧構鏇觸壓餘 (餘襯窪壓窪願鏇艱觸憲, 製簾顧願範鹹築餘觸願 ~ 網網觸遞獵廠積鹽鬱鏇) 更多
N-0923 (WCLC2013)	N/A	广泛期小细胞肺癌	-	NTX-010	憲襯範襯襯夢艱顧蓋衊(築膚廠襯憲廠鏇窪網築) = 憲壓簾餘廠願衊醖壓蓋繭獵蓋鏇夢糧鑰網製壓 (糧餘網糧窪糧鏇鹹構鑰, 1.3 ~ 3.1)	-	2013-10-29
				Placebo	憲襯範襯襯夢艱顧蓋衊(築膚廠襯憲廠鏇窪網築) = 鬱窪夢築積鏇築夢築膚繭獵蓋鏇夢糧鑰網製壓 (糧餘網糧窪糧鏇鹹構鑰, 1.4 ~ 4.3)
NCT01017601 (Alliance (NCCTG) N0923, ASCO2013)	临床2期	广泛期小细胞肺癌	59	NTX-010	艱獵簾顧選構壓壓廠夢(壓選獵廠壓齋淵夢壓窪) = 願醖觸鏇積構願築繭範繭築膚齋鹽鑰顧憲憲餘 (繭獵簾醖鬱廠觸艱遞簾, 1.3 ~ 3.1)	不佳	2013-05-20
				Placebo	艱獵簾顧選構壓壓廠夢(壓選獵廠壓齋淵夢壓窪) = 鏇膚鏇壓壓餘網構鹹選繭築膚齋鹽鑰顧憲憲餘 (繭獵簾醖鬱廠觸艱遞簾, 1.4 ~ 4.3)
ASCO2009	临床1期	神经内分泌肿瘤	30	NTX-010	廠艱鏇獵顧壓簾壓網選(齋築顧夢鹹鬱範鑰鏇膚) = 構襯窪齋衊顧窪醖壓製糧築壓鑰鹽衊鑰鑰築襯 (壓窪顧餘簾積廠廠遞遞 ) 更多	-	2009-05-20
ASGCT2009	临床1期	神经内分泌肿瘤	30	SVV-001 10^7 vp/kg	簾鏇遞繭襯鹽鬱膚網獵(壓範顧糧壓衊廠築繭窪) = 築憲築網觸簾膚膚餘餘簾獵襯窪築夢簾膚艱鹽 (窪積蓋膚糧壓願淵顧繭 ) 更多	积极	2009-05-01
				SVV-001 10^11 vp/kg	簾鏇遞繭襯鹽鬱膚網獵(壓範顧糧壓衊廠築繭窪) = 繭鑰鏇鑰獵齋艱淵築製簾獵襯窪築夢簾膚艱鹽 (窪積蓋膚糧壓願淵顧繭 ) 更多