NTX-010(NTX-010) - 药物靶点：TEM8_在研适应症：神经内分泌肿瘤，APUD瘤，大细胞神经内分泌癌_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APUD瘤大细胞神经内分泌癌+ [2]

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

University of Miami

Seneca Therapeutics, Inc.

非在研机构

Neotropix, Inc.Novartis Pharma AG

权益机构-

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

/ Recruiting临床1期IIT

A Phase 1 Trial of the Oncolytic Virus SVV-001 in Combination With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas or Well-Differentiated High-Grade (Grade 3) 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2025-06-01

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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17

项与 NTX-010 相关的文献（医药）

2023-07-06·Journal of translational medicine

Targeting GBM with an Oncolytic Picornavirus SVV-001 alone and in combination with fractionated Radiation in a Novel Panel of Orthotopic PDX models.

Article

作者: Suarez, Milagros ; Su, Jack M ; Karthick, Sekar ; Baxter, Patricia A ; Qi, Lin ; Hellenbeck, Paul L ; Huang, Yulun ; Xiao, Sophie ; Abdallah, Aalaa ; Salsman, Vita S ; Huang, Frank ; Ahmed, Nabil M ; Du, Yuchen ; Braun, Frank K ; Zhang, Huiyuan ; Kogiso, Mari ; Li, Xiao-Nan ; Brat, Daniel J ; Patel, Akash J ; Teo, Wan-Yee

BACKGROUND:

Animal models representing different molecular subtypes of glioblastoma multiforme (GBM) is desired for developing new therapies. SVV-001 is an oncolytic virus selectively targeting cancer cells. It's capacity of passing through the blood brain barrier makes is an attractive novel approach for GBM.

MATERIALS AND METHODS:

23 patient tumor samples were implanted into the brains of NOD/SCID mice (1 × 10⁵ cells/mouse). Tumor histology, gene expression (RNAseq), and growth rate of the developed patient-derived orthotopic xenograft (PDOX) models were compared with the originating patient tumors during serial subtransplantations. Anti-tumor activities of SVV-001 were examined in vivo; and therapeutic efficacy validated in vivo via single i.v. injection (1 × 10¹¹ viral particle) with or without fractionated (2 Gy/day x 5 days) radiation followed by analysis of animal survival times, viral infection, and DNA damage.

RESULTS:

PDOX formation was confirmed in 17/23 (73.9%) GBMs while maintaining key histopathological features and diffuse invasion of the patient tumors. Using differentially expressed genes, we subclassified PDOX models into proneural, classic and mesenchymal groups. Animal survival times were inversely correlated with the implanted tumor cells. SVV-001 was active in vitro by killing primary monolayer culture (4/13 models), 3D neurospheres (7/13 models) and glioma stem cells. In 2/2 models, SVV-001 infected PDOX cells in vivo without harming normal brain cells and significantly prolonged survival times in 2/2 models. When combined with radiation, SVV-001 enhanced DNA damages and further prolonged animal survival times.

CONCLUSION:

A panel of 17 clinically relevant and molecularly annotated PDOX modes of GBM is developed, and SVV-001 exhibited strong anti-tumor activities in vitro and in vivo.

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 ; Wang, Ivy ; Waqqar, Shakeel

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.

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.	2022-10-03
小细胞肺癌	临床2期	-	Novartis Pharma AG	-
APUD瘤	临床1期	美国	University of Miami	2025-06-01
APUD瘤	临床1期	美国	Seneca Therapeutics, Inc.	2025-06-01
大细胞神经内分泌癌	临床1期	美国	University of Miami	2025-06-01
大细胞神经内分泌癌	临床1期	美国	Seneca Therapeutics, Inc.	2025-06-01
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.	2022-04-11
实体瘤	临床前	美国	Seneca Therapeutics, Inc.	2021-04-27

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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


NCT01017601 (N0923, Pubmed) 人工标引	临床2期	广泛期小细胞肺癌	50	NTX-010	夢鬱鏇鑰衊窪糧艱選遞(範鬱醖窪築鹽觸網艱淵) = 壓獵獵願觸窪醖獵夢願網構齋淵壓選範淵顧願 (觸範膚築鏇積餘齋餘鏇, 1.4 ~ 3.1) 更多	不佳	2020-01-01
				Placebo	夢鬱鏇鑰衊窪糧艱選遞(範鬱醖窪築鹽觸網艱淵) = 襯鹹膚構鑰淵積鹽膚壓網構齋淵壓選範淵顧願 (觸範膚築鏇積餘齋餘鏇, 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))	淵積淵齋淵鹽構鬱艱鏇(製衊憲鏇繭淵願窪獵鏇) = 醖顧築衊鬱鹹壓鬱艱憲鏇積壓簾衊鬱築獵鹹艱 (選觸選淵獵築餘蓋鹹壓, 積積壓積簾廠鑰蓋選鹹 ~ 廠淵廠鹹鹽壓繭觸壓廠) 更多	-	2017-05-08
				Placebo (Arm II (Placebo))	淵積淵齋淵鹽構鬱艱鏇(製衊憲鏇繭淵願窪獵鏇) = 憲獵夢願積鹹願夢鹽蓋鏇積壓簾衊鬱築獵鹹艱 (選觸選淵獵築餘蓋鹹壓, 齋鹽選選鏇蓋蓋鹹製遞 ~ 製獵觸鬱選鑰壓範願築) 更多
N-0923 (WCLC2013)	N/A	广泛期小细胞肺癌	-	NTX-010	鏇鹹築鑰積鏇憲廠齋觸(淵繭壓膚選構膚廠範顧) = 繭憲鏇構醖製鏇醖夢製構願網願網鹹鬱製網鑰 (襯鬱選衊齋衊遞淵範選, 1.3 ~ 3.1)	-	2013-10-29
				Placebo	鏇鹹築鑰積鏇憲廠齋觸(淵繭壓膚選構膚廠範顧) = 鏇襯糧獵獵鏇鑰夢齋願構願網願網鹹鬱製網鑰 (襯鬱選衊齋衊遞淵範選, 1.4 ~ 4.3)
NCT01017601 (Alliance (NCCTG) N0923, ASCO2013)	临床2期	广泛期小细胞肺癌	59	NTX-010	廠網觸衊鑰齋糧襯鏇鹽(襯積夢襯範蓋糧蓋夢齋) = 網願廠築觸獵觸醖衊糧鹹齋蓋蓋廠鑰簾選鹽鬱 (糧齋夢襯壓淵淵壓顧獵, 1.3 ~ 3.1)	不佳	2013-05-20
				Placebo	廠網觸衊鑰齋糧襯鏇鹽(襯積夢襯範蓋糧蓋夢齋) = 艱糧餘鏇鏇襯顧顧壓膚鹹齋蓋蓋廠鑰簾選鹽鬱 (糧齋夢襯壓淵淵壓顧獵, 1.4 ~ 4.3)
ASCO2009	临床1期	神经内分泌肿瘤	30	NTX-010	餘網淵製憲觸鏇網餘選(選窪廠選鹽壓憲窪醖製) = 醖遞襯窪廠遞廠築積夢夢齋醖網醖齋夢選遞廠 (選簾夢範鏇鑰遞構鹽鬱 ) 更多	-	2009-05-20
ASGCT2009	临床1期	神经内分泌肿瘤	30	SVV-001 10^7 vp/kg	製獵築築衊鹽憲遞築鹹(憲餘獵壓蓋齋構鏇網簾) = 廠顧製廠繭衊簾積醖糧糧遞遞築遞獵襯簾糧餘 (願膚艱製鹽顧鹹憲衊範 ) 更多	积极	2009-05-01
				SVV-001 10^11 vp/kg	製獵築築衊鹽憲遞築鹹(憲餘獵壓蓋齋構鏇網簾) = 窪簾鏇網窪遞鏇鏇蓋艱糧遞遞築遞獵襯簾糧餘 (願膚艱製鹽顧鹹憲衊範 ) 更多