GEN-0101(GEN-0101) - 在研适应症：黑色素瘤，间皮瘤，前列腺癌_专利_临床

概要

基本信息

药物类型

溶瘤病毒

别名

HVJ-E

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Osaka UniversityTSD Japan, Inc.

ISHIHARA SANGYO KAISHA LTD.

非在研机构-

最高研发阶段临床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

13

项与 GEN-0101 相关的临床试验

NCT03818893 / Unknown status临床2期IIT

Phase Ib/II Investigator Initiated Safety and Efficacy Clinical Trial of Combination Therapy of Intracutaneous GEN0101 With Intravenous Pembrolizmub in Patients Who Have Advanced Melanoma

This is a multi-center, open-labeled, non-randomized, single arm investigator-initiated trial to evaluate the safety and efficacy of GEN0101 and Pembrolizmub combination in patients with advanced melanoma.

开始日期2019-03-01

申办/合作机构

Osaka University

[+2]

JPRN-jRCT2080224548 / Completed临床2期IIT

Phase II multicenter investigator-initiated clinical trial to evaluate safety and efficacy of combination therapy with GEN0101 and standard chemotherapy in patients suffering from pleural mesothelioma.

开始日期2019-01-10

申办/合作机构-

JPRN-JapicCTI-194617 / Completed临床2期IIT

Phase II multicenter investigator-initiated clinical trial to evaluate safety and efficacy of combination therapy with GEN0101 and standard chemotherapy in patients suffering from pleural mesothelioma.

开始日期2019-01-10

申办/合作机构-

100 项与 GEN-0101 相关的临床结果

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100 项与 GEN-0101 相关的转化医学

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100 项与 GEN-0101 相关的专利（医药）

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86

项与 GEN-0101 相关的文献（医药）

2024-01-12·Reproduction

The press-assisted fusion scheme significantly mitigates the quantity of HVJ-E required in mitochondrial replacement techniques

Article

作者: Lyu, Qifeng ; Lin, Kaibo ; Li, Danjun ; Liao, Xiaoyu ; Chen, Chen ; Kuang, Yanping ; Jiang, Shutian ; Ma, Meng ; Li, Wenzhi ; Jin, Wei

In briefThe impact of HVJ-E employed in mitochondrial replacement techniques (MRTs) on embryonic development remains uncertain. This study has exhibited the influence of HVJ-E utilized in MRTs on embryonic development and has devised a novel HVJ-E-induced fusion approach to curtail the amount of HVJ-E employed in MRTs.AbstractMitochondrial replacement techniques (MRTs) provide a viable option for women carrying pathogenic mitochondrial DNA (mtDNA) variants to conceive disease-free offspring with a genetic connection. In comparison to electrofusion, HVJ-E-induced fusion has been identified as the most promising approach for clinical translation of MRTs due to its absence of electrical interference. However, despite confirmation of the absence of RNA activity in HVJ-E, a reduction in blastocyst quality has been observed in various MRTs studies utilizing the HVJ-E-induced fusion scheme. Recent investigations have revealed a dose-dependent elevation of reactive oxygen species (ROS) levels in various cancer cells incubated with HVJ-E. However, the impact of HVJ-E as a sole determinant on embryonic development in MRTs remains unverified. This investigation establishes that the augmented concentration of HVJ-E utilized in the conventional HVJ-E fusion protocol is an autonomous variable that influences embryonic development in MRTs. This effect may be attributed to amplified DNA damage resulting from heightened levels of ROS in reconstructed embryos. To mitigate the presence of HVJ-E in reconstructed zygotes while maintaining optimal fusion efficiency in MRTs, a novel HVJ-E-induced fusion approach was devised, namely, press-assisted fusion. This technique offers potential advantages in reducing detrimental factors that impede embryo development in MRTs.

2023-09-06·Animals : an open access journal from MDPI

The Effects of 1-Deoxynojirimycin from Mulberry on Oxidative Stress and Inflammation in Laying Hens and the Direct Effects on Intestine Epithelium Cells In Vitro.

Article

作者: Qu, Liang ; Feng, Yuan ; Barcenas, Adileidys Ruiz ; Shen, Manman ; Zhao, Chengfeng ; Serrano, Boris Ramos ; Li, Tao ; Wang, Mingzhu ; Zhao, Weiguo

The intestine is highly vulnerable to various factors and has been proposed as a promising determinant for poultry health. Phytogenic or plant-derived feed additives can be used to help improve intestinal health. In this study, we aimed to investigate the effects of DNJ on the antioxidative parameters, including malondialdehyde (MDA), total superoxide dismutase (T-SOD), catalase (CAT), glutathione peroxidase (GSH-Px), and inflammatory cytokines (IL-6, IL-1β, and TNF-α), in plasma and intestinal tissues using layers supplemented with or without the DNJ extract of mulberry leaves (DNJ-E) via the ELISA method. A total of 192 healthy Hy-Line Brown layers, aged 47 weeks old, were used to conduct a 56-day study. All hens were randomly separated into four groups as follows: a basal diet containing 0 mg/kg DNJ-E(CON), 50 mg/kg, 100 mg/kg, and 150 mg/kg DNJ-E. Furthermore, the potential mechanism by which DNJ influences intestinal function was also investigated in in vitro cultured intestinal epithelium cells (IEC) with quantification methods including the use of a cell counting kit-8 (CCK8), ELISA, qRT-PCR, and ROS detection. The results showed that CAT in plasma significantly increased following 50 mg/kg DNJ-E supplementation. Moreover, 50 mg/kg DNJ-E supplementation was associated with increases in T-SOD in the jejunum and ileum. However, there was no significant difference in inflammatory cytokines between groups in in vivo experiments. Subsequent in vitro IEC studies revealed that cell viability increased significantly following 5 µM and 10 µM DNJ treatments while decreasing significantly following 20 µM DNJ treatment. Antioxidative parameters improved at 5 µM and 10 µM DNJ concentrations. However, there were no ameliorative effects on antioxidant parameters observed under 20 µM DNJ treatment. The expression levels of Nrf2 mRNA increased significantly under DNJ treatment. DNJ treatment was associated with significant changes in the expression of genes of inflammatory cytokines. In conclusion, our study revealed that DNJ could improve oxidative stress and inflammation responses in the chicken intestine. These findings provide a theoretical reference for the development of functional feed additives that regulate intestinal health and lay the foundation for systematically revealing the mechanism of DNJ.

2022-08-01·Cancer Immunology, Immunotherapy2区 · 医学

A phase I dose-escalation, safety/tolerability, and preliminary efficacy study of the intratumoral administration of GEN0101 in patients with advanced melanoma

2区 · 医学

Article

作者: Yamazaki, Naoya ; Kiyohara, Eiji ; Tanemura, Atsushi ; Nakajima, Toshihiro ; Fujimoto, Manabu ; Katayama, Ichiro ; Kaneda, Yasufumi ; Myoui, Akira ; Kiyohara, Yoshio ; Sakura, Kazuma

AbstractDespite recent advance in immunotherapy agents, safe new therapies that enhance the effects of immune checkpoint inhibitors are still required to develop. We previously demonstrated that hemagglutinating virus of Japan-envelope (HVJ-E) induced not only direct tumor cell death but also antitumor immunity through the activation of T and natural killer (NK) cells, thereafter, developed a manufacturing process of HVJ-E (GEN0101) for clinical use. We here performed a phase Ia clinical trial of intratumoral GEN0101 administration in six patients with stage IIIC or IV malignant melanoma. The primary aim was to evaluate the safety and tolerability of GEN0101, and the secondary aim was to examine the objective tumor response. Patients were separated into two groups (n = 3 each) and received a low dose of 30,000 and high dose of 60,000 mNAU of GEN0101. All patients completed a two-week follow-up evaluation without severe adverse events. The overall response rate was 33% (2 of 6), with 2 partial responses in the high-dose group and 2 with stable disease, and 2 with progressive disease in the low-dose group. Local complete or partial responses were observed in 11 of 18 (61%) target lesions. One patient demonstrated shrinkage of lung metastases after the treatment. The activity of NK cells and interferon-γ levels were increased in the circulation, indicating augmentation of antitumor immunity by GEN0101. This trial showed not only the safety and tolerability but also the significant antitumor effect of GEN0101, suggesting that GEN0101 might be a promising new drug for patients with advanced melanoma.

100 项与 GEN-0101 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
黑色素瘤	临床2期	-	TSD Japan, Inc.	-
间皮瘤	临床2期	-	ISHIHARA SANGYO KAISHA LTD.	-
间皮瘤	临床2期	-	TSD Japan, Inc.	-
间皮瘤	临床2期	-	Osaka University	-
前列腺癌	临床2期	-	Osaka University	-
前列腺癌	临床2期	-	ISHIHARA SANGYO KAISHA LTD.	-
前列腺癌	临床2期	-	TSD Japan, Inc.	-
去势抵抗性前列腺癌	临床1期	日本	Osaka University	2015-05-01

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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


WCLC2018	N/A	恶性胸膜间皮瘤	6	HVJ-E	(積範簾築餘蓋簾糧顧壓) = 83.3% 築艱餘淵淵餘鬱鬱範鑰 (網衊艱鹽製網顧選齋衊 ) 更多	-	2018-09-24