Tumour cells apoptosis factor (Immune System Key)(Tumour cells apoptosis factor (Immune System Key)) - 药物靶点：IL-33R_在研适应症：急性髓性白血病，骨髓增生异常综合征，KRAS突变肿瘤_专利_临床

概要

基本信息

药物类型

肿瘤坏死因子

别名

Nerofe

靶点

IL-33R

作用机制

IL-33R调节剂(白介素1受体样蛋白1调节剂)、血管生成抑制剂、细胞凋亡刺激剂

治疗领域

肿瘤血液及淋巴系统疾病神经系统疾病

在研适应症

急性髓性白血病骨髓增生异常综合征KRAS突变肿瘤+ [2]

非在研适应症

晚期癌症卵巢癌三阴性乳腺癌

原研机构

Immune System Key (ISK) Ltd.

在研机构

Immune System Key (ISK) Ltd.

非在研机构-

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-

关联

5

项与 Tumour cells apoptosis factor (Immune System Key) 相关的临床试验

NCT05661201 / Recruiting临床1期IIT

Phase I Study of NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors

The goal of this clinical trial is to learn about the safety of NEROFE and doxorubicin and how well it works in patients with advanced/unresectable or metastatic solid KRAS-mutated and ST-positive solid tumors. The main question it aims to answer is to find the recommended dose and scheduled for the combination of NEROFE and doxorubicin. Participants will receive weekly doses of NEROFE and doxorubicin.

开始日期2023-04-12

申办/合作机构

Georgetown University

[+1]

NCT04365179 / Recruiting临床1期

An Open-Label Phase 1b Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

This is an open-label Phase 1b study of NEROFE following a traditional 3+3 design to assess safety and to determine the Recommended Phase 2 Dose (RP2D) of NEROFE in patients with MDS or AML. IV NEROFE will be administered three times per week on alternate days. The exact dosage will be determined using the body surface area (BSA) measured on Day 1 of each cycle.

开始日期2020-06-18

申办/合作机构

Immune System Key (ISK) Ltd.

[+1]

NCT03059615 / Withdrawn临床2期

A Phase 2a, Open-Label, Two Stage Study: Stage A: Dose-Range Finder Study to Assess the Safety and Efficacy of Two Doses of Nerofe and Two Doses of Nerofe in Combination With Doxorubicin in Subjects With Acute Myelogenous Leukemia or High Risk Myelodysplastic Syndrome (AML/High Risk MDS). Stage B: Dose Confirmation Study to Assess the Safety and Efficacy of Nerofe or Nerofe in Combination With Doxorubicin in Subjects With AML/ High Risk MDS

This is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles).
Evaluation will include safety procedures, blood level of study drug in certain time points, immune system response and tests checking the mechanism of the drug action.

开始日期2018-10-25

申办/合作机构

Immune System Key (ISK) Ltd.

100 项与 Tumour cells apoptosis factor (Immune System Key) 相关的临床结果

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100 项与 Tumour cells apoptosis factor (Immune System Key) 相关的转化医学

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100 项与 Tumour cells apoptosis factor (Immune System Key) 相关的专利（医药）

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1

项与 Tumour cells apoptosis factor (Immune System Key) 相关的文献（医药）

2023-07-01·Oncotarget

Transformation of immunosuppressive mtKRAS tumors into immunostimulatory tumors by Nerofe and Doxorubicin.

Article

作者: Sandler, Uziel ; Devary, Orly ; Ohana, Joel ; Devary, Yoram

Members of the rat sarcoma viral oncogene (RAS) subfamily KRAS are frequently mutated oncogenes in human cancers and have been identified in pancreatic ductal, colorectal, and lung adenocarcinomas. In this study, we show that a derivative of the hormone peptide Tumor Cell Apoptosis Factor (TCApF), Nerofe^™ (dTCApFs), in combination with Doxorubicin (DOX) substantially reduces viability of tumor cells. It was observed that the combination of Nerofe and DOX downregulated KRAS signaling via miR217 upregulation, resulting in enhanced apoptosis of tumor cells. In addition, the combination of Nerofe and DOX also resulted in activation of the immune system against tumor cells, manifested by an increase in the immunostimulatory cytokines IL-2 and IFN-γ as well as the recruitment of NK cells and M1 macrophages to the tumor site.

100 项与 Tumour cells apoptosis factor (Immune System Key) 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
晚期癌症	临床3期	以色列	Immune System Key (ISK) Ltd.	2013-12-01
KRAS突变肿瘤	临床1期	美国	Immune System Key (ISK) Ltd.	2023-04-12
阿尔茨海默症	临床1期	美国	Immune System Key (ISK) Ltd.	2022-08-10
实体瘤	临床1期	美国	Immune System Key (ISK) Ltd.	2022-08-10
急性髓性白血病	药物发现	以色列	Immune System Key (ISK) Ltd.	2018-10-25
骨髓增生异常综合征	药物发现	以色列	Immune System Key (ISK) Ltd.	2018-10-25
卵巢癌	药物发现	以色列	Immune System Key (ISK) Ltd.	2018-09-06
三阴性乳腺癌	药物发现	以色列	Immune System Key (ISK) Ltd.	2018-09-06

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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


NCT01690741 (pubmed) 人工标引	临床1期	实体瘤	17	dTCApFs	(顧鹹築齋鏇窪艱醖繭憲) = 齋繭築窪範憲齋窪鏇網艱鏇蓋鑰窪餘鬱鑰鏇糧 (憲餘醖鹹獵鹹鬱艱膚願 ) 更多	积极	2018-01-01