Delving into the Latest Updates on Tumour cells apoptosis factor (Immune System Key) with Synapse

Overview

Basic Info

Drug Type

Tumor necrosis factors

Synonyms

Nerofe

Target

IL-33R

Mechanism

IL-33R modulators(Interleukin-1 receptor-like 1 modulators), Angiogenesis inhibitors, Apoptosis stimulants

Therapeutic Areas

NeoplasmsHemic and Lymphatic DiseasesNervous System Diseases

Active Indication

Acute Myeloid LeukemiaMyelodysplastic SyndromesKRAS mutation-related tumors+ [2]

Inactive Indication

Advanced cancerOvarian CancerTriple Negative Breast Cancer

Originator Organization

Immune System Key (ISK) Ltd.

Active Organization

Immune System Key (ISK) Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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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.

Start Date12 Apr 2023

Sponsor / Collaborator

Georgetown University

[+1]

NCT04365179 / RecruitingPhase 1

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.

Start Date18 Jun 2020

Sponsor / Collaborator

Immune System Key (ISK) Ltd.

[+1]

NCT03059615 / WithdrawnPhase 2

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.

Start Date25 Oct 2018

Sponsor / Collaborator

Immune System Key (ISK) Ltd.

100 Clinical Results associated with Tumour cells apoptosis factor (Immune System Key)

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100 Translational Medicine associated with Tumour cells apoptosis factor (Immune System Key)

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100 Patents (Medical) associated with Tumour cells apoptosis factor (Immune System Key)

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Literatures (Medical) associated with Tumour cells apoptosis factor (Immune System Key)

01 Jul 2023·Oncotarget

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

Article

Author: 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 Deals associated with Tumour cells apoptosis factor (Immune System Key)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
KRAS mutation-related tumors	Phase 1	US	Immune System Key (ISK) Ltd.	12 Apr 2023
Alzheimer Disease	Phase 1	US	Immune System Key (ISK) Ltd.	10 Aug 2022
Solid tumor	Phase 1	US	Immune System Key (ISK) Ltd.	10 Aug 2022
Acute Myeloid Leukemia	Phase 1	IL	Immune System Key (ISK) Ltd.	25 Oct 2018
Myelodysplastic Syndromes	Phase 1	IL	Immune System Key (ISK) Ltd.	25 Oct 2018
Ovarian Cancer	Phase 1	IL	Immune System Key (ISK) Ltd.	06 Sep 2018
Triple Negative Breast Cancer	Phase 1	IL	Immune System Key (ISK) Ltd.	06 Sep 2018
Advanced cancer	Preclinical	IL	Immune System Key (ISK) Ltd.	01 Dec 2013