Overview
Tengonermin, also known as NGR-hTNF, is a vascular-targeting drug. It is a recombinant protein and peptide-targeted agent consisting of the human Tumour Necrosis Factor-α (TNF-α) conjugated with the CNGRCG peptide. This drug works by modifying the tumor microenvironment and increasing intratumoral chemotherapy penetration and T-cell infiltration. NGR-hTNF specifically targets angiogenic tumor blood vessels using the NGR motif. Literature demonstrates that NGR-peptides bind to a CD13 isoform, of which expression is restricted to tumor vasculature cells. A study also demonstrated that binding of the NGR-motif to CD13 determined both the homing of NGR-hTNF to tumor vessels and the increase in its antiangiogenic activity.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Clinical and Pharmacological Profile of Tengonermin (NGR-hTNF): A Vascular-Targeting Agent's Journey from Promise to Pivotal Failure
Executive Summary
Tengonermin, also known as NGR-hTNF, is an investigational biotechnology-derived therapeutic agent engineered as a novel vascular-targeting drug for the treatment of solid tumors. Its design represents a sophisticated approach to cytokine therapy, aiming to harness the potent anti-tumor effects of Tumor Necrosis Factor-alpha (TNF-α) while mitigating the severe systemic toxicities that plagued earlier, untargeted applications of this cytokine. The drug is a recombinant fusion protein, comprising human TNF-α chemically conjugated to a tumor-homing peptide, CNGRCG. This peptide selectively targets an isoform of the CD13 receptor that is specifically overexpressed on the endothelial cells of the tumor neovasculature. This targeted delivery mechanism is designed to concentrate the pharmacological activity of TNF-α within the tumor microenvironment, thereby increasing the permeability of tumor blood vessels to enhance the penetration of co-administered chemotherapies and immune cells, and directly inducing apoptosis in angiogenic endothelial cells.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/01/15 | Phase 2 | Completed | AGC Biologics S.p.A. | ||
2018/05/24 | Phase 2 | Completed | Andres J. M. Ferreri | ||
2011/05/23 | Phase 2 | Completed | AGC Biologics S.p.A. | ||
2011/05/23 | Phase 2 | Completed | AGC Biologics S.p.A. | ||
2010/04/02 | Phase 3 | Completed | AGC Biologics S.p.A. | ||
2009/10/14 | Phase 2 | Completed | AGC Biologics S.p.A. | ||
2009/04/08 | Phase 1 | Completed | AGC Biologics S.p.A. | ||
2008/05/08 | Phase 2 | Completed | AGC Biologics S.p.A. | ||
2007/06/08 | Phase 2 | Completed | AGC Biologics S.p.A. | ||
2007/06/08 | Phase 2 | Completed | AGC Biologics S.p.A. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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