Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Darleukin (L19IL2): A Comprehensive Monograph on a Tumor-Targeted Immunocytokine
Executive Summary
Darleukin, identified by the research code L19IL2 and the DrugBank ID DB17157, is an investigational, fully-human immunostimulatory biopharmaceutical. It is classified as an immunocytokine, a type of recombinant fusion protein engineered to overcome the limitations of systemic cytokine therapy. Darleukin consists of two key components: the human cytokine interleukin-2 (IL-2) and the human L19 antibody. The L19 antibody moiety is designed to specifically target the extra-domain B (EDB) of fibronectin, a protein isoform that is highly expressed within the tumor microenvironment (TME) and associated with angiogenesis, but is largely absent in healthy, mature tissues. This targeted delivery mechanism is central to Darleukin's therapeutic strategy, enabling the concentration of IL-2's potent immunostimulatory effects directly at the site of disease, thereby enhancing its therapeutic index while mitigating the severe systemic toxicities associated with high-dose, untargeted IL-2 administration.
The mechanism of action involves the selective localization of Darleukin within the tumor stroma, followed by the activation of a robust anti-tumor immune response. The IL-2 payload stimulates the proliferation and activation of tumor-specific cytotoxic CD8+ T lymphocytes and Natural Killer (NK) cells, which are critical effectors in the eradication of cancer cells. Clinical investigations, particularly with intralesional administration, have demonstrated that this localized immune activation can translate into a systemic anti-tumor effect, leading to the regression of non-injected metastatic lesions.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/22 | Not Applicable | Not yet recruiting | Hansoh BioMedical R&D Company | ||
2025/08/11 | Not Applicable | Not yet recruiting | Hansoh BioMedical R&D Company | ||
2025/08/01 | Not Applicable | Recruiting | |||
2025/05/09 | Phase 1 | Not yet recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | ||
2025/04/20 | Phase 3 | Not yet recruiting | Hansoh BioMedical R&D Company | ||
2025/03/19 | Phase 1 | Recruiting | |||
2025/02/13 | Phase 1 | Recruiting | Hansoh BioMedical R&D Company | ||
2024/11/21 | Phase 1 | Not yet recruiting | Hansoh BioMedical R&D Company | ||
2024/08/13 | Phase 1 | Recruiting | |||
2024/07/30 | Phase 3 | Not yet recruiting | Hansoh BioMedical R&D Company |
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 |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.