Overview
Aldesleukin, a lymphokine, is produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human interleukin-2 gene. Genetic engineering techniques were used to modify the human IL-2 gene, and the resulting expression clone encodes a modified human interleukin-2. This recombinant form differs from native interleukin-2 in the following ways: a) Aldesleukin is not glycosylated because it is derived from E. coli; b) the molecule has no N-terminal alanine; the codon for this amino acid was deleted during the genetic engineering procedure; c) the molecule has serine substituted for cysteine at amino acid position 125.
Background
Aldesleukin, a lymphokine, is produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human interleukin-2 gene. Genetic engineering techniques were used to modify the human IL-2 gene, and the resulting expression clone encodes a modified human interleukin-2. This recombinant form differs from native interleukin-2 in the following ways: a) Aldesleukin is not glycosylated because it is derived from E. coli; b) the molecule has no N-terminal alanine; the codon for this amino acid was deleted during the genetic engineering procedure; c) the molecule has serine substituted for cysteine at amino acid position 125.
Indication
For treatment of adults with metastatic renal cell carcinoma.
Associated Conditions
- Metastatic Melanoma
- Metastatic Renal Cell Carcinoma ( mRCC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/01 | Phase 1 | Not yet recruiting | |||
2024/11/15 | Phase 2 | Recruiting | |||
2024/10/03 | Phase 1 | Not yet recruiting | City of Hope Medical Center | ||
2024/05/24 | N/A | Recruiting | |||
2024/02/12 | Phase 1 | Recruiting | |||
2024/02/01 | Phase 1 | Active, not recruiting | |||
2024/01/12 | Phase 1 | Not yet recruiting | Inge Marie Svane | ||
2023/08/14 | Phase 1 | Recruiting | |||
2023/04/20 | Phase 1 | Completed | |||
2023/04/06 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Clinigen Limited | 76310-022 | INTRAVENOUS | 1.1 mg in 1 mL | 9/19/2019 | |
| Iovance Biotherapeutics, Inc | 73776-022 | INTRAVENOUS | 1.1 mg in 1 mL | 1/31/2024 | |
| Prometheus Laboratories Inc. | 65483-116 | INTRAVENOUS | 1.1 mg in 1 mL | 8/31/2018 |
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. | |||||