Overview
Efavaleukin alfa is a fusion protein consisting of interleukin mutein fused to the C-terminus of an immunoglobulin G Fc domain by way of a G4S linker. It is under investigation in clinical trial NCT03422627 (Safety and Efficacy of AMG 592 in Subjects With Steroid Refractory Chronic Graft Versus Host Disease).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Efavaleukin Alfa (AMG 592): A Comprehensive Analysis of a Treg-Selective IL-2 Mutein from Bench to Clinical Discontinuation
Section I: Executive Summary
Efavaleukin alfa (also known as AMG 592) represents a sophisticated example of rational drug design in modern biotechnology, developed by Amgen as a potential therapy for a range of autoimmune and inflammatory diseases. The molecule is a recombinant fusion protein, precisely engineered to address a fundamental challenge in immunology: how to leverage the therapeutic, immunosuppressive properties of Interleukin-2 (IL-2) without invoking its potent, pro-inflammatory effects. This was achieved by creating an IL-2 "mutein" with specific amino acid mutations to decrease its affinity for the intermediate-affinity IL-2 receptor subunit (IL-2Rβ) and increase its dependence on the high-affinity subunit (IL-2Rα, or CD25). This design preferentially targets regulatory T cells (Tregs), which constitutively express high levels of CD25 and are critical for maintaining immune tolerance. By fusing this IL-2 mutein to an immunoglobulin G1 (IgG1) Fc fragment, Amgen also engineered a significantly extended pharmacokinetic half-life, allowing for more convenient dosing regimens.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/02 | Phase 1 | Completed | |||
2023/05/24 | Phase 1 | Completed | |||
2023/01/05 | Phase 2 | Terminated | |||
2021/08/03 | Phase 2 | Terminated | |||
2021/08/03 | Phase 1 | Completed | |||
2020/12/23 | Phase 2 | Terminated | |||
2018/03/01 | Phase 1 | Completed | |||
2018/02/06 | Phase 1 | Terminated | |||
2018/01/25 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| 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 |
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| 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. | |||||
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