Efavaleukin alfa
- Generic Name
- Efavaleukin alfa
- Drug Type
- Biotech
- CAS Number
- 2049067-94-7
- Unique Ingredient Identifier
- YNH9K62UXU
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).
Background
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 Report
Name: Efavaleukin alfa Name (English): Efavaleukin alfa DrugBank ID: DB16149 Type: Biotech CAS Number: 2049067-94-7
Description: Efavaleukin alfa is a novel interleukin-2 (IL-2) mutein Fc fusion protein. It is designed to selectively expand regulatory T cells (Treg) by preferentially binding to the high-affinity IL-2 receptor alpha chain (CD25), which is constitutively expressed at high levels on Tregs. This preferential binding leads to increased cell surface retention and sustained Treg signaling compared to recombinant IL-2.
Mechanism of Action: Efavaleukin alfa is an IL-2 mutein with an introduced mutation that decreases its binding to IL-2Rβ and increases its dependence on IL-2Rα (CD25). This modification allows for selective binding to the high-affinity IL-2 receptor on Tregs, promoting their expansion and function without significantly affecting other immune cells like conventional CD4+ T cells, CD8+ T cells, or natural killer (NK) cells.
Clinical Development: Efavaleukin alfa has been under investigation for the treatment of inflammatory and autoimmune diseases, including:
- Systemic Lupus Erythematosus (SLE): Phase 1b and Phase 2 clinical trials have evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of efavaleukin alfa in patients with SLE. Initial results showed that the drug was well-tolerated and led to selective and prolonged Treg expansion in these patients. However, Amgen discontinued its Phase 2b study in SLE due to futility.
- Ulcerative Colitis: Efavaleukin alfa is also being evaluated in a Phase 2 long-term extension study for the treatment of moderately to severely active ulcerative colitis.
Clinical Trials
FDA Approved Products
Singapore Approved Products
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