Drug intelligence / Profile preview

imneskibart + aldesleukin

Development stage
Phase 2
Lead developer
Aulos Bioscience, Inc.
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Intravenous, Subcutaneous
01

Overview

Imneskibart (AU-007) plus aldesleukin is an investigational combination cancer immunotherapy from Aulos Bioscience. Imneskibart is a human IgG1 monoclonal antibody, designed with AI, that binds interleukin-2 (IL-2). It blocks IL-2 from binding CD25 (the alpha chain of the trimeric IL-2 receptor). It still lets IL-2 engage the dimeric IL-2 receptor (CD122/CD132). Aldesleukin is recombinant human IL-2 (brand name Proleukin). It is given as a low-dose subcutaneous loading dose at the start of each cycle. Together, the pair is meant to expand effector cells (CD8 T cells and NK cells) while reducing regulatory T cells (Tregs). In the clinical studies, imneskibart is given intravenously at 9 mg/kg every 2 weeks. Aldesleukin is given at 135,000 IU/kg subcutaneously on day 1 of each cycle. The combination is in a phase 1/2 trial, with or without the PD-1 inhibitor nivolumab or the PD-L1 inhibitor avelumab. It is being tested in checkpoint-inhibitor-refractory cutaneous melanoma and PD-L1-positive non-small cell lung cancer (NSCLC). Isolated complete responses have also been reported in bladder cancer and nasopharyngeal head and neck cancer. The combination is not approved.

Other names
AU-007 + ProleukinAU-007 + aldesleukinimneskibart + Proleukinimneskibart + recombinant human IL-2imneskibart + recombinant human interleukin-2
02

Targets

IL-2 (Interleukin 2)IL2RB (IL-2 receptor beta chain)IL2RG (Interleukin-2 receptor gamma subunit)

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