Advancing a True Stand-Apart in the Competitive Field of Immuno-Oncology
Our lead asset, imneskibart (AU-007), is a potential best-in-class, wholly owned investigational antibody that is unlike any other IL-2 therapeutic. Allow us to explain why.
A distinctly different approach in IO
Imneskibart is a human monoclonal antibody with drug-like properties that provides advantages over non-natural biologics and that was designed with the assistance of artificial intelligence. Monoclonal antibodies are known for their developability as well as their ease of manufacturing and administration.
With imneskibart, Aulos™ is advancing clinical development of a novel therapeutic that is different from all other IL-2 therapeutics currently in development – it binds to the portion of IL-2 that interacts with the CD25 receptor subunit, preventing regulatory T cell expansion that can lead to immune activation while allowing IL-2 to bind to CD8 effector T cells, which expands CD8 effector T cells and drives tumor killing. Read more about how Aulos stands out in the field in Nature Biotechnology.
33% ORR and 67% DCR Observed With Imneskibart Triplet in Doublet CPI-Refractory Metastatic Melanoma
Aulos Bioscience presented positive Phase 2 data from its imneskibart study at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting, held May 29–June 2, 2026, in Chicago, Illinois. The Phase 2 data demonstrate clinically meaningful activity, with a 33% objective response rate (ORR) and 67% disease control rate (DCR) observed in the imneskibart triplet regimen in patients with metastatic melanoma whose disease progressed following earlier treatment with potent checkpoint inhibitor doublets. The data also reinforce that imneskibart and low-dose, subcutaneous aldesleukin, with or without nivolumab, exhibits unique pharmacodynamic, biological and pharmacokinetic effects in the IL-2 class, with a higher peripheral blood CD8/Treg ratio correlating with increased survival.
View Abstracts and Publications for additional key findings presented at ASCO.
Imneskibart + Low-Dose Subcutaneous IL-2 ± Nivolumab in Patients With CPI-Refractory Cutaneous Melanoma: Promising Results From an Ongoing Phase 1/2 Study
McKean M, Haydon A, Frentzas S, et al.
Poster presentation at the American Society of Clinical Oncology (ASCO), May 2026
Imneskibart has been rigorously evaluated for safety and preclinical efficacy. Numerous preclinical studies have shown that imneskibart tips the delicate balance toward immune activation (CD8+ effector T cell, NK cell and NKT cell activity) and away from immune suppression (regulatory T cell activity). In in vivo studies, imneskibart treatment results in tumor growth inhibition in animal models resistant to immune checkpoint inhibitors. Additional study findings show that imneskibart exhibits favorable pharmacokinetic (PK) properties and a long serum half-life for improved dosing regimens.
Aulos has advanced imneskibart to the Phase 2 portion of its Phase 1/2 clinical trial following demonstration in Phase 1 of a well-tolerated safety profile and early anti-tumor activity in heavily pre-treated patients with unresectable locally advanced or metastatic solid tumor cancers. Expansion cohorts are focusing on melanoma and non-small cell lung cancer (NSCLC).
