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.
Imneskibart Data Show Deep, Durable Tumor Shrinkages in Melanoma, Early Objective Responses in NSCLC
Aulos Bioscience presented promising Phase 2 data from its imneskibart study at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, held November 5-9, 2025, in National Harbor, Maryland. The new Phase 2 data demonstrate sustained and significant anti-tumor activity in patients with melanoma that progressed on prior doublet checkpoint inhibitor (CPI) therapy and early signals of objective responses in patients with NSCLC whose tumors progressed on prior CPI therapy, with or without chemotherapy. These findings strengthen previously reported results that a combination of imneskibart and low-dose, subcutaneous aldesleukin exhibits unique activity in the IL-2 class. The data also reinforce that a persistent reduction in Tregs coupled with a higher CD8/Treg ratio is associated with longer overall survival, progression-free survival and time on treatment for patients.
View Abstracts and Publications for additional key findings presented at SITC.
Imneskibart (AU-007), a Human Monoclonal Antibody (mAb) That Binds IL-2 and Prevents CD25 Binding, + Low-Dose Subcutaneous IL-2: Phase 2 Update on CPI-Refractory Melanoma and Non-Small Cell Lung Cancer (NSCLC)
McKean M, Frentzas S, Powderly J, et al.
Poster presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), November 2025
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).
