Advancing a True Stand-Apart in the Competitive Field of Immuno-Oncology
Our lead asset, 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
AU-007 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 AU-007, 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.
AU-007 Data Show Continued Strong Evidence of Anti-Tumor Activity and Durable Response at AACR
Aulos Bioscience presented positive Phase 1 and interim Phase 2 data from its AU-007 study at the American Association for Cancer Research (AACR) Annual Meeting, held April 25-30, 2025, in Chicago, Illinois. Interim Phase 2 data reveal clear evidence of deep and durable tumor shrinkages, including complete and partial responses, in patients whose tumors were refractory to treatment and had achieved no responses from highly potent prior immuno-oncology regimens. Additionally, AU-007 and low-dose, subcutaneous aldesleukin continues to demonstrate a unique pharmacodynamic profile in the IL-2 class, with Tregs decreasing, CD8 effector T cells expanding, and the CD8/Treg ratios increasing at all AU-007 dose levels. These results reinforce the previously reported observation that CD8 effector T cell expansion and Treg reduction correlates with clinical efficacy.
View Abstracts and Publications for additional key findings presented at SITC.
AU-007, a Human Monoclonal Antibody (mAb) That Binds to IL-2 and Inhibits CD25 Binding, Plus Low-Dose Aldesleukin, in Advanced Solid Tumors: Phase 2 Update
McKean M, Frentzas S, Rasco D, et al.
Poster presentation at the American Association for Cancer Research (AACR) Annual Meeting, April 2025
AU-007 has been rigorously evaluated for safety and preclinical efficacy. Numerous preclinical studies have shown that AU-007 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, AU-007 treatment results in tumor growth inhibition in animal models resistant to immune checkpoint inhibitors. Additional study findings show that AU-007 exhibits favorable pharmacokinetic (PK) properties and a long serum half-life for improved dosing regimens.
Aulos has advanced AU-007 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. The first expansion cohorts will focus on melanoma and renal cell carcinoma.
