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 IL-2 investigational product that is unlike any other IL-2 therapeutic. Allow us to explain why.
A distinctly different approach in IO
AU-007 is a computationally designed, IL-2 human monoclonal antibody with drug-like properties that provides advantages over non-natural biologics. 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 activates interleukin-2 against tumors by shutting down the IL-2-driven induction of regulatory T cell expansion that can inhibit immune activation, and prevents IL-2 from binding to vascular endothelium, which is associated with vascular leak syndrome and pulmonary edema. Read more about how Aulos stands out in the field in Nature Biotechnology.
Phase 2 Dose Selection Data Further Validate AU-007’s Distinct Advantages in IL-2 Class
Aulos Bioscience presented dose selection data for Phase 2 expansion cohorts in the AU-007 Phase 1/2 trial at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, held October 23-25, 2024, in Barcelona, Spain. The results affirm AU-007’s continued distinction in the IL-2 class, with a unique profile of Treg reduction and correlated longer progression-free survival outcomes, coupled with increases in tumor-killing effector T cells and natural killer cells. Additionally, safety data demonstrate manageable toxicity for AU-007 and low-dose, subcutaneous aldesleukin, with no vascular leak syndrome or pulmonary edema at all dose levels evaluated.
View Abstracts and Publications for additional data and analyses presented at the EORTC-NCI-AACR Symposium.
Determination of the phase 2 dose of AU-007, an AI-designed human monoclonal antibody that redirects IL-2 to T effector cells
Wyant T, Rasco D, McKean M, et al.
Poster presentation at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, October 2024
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.