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 an IL-2 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 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.
Strong Evidence of AU-007’s Anti-Tumor Activity in Advanced Solid Tumor Cancers Presented at SITC
Aulos Bioscience presented positive Phase 1 and preliminary Phase 2 data from its AU-007 study at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, held November 6-10, 2024, in Houston, Texas. Preliminary Phase 2 data reveal that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in melanoma, a finding consistent with Phase 1 data demonstrating clinical activity in a range of patients whose tumors had progressed through prior checkpoint inhibitors. Additionally, data from all 77 patients show durable Treg reduction – a result unprecedented in the IL-2 class – and correlated progression-free survival.
View Abstracts and Publications for additional key findings presented at SITC.
A Phase 1/2 Dose Escalation and Cohort Expansion Study of AU-007, a Human Monoclonal Antibody (mAb) That Binds to IL-2 and Inhibits CD25 Binding, Plus Low-Dose Aldesleukin in Advanced Solid Tumors
McKean M, Frentzas S, Rasco D, et al.
Poster presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), November 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.
