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 T regulatory 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.
Initial Data From Phase 1/2 Clinical Trial of AU-007 Show Trend in Decreasing Tregs
Aulos Bioscience presented early data from its first-in-human Phase 1/2 clinical trial of AU-007 at the SITC Annual Meeting, held November 8-12, 2022, in Boston, Massachusetts. Initial pharmacokinetic data from the first three patients administered AU-007 as a monotherapy demonstrate characteristics similar to other IgG1 therapeutic human monoclonal antibodies. The early clinical data also show trends toward decreasing Tregs with corresponding increases in the CD8/Treg ratio, initial interferon-gamma increases, and decreasing absolute eosinophils – all presenting a unique profile among current IL-2 therapeutics.
View Abstracts and Publications for additional information on AU-007’s highly differentiated mechanism of action.
Initial results from dose escalation of a phase 1/2, first-in-human, open label study of AU-007, a monoclonal antibody that binds to IL-2 and prevents its binding to CD25, in patients with solid tumors
Vasselli J, De Souza P, Frentzas S, et al.
Poster presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), November 2022
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+ T effector cell, NK cell and NKT cell activity) and away from immune suppression (T regulatory 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.
A Phase 1/2 clinical trial evaluating the safety, tolerability and immunogenicity of AU-007 in patients with unresectable locally advanced or metastatic cancer initiated in May 2022.