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.
Updated Phase 1/2 Data at ASCO Demonstrate AU-007’s Ability to Reduce Large-Volume Tumors
Aulos Bioscience presented positive interim data from its Phase 1/2 clinical trial of AU-007 at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, held May 31–June 4, 2024, in Chicago, Illinois. Preliminary results show durable anti-tumor activity in multiple solid tumor types among heavily pre-treated patients, including patients whose tumors have progressed through checkpoint inhibitors. The results confirm the ability of AU-007 to harness the power of IL-2 to reduce solid tumors and support ongoing and planned Phase 2 expansion cohorts in combination with low-dose aldesleukin in melanoma, renal cell carcinoma and non-small cell lung cancer.
View Abstracts and Publications for information on key findings from the updated results presented at ASCO.
Updated results of a phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors
Rasco D, McKean M, Haydon A, et al.
Poster presentation at the American Society of Clinical Oncology (ASCO), June 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.
