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.
New Phase 1 Dose Escalation Cohorts Data for AU-007 Show Well-Tolerated Safety Profile and Anti-Tumor Activity
Aulos Bioscience presented new safety and efficacy data from the ongoing Phase 1 dose escalation portion of its Phase 1/2 clinical trial of AU-007 at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held November 1-5, 2023, in San Diego, California. The data continue to indicate that AU-007 is well tolerated as a monotherapy treatment or in a combination therapy regimen with low-dose, subcutaneous aldesleukin (recombinant human IL-2). Additionally, preliminary evidence of anti-tumor activity was observed in heavily pre-treated patients, including in patients with melanoma, renal cell carcinoma and non-small cell lung cancer whose tumors had progressed through checkpoint inhibitors.
View Abstracts and Publications for additional information on AU-007’s highly differentiated mechanism of action.
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: Interim results from dose escalation (NCT05267626)
Frentzas S, Ahern E, Weickhardt A, et al.
Poster presentation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), November 2023
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.
