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 evolved, IL-2 human monoclonal antibody with drug-like properties that provides advantages over non-natural biologics. Monoclonal antibodies are known for their developability that has been proven preclinically 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.
Novel IL-2 Therapy Holds Potential to Eradicate Solid Tumors
Aulos Bioscience presented preclinical data demonstrating anti-tumor activity of AU-007 at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting on November 10-14, 2021. The positive data support the ability of AU-007 to specifically block IL-2’s binding to CD25 and inhibit tumor growth in multiple cancer models. Data also demonstrate the potential of this novel IL-2 therapeutic, with its differentiated mechanism of action, to break the negative feedback loop caused by IL-2 and prevent Treg expansion.
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.
We are initially evaluating AU-007 as a monotherapy, but future clinical testing is expected to include combinations such as regimens with checkpoint inhibitors.