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 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.
Preclinical Data Demonstrate Ability of Novel IL-2 Therapy to Eliminate Solid Tumors
Aulos Bioscience has released preclinical data demonstrating strong anti-cancer activity in murine models when AU-007 is dosed in combination with checkpoint inhibitors, including complete MC38 colorectal tumor elimination. The positive data underscore AU-007’s potential as an IL-2 therapeutic as Aulos prepares to initiate a Phase 1/2, first-in-human clinical trial of AU-007 in solid tumor indications.
View Abstracts and Publications for additional information on AU-007’s unique mechanism of action.
AU-007, a computationally designed human antibody to the CD25-interacting domain of IL-2, demonstrates strong activity in murine syngeneic tumors in combination with IL-2 and PD-1 or PD-L1 antibodies
Amit I, Levin I, Wyant T, et al.
Preclinical poster, March 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.
We are initially evaluating AU-007 as a monotherapy, but future clinical testing is expected to include combinations such as regimens with checkpoint inhibitors.