Aulos Bioscience Announces Preclinical Data Demonstrating Ability of Novel IL-2 Therapeutic AU-007 to Eliminate Solid Tumors

Data show significant tumor growth inhibition with AU-007, a computationally designed, human IgG1 monoclonal antibody, and complete tumor eradication when dosed in combination with checkpoint inhibitors

Phase 1/2 clinical trial planning in progress, with initiation anticipated 1H 2022

Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, has shared new preclinical data demonstrating solid tumor elimination when dosing AU-007, a monoclonal antibody computationally designed by Biolojic Design. Data were presented at a recent antibody biology and engineering conference.

“These preclinical data strongly support AU-007’s unique mechanism of action as an antibody that can promote anti-cancer activity, including complete tumor elimination when used with checkpoint inhibitors in a murine model of cancer,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “AU-007’s ability to redirect IL-2 toward immune activation and away from immune suppression and vascular endothelium is a novel approach to long-standing obstacles in immunotherapy. The new data underscore the potential we see in AU-007 as we prepare to initiate a Phase 1/2, first-in-human clinical trial of AU-007 in solid tumor indications.”

To address the challenges of existing interleukin-2 (IL-2) treatments, Biolojic Design used its artificial intelligence platform to computationally design AU-007, a human antibody that precisely blocks IL-2 from binding to CD25 in trimeric receptors while preserving IL-2’s binding to dimeric CD122/CD132 receptors. Through this differentiated mechanism of action, AU-007 could promote immune effector activation while preventing T regulatory (Treg) cell expansion and vascular leak syndrome driven by IL-2. AU-007 has also been shown to break the autoinhibitory loop caused by endogenous IL-2 secreted from activated CD4 T helper cells and CD8 T effector cells that would otherwise lead to Treg expansion and immune suppression.

The new data demonstrate strong anti-cancer activity in murine models when AU-007 is dosed with a single dose of human IL-2 (hIL-2), as well as in combination with a single dose of hIL-2 and checkpoint inhibitors. In a recent murine preclinical study, AU-007 with a single loading dose of hIL-2 and PD-1 antibody demonstrated MC38 colorectal tumor regressions, with complete tumor elimination achieved in five of 10 cases. Additionally, AU-007 with a single loading dose of hIL-2 and PD-L1 antibody similarly demonstrated tumor regressions, with complete tumor elimination achieved in five of nine cases. AU-007 has been shown to be safe and well tolerated in primate toxicology studies (data not presented), does not cross-react with human tissues, and is on track to become the first computationally designed human antibody to enter clinical development.

In February, Aulos Bioscience announced it had received approval from the Monash Health Human Research Ethics Committee (HREC) to initiate a Phase 1/2, first-in-human trial of AU-007 in Australia. Aulos anticipates initiating enrollment and dosing in the first half of 2022.

The poster presentation is available on the Aulos Bioscience website.

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

About Aulos

Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through best-in-class IL-2 therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a computationally designed human antibody that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and ATP with $40 million in Series A funding from ATP and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulosbio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220321005078/en/