Trials in Progress poster describes design of recently initiated Phase 1/2 study of AU-007 for treatment of solid tumors

Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today shared a Trials in Progress poster that is being presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting. The poster showcases the study design for the company’s first-in-human Phase 1/2 trial of AU-007 that is currently enrolling patients in Australia. AU-007 is a human monoclonal antibody computationally designed by Biolojic Design, with a highly differentiated approach to harnessing the power of interleukin-2 (IL-2) to eradicate solid tumors.

“AU-007 stands apart with a mechanism of action that is entirely different from every other IL-2 therapeutic in development,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “This Phase 1/2 study is the first time that a computationally designed human monoclonal antibody has been tested in humans. By addressing the IL-2 negative feedback loop, we believe AU-007 could potentially subdue immune suppression and prevent the toxic side effects of IL-2, leading to a novel treatment for solid tumor cancers.”

The Trials in Progress poster describes how AU-007 can bind human IL-2 with picomolar affinity and precisely block IL-2’s binding to CD25, without hindering IL-2’s binding to CD132/CD122. Through this unique mechanism of action, AU-007 can transform the IL-2 negative feedback loop into a positive one, tipping the balance toward immune activation and away from immune suppression. Recently released preclinical data of murine models demonstrate that redirected IL-2 signaling by AU-007 can lead to significant tumor growth inhibition, and complete MC38 colorectal tumor elimination when AU-007 is dosed in combination with checkpoint inhibitors.

The company’s Phase 1/2 trial (NCT05267626) is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Phase 1 consists of three dose escalation arms evaluating AU-007 either as a monotherapy, in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin administered once every two weeks. The Phase 2 portion of the trial evaluates a dosing regimen selected from dose escalation for expansion in specified tumor types to further define the safety and initial efficacy of AU-007. Dosing of patients commenced in May, and preliminary data from the Phase 1 portion of the clinical trial is expected by late 2022.

The Trials in Progress poster is available to meeting registrants as an e-poster on the ASCO Annual Meeting website and will be presented live in the Trials in Progress poster session “Developmental Therapeutics—Immunotherapy” on Sunday, June 5, 2022, 8:00 a.m. to 11:00 a.m. CDT.

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.

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