Interim Results From Phase 1/2 Clinical Trial in Solid Tumor Cancers Demonstrate Aulos Bioscience’s AU-007 is Well Tolerated and Uniquely Reduces Regulatory T Cells

New data in ASCO 2023 abstract show continued trend in decreasing Tregs and eosinophils, bolstering novel mechanism of action of AU-007, Aulos’ computationally designed antibody in the IL-2 class

Initial anti-tumor activity has been observed since the ASCO data cutoff date, with additional data anticipated by year-end as the Phase 1/2 trial continues to enroll patients

Excerpt from the Press Release:

Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today shared interim results from an ongoing Phase 1/2 trial of AU-007, as detailed in the online publication of Abstract e14507 at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. The data indicate that AU-007 is well tolerated in patients with unresectable locally advanced or metastatic cancer. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors.

“These new interim data support our belief that AU-007 offers a novel mechanism of action among IL-2 therapeutics in development, as demonstrated by AU-007’s pharmacodynamic and safety profile to date,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “In addition, we are further encouraged that, since the data cutoff date, we are seeing early signs of anti-tumor activity in patients, which is consistent with preclinical findings that demonstrate AU-007’s unique ability to bind to IL-2 and redirect it from regulatory T cells, which suppress the immune system, to effector T cells and natural killer cells that can kill tumor cells. AU-007 is the only IL-2 therapy in development that precisely binds to IL-2 instead of the IL-2 receptor, and that turns an immunosuppressive negative feedback loop into a positive feedback loop. This gives AU-007 distinct mechanistic advantages as a potential new cancer therapeutic. As the study continues and we expand the number of trial sites in the United States and Australia, we look forward to presenting additional clinical data in the future.”

AU-007 is the first computationally designed human monoclonal antibody in a human clinical trial. Created by Biolojic Design, the antibody binds with exquisite precision to IL-2, preventing IL-2 from binding to the CD25 subunit contained in trimeric IL-2 receptors expressed on immunosuppressive regulatory T cells (Tregs), vascular and pulmonary endothelium, and eosinophils.

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