Aulos Bioscience Presents Initial Data From First-in-Human Phase 1/2 Clinical Trial of Computationally Designed Antibody AU-007 at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting

Data show trend in decreasing Tregs, presenting unique profile among current IL-2 therapeutics

Adding Phase 1/2 clinical trial sites in the U.S. following recent IND application clearance

Excerpt from the Press Release:

LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today presented early data from its Phase 1/2 study of AU-007. AU-007 is a human monoclonal antibody computationally designed by Biolojic Design to harness the power of interleukin-2 (IL-2) and eradicate solid tumors. Data were presented in a poster presentation at the 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting in Boston, Massachusetts.

Initial pharmacokinetic data from the first three patients administered AU-007 as a monotherapy demonstrate characteristics similar to other IgG1 therapeutic human monoclonal antibodies. Further, the data are consistent with the novel mechanism of action of the antibody. AU-007 binds IL-2 with high specificity and picomolar affinity, and completely inhibits IL-2’s binding to the CD25 subunit contained in trimeric IL-2 receptors expressed on immunosuppressive T regulatory cells (Tregs), vascular and pulmonary endothelium, and eosinophils. It does this without hindering IL-2’s binding to dimeric IL-2 receptors that contain CD122 and CD132 and are expressed on T effector and NK cells. Both T effector and NK cells are cell types that can kill tumor cells.

The early clinical data with AU-007 show trends toward decreasing Tregs with corresponding increases in the CD8/Treg ratio, initial interferon-gamma increases, and decreasing absolute eosinophils.

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