Aulos Bioscience Presents Preclinical Data Demonstrating Anti-Tumor Activity of AU-007, a Novel IL-2 Therapeutic, at 36th Society for Immunotherapy of Cancer (SITC) Annual Meeting

Data support ability of AU-007, a computationally evolved, human IgG1 monoclonal antibody, to specifically block IL-2’s binding to CD25 and inhibit tumor growth in multiple cancer models

Data show potential of novel cancer treatment to break negative feedback loop caused by IL-2 and prevent Treg expansion

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 shared preclinical data for AU-007, a computationally evolved human antibody that leverages a highly differentiated approach to harnessing the power of IL-2 to eradicate solid tumors. Data were presented in a poster presentation at the 36th Society for Immunotherapy of Cancer (SITC) Annual Meeting.

“These positive preclinical data demonstrate the ability of AU-007 to tip the balance toward immune activation and away from immune suppression by preventing IL-2 from binding to T regulatory cells,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “While high-dose IL-2 has shown clinical benefit, associated toxicities have limited its therapeutic use. With AU-007, we are leveraging a mechanism of action unlike any other IL-2 therapeutic in development, with the potential for lower toxicity and a sustained anti-tumor response. Supported by these data, we are continuing to advance AU-007 into a Phase 1/2 clinical trial.”

AU-007 mediates human immune activation by precisely blocking an epitope on IL-2 that binds to CD25. This action redirects IL-2 to promote T effector cell expansion through binding the IL-2 receptor CD122/132 dimer while uniquely breaking the IL-2 negative feedback loop and blocking T regulatory cell (Treg) expansion, which requires activation through the CD25-containing IL-2 receptor trimer (CD25/CD122/CD132). Aulos Bioscience presented data at SITC establishing both the specificity and activity of AU-007. In preclinical studies, AU-007 was shown to bind human IL-2 with picomolar affinity and completely inhibit its binding to CD25 while preserving binding to CD122/CD132. When evaluated for activity in mouse models of cancer, administration of AU-007 complexed with human IL-2 resulted in expansion of CD8+ T effector cells, NK cells and NKT cells in a dose-dependent manner, but had no effect on the expansion of CD4+ Tregs. Additionally, AU-007 was shown to inhibit downstream signaling of IL-2 on human CD4+ Tregs, as measured by STAT phosphorylation, in a dose-dependent manner, but did not affect IL-2 signaling on human CD8+ T effector cells, NK cells and NKT cells.

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