MedPath

AU-007

Generic Name
AU-007

Aulos Bioscience to Present Promising Phase 2 Data for Novel IL-2 Therapeutic in Melanoma Treatment

• Aulos Bioscience will present new Phase 2 data for AU-007, an AI-designed monoclonal antibody targeting IL-2, showing promising results in second-line melanoma treatment at the upcoming AACR Annual Meeting. • AU-007's unique mechanism prevents IL-2 from binding to regulatory T cells while allowing it to activate effector T cells and NK cells, potentially overcoming limitations of traditional IL-2 therapies. • The novel therapeutic may significantly reduce serious side effects associated with high-dose IL-2 therapy, including vascular leak syndrome and pulmonary edema, by preventing IL-2 binding to CD25-containing receptors.

Aulos Bioscience Doses First Patient in Phase 2 NSCLC Trial of AU-007, Avelumab, and Aldesleukin Combination

• Aulos Bioscience has dosed the first patient in a Phase 2 trial evaluating AU-007, avelumab, and low-dose aldesleukin for non-small cell lung cancer (NSCLC). • The trial is a collaboration with Merck KGaA and focuses on second-line treatment for PD-L1+ NSCLC patients who have progressed after first-line checkpoint inhibitor therapy. • Preclinical data showed the combination of AU-007 with avelumab and IL-2 resulted in strong anti-cancer activity, including complete tumor eradication. • Aulos Bioscience plans to share preliminary data from this Phase 2 cohort in the first half of 2025.

Aulos Bioscience's AU-007 Shows Promise in Phase 1/2 Trial with Novel IL-2 Therapeutic Approach

• Aulos Bioscience presented data on AU-007, a novel IL-2 therapeutic, at the EORTC-NCI-AACR Symposium, highlighting its unique mechanism of action. • AU-007 demonstrated Treg reduction correlated with longer progression-free survival and increased effector T cells, suggesting potential clinical benefits. • Phase 2 expansion cohorts are ongoing in renal cell carcinoma, melanoma, and non-small cell lung cancer to evaluate optimal dosing schedules. • The AI-designed antibody shows a manageable safety profile, with no vascular leak syndrome or pulmonary edema observed in the evaluated dose levels.

Aulos Bioscience's AU-007 Shows Promise in Phase 2 Solid Tumor Trial

• Aulos Bioscience is set to present Phase 2 data on AU-007, a novel IL-2 therapeutic antibody, at the SITC 2024 Annual Meeting. • AU-007 uniquely targets the CD25-binding portion of IL-2, enhancing anti-tumor immunity by selectively activating effector T cells and NK cells. • The Phase 2 trial data includes early results in melanoma and renal cell carcinoma, building on previously presented positive clinical data. • AU-007 aims to improve upon traditional IL-2 therapies by reducing immunosuppression and toxicities like vascular leak syndrome.
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