Aulos Bioscience is poised to present updated Phase 2 data from its Phase 1/2 clinical trial of AU-007, a human IgG1 monoclonal antibody targeting the CD25-binding portion of IL-2, in patients with advanced solid tumors. The data will be shared at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, taking place November 6-10, 2024. These findings build upon previously presented clinical data and offer insights into AU-007's potential as a novel immuno-oncology therapeutic.
AU-007's unique mechanism of action leverages IL-2 to bolster anti-tumor immune responses. Unlike traditional IL-2 therapies, AU-007 is designed to prevent IL-2 from binding to trimeric receptors on regulatory T cells (Tregs) while preserving its ability to bind and expand effector T cells and NK cells. This selective targeting aims to shift the balance of the immune system towards activation and away from suppression, potentially mitigating the negative feedback loop and toxicities associated with high-dose IL-2 treatments.
Key Details of the Presentation
The poster presentation, titled "A phase 1/2 dose escalation and cohort expansion study of AU-007, a human monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, plus low-dose aldesleukin in advanced solid tumors," will be presented on Friday, November 8, 2024, from 9:00 a.m. to 7:00 p.m. CST. The abstract number is 685. The presentation will include early Phase 2 data in melanoma and renal cell carcinoma.
AU-007's Differentiated Approach
AU-007's design also aims to reduce vascular leak syndrome and pulmonary edema, common side effects of high-dose IL-2 therapy, by preventing IL-2 from binding to CD25-containing receptors on eosinophils, vasculature, and pulmonary endothelium.
"The Phase 2 dose expansion data for our monoclonal antibody, AU-007, continue to build upon the positive clinical data presented at ASCO and we look forward to presenting further details, particularly early Phase 2 data in melanoma and renal cell carcinoma, at the SITC Annual Meeting," said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer.
The Phase 1/2 clinical trial program for AU-007 is ongoing, with study locations in the United States and Australia. More information can be found at ClinicalTrials.gov (identifier: NCT05267626).
