Aulos Bioscience to Present Updated Phase 2 Data for AI-Designed Imneskibart in Checkpoint Inhibitor-Refractory Cancers at SITC 2025
Key Insights
Aulos Bioscience (search) will present updated Phase 2 data for imneskibart (AU-007) in checkpoint inhibitor-refractory melanoma (search) and non-small cell lung cancer (search) at the SITC 40th Annual Meeting in November 2025.
Imneskibart is a human monoclonal antibody designed using artificial intelligence that selectively binds IL-2 and prevents CD25 (search) binding to redirect immune responses toward tumor killing.
The novel mechanism prevents IL-2 from binding to regulatory T cells while allowing effector T cell and NK cell expansion, potentially reducing toxicities associated with traditional IL-2 therapy.
Aulos Bioscience (search) announced it will present updated Phase 2 data for its lead immune-activating antibody therapeutic imneskibart (AU-007) at the Society for Immunotherapy of Cancer (search) (SITC) 40th Annual Meeting. The data focuses on patients with checkpoint inhibitor (CPI)-refractory melanoma (search) and non-small cell lung cancer (search) (NSCLC (search)), representing a significant patient population with limited treatment options.
Novel AI-Designed Mechanism of Action
Imneskibart represents a unique approach to IL-2 therapy, designed using artificial intelligence to be highly selective to the CD25 (search)-binding portion of IL-2. The human IgG1 monoclonal antibody employs a mechanism of action unlike any other IL-2 therapeutic currently in development.
The drug works by preventing IL-2, whether exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This selective blocking prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression.
Addressing IL-2 Therapy Limitations
Traditional IL-2 therapy has been associated with significant toxicities, including vascular leak syndrome (search) and pulmonary edema (search). Imneskibart addresses these concerns by preventing IL-2 from binding to CD25 (search)-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce these adverse effects associated with high-dose IL-2 therapy.
Clinical Trial Program Details
The ongoing Phase 1/2 clinical trial program is being conducted in multiple locations across the United States and Australia. The study is registered on ClinicalTrials.gov under identifier NCT05267626, with additional information available through dedicated study websites for both U.S. and Australian sites.
Conference Presentation Details
The updated Phase 2 data will be presented as a poster titled "Imneskibart, a human monoclonal antibody (mAb) that binds IL-2 and prevents CD25 (search) binding, + low-dose subcutaneous IL-2: Phase 2 update on CPI-refractory melanoma (search) and non-small cell lung cancer (search) (NSCLC (search))." The presentation is scheduled for Friday, November 7, 2025, from 10:00 a.m. to 7:00 p.m. EST in the Prince George ABC Exhibit Halls at the Gaylord National Resort and Convention Center. An electronic version will also be available on the SITC 2025 virtual meeting platform.
Company Background
Aulos Bioscience (search) is an immuno-oncology company focused on developing immune-activating antibody therapeutics that direct patients' immune systems toward killing tumor cells. The company was founded through a collaboration between Biolojic Design (search) and Apple Tree Partners (search) (ATP), combining world-class machine learning capabilities with deep understanding of the immune system. The leadership team consists of pioneers in artificial intelligence, antibody development, and cancer (search) immunotherapies.