Aulos Bioscience to Present Updated Phase 2 Data for Imneskibart (AU-007) in CPI-Refractory Melanoma and NSCLC at SITC 40th Annual Meeting
Aulos Bioscience, a pioneering immuno-oncology company dedicated to transforming cancer care through the development of innovative immune-activating therapies, has announced that it will present updated Phase 2 clinical data for its lead therapeutic candidate, imneskibart (AU-007), in patients with checkpoint inhibitor (CPI)-refractory melanoma and non-small cell lung cancer (NSCLC). The presentation is scheduled to take place during the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which will be held both virtually and in-person at the Gaylord National Resort and Convention Center in National Harbor, Maryland, from November 5 to 9, 2025.
Imneskibart represents a novel approach in immuno-oncology. It is a human monoclonal antibody that selectively binds to interleukin-2 (IL-2) while preventing its interaction with CD25. This unique mechanism of action allows imneskibart to enhance anti-tumor immune responses by preferentially stimulating effector T cells and natural killer (NK) cells, while minimizing activation of regulatory T cells (Tregs) that can dampen immune activity in the tumor microenvironment. By combining imneskibart with low-dose subcutaneous IL-2, the therapy aims to create a more potent and sustained anti-tumor immune response, particularly in patients who have experienced disease progression despite prior checkpoint inhibitor therapy.
The SITC Annual Meeting is the premier gathering of immuno-oncology experts, researchers, and clinicians worldwide. It provides an important platform for sharing advances in cancer immunotherapy, including emerging therapies, combination strategies, and mechanistic insights into anti-tumor immune responses. Aulos Bioscience’s participation at SITC underscores the company’s commitment to contributing to the scientific understanding of immuno-oncology treatments and advancing therapeutic options for patients with difficult-to-treat cancers.
Details of Poster Presentation
Aulos Bioscience’s updated Phase 2 data for imneskibart will be shared in a poster presentation, providing in-depth information on its ongoing clinical study in patients with CPI-refractory melanoma and NSCLC. The presentation details are as follows:
- Poster Title: Imneskibart, a human monoclonal antibody (mAb) that binds IL-2 and prevents CD25 binding, + low-dose subcutaneous IL-2: Phase 2 update on CPI-refractory melanoma and non-small cell lung cancer (NSCLC)
- Abstract Number: 651
- Date and Time: Friday, November 7, 2025, from 10:00 a.m. to 7:00 p.m. EST
- Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center, National Harbor, Maryland
- Virtual Access: An electronic version of the poster will be accessible on the SITC 2025 virtual meeting platform
The poster will include a detailed analysis of clinical outcomes, safety, and immunologic activity observed in patients treated with imneskibart in combination with low-dose subcutaneous IL-2. These data are expected to provide important insights into the therapy’s ability to overcome resistance to prior checkpoint inhibitor treatments, which is a significant unmet need in both melanoma and NSCLC.
Checkpoint Inhibitor-Refractory Cancers: A High Unmet Need
Checkpoint inhibitors, including anti-PD-1, anti-PD-L1, and anti-CTLA-4 antibodies, have transformed the treatment landscape for melanoma and NSCLC, providing durable responses in a subset of patients. However, many patients either do not respond to these therapies initially (primary resistance) or experience disease progression after an initial response (acquired resistance). CPI-refractory patients face limited treatment options and generally have poor prognoses.
Imneskibart is being investigated specifically in this patient population to assess whether its unique immunomodulatory mechanism can reinvigorate anti-tumor immune responses in tumors that have become resistant to conventional checkpoint blockade. By targeting IL-2 while avoiding Treg activation, the therapy aims to preferentially stimulate cytotoxic T cells and NK cells, which are critical mediators of tumor regression.
Scientific Rationale for Imneskibart + Low-Dose IL-2 Combination
IL-2 has long been recognized for its ability to stimulate immune cell proliferation and activation, but its clinical use has been limited by severe toxicities and the simultaneous activation of immunosuppressive Tregs. Imneskibart’s selective binding to IL-2 and inhibition of CD25 interaction addresses these challenges by modulating the immune system in a way that favors anti-tumor activity while reducing adverse effects.
Preclinical studies have shown that imneskibart, when combined with low-dose IL-2, can enhance effector T cell and NK cell expansion, leading to improved tumor clearance in experimental models. Early clinical results have demonstrated promising signs of efficacy, including objective responses and disease stabilization, as well as a favorable safety and tolerability profile. The Phase 2 data to be presented at SITC will provide further clarity on these observations in a larger cohort of patients.
Company Mission and Focus
Aulos Bioscience is an immuno-oncology company focused on developing therapies that harness the body’s immune system to fight cancer more effectively. Its mission is to transform cancer care by advancing innovative treatments that not only extend survival but also improve the quality of life for patients with difficult-to-treat malignancies. By pursuing cutting-edge antibody-based therapies like imneskibart, Aulos aims to address significant unmet needs in oncology, particularly for patients who have limited options following standard-of-care treatments.
Participation at high-profile conferences like SITC is a key part of Aulos Bioscience’s strategy to engage with the broader scientific community, share important clinical insights, and foster collaborations that accelerate the development of new immunotherapies. The presentation of updated Phase 2 data for imneskibart represents a significant milestone in the company’s ongoing clinical program and underscores its commitment to delivering impactful therapies for patients with CPI-refractory melanoma and NSCLC.
