Aulos Bioscience Begins Phase 2 Trial of AU-007 with Nivolumab for Melanoma

On April 14, 2025, Aulos Bioscience, based in Larkspur, CA, USA, announced the dosing of the first patient in a new Phase 2 expansion cohort aimed at evaluating a promising cancer treatment approach for melanoma patients. The trial involves a combination of AU-007, the anti-PD-1 antibody nivolumab, and low-dose, subcutaneous aldesleukin. This cohort is part of Aulos' broader Phase 1/2 clinical trial focusing on patients with unresectable locally advanced or metastatic cancer.

Earlier preliminary data presented at the Society for Immunotherapy of Cancer's 39th Annual Meeting indicated that AU-007 combined with low-dose aldesleukin exhibits clinical activity in melanoma patients, achieving durable objective responses. This positive outcome has propelled the progression of the trial to include nivolumab in the treatment regimen.

Aron Knickerbocker, the president and CEO of Aulos Bioscience, expressed enthusiasm for the commencement of this new Phase 2 cohort. He highlighted AU-007's unique mechanism and the encouraging data already obtained, suggesting that AU-007 has significant potential as an innovative immuno-oncology treatment across various cancer types. In addition to melanoma, the company has initiated a Phase 2 cohort targeting non-small cell lung cancer in combination with the anti-PD-L1 antibody avelumab.

AU-007 distinguishes itself as the first human monoclonal antibody designed with the aid of artificial intelligence to enter human clinical trials. It operates by targeting interleukin-2 (IL-2) and binding specifically to the part of IL-2 that interacts with CD25. This prevents IL-2 from attaching to high-affinity IL-2 receptors found on regulatory T cells, vasculature, pulmonary tissue, and eosinophils. Instead, IL-2 is redirected to medium-affinity receptors on effector T cells and natural killer cells, which are essential for expanding and destroying tumor cells.

Aulos plans to present preliminary data from the Phase 2 cohort of AU-007, nivolumab, and low-dose aldesleukin as a second-line treatment for melanoma in the latter half of 2025. Furthermore, new data will be showcased at the American Association for Cancer Research Annual Meeting, focusing on AU-007 and low-dose aldesleukin without a checkpoint inhibitor for melanoma.

AU-007 is a human IgG1 monoclonal antibody, meticulously designed through artificial intelligence to target the CD25-binding portion of IL-2. This unique mechanism redirects IL-2 to bolster anti-tumor immune responses by preventing IL-2 from interacting with trimeric receptors on regulatory T cells, thus avoiding a negative feedback loop common in other IL-2 therapies. It also prevents IL-2 from binding to CD25-containing receptors on eosinophils, vascular, and pulmonary endothelium, potentially mitigating the side effects such as vascular leak syndrome and pulmonary edema associated with high-dose IL-2 treatments.

Aulos Bioscience is committed to advancing cancer care through immune-activating antibody therapeutics, directing patients' immune systems to eradicate tumor cells. Founded by Biolojic Design and Apple Tree Partners, Aulos leverages state-of-the-art machine learning in conjunction with a profound understanding of the immune system. Its first clinical candidate, AU-007, is designed to enhance tumor destruction while minimizing the immunosuppression and side effects typically linked with the IL-2 pathway. The leadership team comprises pioneers in artificial intelligence, antibody development, and cancer immunotherapy.