Aulos Bioscience, an innovative immuno-oncology company focused on developing potentially groundbreaking IL-2 therapeutics to revolutionize cancer care, has announced the dosing of its first patient in a Phase 2 clinical trial. The trial evaluates the combination of AU-007, avelumab (a PD-L1 antibody), and low-dose subcutaneous aldesleukin for the second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC). This new Phase 2 cohort is part of Aulos’ ongoing Phase 1/2 clinical trial program and is being conducted in collaboration with Ares Trading S.A., a Swiss subsidiary of Merck KGaA, Darmstadt, Germany.
Aron Knickerbocker, President and CEO of Aulos Bioscience, expressed enthusiasm about moving forward with the combination therapy. “We are excited to evaluate this combination in a clinical setting, especially after seeing encouraging results in preclinical studies, which showed a significant synergy between AU-007 and avelumab, including the complete elimination of established solid tumors,” he said. “By combining avelumab’s unique mechanism with AU-007 and low-dose subcutaneous aldesleukin, we believe this therapy could offer a new treatment option for patients with advanced or metastatic PD-L1+ non-small cell lung cancer who have not responded to first-line checkpoint inhibitor therapy.”
Aulos had previously announced a collaboration with Ares Trading S.A. in May, which includes a supply agreement to use avelumab in combination with AU-007 and aldesleukin as part of the ongoing Phase 2 cohort. Avelumab, a human anti-PD-L1 antibody approved for use in a variety of cancers, is the only PD-L1 or PD-1 antibody that includes Fc effector function. This function allows avelumab to engage natural killer (NK) cells to induce antibody-dependent cellular cytotoxicity (ADCC), which helps kill tumor cells. Additionally, avelumab disrupts the PD-1/PD-L1 pathway, which typically inhibits T cell function, providing further immune system activation.
AU-007 is an exciting new therapeutic developed using artificial intelligence (AI) that is a human IgG1 monoclonal antibody designed to selectively target the CD25-binding region of IL-2. This novel approach is unlike any other IL-2 therapeutic currently in development. In preclinical studies, AU-007 demonstrated strong anti-cancer activity, including complete tumor eradication when combined with human interleukin-2 (hIL-2) and a surrogate of avelumab. These results highlight AU-007’s potential in cancer immunotherapy.
The ongoing Phase 1/2 trial of AU-007 is enrolling patients with unresectable locally advanced or metastatic cancer at several clinical sites across the United States and Australia. The early data from the trial, which was presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting earlier this month, showed encouraging results, including evidence of AU-007’s anti-tumor activity. Preliminary Phase 2 data indicate that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in melanoma. In addition, data from all 77 patients in the trial show that AU-007 led to durable reductions in regulatory T cells (Tregs), a promising outcome in the IL-2 class, and correlated with progression-free survival.
Looking ahead, Aulos plans to release further preliminary data from the Phase 2 cohort of the AU-007, avelumab, and aldesleukin combination for PD-L1+ NSCLC in the first half of 2025.
About AU-007
AU-007 is a highly selective human IgG1 monoclonal antibody developed through artificial intelligence. It targets the CD25-binding region of IL-2 to enhance anti-tumor immune responses while limiting the typical immunosuppressive effects seen with other IL-2-based treatments. AU-007 works by preventing IL-2—whether exogenous or produced by effector T cells—from binding to regulatory T cells, a critical step that allows the immune system to focus its activity on tumor-killing effector T cells and NK cells. This selective mechanism reduces the unwanted side effects commonly associated with high-dose IL-2 therapies, such as vascular leak syndrome and pulmonary edema.
About Aulos Bioscience
Aulos Bioscience is an immuno-oncology company dedicated to revolutionizing cancer care through the development of next-generation IL-2 therapeutics. By leveraging artificial intelligence and a deep understanding of immune system mechanisms, Aulos is creating therapies that effectively direct the immune system to target and destroy tumor cells while minimizing the harmful side effects typically seen in cancer immunotherapy. The company’s lead candidate, AU-007, is the first human antibody designed using AI that harnesses the power of IL-2 for tumor killing. Founded by Biolojic Design and Apple Tree Partners (ATP), Aulos is at the forefront of antibody development, cancer immunotherapies, and the application of AI in drug design.
