Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, today announced dosing of the first patient with AU-007, avelumab, a PD-L1 antibody with Fc effector function, and low-dose, subcutaneous aldesleukin in a Phase 2 cohort focused on the second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC). The Phase 2 cohort is a clinical trial collaboration with Ares Trading S.A., a Swiss subsidiary of Merck KGaA, Darmstadt, Germany, and part of Aulos’ Phase 1/2 clinical trial of AU-007.

“We are excited to move forward with evaluating this combination therapy in a clinical setting after seeing encouraging synergy with AU-007 and a surrogate model of avelumab in preclinical studies including complete elimination of established solid tumors,” said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer. “Avelumab’s profile, coupled with AU-007 and low-dose, subcutaneous aldesleukin, could potentially offer a new therapeutic option for patients with advanced or metastatic PD-L1+ non-small cell lung cancer that has progressed following first-line therapy with a checkpoint inhibitor. We thank Merck KGaA, Darmstadt, Germany, the patients and the clinical trial investigators who have chosen to participate in this clinical trial.”

In May, Aulos announced a collaboration and supply agreement with Ares Trading S.A., a Swiss subsidiary of Merck KGaA, Darmstadt, Germany, for use of avelumab in combination with AU-007 and low-dose, subcutaneous aldesleukin in an additional Phase 2 cohort of the AU-007 Phase 1/2 clinical trial. Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody approved for use in multiple tumor types. Avelumab is the only approved PD-L1 or PD-1 antibody with Fc effector function, and has been shown in vitro to engage natural killer (NK) cells to kill tumor cells by a process known as antibody-dependent cellular cytotoxicity (ADCC), while also interrupting the PD-1/PD-L1 pathway that inhibits effector T cell (Teff) function.

AU-007 is the first human IgG1 monoclonal antibody designed by leveraging artificial intelligence to enter a human clinical trial. In preclinical studies, strong anti-cancer activity, including complete tumor eradications, was observed when AU-007 was dosed with a single loading dose of human interleukin-2 (hIL-2) and an anti-PD-L1 surrogate of avelumab.

The AU-007 Phase 1/2 study is currently enrolling patients with unresectable locally advanced or metastatic cancer at multiple clinical trial site locations in the United States and Australia. Positive Phase 1 and preliminary Phase 2 data presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting earlier this month shows evidence of AU-007’s anti-tumor activity. Preliminary Phase 2 data reveal that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in melanoma. Additionally, data from all 77 patients show durable Treg reduction – a compelling result in the IL-2 class – and correlated progression-free survival.

Aulos plans to share preliminary data from the Phase 2 cohort studying AU-007 with avelumab and low-dose, subcutaneous aldesleukin as a second-line treatment for PD-L1+ NSCLC in the first half of 2025.