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.

About AU-007

AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either 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 prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

About Aulos

Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through best-in-class IL-2 therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners (ATP) and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulosbio.com, X (@AulosBioscience) and LinkedIn.

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