Aulos Bioscience Enters Into Clinical Trial Collaboration and Supply Agreement With Merck KGaA, Darmstadt, Germany To Study Combination of Bavencio® With AU-007

Combination of novel IL-2 therapeutic AU-007, Bavencio® (avelumab) and aldesleukin in Phase 2 cohort of AU-007 clinical trial to build on compelling preclinical evidence of eradication of solid tumors

Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today announced a new collaboration and supply agreement with Ares Trading S.A., a Swiss subsidiary of Merck KGaA, Darmstadt, Germany, for use of Bavencio® (avelumab) in a clinical study of its lead human monoclonal antibody candidate, AU-007. Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will provide Aulos with a free supply of Bavencio to evaluate in combination with AU-007 and low-dose, subcutaneous aldesleukin in an additional Phase 2 cohort of Aulos’ Phase 1/2 clinical trial of AU-007 in solid tumor cancers. Bavencio is a human anti-programmed death ligand-1 (PD-L1) antibody approved for use in multiple clinical indications.

“We are excited to embark on this clinical trial collaboration with Merck KGaA, Darmstadt, Germany, which will enable our team to further investigate AU-007 in tandem with an anti-PD-L1 antibody, based on positive preclinical results,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “We believe Bavencio may offer distinct mechanistic synergy with AU-007 when compared to other immune checkpoint inhibitors because it is the only approved anti-PD-L1 antibody that has effector function and engages natural killer cells to kill tumor cells by a process known as ADCC, while also interrupting the PD-L1/PD-1 checkpoint that inhibits effector T cells. This unique profile of Bavencio, along with the ability of AU-007 and aldesleukin to accelerate the activation and expansion of effector T cells and natural killer cells, holds promise for creating a powerful combination therapeutic regimen that may eradicate tumor cells in multiple cancer types.”

AU-007 is the first human IgG1 monoclonal antibody designed using 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 in combination with a single loading dose of human interleukin-2 (hIL-2) and an anti-PD-L1 surrogate of avelumab.

A Phase 1/2 study is currently evaluating AU-007 and is enrolling patients with unresectable locally advanced or metastatic cancer at multiple clinical trial site locations in the United States and Australia. Interim data from the Phase 1 portion of the study indicate that AU-007 is the only IL-2 therapy ever to demonstrate an overall trend in decreasing regulatory T cells (Tregs) and eosinophils, with encouraging early signs of anti-tumor activity.

Aulos plans to present additional Phase 1 data and preliminary Phase 2 data, with a focus on melanoma and renal cell carcinoma, at an upcoming medical conference. The company anticipates commencing patient enrollment in the Phase 2 cohort studying Bavencio with AU-007 and aldesleukin in the second half of 2024.

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody 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 leverages 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 computationally designed human antibody 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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