On May 15, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported 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 (Press release, , MAY 15, 2024, View Source [SID1234643315]). 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.
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"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).