On May 5, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported it has dosed the first patient in a Phase 1/2 clinical trial of AU-007 for the treatment of solid tumors (Press release, Aulos Bioscience, MAY 5, 2022, View Source [SID1234613609]). AU-007 is a human monoclonal antibody computationally designed by Biolojic Design, with a highly differentiated approach to harnessing the power of interleukin-2 (IL-2) to eradicate solid tumors.

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"We are very pleased to begin patient dosing in our Phase 1/2 trial of AU-007, as it marks a significant milestone in our advancement to a clinical-stage company," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "This rapid progress speaks to the strength of our team at Aulos to collaborate efficiently and successfully move our first investigational therapy into the clinic. AU-007 has a mechanism of action completely distinct from anything ever tested in a human clinical trial, and we believe it addresses the key challenges associated with the therapeutic application of IL-2."

Currently approved therapy requires high doses of IL-2 that is associated with frequent and dangerous toxicities, including increased risk of pulmonary edema and capillary leakage. In preclinical studies, AU-007 has been shown to block IL-2 from binding to CD25 in trimeric receptors while preserving IL-2’s binding to dimeric CD122/CD132 receptors. This unique mechanism of action allows for anti-cancer activity from immune effector activation while preventing immunosuppressive T regulatory (Treg) cell expansion and vascular leakage driven by IL-2. Recently released preclinical data demonstrate significant tumor growth inhibition in murine models with AU-007, and complete MC38 colorectal tumor elimination when AU-007 is dosed in combination with checkpoint inhibitors.

The Phase 1/2 trial is a two-part, open label, first-in-human study currently enrolling patients in Australia. The study evaluates the safety, tolerability and immunogenicity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Phase 1 consists of three dose escalation arms that evaluate AU-007 either as a monotherapy, in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin administered once every two weeks. The Phase 2 portion of the trial evaluates a dosing regimen selected from dose escalation for expansion in specified tumor types to further define the safety and initial efficacy of AU-007. Initial data from the Phase 1 portion of the clinical trial is anticipated in late 2022.

To learn more about the clinical trial program, please visit ClinicalTrials.gov, using the identifier NCT05267626.

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 T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector 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 trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.