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Aulos Bioscience Initiates Phase 1/2 Clinical Trial of IL-2 Therapeutic AU-007 for the Treatment of Solid Tumors

Clinical program advancement represents key milestone for Aulos as a clinical-stage company and AU-007’s potential as a novel cancer treatment

Excerpt from the Press Release:

LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today announced it has dosed the first patient in a Phase 1/2 clinical trial of AU-007 for the treatment of solid tumors. 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.

“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.

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