eClinical Technology and Industy News

First Patient Dosed in Phase 2 Portion of Aulos Bioscience’s Phase 1/2 Clinical Trial for AU-007, a Computationally Designed IL-2 Antibody for Solid Tumor Cancers

Preliminary Phase 2 data in melanoma, renal cell carcinoma anticipated to be presented by mid-2024

Excerpt from the Press Release:

LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of best-in-class IL-2 therapeutics, today announced dosing of the first patient in the initial Phase 2 expansion cohorts of its Phase 1/2 clinical trial evaluating AU-007 for treatment of unresectable locally advanced or metastatic cancers. AU-007 is a human IgG1 monoclonal antibody designed to harness the power of interleukin-2 (IL-2) to eradicate solid tumors, and the first AI-designed human monoclonal antibody to be tested in a clinical trial. Phase 1 data demonstrate that AU-007 is currently the only IL-2 agent that can reduce regulatory T cells (Tregs), which suppress the immune system.

“Dosing of the first patient in the Phase 2 portion of our AU-007 Phase 1/2 study marks a significant milestone as we advance development of this promising, novel IL-2 therapeutic for the treatment of solid tumor cancers,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “AU-007 was created to solve pressing safety and efficacy challenges associated with IL-2 therapeutics, and we are encouraged by ongoing new Phase 1 data that indicate clinical activity in several heavily pre-treated patients whose tumors progressed through checkpoint inhibitors. We are grateful to the participating patients and investigators in this clinical trial, and look forward to enrolling additional patients and presenting clinical data from the Phase 2 expansion cohorts later this year.”

Aulos’ Phase 1/2 clinical trial is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. The initial Phase 2 expansion cohorts focus on melanoma and renal cell carcinoma (RCC), with AU-007 administered every two weeks in combination with a single loading dose of low-dose, subcutaneous Proleukin® (aldesleukin; recombinant human IL-2), or with AU-007 and low-dose, subcutaneous Proleukin, both administered every two weeks.

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