First U.S. Patient Dosed in Aulos Bioscience’s Phase 1/2 Clinical Trial of AU-007, a Novel IL-2 Therapeutic for the Treatment of Solid Tumors

Dosing marks first time a computationally designed monoclonal antibody enters human trial in the U.S.

U.S. enrollment begins in North Carolina, with additional sites being planned nationwide

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 that the first patient has been dosed in the United States in its Phase 1/2 clinical trial evaluating AU-007 for the treatment of solid tumors. AU-007 is a human monoclonal antibody computationally designed by Biolojic Design to harness the power of interleukin-2 (IL-2) and eradicate solid tumors.

“We’re pleased that our team has satisfied the FDA’s inquiries, enabling us to enroll and dose patients in the United States in our Phase 1/2 trial of AU-007,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “As the first computationally designed monoclonal antibody to enter a human clinical trial, AU-007 holds promise to become a potential new therapy for patients with advanced or metastatic solid tumor cancers. Based on early clinical data and strong preclinical data, it appears that AU-007 is safe and well tolerated to date. We thank the patients and clinical trial investigators who have chosen to participate in our study. We look forward to significantly expanding the number of trial sites in both the U.S. and Australia as well as presenting updated clinical data by year-end.”

The Phase 1/2 clinical trial of AU-007 is a single, global protocol currently enrolling patients at four site locations in Australia and one site in Huntersville, North Carolina. The open label, first-in-human study is evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Phase 1 consists of three dose escalation arms evaluating AU-007 either as a monotherapy, in combination with a single loading dose of recombinant human IL-2 (aldesleukin), or with both AU-007 and aldesleukin administered once every two weeks. The aldesleukin will be administered subcutaneously, at much lower doses and much less frequently than the approved regimen of intravenously administered aldesleukin. The Phase 2 portion of the trial will evaluate a dosing regimen selected from dose escalation for expansion in specified tumor types to further define the safety and initial efficacy of AU-007.

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