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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

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.”

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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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“In low doses, IL-2 is an immune suppressant and at high levels, it is toxic. With AU-007, we are seeking to overcome these challenges through precision routing of IL-2 while producing an anti-cancer effect,” said Jim Vasselli, M.D., Aulos Bioscience’s chief medical officer. “The unique profile we’ve seen so far with AU-007 gives it an advantage over all other IL-2 therapies currently in development. Through artificial intelligence, AU-007 has been designed to redirect IL-2 away from immunosuppressive Tregs and the vasculature and toward T effector and NK cells. By binding to IL-2 and not the IL-2 receptor, AU-007 has shown promising preclinical and initial clinical evidence that it can break the negative feedback loop to Tregs.”

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Early clinical data from the Phase 1/2 study were presented at the 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting in November. The data showed an overall trend toward decreasing Tregs, which is consistent with data findings in preclinical studies – and completely unlike data reported from other IL-2 therapeutics, which demonstrate substantial increases in T regulatory cells (Tregs) due to the negative feedback loop induced by IL-2 produced endogenously by activated T cells. Additionally, initial pharmacokinetic data from the first three patients administered AU-007 as a monotherapy demonstrate characteristics similar to other IgG1 therapeutic human monoclonal antibodies.

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