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

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.

“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.”

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.

To learn more about the clinical trial program, including study locations in the U.S. and Australia, please visit ClinicalTrials.gov (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.

About Aulos

Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through best-in-class IL-2 therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a computationally designed human antibody that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and ATP with $40 million in Series A funding from ATP and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulosbio.com.

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