Interim Results From Phase 1/2 Clinical Trial in Solid Tumor Cancers Demonstrate Aulos Bioscience’s AU-007 is Well Tolerated and Uniquely Reduces Regulatory T Cells

New data in ASCO 2023 abstract show continued trend in decreasing Tregs and eosinophils, bolstering novel mechanism of action of AU-007, Aulos’ computationally designed antibody in the IL-2 class

Initial anti-tumor activity has been observed since the ASCO data cutoff date, with additional data anticipated by year-end as the Phase 1/2 trial continues to enroll patients

Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today shared interim results from an ongoing Phase 1/2 trial of AU-007, as detailed in the online publication of Abstract e14507 at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. The data indicate that AU-007 is well tolerated in patients with unresectable locally advanced or metastatic cancer. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors.

“These new interim data support our belief that AU-007 offers a novel mechanism of action among IL-2 therapeutics in development, as demonstrated by AU-007’s pharmacodynamic and safety profile to date,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “In addition, we are further encouraged that, since the data cutoff date, we are seeing early signs of anti-tumor activity in patients, which is consistent with preclinical findings that demonstrate AU-007’s unique ability to bind to IL-2 and redirect it from regulatory T cells, which suppress the immune system, to effector T cells and natural killer cells that can kill tumor cells. AU-007 is the only IL-2 therapy in development that precisely binds to IL-2 instead of the IL-2 receptor, and that turns an immunosuppressive negative feedback loop into a positive feedback loop. This gives AU-007 distinct mechanistic advantages as a potential new cancer therapeutic. As the study continues and we expand the number of trial sites in the United States and Australia, we look forward to presenting additional clinical data in the future.”

AU-007 is the first computationally designed human monoclonal antibody in a human clinical trial. Created by Biolojic Design, the antibody binds with exquisite precision to IL-2, preventing IL-2 from binding to the CD25 subunit contained in trimeric IL-2 receptors expressed on immunosuppressive regulatory T cells (Tregs), vascular and pulmonary endothelium, and eosinophils. While AU-007 prevents IL-2 from attaching to Tregs, it doesn’t affect IL-2’s ability to bind to dimeric IL-2 receptors expressed on effector T cells (Teff) and natural killer (NK) cells. This allows Teff and NK cells to expand and kill tumor cells.

The Phase 1/2 clinical trial of AU-007 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. Data shared in the ASCO abstract show that AU-007 at doses up to 4.5 mg/kg every two weeks is well tolerated in eight patients (as of the data cutoff date of February 1, 2023), with no dose-limiting toxicities and all treatment-related adverse events mild (Grade 1). Three of the four tumor evaluable patients had a best response of stable disease, and two patients continue treatment as of the data cutoff date.

In addition, all seven patients with available pharmacodynamic data demonstrate overall decreasing Tregs (percentage change and absolute) and eosinophils. This finding is in stark contrast to data from other IL-2 therapeutics, which show increases in Tregs that cannot be controlled and may result in immune suppression instead of activation. Initial pharmacokinetic data (0.5 and 1.5 mg/kg) from the AU-007 trial also demonstrate continued dose proportional serum concentrations of the compound, with characteristics similar to IgG1 therapeutic human monoclonal antibodies. This indicates the antibody is behaving predictably and has a half-life that will allow for dosing every two weeks.

The Phase 1/2 trial of AU-007 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. The trial is currently enrolling patients at multiple site locations in the U.S. and Australia.

To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

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 effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells 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, Twitter (@AulosBioscience) and LinkedIn.

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