Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today announced the presentation of encouraging pharmacodynamic data from the ongoing Phase 1 dose escalation portion of its Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers. The new data will be featured at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 11-15, 2023, in Boston, Massachusetts.

“The Phase 1 dose escalation data for our lead candidate, AU-007, builds upon the favorable safety profile data shared during ASCO earlier this year,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “We’re extremely encouraged by these latest data. In assessing the biological activity of AU-007 alone or with low dose, subcutaneous aldesleukin in patients with advanced solid tumor cancers, data show a reduction in the circulating cell counts of patients’ regulatory T cells, which suppress the immune system, as well as eosinophils, which at high cell counts can be associated with toxicity in the lungs. At the same time, the data demonstrate an overall trend in increasing natural killer cells and effector T cells that can kill tumor cells. These insights underscore that AU-007, the first human monoclonal antibody designed using artificial intelligence to be tested in a clinical trial, has a unique mechanism of action that enables it to bind to IL-2, rather than IL-2 receptors, with exquisite precision. Our new data confirm that by binding only to the portion of IL-2 that binds to CD25, AU-007 accurately redirects IL-2 away from high-affinity IL-2 receptors on immunosuppressive regulatory T cells and eosinophils to medium-affinity receptors on natural killer cells and effector T cells. No other IL-2 therapy in development exhibits these capabilities. We look forward to presenting further details at the AACR-NCI-EORTC International Conference.”

Details of the poster presentation are as follows:

Poster Number and Title: C033: Preliminary pharmacodynamic evaluation of AU-007 in phase 1 dose escalation trial in patients with advanced solid tumors

Abstract: 35393

Session: Poster Session C

Session Date and Time: Saturday, October 14, 2023, 12:30-4:00 p.m. EDT

The poster will be presented in Level 2, Exhibit Hall D at the John B. Hynes Veterans Memorial Convention Center (Hynes Convention Center).

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.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

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, and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulosbio.com, X (Twitter) at @AulosBioscience and LinkedIn.

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