Aulos Bioscience Announces Presentation of Updated Safety and Efficacy Data From First-in-Human Phase 1/2 Clinical Trial of AU-007 at 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting

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 new safety and efficacy data from the 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 will be presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. 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. The SITC meeting is being held virtually and in San Diego, California, from November 1-5, 2023.

“Using artificial intelligence, AU-007 is designed to bind to IL-2 precisely instead of the IL-2 receptor. The result is a novel mechanism of action showing early promise in overcoming long-standing challenges for IL-2 therapies,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “As patient enrollment continues at multiple study locations in the United States and Australia, we look forward to presenting updated safety and efficacy data from the Phase 1 portion of the study at the SITC Annual Meeting.”

Details of the poster presentation are as follows:

Poster Title: A phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors: Interim results from dose escalation

Abstract: 717

Date and Time: Friday, November 3, 2023, 9:00 a.m.-7:00 p.m. PDT

The poster will be presented in the Poster Hall, Exhibit Halls A and B1 at the San Diego Convention Center. It will also be available as an ePoster on display on the SITC 2023 virtual meeting platform.

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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