Aulos Bioscience to Present Initial Safety Data From First-in-Human Phase 1/2 Clinical Trial of IL-2 Therapeutic AU-007 at 37th 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 initial safety data from patients who received monotherapy treatment in the Phase 1/2 trial of AU-007 will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. AU-007 is a monoclonal antibody computationally designed by Biolojic Design that is highly selective for the CD25-binding portion of interleukin-2 (IL-2). The SITC meeting is being held virtually and in Boston, Massachusetts, from November 8-12, 2022.

“As the first computationally designed human monoclonal antibody ever to enter a clinical trial, AU-007 offers a novel approach for treating solid tumor cancers by redirecting IL-2, tipping the balance toward immune activation and away from immune suppression and vascular leak,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “As we continue to enroll patients in the AU-007 Phase 1/2 study in Australia, we look forward to presenting initial safety results at the SITC Annual Meeting.”

Poster Title: Initial results from dose escalation of a phase 1/2 first-in-human, open label study of AU-007, a monoclonal antibody that binds to IL-2 and prevents its binding to CD25, in patients with solid tumors

Abstract: 775

Date and Time: Thursday, November 10, 2022, 9:00 a.m.-9:00 p.m. EST

Presenter: Jim Vasselli, M.D., Chief Medical Officer, Aulos Bioscience

The poster will be presented in the Poster Hall, Hall C at the Boston Convention and Exhibition Center. It will also be available as an ePoster on display on the SITC 2022 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 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.

Aulos is evaluating AU-007 in an open label, first-in-human Phase 1/2 clinical trial designed to assess the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. To learn more about the clinical trial program, visit ClinicalTrials.gov (NCT05267626).

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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