Phase 2 study follows on positive Phase 1 data showing early anti-tumor activity in heavily pre-treated patients and well-tolerated safety profile

Phase 2 portion to assess AU-007 in combination with low-dose Proleukin®, with initial expansion cohorts planned in melanoma and renal cell carcinoma

Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of best-in-class IL-2 therapeutics, today announced plans to initiate the Phase 2 portion of its Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers of the skin and kidney. 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.

“We are very pleased with the safety profile of AU-007 when paired with low-dose Proleukin based on clinical results to date, and we are thrilled to take the AU-007 program to the next stage in its clinical development,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “Since our last data cutoff date of October 13, 2023 (data presented at SITC), new data indicate clinical activity in several patients, including disease control and objective response results. This is encouraging as the anti-tumor activity has been observed in heavily pre-treated patients whose tumors had progressed through checkpoint inhibitors. We look forward to the Phase 2 portion of this study and presenting clinical data from the expansion cohorts next year.”

Aulos’ Phase 1/2 clinical trial 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. The trial is currently enrolling patients at multiple locations in the United States and Australia.

The first Phase 2 expansion cohorts will focus on melanoma and renal cell carcinoma (RCC). These Phase 2 cohorts will evaluate AU-007 in combination with a single loading dose of low-dose, subcutaneous Proleukin (aldesleukin; recombinant human IL-2), or with AU-007 and low-dose, subcutaneous Proleukin administered every two weeks.

Clinical data from the Phase 1/2 study were presented at the 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting in November. The Phase 1 dose escalation cohort data indicated that AU-007 is well tolerated as a monotherapy treatment or in a combination therapy regimen with low-dose, subcutaneous Proleukin, with no pulmonary or generalized edema, vasculature leakage or dose-limiting toxicity to date. Additionally, tumor shrinkage was observed in patients with melanoma, bladder, kidney and lung cancers.

Created by Biolojic Design, AU-007 is the first computationally designed monoclonal antibody to be tested in a clinical trial. The antibody was designed using artificial intelligence and has a mechanism of action that is completely unique in the IL-2 therapeutic space. AU-007 has the ability to bind precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on regulatory T cells (Tregs), vasculature, pulmonary tissue and eosinophils. This allows IL-2 to redirect to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells.

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 CD25-containing receptors on eosinophils, as well as 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 Apple Tree Partners (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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