First Patient Dosed in Phase 2 Portion of Aulos Bioscience’s Phase 1/2 Clinical Trial for AU-007, a Computationally Designed IL-2 Antibody for Solid Tumor Cancers

Preliminary Phase 2 data in melanoma, renal cell carcinoma anticipated to be presented by mid-2024

Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of best-in-class IL-2 therapeutics, today announced dosing of the first patient in the initial Phase 2 expansion cohorts of its Phase 1/2 clinical trial evaluating AU-007 for treatment of unresectable locally advanced or metastatic cancers. AU-007 is a human IgG1 monoclonal antibody designed to harness the power of interleukin-2 (IL-2) to eradicate solid tumors, and the first AI-designed human monoclonal antibody to be tested in a clinical trial. Phase 1 data demonstrate that AU-007 is currently the only IL-2 agent that can reduce regulatory T cells (Tregs), which suppress the immune system.

“Dosing of the first patient in the Phase 2 portion of our AU-007 Phase 1/2 study marks a significant milestone as we advance development of this promising, novel IL-2 therapeutic for the treatment of solid tumor cancers,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “AU-007 was created to solve pressing safety and efficacy challenges associated with IL-2 therapeutics, and we are encouraged by ongoing new Phase 1 data that indicate clinical activity in several heavily pre-treated patients whose tumors progressed through checkpoint inhibitors. We are grateful to the participating patients and investigators in this clinical trial, and look forward to enrolling additional patients and presenting clinical data from the Phase 2 expansion cohorts later this 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 initial Phase 2 expansion cohorts focus on melanoma and renal cell carcinoma (RCC), with AU-007 administered every two weeks 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, both administered every two weeks.

Created by Biolojic Design, AU-007’s unique computational design allows it 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 Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Phase 1 dose escalation cohort data presented at two separate medical meetings last fall demonstrate that when AU-007 is administered to patients as monotherapy or in combination with low doses of Proleukin, the number of immunosuppressive Tregs decreases and the numbers of Teffs and NK cells increase. Additionally, data indicate that AU-007 is well tolerated and tumor shrinkage was observed in patients with melanoma, bladder, kidney, head and neck, and lung cancers.

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 (@AulosBioscience) and LinkedIn.

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