Funds from ATP will continue to sustain the progress of Aulos’ novel IL-2 therapeutic AU-007 through a Phase 2 trial in solid tumor cancers

The additional funding is substantiated by interim data from Aulos’ ongoing Phase 1/2 trial released during the 2023 ASCO Annual Meeting in which AU-007 demonstrated encouraging safety, pharmacodynamic trends of decreasing Tregs and eosinophils, and early positive signs of anti-tumor activity

Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today announced $20 million in Series A extension funding committed by Apple Tree Partners (ATP). The funds will be used to advance Aulos’ lead human monoclonal antibody candidate, AU-007, through its initial Phase 2 clinical study in solid tumor cancers.

“We are very pleased to strengthen this partnership with our visionary founders at ATP as we further develop AU-007, which has already demonstrated promising early clinical results in the treatment of solid tumors,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “This new funding underscores the potential of AU-007 and its unique mechanism of action, which prevents IL-2 from binding to Tregs, blood vessels and eosinophils while accurately redirecting IL-2 to activate cancer-killing effector T cells and NK cells. We look forward to establishing proof of concept and continuing development through the Phase 2 portion of the study.”

Today’s announced funding follows ATP’s initial $40 million Series A funding announced in January 2021, soon after Aulos was spun out from co-founder Biolojic Design, a biotechnology company in Israel specializing in artificial intelligence and computationally designed functional antibodies. Biolojic Design used its machine learning algorithms to create AU-007 to harness the power of interleukin-2 (IL-2) to eradicate solid tumors. AU-007 is the first human monoclonal antibody designed using artificial intelligence to have entered a human clinical trial.

The antibody is currently being evaluated in a Phase 1/2 clinical trial that is enrolling patients with unresectable locally advanced or metastatic cancer at multiple clinical trial site locations in the United States and Australia. Interim Phase 1/2 data released during the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting show that AU-007 is well tolerated in patients. Data also indicate that it is the only IL-2 therapy ever to demonstrate an overall trend in decreasing regulatory T cells (Tregs) and eosinophils, with encouraging early signs of anti-tumor activity.

“Our excitement in launching Aulos and our continued support of the company are rooted in the potential of AU-007, which offers distinct competitive advantages over other IL-2 therapies with its ability to bind to IL-2 instead of the IL-2 receptor,” said Michael Ehlers, M.D., Ph.D., chief scientific officer of ATP and a venture partner at the firm. “We like what we are seeing at this early stage of clinical development, and Aulos’ management team has extensive experience and a track record of success. We believe Aulos could potentially transform the IL-2 therapeutic class and current approaches to multiple cancers.”

The company anticipates transitioning to the Phase 2 portion of the AU-007 study in the fall as well as presenting updated clinical data by year-end.

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.

Aulos is advancing AU-007 through a Phase 1/2 study in solid tumor cancers. To learn more about the 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, Twitter (@AulosBioscience) and LinkedIn.

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