On August 1, 2023 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported $20 million in Series A extension funding committed by Apple Tree Partners (ATP) (Press release, Aulos Bioscience, AUG 1, 2023, View Source [SID1234633575]). 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.
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"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) (Free ASCO Whitepaper) 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).