Aulos Bioscience, an immuno-oncology company focused on developing novel IL-2 therapeutics, announced today it will present promising new Phase 2 clinical data for its lead candidate AU-007 in the treatment of melanoma at the upcoming American Association for Cancer Research (AACR) Annual Meeting, scheduled for April 25-30, 2025, in Chicago.
The presentation will showcase results from the Phase 2 portion of the company's ongoing Phase 1/2 clinical trial, specifically highlighting AU-007's efficacy in second-line treatment of melanoma. AU-007 is a human IgG1 monoclonal antibody designed with artificial intelligence assistance to harness interleukin-2's (IL-2) anti-cancer properties while minimizing associated toxicities.
Novel Mechanism of Action
AU-007 represents a significant advancement in IL-2-based cancer immunotherapy with a mechanism unlike other IL-2 therapeutics currently in development. The antibody selectively binds to the CD25-binding portion of IL-2, effectively redirecting this cytokine to enhance anti-tumor immune responses.
Dr. Aron Knickerbocker, CEO of Aulos Bioscience, explained, "AU-007's innovative approach prevents IL-2 from binding to trimeric receptors on regulatory T cells while still allowing it to activate effector T cells and NK cells. This selective binding breaks the negative feedback loop that has limited the effectiveness of previous IL-2 therapies."
This mechanism biases the immune system toward activation rather than suppression, potentially offering a more effective approach to treating solid tumors. The antibody was designed using advanced artificial intelligence from co-founder Biolojic Design, combined with deep immunological expertise.
Reduced Toxicity Profile
A key advantage of AU-007 appears to be its improved safety profile compared to traditional high-dose IL-2 therapy, which has been limited by severe toxicities despite demonstrated efficacy in certain cancers.
"AU-007 prevents IL-2 from binding to CD25-containing receptors on eosinophils, vasculature, and pulmonary endothelium," noted a company spokesperson. "This may significantly reduce the vascular leak syndrome and pulmonary edema that have historically been associated with high-dose IL-2 treatment."
These safety improvements could potentially expand the patient population eligible for IL-2-based immunotherapy, which has traditionally been restricted to those healthy enough to tolerate significant toxicities.
Clinical Trial Details
The poster presentation at AACR will provide updated data from the Phase 2 portion of Aulos' Phase 1/2 clinical trial. The poster, titled "AU-007, a human monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, plus low-dose aldesleukin, in advanced solid tumors: Phase 2 update," will be presented on Tuesday, April 29, 2025, from 9:00 a.m. to 12:00 p.m. CDT in Poster Section 49 at McCormick Place.
The ongoing clinical trial (NCT05267626) is evaluating AU-007 in patients with unresectable locally advanced or metastatic solid tumors, with study sites in both the United States and Australia.
Melanoma Treatment Landscape
Melanoma represents a significant unmet medical need, particularly for patients who have progressed on first-line therapies. While immune checkpoint inhibitors have revolutionized melanoma treatment, many patients either don't respond or develop resistance to these therapies.
IL-2 has shown efficacy in melanoma historically, but its use has been limited by toxicity concerns. AU-007's approach of redirecting IL-2 activity could potentially provide a new option for these patients.
Company Background
Aulos Bioscience was founded through a collaboration between Biolojic Design and Apple Tree Partners (ATP). The company focuses on developing immunotherapies that leverage the power of IL-2 while overcoming the limitations that have historically restricted its use.
The company's approach combines artificial intelligence for antibody design with deep expertise in cancer immunotherapy, positioning Aulos at the intersection of computational biology and precision medicine.
For patients and healthcare providers interested in learning more about the AU-007 clinical trial program, information is available at ClinicalTrials.gov (identifier: NCT05267626) and through the study websites www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).
