Phase 2 Initiation: Aulos Bioscience's AI-Designed IL-2 Antibody Trial for Solid Tumors

Aulos Bioscience, a company at the forefront of immuno-oncology, has reached a pivotal moment in its clinical trials for AU-007, a groundbreaking monoclonal antibody. The company has initiated dosing in the Phase 2 expansion of its Phase 1/2 study, which is aimed at patients suffering from inoperable or metastatic cancers. AU-007 is a novel therapeutic that employs the body's own interleukin-2 (IL-2) to target and eliminate solid tumors. Notably, it is the first AI-designed monoclonal antibody to undergo clinical testing, and it has shown the unique ability to reduce the number of regulatory T cells (Tregs) that typically dampen immune responses.
Aron Knickerbocker, CEO of Aulos Bioscience, has expressed optimism regarding the Phase 1 data, which have shown promising results in patients who have not responded to checkpoint inhibitors. The company is now preparing to enroll more patients and anticipates presenting Phase 2 data by mid-2024.
The Phase 1/2 trial is an open-label study that assesses the safety and efficacy of AU-007 in patients with advanced-stage cancer. The Phase 2 expansion is particularly focused on melanoma and renal cell carcinoma (RCC), with AU-007 being administered in combination with low-dose Proleukin® (aldesleukin; recombinant human IL-2). AU-007's innovative design, facilitated by Biolojic Design, allows it to bind to IL-2 in a way that prevents it from interacting with high-affinity receptors on Tregs and other cells, thereby redirecting it to medium-affinity receptors on effector T cells and NK cells to enhance their tumor-killing capabilities.
Clinical data from the Phase 1 dose escalation have demonstrated that AU-007, when used as a monotherapy or in combination with low doses of Proleukin, can decrease Tregs while increasing the number of effector T cells and NK cells. Moreover, AU-007 has shown good tolerability and has led to tumor reduction in patients with various types of cancer, including melanoma, bladder, kidney, head and neck, and lung.
For further information on the AU-007 clinical trial, interested parties can visit ClinicalTrials.gov with the identifier NCT05267626. In the United States, more details can be found at www.solidtumorstudy.com, while Australian patients and health professionals can refer to www.solidtumourstudy.com.
AU-007 is a computationally designed antibody that selectively targets the CD25-binding part of IL-2, enhancing anti-tumor immune responses by preventing IL-2 from binding to trimeric receptors on Tregs. This mechanism of action is distinct from other IL-2 therapeutics, as it avoids the negative feedback loop and minimizes the immunosuppressive and toxic effects often linked to high-dose IL-2 treatments.
Aulos Bioscience, founded by Biolojic Design and Apple Tree Partners (ATP), is dedicated to transforming cancer care with cutting-edge IL-2 therapeutics. The company combines advanced machine learning with deep immunological knowledge to develop therapies that direct the immune system to eliminate cancer cells. Aulos is led by experts in AI, antibody development, and cancer immunotherapy and is committed to advancing cancer treatment through innovative approaches.