Aulos Bioscience has revealed new safety and efficacy data from the Phase I dose escalation portion of its Phase I/II clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumour cancers.
The data will be presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, being held in San Diego, California, from 1-5 November 2023.
“Using artificial intelligence, AU-007 is designed to bind to IL-2 precisely instead of the IL-2 receptor. The result is a novel mechanism of action showing early promise in overcoming long-standing challenges for IL-2 therapies,” said Aron Knickerbocker, Aulos Bioscience’s Chief Executive Officer.
In May 2023, the company reported early trial data which showed that, at that stage in the trial, three of the four tumour evaluable patients had a best response of stable disease.
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a novel mechanism of action, 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 oedema associated with high-dose IL-2 therapy.