Aulos Bioscience Shares Phase 2 Dose Data for IL-2 Antibody AU-007 at EORTC-NCI-AACR Symposium

Aulos Bioscience, an innovative immuno-oncology firm based in Larkspur, California, is making strides in cancer treatment through the development of potentially superior IL-2 therapeutics. The company recently shared critical data and analyses used to determine dose selection for Phase 2 expansion cohorts in a Phase 1/2 clinical trial of its leading candidate, AU-007. This data was presented at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain.

AU-007 shows promising results in reducing regulatory T cells (Tregs) and correlating deeper reductions in peripheral Treg counts with longer progression-free survival (PFS) outcomes in patients across various dose levels, tumor types, and lines of therapy. Additionally, with increasing doses of subcutaneously administered aldesleukin (recombinant human IL-2), there were observed increases in interferon-gamma and effector T cells (Teffs). These outcomes suggest that AU-007 can potentially deliver better clinical results compared to other IL-2 therapeutics in development.

Aron Knickerbocker, president and CEO of Aulos Bioscience, commented on the significance of these findings, highlighting AU-007's ability to enhance Teff and natural killer (NK) cell levels. He emphasized the mild and tolerable safety profile of AU-007, reinforcing the belief in its potential as a leading IL-2 therapeutic for solid tumor cancers. The company anticipates presenting new Phase 2 clinical efficacy and safety data, particularly focusing on melanoma and renal cell carcinoma, before the end of the year.

AU-007, developed by Biolojic Design, is the first human IgG1 monoclonal antibody designed using artificial intelligence (AI) to enter human clinical trials. Its novel mechanism of action involves binding specifically to IL-2, rather than IL-2 receptors. By targeting only the portion of IL-2 that binds to CD25, AU-007 prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, and eosinophils. Instead, it redirects IL-2 to medium-affinity receptors on Teffs and NK cells, facilitating their expansion and tumor cell destruction.

The safety profile of AU-007, presented at the EORTC-NCI-AACR Symposium, indicated manageable toxicity levels and the absence of vascular leak syndrome or pulmonary edema across all evaluated dose levels. The pharmacokinetic data for AU-007 demonstrated typical characteristics of an IgG1-LALA monoclonal antibody, with no evidence of neutralizing anti-drug antibody (ADA) activity and a half-life of over 15 days. Ongoing clinical investigations seek to determine the optimal dosing schedule for AU-007 in Phase 2 dose expansion cohorts, evaluating the efficacy of single and multiple loading doses of aldesleukin.

Researchers are currently assessing dosing regimens of 9 mg/kg for AU-007 every two weeks, paired with 135K IU/kg subcutaneous aldesleukin, administered either on a single loading dose schedule or a bi-weekly multiple dose schedule. The Phase 2 expansion portion of the trial is being conducted on patients with renal cell carcinoma, melanoma, and non-small cell lung cancer, testing these two dosing regimens.

The poster detailing these findings, titled "PB452: Determination of the phase 2 dose of AU-007, an AI-designed human monoclonal antibody that redirects IL-2 to T effector cells," was made available to attendees of the EORTC-NCI-AACR Symposium as an electronic poster. It was also presented live during the poster session focused on new therapies in immuno-oncology.

In summary, AU-007 represents a significant advancement in the field of IL-2 therapeutics, offering a unique approach to cancer treatment by enhancing effector T cell and NK cell activity while maintaining a manageable safety profile. Aulos Bioscience's ongoing research and upcoming data presentations are eagerly anticipated as the development of AU-007 progresses.