On October 31, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AU-007, a monoclonal antibody computationally designed by Biolojic Design (Press release, Aulos Bioscience, OCT 31, 2022, View Source [SID1234622635]). AU-007 leverages a unique approach to harnessing the power of interleukin-2 (IL-2) to eradicate solid tumors. This is the first time that a computationally designed human monoclonal antibody has been cleared for human trials in the United States.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled to have received IND clearance to advance our AU-007 program and expand our Phase 1/2 clinical trial into the United States," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "Receiving IND clearance is a testament to the strength of the preclinical data and initial clinical data from Australia. AU-007’s mechanism of action is unique among all other IL-2 therapeutics in development, and we are excited to pursue the promise of AU-007 in solid tumor cancer care."

The company’s Phase 1/2 clinical trial (NCT05267626) is an open label, first-in-human study currently enrolling patients in Australia. The study is evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Initial safety results from the ongoing clinical trial will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held November 8-12, 2022, in Boston, Massachusetts.

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 T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector 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.