Aulos Bioscience Announces FDA Clearance of IND Application for AU-007, a Novel Immunotherapy for the Treatment of Solid Tumors

AU-007 represents the company’s first program to receive IND clearance

Expansion of Phase 1/2 clinical study into the U.S. marks major milestone for first-ever human trial of a computationally designed human monoclonal antibody for cancer treatment

LARKSPUR, Calif.--(BUSINESS WIRE)--Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today announced 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. 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.

“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) 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.

About Aulos

Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through best-in-class IL-2 therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a computationally designed human antibody that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and ATP with $40 million in Series A funding from ATP and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulosbio.com.