Aulos Bioscience Receives HREC Approval to Initiate First-in-Human Clinical Trial Evaluating Anti-Tumor Activity of Novel IL-2 Therapeutic AU-007

New data demonstrate eradication of solid tumors in preclinical study

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 it has obtained approval from the Monash Health Human Research Ethics Committee (HREC) to initiate a Phase 1/2, first-in-human trial of AU-007, a monoclonal antibody computationally designed by Biolojic Design. AU-007 leverages a highly differentiated approach to harnessing the power of interleukin-2 (IL-2) to eradicate solid tumors.

The Phase 1/2 study will be conducted in partnership with Monash Health, the largest public health service provider in Victoria, Australia. The study will evaluate the safety, tolerability and immunogenicity of AU-007 as a monotherapy and in combination with aldesleukin in patients with unresectable locally advanced or metastatic cancer. Aulos anticipates initiating enrollment and dosing in the first half of 2022, with preliminary data expected by year end.

“We are excited to move forward with the clinical development of AU-007 as a novel approach to treating cancers,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “New preclinical data show strong evidence of anti-cancer activity, including complete tumor elimination when dosed in combination with checkpoint inhibitors. These data provide further validation that AU-007 can tip the delicate balance toward immune activation and away from immune suppression without eliciting IL-2’s immunosuppressive and toxic effects, and we look forward to sharing the results in the future.”

Aulos will be attending the Gordon Research Conference “Antibody Biology and Engineering” meeting, being held March 13-18, 2022, in Ventura, California.

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 the body’s own 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’ own immune systems toward killing tumor cells. Matching world-class machine learning from founder and partner 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.

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