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, 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.

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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.

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“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.

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