Aulos Bioscience is set to commence a Phase I/II clinical trial of its antibody, AU-007, for solid tumours following approval from the Monash Health Human Research Ethics Committee (HREC).

To be carried out in collaboration with Monash Health in Australia, the first-in-human trial will analyse the safety, tolerability and immunogenicity of AU-007 as a single agent and along with aldesleukin in unresectable locally advanced or metastatic cancer patients. 

The company plans to commence subject enrolment and dosing in the trial in the first half of this year while initial results are anticipated by the end of the year.

Biolojic Design computationally designed AU-007, the human immunoglobulin G1 (IgG1) monoclonal antibody that is selective to interleukin-2’s (IL-2) CD25-binding portion. 

As against various other IL-2 therapies being developed currently, AU-007 employs a well-differentiated method to use IL-2 of the body to boost anti-tumour immune effects. 

This is attained by averting exogenous or T effector cell-secreted IL-2 from attaching to trimeric receptors seen on T regulatory cells while permitting it to attach and expand T effector and NK cells. 

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By GlobalData

Aulos Bioscience CEO Aron Knickerbocker said: “New preclinical data show strong evidence of anti-cancer activity, including complete tumour 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.”

In November last year, the company reported preclinical data that back AU-007’s potential to specifically hinder attachment of IL-2 to CD25 and hinder the growth of tumours in various cancer models.