Aulos Bioscience Presents Poster on Phase 1/2 Clinical Trial of Computationally Designed IL-2 Antibody AU-007 at 2022 ASCO Annual Meeting

27 May 2022
ASCOClinical ResultCollaborateAntibodyImmunotherapy
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 shared a Trials in Progress poster that is being presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting. The poster showcases the study design for the company’s first-in-human Phase 1/2 trial of AU-007 that is currently enrolling patients in Australia. AU-007 is a human monoclonal antibody computationally designed by Biolojic Design, with a highly differentiated approach to harnessing the power of interleukin-2 (IL-2)IL-2) to eradicate solid tumors.
“AAU-007stands apart with a mechanism of action that is entirely different from every other IIL-2therapeutic in development,” said Aron Knickerbocker, AAulos Biosciences chief executive officer. “This Phase 1/2 study is the first time that a computationally designed human monoclonal antibody has been tested in humans. By addressing the IIL-2negative feedback loop, we believe AAU-007could potentially subdue immune suppression and prevent the toxic side effects of IIL-2 leading to a novel treatment for ssolid tumor cancers
The Trials in Progress poster describes how AAU-007can bind human IIL-2with picomolar affinity and precisely block IIL-2s binding to CD25, without hindering IIL-2s binding to CCD132CCD122 Through this unique mechanism of action, AAU-007can transform the IIL-2negative feedback loop into a positive one, tipping the balance toward immune activation and away from immune suppression. Recently released preclinical data of murine models demonstrate that redirected IIL-2signaling by AAU-007can lead to significant ttumorgrowth inhibition, and complete MMC38 colorectal tumorelimination when AAU-007is dosed in combination with checkpoint inhibitors.
The company’s Phase 1/2 trial (NCT05267626) is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AAU-007in patients with unresectable locally advanced or metastatic cancer. Phase 1 consists of three dose escalation arms evaluating AAU-007either as a monotherapy, in combination with a single loading dose of aaldesleukin or with both AAU-007and aaldesleukinadministered once every two weeks. The Phase 2 portion of the trial evaluates a dosing regimen selected from dose escalation for expansion in specified ttumortypes to further define the safety and initial efficacy of AAU-007 Dosing of patients commenced in May, and preliminary data from the Phase 1 portion of the clinical trial is expected by late 2022.
The Trials in Progress poster is available to meeting registrants as an e-poster on the ASCO Annual Meeting website and will be presented live in the Trials in Progress poster session “Developmental Therapeutics—Immunotherapy” on Sunday, June 5, 2022, 8:00 a.m. to 11:00 a.m. CDT.
About AAU-007
AAU-007is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IIL-2 With a mechanism of action unlike any other IIL-2therapeutic in development, AAU-007leverages IIL-2to reinforce anti-ttumorimmune effects. This is achieved by preventing IIL-2 either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IIL-2to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IIL-2based treatments and biases the immune system toward activation over suppression. AAU-007also prevents IIL-2from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and ppulmonary edemaassociated with high-dose IIL-2therapy.
About AAulos
AAulos Bioscienceis an immuno-oncology company working to revolutionize ccancerpatient care through best-in-class IIL-2therapeutics that direct patients’ immune systems toward killing ttumorcells. Matching world-class machine learning from co-founder BBiolojic Designwith an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AAU-007 is a computationally designed human antibody that harnesses the power of IIL-2to induce ttumorkilling while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by BBiolojic Designand ATP with $40 million in Series A funding from ATP and is led by pioneers in the field of artificial intelligence, antibody development and ccancerimmunotherapies. For more information, visit www.aulosbio.com.<br>
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