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    DRUG:

    imneskibart (AU-007)

    i
    Other names: AU-007
    Associations

    News

    Trials
    Company:
    Aulos Biosci
    Drug class:
    IL-2 stimulant, CD25 inhibitor
    Related drugs:
    Associations

    News

    Trials
    6ms
    Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
    P1/2, N=136, Recruiting, Aulos Bioscience, Inc. | Trial completion date: Jan 2025 --> Sep 2025 | Trial primary completion date: Oct 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Proleukin (aldesleukin) • imneskibart (AU-007)
    8ms
    Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
    P1/2, N=136, Recruiting, Aulos Bioscience, Inc. | N=69 --> 136 | Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Jul 2024 --> Oct 2024
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Proleukin (aldesleukin) • imneskibart (AU-007)
    1year
    A phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors: interim results from dose escalation (SITC 2023)
    Conclusions AU-007 +/- aldesleukin reduces serum Tregs and increases NK and CD8 cells, consistent with AU-007’s mechanism of action. The mild toxicity, pharmacodynamic and early objective efficacy findings in heavily pretreated patients warrant continued escalation of AU-007 +/- aldesleukin.
    Clinical • P1/2 data • Metastases
    |
    CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2) • FCGR2A (Fc fragment of IgG receptor IIa) • FCGR2B (Fc Fragment Of IgG Receptor IIb) • IL2RG (Interleukin 2 Receptor Subunit Gamma)
    |
    imneskibart (AU-007)
    over1year
    Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
    P1/2, N=69, Recruiting, Aulos Bioscience, Inc. | Trial completion date: Mar 2024 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Proleukin (aldesleukin) • imneskibart (AU-007)
    over1year
    A phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors: Interim results. (ASCO 2023)
    AU-007 monotherapy at doses up to 4.5 mg/kg Q2W is safe and well tolerated, with initial signs of immune modulation consistent with AU-007’s mechanism of action. These findings warrant continued escalation and combination with aldesleukin. Clinical trial information: NCT05267626.
    Clinical • P1/2 data • Metastases
    |
    IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2) • FCGR2A (Fc fragment of IgG receptor IIa) • FCGR2B (Fc Fragment Of IgG Receptor IIb)
    |
    imneskibart (AU-007)
    2years
    Initial results from dose escalation of a phase 1/2 first-in-human, open label study of AU-007, a monoclonal antibody that binds to IL-2 and prevents its binding to CD25, in patients with solid tumors (SITC 2022)
    Data from additional patients are expected to be presented in the poster. Trial Registration NCT05267626 Ethics Approval HREC: Monash Health Human Research Ethics Committee CT-2021-CTN-03938-1 All of the participants in this study gave informed consent before taking part in the study.
    Clinical • P1/2 data
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2) • FCGR2A (Fc fragment of IgG receptor IIa) • FCGR2B (Fc Fragment Of IgG Receptor IIb)
    |
    imneskibart (AU-007)
    over2years
    Trial in progress: A phase 1-2, first-in-human, open label, dose escalation and expansion study of AU-007, a monoclonal antibody that binds to IL-2 and inhibits IL-2Rα binding, in patients with advanced solid tumors. (ASCO 2022)
    Thus, AU-007 redirects endogenously produced or exogenous IL-2 (aldesleukin) towards activation of immune stimulating T effector and NK cells, while diminishing Treg activation and expansion. Patients with advanced melanoma, RCC and other tumors including, but not limited to, Merkel Cell Carcinoma, NSCLC, and urothelial cancer are eligible. Enrolment to the study commences in Australia, with US sites planned to open later in 2022.
    Clinical • P1/2 data
    |
    IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2) • FCGR2A (Fc fragment of IgG receptor IIa) • FCGR2B (Fc Fragment Of IgG Receptor IIb)
    |
    FCGR2B expression
    |
    Proleukin (aldesleukin) • imneskibart (AU-007)