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    DRUG:

    ORM-5029

    i
    Other names: ORM-5029
    Company:
    Orum Therap
    Drug class:
    HER2-targeted antibody-drug conjugate, HER3-targeted antibody-drug conjugate, GSPT1 degrader
    Related drugs:
    1m
    Study of ORM-5029 in Subjects with HER2-Expressing Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=87, Active, not recruiting, Orum Therapeutics USA, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    ORM-5029
    over1year
    A phase 1, first-in-human, open label, escalation and expansion study of ORM-5029, a highly potent GSPT1 degrader targeting HER2, in patients with HER2-expressing advanced solid tumors. (ASCO 2023)
    ORM-5029 is a first-in-class human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) comprised of SMol006, a highly potent GSPT1 degrader, conjugated to pertuzumab, a clinically validated antibody...ORM-5029 showed robust in vitro and in vivo efficacy in multiple HER2-expressing models with comparable activity to trastuzumab deruxtecan and strong activity in trastuzumab emtansine-refractory models...Escalation cohort 1 was completed without DLT; enrollment in cohort 2 began as of December 2022. Clinical trial information: NCT05511844.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • GSPT1 (G1 To S Phase Transition 1)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 expression
    |
    Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • ORM-5029
    almost2years
    Development of RNAscope multiplex-based assay for exploratory pharmacodynamic biomarkers assessment in breast cancer patients from Phase I clinical trial of ORM-5029, a potent GSPT1 degrader (AACR 2023)
    It delivers a highly potent and precise catalytic GSPT1 protein degrader molecule (SMol006) selectively to HER2-expressing tumor cells via conjugation to pertuzumab. The optimized protocol is currently being developed into RNAscope multiplex workflow using BT474 FFPE sections and tissue microarrays. In summary, RNAscope multiplex assay could be used as a method to determine pharmacodynamic response in HER2+ breast cancer patients treated with ORM-5029.
    Clinical • P1 data • PK/PD data
    |
    HER-2 (Human epidermal growth factor receptor 2) • GSPT1 (G1 To S Phase Transition 1) • DDIT3 (DNA-damage-inducible transcript 3) • ATF3 (Activating Transcription Factor 3)
    |
    HER-2 expression
    |
    Perjeta (pertuzumab) • ORM-5029
    2years
    Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=87, Recruiting, Orum Therapeutics USA, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    ORM-5029
    over2years
    Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=87, Not yet recruiting, Orum Therapeutics USA, Inc.
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    ORM-5029