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    TEST:
    OncoSignature® Test

    Company:
    Acrivon Therap
    Type:
    Laboratory Developed Test
    4ms
    A phase II study of ACR-368 in patients with ovarian (OvCa) or endometrial carcinoma (EnCa) and prospective validation of OncoSignature patient selection (NCT05548296) (ESMO 2024)
    BM-negative pts (Arm 2) received ACR-368 at RP2D with ultra-low dose of gemcitabine (ULDG; 10 mg/m2). Initial clinical data from this prospective trial supports the clinical utility of the ACR-368-OncoSignature as a pts selection tool to identify OvCa and EnCa pts sensitive to ACR-368.
    P2 data • Clinical
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    OncoSignature® Test
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    gemcitabine • prexasertib (ACR-368)
    9ms
    Acrivon predictive precision proteomics (AP3) uncovers mechanism of resistance to ACR-368, a clinical-stage CHK1/2 inhibitor, and identifies rational combination treatment (AACR 2024)
    Here, we demonstrate the utility of AP3 for the identification of a key druggable resistance mechanism to ACR-368 and how to overcome that with low dose gemcitabine (gem), providing OncoSignature negative patients with a new potential therapeutic option. These data supported a dose escalation Phase 1b/2 clinical study of low dose gem with ACR-368 to evaluate the efficacy and safety of the combination in ACR-368 OncoSignature negative patients (NCT05548296). This shows the potential of AP3 for unbiased elucidation of actionable drug resistance mechanisms and rapid clinical implementation in our trials, which have recently confirmed clinical activity.
    Clinical
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    OncoSignature® Test
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    gemcitabine • prexasertib (ACR-368)
    12ms
    Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Ovarian Cancer (GlobeNewswire)
    "Acrivon Therapeutics, Inc...announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. The designation reflects FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions."
    FDA event
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    OncoSignature® Test
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    prexasertib (ACR-368)
    1year
    Validation of the OncoSignature assay, an ACR-368-tailored response-predictive quantitative multiplexed immunofluorescent assay for prediction of sensitivity to the CHK1/2 inhibitor ACR-368 in individual patients with cancerin individual. (AACR-NCI-EORTC 2023)
    No abstracts available
    Clinical
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    OncoSignature® Test
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    prexasertib (ACR-368)
    1year
    Identification of biomarkers predictive of sensitivity to the CHK1/2 inhibitor ACR-368 using highresolution phosphoproteomics and development of an ACR-368-tailored patient responder identification 3-marker test, ACR-368 OncoSignature. (AACR-NCI-EORTC 2023)
    No abstracts available
    Clinical
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    OncoSignature® Test
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    prexasertib (ACR-368)
    over1year
    CDK8 inhibition potentiates the efficacy of niraparib in homologous recombination proficient cancer cell lines (AACR 2023)
    RVU120, a first in-class CDK8/19 inhibitor in phase I clinical trial demonstrated preclinical efficacy in acute myeloid leukemia PDX models. The potential benefit of CDK8/19i+niraparib combination will be further explored in PARPi-resistant models. Molecular studies are underway to explore potential biomarkers associated with synergy response, and to analyze the downstream effects on DNA Damage Response.
    Preclinical • PARP Biomarker • BRCA Biomarker
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • CDK7 (Cyclin Dependent Kinase 7) • CDK9 (Cyclin Dependent Kinase 9)
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    BRCA wild-type
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    OncoSignature® Test
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    Zejula (niraparib) • RVU120
    over2years
    Akoya Biosciences to Partner with Acrivon Therapeutics for the Clinical Development of Acrivon’s Proprietary OncoSignature Test into a Companion Diagnostic (GlobeNewswire)
    "Akoya Biosciences, Inc...and Acrivon Therapeutics, Inc...announced an agreement to co-develop, validate, and commercialize Acrivon’s OncoSignature® test, a first-of-its-kind companion diagnostic....Akoya, in partnership with Acrivon, will develop, clinically validate, and seek regulatory co-approval for the OncoSignature® test, and, pending ACR-368 approval, commercialize the test as the exclusive provider of the companion diagnostic required for prescribing ACR-368."
    Licensing / partnership
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    OncoSignature® Test
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    prexasertib (ACR-368)