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    DRUG:

    cusatuzumab (ARGX-110)

    i
    Other names: ARGX-110, ARGX 110, JNJ‑74494550, JNJ-4550, OV-1001
    Company:
    OncoVerity, argenx
    Drug class:
    CD70 inhibitor
    Related drugs:
    13d
    OV-AML-1231: A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy (clinicaltrials.gov)
    P2, N=120, Active, not recruiting, OncoVerity, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD4 (CD4 Molecule)
    |
    Venclexta (venetoclax) • azacitidine • cusatuzumab (ARGX-110)
    14d
    CD70/CD27 signaling promotes the pathogenesis of multiple myeloma and represents a promising therapeutic target. (PubMed, Leukemia)
    Furthermore, the ADCC-enhanced anti-CD70 antibody, cusatuzumab, demonstrated high efficacy in treating myeloma in xenotransplantation models. Collectively, these findings underscore the critical role of CD70/CD27 signaling in activating MAPK/ERK and Wnt pathways essential for MM progression. Targeting CD70 with blocking or ADCC-enhanced antibodies represents a promising therapeutic strategy, particularly for advanced MM stages characterized by high CD70 expression.
    Journal • IO biomarker
    |
    CD70 (CD70 Molecule) • CD27 (CD27 Molecule)
    |
    cusatuzumab (ARGX-110)
    16d
    CULMINATE: A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy (clinicaltrials.gov)
    P2, N=103, Completed, OncoVerity, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    azacitidine • cusatuzumab (ARGX-110)
    8ms
    CULMINATE: A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy (clinicaltrials.gov)
    P2, N=103, Active, not recruiting, OncoVerity, Inc. | Trial completion date: Aug 2025 --> May 2026
    Trial completion date
    |
    azacitidine • cusatuzumab (ARGX-110)
    12ms
    ELEVATE: Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=61, Active, not recruiting, OncoVerity, Inc. | Trial completion date: May 2025 --> May 2026 | Trial primary completion date: May 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • cusatuzumab (ARGX-110)
    1year
    CULMINATE: A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy (clinicaltrials.gov)
    P2, N=103, Active, not recruiting, OncoVerity, Inc. | Trial completion date: Aug 2024 --> Aug 2025
    Trial completion date
    |
    azacitidine • cusatuzumab (ARGX-110)
    over1year
    CULMINATE: A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy (clinicaltrials.gov)
    P2, N=103, Active, not recruiting, OncoVerity, Inc. | Trial completion date: Aug 2023 --> Aug 2024
    Trial completion date
    |
    azacitidine • cusatuzumab (ARGX-110)
    over1year
    A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy (clinicaltrials.gov)
    P2, N=120, Recruiting, OncoVerity, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Venclexta (venetoclax) • azacitidine • cusatuzumab (ARGX-110)
    over1year
    ELEVATE: Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=61, Active, not recruiting, OncoVerity, Inc. | Phase classification: P1b --> P1 | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
    Phase classification • Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • cusatuzumab (ARGX-110)
    almost2years
    A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, OncoVerity, Inc.
    New P2 trial
    |
    Venclexta (venetoclax) • azacitidine • cusatuzumab (ARGX-110)
    over2years
    Monoclonal Antibodies Targeting LIGHT Block Ltbr Signalling and Eliminate Acute Myeloid Leukemia Stem Cells (ASH 2023)
    We recently documented that targeting CD70, the ligand of the tumor necrosis factor receptor (TNFR) CD27, by the antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced monoclonal antibody (mAb) cusatuzumab eliminates LSC...Our findings reveal that LIGHT/LTbR-signalling is crucial for the pathogenesis of AML and especially for the maintenance and expansion of LSCs. We developed and validated novel LIGHT targeting mAbs in vitro and in vivo for further development in clinical trials.
    IO biomarker
    |
    TNFA (Tumor Necrosis Factor-Alpha) • CD70 (CD70 Molecule) • CD34 (CD34 molecule) • CD27 (CD27 Molecule) • LTBR (Lymphotoxin Beta Receptor)
    |
    cusatuzumab (ARGX-110)
    over2years
    Histopathological Markers for Target Therapies in Primary Cutaneous Lymphomas. (PubMed, Cells)
    Moreover, anti-PD1 (nivolumab), anti-PDL1 (pembrolizumab, atezolizumab), anti-CD52 (alemtuzumab), anti-KIR3DL2-CD158k (lacutamab), and anti-CD70 (cusatuzumab) have been tested or are under investigations in phase II trials. In recent years, targeted (biological) therapies have become available also for primary cutaneous T-cell lymphomas (PCTCLs) including anti-CD30 (brentuximab vedotin) in mycosis fungoides, primary cutaneous anaplastic large T-cell lymphoma, lymphomatoid papulosis; anti-CCR4 (mogamulizumab) in Sezary syndrome; anti-CD123 (tagraxofusp) in blastic plasmocytoid cell neoplasm. The expression of these epitopes on neoplastic cells in skin biopsies or blood samples plays a central role in the management of PCTCL patients. This narrative review aims to provide readers with an update on the latest advances in the newest therapeutic options for PCTCLs.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • CCR4 (C-C Motif Chemokine Receptor 4) • CD70 (CD70 Molecule) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Adcetris (brentuximab vedotin) • Campath (alemtuzumab) • Poteligeo (mogamulizumab-kpkc) • Elzonris (tagraxofusp-erzs) • cusatuzumab (ARGX-110) • lacutamab (IPH4102)