^
    8ms
    CL1-65487-003: Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=57, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    azacitidine • S65487
    1year
    Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=60, Terminated, Institut de Recherches Internationales Servier | Completed --> Terminated; The study was prematurely terminated on 14th March 2023 for strategic considerations due to the limited efficacy seen with this treatment in monotherapy. This decision was not based on any safety concerns.
    Trial termination
    |
    S65487
    over1year
    VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma) (clinicaltrials.gov)
    P1, N=37, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons
    Trial termination • Combination therapy
    |
    MIK665 • S65487
    over1year
    CL1-65487-003: Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=57, Active, not recruiting, Institut de Recherches Internationales Servier | Recruiting --> Active, not recruiting | N=109 --> 57
    Enrollment closed • Enrollment change
    |
    azacitidine • S65487
    over1year
    CL1-65487-003: Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=109, Recruiting, Institut de Recherches Internationales Servier | Trial completion date: Jan 2026 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    azacitidine • S65487
    over1year
    Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=60, Completed, Institut de Recherches Internationales Servier | Active, not recruiting --> Completed | Trial completion date: Jul 2023 --> Nov 2023 | Trial primary completion date: Jul 2023 --> Nov 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    S65487
    almost2years
    VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma) (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial primary completion date • Combination therapy
    |
    MIK665 • S65487
    2years
    VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma) (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2023 --> Apr 2024
    Trial completion date • Combination therapy
    |
    MIK665 • S65487
    over2years
    VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma) (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2024 --> Dec 2023 | Trial primary completion date: Sep 2024 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    MIK665 • S65487
    over2years
    Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=83, Recruiting, Institut de Recherches Internationales Servier | N=62 --> 83 | Trial completion date: Jun 2025 --> Jan 2025 | Trial primary completion date: Jun 2025 --> Feb 2024
    Enrollment change • Trial completion date • Trial primary completion date
    |
    azacitidine • S65487
    over4years
    [VIRTUAL] Identification of S65487/VOB560 as a potent and selective intravenous 2nd-generation BCL-2 inhibitor active in wild-type and clinical mutants resistant to Venetoclax (AACR 2021)
    Strong and persistent tumor regression in xenograft models of lymphoid malignancies in mouse and rat were observed at well tolerated doses following weekly IV administration of S65487 in combination with the MCL-1-specific inhibitor, S64315/MIK665. Altogether, these data demonstrate that S65487/VOB560 has significant therapeutic potential against human lymphoid and myeloid malignancies as well as in patients with Venetoclax resistant leukemias. Clinical studies are currently ongoing with S65487/VOB560 (NCT03755154).
    Clinical • IO biomarker
    |
    BCL2L1 (BCL2-like 1)
    |
    BCL2 mutation • BCL2 G101V
    |
    Venclexta (venetoclax) • Bcl-2 Family Inhibitors • MIK665 • S65487