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    DRUG:

    pamlectabart tismanitin (HDP-101)

    i
    Other names: HDP-101, HDP101, HDP 101, HDP-101-ATAC
    Company:
    Heidelberg Pharma, Huadong Medicine
    Drug class:
    RNA polymerase 2 inhibitor, BCMA-targeted antibody-drug conjugate
    Related drugs:
    5ms
    HDP-101-01: Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=78, Recruiting, Heidelberg Pharma AG | Trial completion date: May 2025 --> May 2026 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date
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    pamlectabart tismanitin (HDP-101)
    1year
    Hdp-101, an Anti-BCMA Antibody-Drug Conjugate with a Novel Payload Amanitin in Patients with Relapsed Multiple Myeloma, Initial Findings of the First in Human Study (ASH 2023)
    Currently the study is enrolling patients in Cohort #4 at the dose of 80μg/Kg. Additional updates will be provided at the 2023 ASH Annual Meeting.
    Clinical • P1 data
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    SDC1 (Syndecan 1)
    |
    pamlectabart tismanitin (HDP-101)
    2years
    Hdp-101, an Anti-BCMA Antibody-Drug Conjugate with a Novel Payload Amanitin in Patients with Relapsed Multiple Myeloma, Initial Findings of the First in Human Study (ASH 2022)
    The study continues to enroll patient to higher dose cohorts. An updated dataset will be presented at the ASH2022 meeting.
    Clinical • P1 data
    |
    SDC1 (Syndecan 1)
    |
    pamlectabart tismanitin (HDP-101)
    4years
    [VIRTUAL] A First in Human Study Planned to Evaluate Hdp-101, an Anti-BCMA Amanitin Antibody-Drug Conjugate with a New Payload and a New Mode of Action, in Multiple Myeloma (ASH 2020)
    The design of the study ensures a safe dose escalation to reach a potential clinical benefit in a patient who have limited or no therapeutic options. The study is expected to enroll patients in early 2021.
    P1 data
    |
    TP53 (Tumor protein P53) • SDC1 (Syndecan 1)
    |
    pamlectabart tismanitin (HDP-101)
    4years
    [VIRTUAL] The Anti-B-Cell Maturation Antigen (BCMA) Antibody-α-Amanitin Conjugate Hdp-101 Induces Immunogenic Cell Death and Immunologic Memory in Models of Multiple Myeloma (ASH 2020)
    Using our current knowledge of ER stress activation and induction of ICD, we evaluated the combination of bortezomib and HDP-101 in H929, MM1.S, and MOLP-8 cells and primary samples. Our results support the statement that HDP-101 is a novel anti-BCMA antibody drug conjugate that shows potent activity against drug-naïve and –resistant models of myeloma, and has the potential to show enhanced anti-tumor activity against del 17 p myeloma. Moreover, its mechanism of action involves both a direct cytotoxic effect, as well as the induction of immunogenic cell death, with the latter potentially leading to immunologic memory. These studies were supported by a Leukemia & Lymphoma Society Specialized Center of Research (SCOR-12206-17).
    IO biomarker
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    SDC1 (Syndecan 1) • HMGB1 (High Mobility Group Box 1)
    |
    bortezomib • pamlectabart tismanitin (HDP-101)