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    DRUG CLASS:

    RNA polymerase 2 inhibitor

    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
    |
    pamlectabart tismanitin (HDP-101)
    9ms
    A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=280, Recruiting, Eli Lilly and Company | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    10ms
    Alloengraftment without significant toxicity or GVHD in CD45 antibody-drug conjugate conditioned Fanconi anemia mice. (PubMed, Blood)
    Moreover, single dose anti-human CD45-ADC given to rhesus macaque nonhuman primates on days -6 or -10 was at least as myeloablative as lethal irradiation. These data suggest that CD45-ADC can potently promote donor alloengraftment and hematopoiesis without significant toxicity or severe GVHD, as seen with lethal irradiation, providing strong support for clinical trial considerations in highly vulnerable FA patients.
    Preclinical • Journal
    |
    FANCA (FA Complementation Group A) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • FANCG (FA Complementation Group G) • FANCC (FA Complementation Group C)
    |
    CD45-ADC
    11ms
    A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=280, Not yet recruiting, Eli Lilly and Company
    New P1 trial
    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
    |
    SDC1 (Syndecan 1)
    |
    pamlectabart tismanitin (HDP-101)
    1year
    CD117 Antibody-Drug Conjugate Conditioning Allows Efficient Engraftment of Gene-Modified CD34+ Cells with Fertility Preservation in a Rhesus Gene Therapy Model (ASH 2023)
    To investigate the activity of CD117-ADC in non-human primates, we administered a single injection of ADC without HSC infusion, resulting in a >99% depletion of CD34+CD90+ bone marrow cells in cynomolgus macaques (n=2 of 3 in 0.1 mg/kg and n=3 in 0.3 mg/kg); similar to the ablation observed with 4 doses of myeloablative busulfan (Bu) (n=3). The transplanted animals with ADC maintained their fertility. Overall, these data indicate that an ADC-based targeted approach offers safer conditioning and could improve the risk-benefit profile in HSC gene therapy.
    Gene therapy
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • CD34 (CD34 molecule) • THY1 (Thy-1 membrane glycoprotein)
    |
    opelkibart elmanitin (MGTA-117) • busulfan