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    DRUG:

    BYON4413

    i
    Other names: BYON4413, BYON 4413
    Company:
    Byondis
    Drug class:
    Alkylating agent, CD123-targeted antibody-drug conjugate
    Related drugs:
    13d
    BYON4413.001: Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Byondis B.V. | Recruiting --> Active, not recruiting | N=100 --> 16 | Trial completion date: Mar 2027 --> Feb 2026 | Trial primary completion date: Dec 2026 --> Sep 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • First-in-human
    |
    BYON4413
    over1year
    BYON4413.001: Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. (clinicaltrials.gov)
    P1, N=100, Recruiting, Byondis B.V. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BYON4413
    almost2years
    Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. (clinicaltrials.gov)
    P1, N=100, Not yet recruiting, Byondis B.V.
    New P1 trial
    |
    BYON4413
    over2years
    Potent in Vitro and In Vivo Efficacy of BYON4413, a Duba-Based Antibody-Drug Conjugate Targeting CD123 in Acute Myeloid Leukemia (ASH 2023)
    In sum, BYON4413 shows great potential to be an effective targeted therapy against AML, MDS, and other CD123+ hematological malignancies such as blastic plasmacytoid dendritic cell neoplasm (BPDCN). Readied with these promising pre-clinical results, we have designed a first-in-human dose-escalation and expansion trial enrolling AML and high-risk MDS patients scheduled to begin in Q12024.
    Preclinical
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • CD34 (CD34 molecule) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 positive • CD123 expression • IL3RA positive
    |
    BYON4413