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    DRUG:

    BYON3521

    i
    Other names: BYON3521, BYON 3521, BYON-3521
    Company:
    Byondis
    Drug class:
    DNA replication inhibitor, c-MET-targeted antibody-drug conjugate
    Related drugs:
    4d
    Understanding the Chemical Characteristics of Payloads and the Expression of Tumor-Associated Antigens of ADCs in Clinical Development. (PubMed, ACS Omega)
    Regarding the conjugation type, only trastuzumab deruxtecan, labetuzumab govitecan, sacituzumab govitecan, BYON3521, and SYD1875 used homogeneous conjugation. An interesting observation was that for some ADCs, TAA expression was higher in normal tissue than in the tumor. In summary, our analysis highlights that only a limited number of ADCs incorporate payloads with favorable physicochemical properties and that several ADCs currently under development target TAAs with higher expression in normal tissues than in the corresponding tumors.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • BYON3521 • labetuzumab govitecan (IMMU-130) • SYD1875
    5ms
    BYON3521.001: A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (clinicaltrials.gov)
    P1, N=31, Completed, Byondis B.V. | Active, not recruiting --> Completed
    Trial completion
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET mutation • MET expression • MET positive
    |
    BYON3521
    over1year
    BYON3521.001: A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, Byondis B.V. | Recruiting --> Active, not recruiting | N=120 --> 31 | Trial completion date: Mar 2025 --> Jul 2024 | Trial primary completion date: Jan 2025 --> Jul 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    BYON3521
    over2years
    Preclinical profile of BYON3521 predicts an effective and safe c-MET-antibody-drug conjugate. (PubMed, Mol Cancer Ther)
    In all, our nonclinical data suggests that BYON3521 is a safe ADC with potential for clinical benefit in patients. A first-in-human dose escalation study is currently ongoing to determine the maximum tolerated dose and recommended dose for expansion (NCT05323045).
    Preclinical • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase) • HGF (Hepatocyte growth factor)
    |
    MET amplification • MET expression
    |
    BYON3521
    over2years
    First in human dose-escalation trial with the c-MET targeting antibody-drug conjugate BYON3521 (AACR 2023)
    To date, BYON3521 is well-tolerated with no DLTs at the investigated dose levels. Patient enrollment is ongoing and updated safety, efficacy and pharmacokinetic data will be presented. After the dose-escalation phase the trial will continue with expanded cohorts of patients with specific c-MET expressing cancer types.
    P1 data
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET mutation • MET expression • MET positive
    |
    BYON3521
    over3years
    A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (clinicaltrials.gov)
    P1, N=120, Recruiting, Byondis B.V.
    New P1 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET mutation • MET positive
    |
    BYON3521