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    DRUG:

    BNT326

    i
    Other names: BNT326, YL202, BNT 326, YL 202, BNT-326, YL-202
    Associations

    News

    Trials
    Company:
    BioNTech, MediLink
    Drug class:
    Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate
    Related drugs:
    Associations

    News

    Trials
    3d
    A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov)
    P2, N=180, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    BNT326
    3d
    A Study of YL202 in Selected Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=200, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    BNT326
    8d
    A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Subjects With Locally Advanced or Metastatic Breast Cancer Who Are TNBC and HR Positive, HER2 Zero, or HER2 Hypoactive (ChiCTR2400089158)
    P2, N=180, Recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • HER-2 expression • HER-2 underexpression • PGR expression • HER-2 negative + HR negative
    |
    BNT326
    2ms
    YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov)
    P1, N=80, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 deletion • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    BNT326
    5ms
    A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov)
    P2, N=180, Active, not recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Active, not recruiting | Initiation date: Jul 2024 --> Apr 2024
    Enrollment closed • Trial initiation date • Metastases
    |
    BNT326
    5ms
    YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov)
    P1, N=80, Active, not recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    BNT326
    5ms
    A Study of YL202 in Selected Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=200, Active, not recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    BNT326
    6ms
    A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC (clinicaltrials.gov)
    P2, N=180, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P2 trial • Metastases
    |
    BNT326
    11ms
    A Study of YL202 in Selected Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=200, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    BNT326
    1year
    A Study of YL202 in Selected Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 positive • ERBB3 expression
    |
    BNT326
    over1year
    Preclinical development of YL202, a novel HER3-targeting antibody-drug conjugate (ADC) with novel DNA topoisomerase I inhibitor for treatment of solid tumors (AACR 2023)
    GLP toxicity studies using cynomolgus monkeys showed that YL202 is well tolerated with calculated therapeutic index (TI, HNSTD/MED) of ~100 for repeat dosing. No lung or platelet toxicity findings were observed at doses up to the maximum tolerated dose (MTD).Based on these preclinical results, it demonstrates that YL202’s advanced ADC design results in an increased therapeutic margin, and YL201 could be further developed in HER3 positive cancer patients.
    Preclinical
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 elevation
    |
    BNT326 • YL201
    almost2years
    A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov)
    P1, N=80, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P1 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 deletion • HR positive + HER-2 negative
    |
    BNT326