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    DRUG:

    BNT323

    i
    Other names: BNT323, DB-1303
    Company:
    BioNTech, DualityBio
    Drug class:
    Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    1m
    A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov)
    P3, N=468, Not yet recruiting, BioNTech SE
    New P3 trial
    |
    paclitaxel • doxorubicin hydrochloride • BNT323
    3ms
    A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer (clinicaltrials.gov)
    P3, N=224, Recruiting, DualityBio Inc.
    New P3 trial • Metastases
    |
    Kadcyla (ado-trastuzumab emtansine) • BNT323
    3ms
    A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (clinicaltrials.gov)
    P3, N=532, Recruiting, DualityBio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression • PGR positive
    |
    capecitabine • albumin-bound paclitaxel • BNT323
    7ms
    A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=631, Recruiting, DualityBio Inc. | N=463 --> 631
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Perjeta (pertuzumab) • BNT323 • itraconazole • ritonavir
    8ms
    A Study of DB-1303 vs Investigator's Choice Chemotherapy in Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=466, Not yet recruiting, DualityBio Inc.
    New P3 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression • PGR positive
    |
    capecitabine • albumin-bound paclitaxel • BNT323
    10ms
    DB-1303, A HER2-Targeting ADC, For Patients With Advanced/Metastatic Endometrial Cancer: Preliminary Clinical Results From An Ongoing Phase 1/2a Trial (NCT05150691) (ESGO 2023)
    No interstitial lung disease occurred. Conclusion DB-1303 demonstrated a manageable safety profile and promising antitumor activity, with high disease control in patients with advanced/metastatic EC.
    Clinical • P1/2 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    BNT323
    1year
    Preclinical pharmacokinetics in cynomolgus monkeys and first in human dose prediction of DB-1303, a HER2-targeting antibody-drug conjugate (AACR 2023)
    DB-1303 exhibited favorable PK characteristics of DB-1303 in cynomolgus monkeys, and is predicted to have large safety margins at the selected doses in the first in human study. At the time of presentation, the first-in-human phase 1/2 study in patients with advanced solid tumors is in progress (NCT05150691).
    P1 data • PK/PD data • Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    BNT323
    over1year
    A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=360, Recruiting, DualityBio Inc. | N=180 --> 360
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    BNT323
    over1year
    DB-1303, a HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising safety profile and anti-tumor efficacy with differentiation from DS-8201a (AACR-NCI-EORTC 2022)
    l In vivo, DB-1303 induced dose-dependent tumor growth inhibition and tumor regression in T-DM1-resistant JIMT-1 xenograft model, HER2 low-expressing Ishikawa xenograft and two HER2-low breast cancer PDX models. At the time of presentation, a first-in-human phase 1/2 study in patients with advanced solid tumors is in progress (NCT05150691). No
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HER-2 expression • HER-2 underexpression
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • BNT323
    2years
    A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Recruiting, DualityBio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    BNT323
    over2years
    A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Not yet recruiting, DualityBio Inc.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    BNT323