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    DRUG:

    D3L-001

    i
    Other names: D3L-001, D3L 001, D3L001
    Company:
    D3 Bio
    Drug class:
    HER2 inhibitor, CD47 inhibitor
    Related drugs:
    1year
    A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=110, Recruiting, D3 Bio (Wuxi) Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD47 (CD47 Molecule)
    |
    HER-2 positive
    |
    D3L-001
    over1year
    A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=110, Not yet recruiting, D3 Bio (Wuxi) Co., Ltd
    New P1 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD47 (CD47 Molecule)
    |
    HER-2 positive
    |
    D3L-001
    over1year
    D3L-001, a novel bispecific antibody targeting HER2 and CD47, demonstrates potent preclinical efficacy in solid tumors. (AACR 2023)
    Many HER2-targeted drugs, including trastuzumab, pertuzumab, lapatinib, trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-DXd), have been approved for treatment of HER2-positive early and metastatic breast cancer (BC)...In both in vitro and in vivo studies using breast cancer HCC1954, JIMT-1 and gastric cancer N87 models, we observed a synergistic effect in the combination of Trastuzumab with Magrolimab...D3L-001 also displayed potent and comparable in vivo efficacy as Enhertu in gastric N87 model, and it showed synergistic in vivo efficacy, when combining with Pertuzumab or Paclitaxel, in breast HCC1954, JIMT-1 and gastric cancer N87 models. D3L-001, a novel HER2×CD47 bsAb, demonstrated potent anti-tumor effect in a variety of solid tumor models via HER2 guided CD47 co-blocking. D3L-001, a novel HER2×CD47 bsAb, demonstrated potent anti-tumor effect in a variety of solid tumor models via HER2 guided CD47 co-blocking. It also showed synergistic efficacy when combining with other anti-tumor agents. D3L-001 will be further evaluated in clinic for its potential as a novel treatment option in HER2-positive BC, GC and other solid tumors.
    Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    HER-2 positive • HER-2 overexpression • CD47 positive + HER-2 positive
    |
    paclitaxel • lapatinib • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • magrolimab (ONO-7913) • D3L-001