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    DRUG:

    trastuzumab imbotolimod (BDC-1001)

    i
    Other names: BDC-1001
    Company:
    Bolt Biotherapeutics
    Drug class:
    HER2 inhibitor, TLR8 agonist, TLR7 agonist
    Related drugs:
    9ms
    BBI-20201001: A First-in-human Study Using BDC-1001 As a Single Agent and in Combination with Nivolumab in Advanced HER2-Expressing Solid Tumors (clinicaltrials.gov)
    P1/2, N=175, Terminated, Bolt Biotherapeutics, Inc. | Trial completion date: Jan 2026 --> Feb 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Oct 2024; Sponsor Decision
    Trial completion date • Trial termination • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 expression
    |
    Opdivo (nivolumab) • trastuzumab imbotolimod (BDC-1001)
    10ms
    BBI-20231001: Trial of BDC-1001 +/- Pertuzumab in Subjects with HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=11, Terminated, Bolt Biotherapeutics, Inc. | Trial completion date: Mar 2025 --> Sep 2024 | Active, not recruiting --> Terminated; Sponsor Decision
    Trial completion date • Trial termination
    |
    HER-2 amplification
    |
    Perjeta (pertuzumab) • trastuzumab imbotolimod (BDC-1001)
    over1year
    BBI-20201001: A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors (clinicaltrials.gov)
    P1/2, N=175, Active, not recruiting, Bolt Biotherapeutics, Inc. | N=390 --> 175 | Trial completion date: Oct 2026 --> Jan 2026
    Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Opdivo (nivolumab) • trastuzumab imbotolimod (BDC-1001)
    over1year
    BBI-20231001: Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=11, Active, not recruiting, Bolt Biotherapeutics, Inc. | N=66 --> 11
    Enrollment change • Combination therapy • Metastases
    |
    Perjeta (pertuzumab) • trastuzumab imbotolimod (BDC-1001)
    over1year
    BBI-20231001: Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Bolt Biotherapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Perjeta (pertuzumab) • trastuzumab imbotolimod (BDC-1001)
    over1year
    BBI-20201001: A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors (clinicaltrials.gov)
    P1/2, N=390, Active, not recruiting, Bolt Biotherapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Opdivo (nivolumab) • trastuzumab imbotolimod (BDC-1001)
    2years
    Phase 2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 +/- pertuzumab in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (SABCS 2023)
    This study is expected to initiate accrual in 2H 2023. For additional information, please contact Bolt Biotherapeutics at 1-650-665-9295 or info@boltbio.com.
    Clinical • P2 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • TLR7 (Toll Like Receptor 7)
    |
    HER-2 positive • HER-2 expression
    |
    Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab imbotolimod (BDC-1001)
    2years
    Phase 2 study of the HER2-targeting TLR7/8 immune stimulating antibody conjugate (ISAC) BDC-1001 monotherapy +/- nivolumab in patients with HER2+ colorectal, endometrial, or gastroesophageal cancer (SITC 2023)
    Exploratory objectives will be pharmacodynamic biomarkers in tumor tissue and in peripheral blood, to help elucidate the mechanism of action and identify biomarkers associated with BDC-1001’s biological activity. Enrollment is ongoing in the United States, Europe, and South Korea
    Clinical • P2 data • PD(L)-1 Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TLR7 (Toll Like Receptor 7)
    |
    Opdivo (nivolumab) • trastuzumab imbotolimod (BDC-1001)
    over2years
    Recommended phase II dose (RP2D) selection and pharmacodynamic (PD) data of the first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients (pts) with advanced HER2-expressing solid tumors (ESMO 2023)
    BDC-1001 was given IV q3w, q2w, or q1w as monotherapy (mono; n=94) and q2w or q1w with nivolumab 240mg q2w (combo; n=37). Conclusions Our novel ISAC BDC-1001 (mono/combo) led to tolerable, encouraging efficacy, translational biomarker data consistent with novel MOA in pts with pretreated HER2+ tumors, particularly at the 20mg/kg q2w RP2D. International phase 2 expansions in HER2+ colorectal, gastroesophageal, and endometrial cancers and a new phase 2 in breast cancer (BDC-1001 ± pertuzumab) have been initiated.
    Clinical • P1 data • P2 data • PK/PD data • PD(L)-1 Biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma)
    |
    HER-2 expression
    |
    Opdivo (nivolumab) • Perjeta (pertuzumab) • trastuzumab imbotolimod (BDC-1001)
    over2years
    Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, Bolt Biotherapeutics, Inc.
    New P2 trial • Combination therapy • Metastases
    |
    HER-2 amplification
    |
    Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab imbotolimod (BDC-1001)
    over2years
    A phase 1/2 study of a first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients with advanced HER2-expressing solid tumors. (ASCO 2023)
    BDC-1001 incorporates a trastuzumab biosimilar (EG12014) conjugated to a proprietary TLR7/8 agonist using a non-cleavable linker and a cell membrane-impermeable payload. An international phase 1/2 study was initiated to evaluate the safety of BDC-1001 ± nivolumab (nivo) and to identify the recommended phase 2 dose (RP2D) considering PK/PD analyses and preliminary efficacy... BDC-1001 mono and combo were well-tolerated. Targeted serum exposure levels were achieved, and encouraging clinical activity was noted in heavily pretreated pts with various HER2 positive tumors, especially in the 20 mg/kg q2w cohorts. Immune biomarker changes from plasma and tumor were consistent with MoA of this ISAC.
    Clinical • P1/2 data • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Opdivo (nivolumab) • trastuzumab imbotolimod (BDC-1001) • Herwenda (trastuzumab biosimilar)
    almost3years
    BBI-20201001: A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors (clinicaltrials.gov)
    P1/2, N=390, Recruiting, Bolt Biotherapeutics, Inc. | Trial completion date: Jul 2023 --> Oct 2026 | Trial primary completion date: Jan 2023 --> Jan 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 expression
    |
    Opdivo (nivolumab) • trastuzumab imbotolimod (BDC-1001)