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    DRUG:

    BB-1701

    i
    Other names: BB-1701, BB1701
    Company:
    BlissBio, Eisai
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    4ms
    Preclinical studies of BB-1701, a HER2-targeting eribulin-containing ADC with potent bystander effect and ICD activity. (PubMed, Antib Ther)
    The preclinical data support the test of BB-1701 in patients with various HER2-expressing cancers, including those resistant to other HER2-targeting ADCs. A phase I clinical trial of BB-1701 (NCT04257110) in patients is currently underway.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Halaven (eribulin mesylate) • BB-1701
    9ms
    A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=135, Recruiting, Eisai Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    BB-1701
    11ms
    A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=135, Not yet recruiting, Eisai Inc.
    New P2 trial • Metastases
    |
    BB-1701
    12ms
    A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=208, Active, not recruiting, Bliss Biopharmaceutical (Hangzhou) Co., Ltd | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Aug 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 expression
    |
    BB-1701
    1year
    Report on Cohort Expansion of Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of BB-1701 in Patients with Locally Advanced/Metastatic HER2 Low Breast Cancer (SABCS 2023)
    Background: BB-1701 is an antibody-drug conjugate (ADC) consisting of a humanized IgG1κ monoclonal anti-HER2 antibody with the same sequence as trastuzumab and eribulin linked together by a cathepsin-cleavable valine-citrulline linker...One patient who achieved PR was previously progressed on sacituzumab govitecan... BB-1701 has demonstrated promising preliminary antitumor activity in HER2 low breast cancer including patients who received prior anti-HER2 ADCs, and a manageable safety profile.
    Clinical • P1 data • PK/PD data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Halaven (eribulin mesylate) • Aidixi (disitamab vedotin) • Trodelvy (sacituzumab govitecan-hziy) • BB-1701
    over1year
    A first-in-human, open label, multiple dose, dose escalation, and cohort expansion phase I study to investigate the safety, tolerability, pharmacokinetics and antitumor activity of BB-1701 in patients with locally advanced/metastatic HER2-expressing solid tumors. (ASCO 2023)
    Background: BB-1701 is an antibody-drug conjugate consisting of a humanized IgG1κ monoclonal antibody and eribulin. BB-1701 was generally well tolerated up to 2.6 mg/kg dose levels and has shown promising antitumor activity in patients with HER2-overexpression solid tumors. Clinical trial information: NCT04257110.
    Clinical • P1 data • PK/PD data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 expression
    |
    Halaven (eribulin mesylate) • BB-1701
    over1year
    Preclinical development of BB-1701, a HER2-tageting eribulin-containing ADC with potent bystander effect and ICD activity (AACR 2023)
    BB-1701 also showed effective tumor suppression in models insensitive to T-DM1 or T-Dxd. In conclusion, these comprehensive preclinical data have strongly supported BB-1701 as a potent antitumor agent to cancers including HER2-low expressing and/or cancers insensitive to other HER2-targeting ADCs. A phase I clinical study of BB-1701 in those patients is ongoing.
    Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • CALR (Calreticulin)
    |
    HER-2 expression • HER-2 underexpression
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Halaven (eribulin mesylate) • BB-1701
    over2years
    A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=208, Recruiting, Bliss Biopharmaceutical (Hangzhou) Co., Ltd | N=88 --> 208 | Trial completion date: Feb 2022 --> Dec 2023 | Trial primary completion date: Feb 2022 --> Aug 2023
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 expression
    |
    BB-1701
    over4years
    A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Positive Solid Tumors (clinicaltrials.gov)
    P1, N=88, Recruiting, Bliss Biopharmaceutical (Hangzhou) Co., Ltd | Initiation date: Mar 2020 --> Jul 2020
    Clinical • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    BB-1701
    over4years
    A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Positive Solid Tumors (clinicaltrials.gov)
    P1, N=88, Recruiting, Bliss Biopharmaceutical (Hangzhou) Co., Ltd | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    BB-1701
    almost5years
    A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Positive Solid Tumors (clinicaltrials.gov)
    P1, N=88, Not yet recruiting, Bliss Biopharmaceutical (Hangzhou) Co., Ltd
    Clinical • New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    BB-1701