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    DRUG:

    bulumtatug fuvedotin (9MW2821)

    i
    Other names: 9MW2821, 9MW 2821, 9MW-2821
    Company:
    Mabwell (Shanghai) Biosci
    Drug class:
    Microtubule inhibitor, Nectin-4-targeted antibody-drug conjugate
    Related drugs:
    1m
    Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules. (PubMed, Front Mol Med)
    Enfortumab vedotin is an NECTIN4-targeting antibody-drug conjugate that is approved for the treatment of urothelial cancer, whereas other ADCs or derivatives that target NECTIN4, such as bulumtatug fuvedotin, SHR-A2102 and zelenectide pevedotin, are being studied in randomized phase III clinical trials. In contrast, arcotatug tavatecan, garetatug rezetecan, sonesitatug vedotin and tecotabart vedotin are anti-CLDN18.2 ADCs in phase III clinical trials for the treatment of CLDN18.2-positive gastric or gastroesophageal junction adenocarcinomas, and raludotatug deruxtecan is an anti-CDH6 ADC in a phase II/III clinical trial for the treatment of platinum-resistant ovarian cancer. ADCs that target cell-cell adhesion molecules are a rapidly emerging class of cancer therapeutics, and bispecific ADCs and longitudinal companion diagnostics are emerging to further improve the clinical benefits of conventional ADCs.
    Review • Journal
    |
    CLDN18 (Claudin 18) • CLDN6 (Claudin 6) • CDH6 (Cadherin 6) • CDH17 (Cadherin 17)
    |
    CLDN18.2 positive
    |
    Padcev (enfortumab vedotin-ejfv) • sonesitatug vedotin (AZD0901) • tecotabart vedotin (LM-302) • zelenectide pevedotin (BT8009) • SHR-A2102 • arcotatug tavatecan (IBI-343) • bulumtatug fuvedotin (9MW2821) • garetatug rezetecan (SHR-A1904) • raludotatug deruxtecan (DS-6000)
    2ms
    Structural basis of nectin-4 recognition by the antibody-drug conjugate 9MW2821. (PubMed, J Biol Chem)
    Based on the structure of nectin-4 D1/9MW2821 Fab complex resolved in this study, we have elucidated the molecular mechanism of 9MW2821 in cancer therapy. The findings provide a basis for optimizing future monoclonal antibodies targeting nectin-4.
    Journal
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • NECTIN1 (Nectin Cell Adhesion Molecule 1)
    |
    bulumtatug fuvedotin (9MW2821)
    2ms
    JS207 Combination Therapy in Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    albumin-bound paclitaxel • bulumtatug fuvedotin (9MW2821)
    4ms
    A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs (clinicaltrials.gov)
    P1, N=52, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: May 2025 --> Aug 2025
    Enrollment open • Trial initiation date
    |
    bulumtatug fuvedotin (9MW2821)
    5ms
    JS207 Combination Therapy in Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    albumin-bound paclitaxel • bulumtatug fuvedotin (9MW2821)
    7ms
    A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=188, Not yet recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P1/2 trial
    |
    bulumtatug fuvedotin (9MW2821)
    7ms
    9MW2821, a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study. (PubMed, Ann Oncol)
    The results suggest that 9MW2821 was tolerable and clinically significant in efficacy in various types of solid tumors besides urothelial cancer. Several pivotal trials are currently in progress. (NCT06196736, NCT06592326, NCT06692166).
    Clinical • P1 data • Journal
    |
    NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    bulumtatug fuvedotin (9MW2821)
    8ms
    9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors (clinicaltrials.gov)
    P1/2, N=260, Not yet recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P1/2 trial
    |
    bulumtatug fuvedotin (9MW2821)
    8ms
    9MW2821-2023-CP301: A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P3, N=432, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd. | Trial completion date: Dec 2028 --> Jul 2027 | Trial primary completion date: Dec 2026 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    paclitaxel • docetaxel • bulumtatug fuvedotin (9MW2821)
    8ms
    A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs (clinicaltrials.gov)
    P1, N=52, Not yet recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P1 trial
    |
    bulumtatug fuvedotin (9MW2821)
    10ms
    9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=60, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi) • bulumtatug fuvedotin (9MW2821)
    11ms
    A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=160, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    bulumtatug fuvedotin (9MW2821)