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    DRUG:

    nesfrotamig (ABL105)

    i
    Other names: ABL105, YH32367, ABL 105, ABL-105, YH-32367, YH 32367
    Company:
    ABL Bio, Yuhan Corp
    Drug class:
    HER2 inhibitor, CD137 agonist
    Related drugs:
    over1year
    Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1/2, N=137, Recruiting, Yuhan Corporation | Trial primary completion date: Jan 2024 --> Oct 2026
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    cisplatin • nesfrotamig (ABL105)
    3years
    Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1/2, N=110, Recruiting, Yuhan Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    nesfrotamig (ABL105)
    over3years
    Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1/2, N=110, Not yet recruiting, Yuhan Corporation
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    nesfrotamig (ABL105)
    over3years
    A novel HER2/4-1BB bispecific antibody, YH32367 (ABL105) exhibits the optimal efficacy and superior safety profile through tumor-directed 4-1BB agonism (AACR 2022)
    Although HER2-targeted therapies such as Herceptin® (trastuzumab) have dramatically improved outcomes for solid cancer patients with HER2 overexpression, it remains a challenge to cure the HER2 positive cancer patients with resistance to current HER2-targeted therapies. These results suggest that YH32367 could be a promising therapeutic for HER2-positive cancer patients, especially with HER2 drug resistance as an effective HER2-targeted therapy. Phase I clinical study is expected to begin in 2022.
    Clinical • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    HER-2 positive • HER-2 overexpression
    |
    Herceptin (trastuzumab) • nesfrotamig (ABL105)
    over4years
    [VIRTUAL] A novel HER2/4-1BB bispecific antibody, YH32367 (ABL105) exerts significant anti-tumor effects through tumor-directed T cell activation (ESMO 2021)
    YH32367 also showed superior efficacies on immune cells activation as well as tumor growth inhibition in both HER2-expressing tumor-bearing hPBMC humanized mice and h4-1BB knock-in mice models compared to the equimolar dosing of trastuzumab and benchmark 4-1BB agonistic antibodies. In conclusion, YH32367 exhibited potent in vitro and vivo effect through tumor-directed T cell activation. It suggests that YH32367 could be promising to develop for the patients with HER2 positive cancer as an effective HER2-directed therapy.
    IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    HER-2 positive • HER-2 overexpression
    |
    Herceptin (trastuzumab) • nesfrotamig (ABL105)