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    DRUG:

    ASN004

    i
    Other names: ASN004, dolaflexin ADC, Fleximer antibody-drug conjugate, ASN 004
    Company:
    Asana BioSci, Kirilys
    Drug class:
    Microtubule inhibitor, 5T4-targeted antibody-drug conjugate
    Related drugs:
    5ms
    Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=19, Completed, Kirilys Therapeutics Inc. | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> May 2024
    Trial completion • Trial completion date • Metastases
    |
    TPBG (Trophoblast Glycoprotein)
    |
    ASN004
    9ms
    Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=19, Active, not recruiting, Kirilys Therapeutics Inc. | Recruiting --> Active, not recruiting | N=45 --> 19 | Trial completion date: Mar 2027 --> Sep 2024 | Trial primary completion date: Mar 2026 --> Jun 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    TPBG (Trophoblast Glycoprotein)
    |
    TPBG expression
    |
    ASN004
    1year
    Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=45, Recruiting, Kirilys Therapeutics Inc. | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    TPBG (Trophoblast Glycoprotein)
    |
    TPBG expression
    |
    ASN004
    over3years
    ASN004, a 5T4-targeting scFv-Fc antibody-drug conjugate with high drug-to-antibody ratio, induces complete and durable tumor regressions in preclinical models. (PubMed, Mol Cancer Ther)
    In head-to-head studies, superior activity of ASN004 was demonstrated against trastuzumab-DM1, in a low-5T4/high-HER2 expressing gastric tumor model, and 10-fold greater potency was found for ASN004 against the 5T4-targeted ADC PF-06263507 in a lung tumor model. In marmoset monkeys, ASN004 was well tolerated at doses up to 1.5 mg/kg Q3W iv, and showed dose-dependent exposure, linear pharmacokinetics, and markedly low exposure of free payload drug. Taken together, these findings identify ASN004 as a promising new ADC therapeutic for clinical evaluation in a broad range of solid tumor types.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TPBG (Trophoblast Glycoprotein)
    |
    HER-2 expression • HER-2-H
    |
    Kadcyla (ado-trastuzumab emtansine) • ASN004 • PF-06263507