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    DRUG:

    VIO-01

    i
    Other names: VIO-01, OX425, OX 425, VIO 01, OX-425, VIO01
    Company:
    Valerio Therap
    Drug class:
    PARP1 inhibitor, KU70/KU80 inhibitor, MRN complex inhibitor
    Related drugs:
    9ms
    A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors (clinicaltrials.gov)
    P1/2, N=6, Terminated, Valerio Therapeutics | N=165 --> 6 | Trial completion date: Dec 2028 --> Jan 2025 | Recruiting --> Terminated | Trial primary completion date: Jan 2026 --> Jan 2025; Business decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    VIO-01
    almost2years
    A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors (clinicaltrials.gov)
    P1/2, N=165, Recruiting, Valerio Therapeutics
    New P1/2 trial
    |
    VIO-01
    over2years
    PARP1 hyperactivation by the decoy oligodeoxynucleotide OX425 mediates DNA repair abrogation and unleashes the anti-tumor immune response (AACR 2023)
    Our results provide preclinical rationale for using OX425 to trigger DNA damage exhaustion and STING activation in cancer cells and initiate inflammatory responses that can be actioned by immune checkpoint inhibitors in patients bearing HRD or HRP tumors
    BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • HRD (Homologous Recombination Deficiency)
    |
    BRCA1 mutation • HRD • HRD + BRCA1 mutation
    |
    Lynparza (olaparib) • VIO-01
    almost3years
    PARP1 trapping and hyperactivation by the decoy agonist OX425 induces DNA repair abrogation and a robust anti-tumor immune response (ESMO-TAT 2023)
    Importantly, OX425 treatment significantly delayed acquired resistance to olaparib in BRCA1 mutated MDA-MB-436 cell-derived xenografts. Conclusions Our results provide a safety profile and preclinical rationale for using OX425 in patients bearing HRD tumors, to trigger DNA damage exhaustion and initiate inflammatory responses in the tumor microenvironment.
    BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • HRD (Homologous Recombination Deficiency) • PARP1 (Poly(ADP-Ribose) Polymerase 1)
    |
    BRCA1 mutation • HRD • HRD + BRCA1 mutation
    |
    Lynparza (olaparib) • VIO-01