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    DRUG:

    abipapogene suvaplasmid (VB10.16)

    i
    Other names: VB10.16, abi-suva
    Associations

    News

    Trials
    Company:
    Nykode Therap
    Drug class:
    Immunostimulant
    Related drugs:
    Associations

    News

    Trials
    11ms
    Safety and efficacy of the therapeutic DNA-based vaccine VB10.16 in combination with atezolizumab in persistent, recurrent or metastatic HPV16-positive cervical cancer: a multicenter, single-arm phase 2a study. (PubMed, J Immunother Cancer)
    The therapeutic DNA-based vaccine VB10.16 combined with atezolizumab was safe and well tolerated showing a promising clinically meaningful efficacy with durable responses in patients with persistent, r/m HPV16-positive cervical cancer, especially if PD-L1-positive.
    P2a data • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • abipapogene suvaplasmid (VB10.16)
    1year
    VB-C-04: Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer. (clinicaltrials.gov)
    P2, N=0, Withdrawn, Nykode Therapeutics ASA | N=130 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • PD(L)-1 companion diagnostic • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • abipapogene suvaplasmid (VB10.16)
    over1year
    Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer. (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting | Initiation date: Dec 2023 --> Apr 2024
    Combination therapy • Enrollment open • Trial initiation date • PD(L)-1 companion diagnostic • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • abipapogene suvaplasmid (VB10.16)
    almost2years
    KEYNOTE-E72: Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1/2, N=51, Recruiting, Nykode Therapeutics ASA | Initiation date: Sep 2023 --> Dec 2023
    Trial initiation date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • IFNG (Interferon, gamma)
    |
    Keytruda (pembrolizumab) • abipapogene suvaplasmid (VB10.16)
    almost2years
    Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer (clinicaltrials.gov)
    P2, N=52, Completed, Nykode Therapeutics ASA | Active, not recruiting --> Completed | Phase classification: P2a --> P2 | Trial completion date: Mar 2024 --> Nov 2023 | Trial primary completion date: Aug 2023 --> Nov 2023
    Trial completion • Phase classification • Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • abipapogene suvaplasmid (VB10.16)
    2years
    Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer. (clinicaltrials.gov)
    P2; N=130; Not yet recruiting; Sponsor:Nykode Therapeutics ASA
    Combination therapy • New P2 trial • PD(L)-1 companion diagnostic • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • abipapogene suvaplasmid (VB10.16)
    2years
    Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1/2, N=51, Recruiting, Nykode Therapeutics ASA | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • abipapogene suvaplasmid (VB10.16)
    over2years
    KEYNOTE-E72: Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1/2, N=51, Not yet recruiting, Nykode Therapeutics ASA
    New P1/2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • abipapogene suvaplasmid (VB10.16)
    over2years
    Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer (clinicaltrials.gov)
    P2a, N=50, Active, not recruiting, Nykode Therapeutics ASA | Trial primary completion date: Mar 2023 --> Aug 2023
    Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • abipapogene suvaplasmid (VB10.16)
    almost4years
    Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer (clinicaltrials.gov)
    P2a, N=50, Active, not recruiting, Nykode Therapeutics AS | Recruiting --> Active, not recruiting | Trial completion date: Jan 2023 --> Mar 2024 | Trial primary completion date: May 2022 --> Mar 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • abipapogene suvaplasmid (VB10.16)
    over5years
    Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer (clinicaltrials.gov)
    P2a; N=50; Recruiting; Sponsor: Vaccibody AS; Not yet recruiting --> Recruiting
    Enrollment open • Clinical
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • abipapogene suvaplasmid (VB10.16)