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    DRUG:

    Papitrol (tirvalimogene teraplasmid)

    i
    Other names: GX-188E, GX-188, pGX27-E6E7, NOV1702
    Company:
    Genexine, National OncoVenture
    Drug class:
    Immunostimulant
    Related drugs:
    9ms
    KEYNOTE-567: The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer (clinicaltrials.gov)
    P1/2, N=65, Completed, Genexine, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Papitrol (tirvalimogene teraplasmid)
    9ms
    GENUINE: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (clinicaltrials.gov)
    P2, N=56, Recruiting, Yonsei University | N=25 --> 56 | Trial primary completion date: Dec 2025 --> Aug 2025
    Enrollment change • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Papitrol (tirvalimogene teraplasmid) • Hyleukin-7 (efineptakin alfa)
    over1year
    Lunit to Present 16 Abstracts at the 2023 ASCO Annual Meeting (PRNewswire)
    "Lunit...announced the presentation of 16 abstracts featuring its AI-biomarker platform at the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago, Illinois, on June 2-6."
    Clinical data • P2 data
    |
    Lunit SCOPE IO
    |
    Keytruda (pembrolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab) • Papitrol (tirvalimogene teraplasmid) • Hyleukin-7 (efineptakin alfa)
    over1year
    TRINITY: HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Combination therapy • Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 28-8 pharmDx
    |
    Opdivo (nivolumab) • Papitrol (tirvalimogene teraplasmid) • Hyleukin-7 (efineptakin alfa)
    over2years
    GENUINE: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (clinicaltrials.gov)
    P2, N=25, Recruiting, Yonsei University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Papitrol (tirvalimogene teraplasmid) • Hyleukin-7 (efineptakin alfa)
    over2years
    KEYNOTE-567: The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer (clinicaltrials.gov)
    P1/2, N=60, Active, not recruiting, Genexine, Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Dec 2022
    Enrollment closed • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Papitrol (tirvalimogene teraplasmid)
    over2years
    GENUINE: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, Yonsei University
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Papitrol (tirvalimogene teraplasmid) • Hyleukin-7 (efineptakin alfa)
    over2years
    TRINITY: HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy (clinicaltrials.gov)
    P2; N=21; Not yet recruiting; Sponsor:Yonsei University
    Combination therapy • New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 28-8 pharmDx
    |
    Opdivo (nivolumab) • Papitrol (tirvalimogene teraplasmid) • Hyleukin-7 (efineptakin alfa)
    over4years
    The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer (clinicaltrials.gov)
    P1/2, N=60, Recruiting, Genexine, Inc. | N=46 --> 60 | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2020 --> Dec 2021
    Clinical • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Papitrol (tirvalimogene teraplasmid)
    over4years
    [VIRTUAL] Efficacy and safety results of pembrolizumab combined with GX-188E, a therapeutic DNA vaccine administration in patients with HPV 16- and/or 18- positive advanced cervical cancer: Phase II interim analysis results (AACR-I 2020)
    Pembrolizumab combined with GX-188E demonstrated a higher response rate than pembrolizumab monotherapy in patients with cervical cancer showing great synergy regardless of PD-L1 expression. The safety profile was manageable and similar to that of pembrolizumab monotherapy. Further evaluation of anti-tumor response and antigen specific immune response is ongoing in a larger number of patients with and without PD-L1 expression.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Papitrol (tirvalimogene teraplasmid)