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    DRUG:

    cretostimogene grenadenorepvec (CG0070)

    i
    Other names: CG0070, CG-0070, CG 0070, oncolytic adenovirus serotype 5
    Company:
    CG Oncology, Kissei
    Drug class:
    GM-CSF agonist, Cell death stimulant
    Related drugs:
    10d
    BOND3: Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin (clinicaltrials.gov)
    P3, N=190, Recruiting, CG Oncology, Inc. | N=110 --> 190 | Trial completion date: Jul 2025 --> Dec 2029 | Trial primary completion date: Jan 2024 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    cretostimogene grenadenorepvec (CG0070)
    3ms
    Study of CG0070 After Transurethral Resection in Patients With IR NMIBC (clinicaltrials.gov)
    P1, N=20, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial
    |
    cretostimogene grenadenorepvec (CG0070)
    5ms
    A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT (clinicaltrials.gov)
    P3, N=426, Recruiting, CG Oncology, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cretostimogene grenadenorepvec (CG0070)
    5ms
    PIVOT-006: A phase 3, randomized study of cretostimogene grenadenorepvec versus observation for the treatment of intermediate risk non-muscle invasive bladder cancer (IR-NMIBC) following transurethral resection of bladder tumor (TURBT). (ASCO-GU 2024)
    Exploratory outcome measures include patient-reported quality of life, biomarker analyses, coxsackie adenovirus receptor and E2F promoter expression, neutralizing antibodies, and markers of immunogenicity. Clinical trial information: Pending.
    Clinical • P3 data
    |
    CSF2 (Colony stimulating factor 2)
    |
    CSF2 expression
    |
    cretostimogene grenadenorepvec (CG0070)
    6ms
    A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT (clinicaltrials.gov)
    P3, N=426, Not yet recruiting, CG Oncology, Inc.
    New P3 trial
    |
    cretostimogene grenadenorepvec (CG0070)
    10ms
    Intravesical Infusion of Oncolytic Virus CG0070 in the Treatment of Bladder Cancer. (PubMed, Methods Mol Biol)
    As a self-replicating biologic, it shares many characteristics with intravesical BCG but has other unique features. Herein, we detail recommended standardized protocols for bladder infusion of CG0070 for the treatment of bladder cancer and provide many useful tips for trouble shooting.
    Journal • Oncolytic virus
    |
    cretostimogene grenadenorepvec (CG0070)
    1year
    CORE1: Phase 2 Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin (BCG) (AUA 2023)
    This initial data on the efficacy and safety of CG0070 plus pembrolizumab for the treatment of BCG unresponsive NMIBC is encouraging. Data on efficacy and safety for all enrolled patients, N=35, as well as biomarker (CAR, E2F, and PDL1) assessment will be presented at the time of the conference.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CSF2 (Colony stimulating factor 2)
    |
    CSF2 expression
    |
    Keytruda (pembrolizumab) • cretostimogene grenadenorepvec (CG0070)
    1year
    Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=30 --> 21 | Trial completion date: Nov 2023 --> Mar 2025 | Trial primary completion date: Nov 2023 --> Mar 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • cretostimogene grenadenorepvec (CG0070)
    over1year
    Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC (clinicaltrials.gov)
    P1, N=30, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • cisplatin • cretostimogene grenadenorepvec (CG0070)
    2years
    CORE1: Phase 2; Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) (AUA 2022)
    Conclusions : The combination of CG0070 and pembrolizumab has been well tolerated with encouraging early efficacy data. An update on this ongoing trial will be provided at the time of presentation.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CSF2 (Colony stimulating factor 2)
    |
    PD-L1 expression • CSF2 expression
    |
    Keytruda (pembrolizumab) • cretostimogene grenadenorepvec (CG0070)
    3years
    [VIRTUAL] CORE1: Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) (ASGCT 2021)
    The study is currently enrolling. An update on trial enrollment and preliminary data will be provided at the time of presentation.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CSF2 (Colony stimulating factor 2)
    |
    PD-L1 expression • CSF2 expression
    |
    Keytruda (pembrolizumab) • cretostimogene grenadenorepvec (CG0070)
    3years
    [VIRTUAL] A Phase 3, Single-Arm Study of CG0070 in Subjects with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) (ASGCT 2021)
    Study enrollment globally is ongoing.
    Clinical • P3 data
    |
    CSF2 (Colony stimulating factor 2)
    |
    CSF2 expression
    |
    cretostimogene grenadenorepvec (CG0070)
    over3years
    [VIRTUAL] A PHASE 3, SINGLE-ARM STUDY OF CG0070 IN SUBJECTS WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (BCG) (SUO 2020)
    Study enrollment across the US and Asia Pacific regions is planned to be completed over the next 24 m. An update on trial enrollment and preliminary data will be presented at the time of presentation. Funding: N/A
    Clinical • P3 data
    |
    CSF2 (Colony stimulating factor 2)
    |
    CSF2 expression
    |
    cretostimogene grenadenorepvec (CG0070)
    over3years
    Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC (clinicaltrials.gov)
    P1, N=30, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
    Clinical • New P1 trial • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • cisplatin • cretostimogene grenadenorepvec (CG0070)