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    DRUG:

    olvimulogene nanivacirepvec (GL-ONC1)

    i
    Other names: GL-ONC1, GL ONC1, GLV-1h68, Olvi-Vec
    Company:
    Genelux, Newsoara Biopharma
    Drug class:
    Immunostimulant, Cytotoxic T lymphocyte stimulant
    Related drugs:
    28d
    Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma (clinicaltrials.gov)
    P1, N=18, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed
    Trial completion
    |
    olvimulogene nanivacirepvec (GL-ONC1)
    2ms
    Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's of Choice Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer (VIRO-25) (clinicaltrials.gov)
    P2, N=142, Recruiting, Genelux Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • docetaxel • albumin-bound paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • olvimulogene nanivacirepvec (GL-ONC1)
    5ms
    Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's of Choice Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer (VIRO-25) (clinicaltrials.gov)
    P2, N=142, Not yet recruiting, Genelux Corporation
    New P2 trial • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • docetaxel • albumin-bound paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • olvimulogene nanivacirepvec (GL-ONC1)
    7ms
    Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076) (clinicaltrials.gov)
    P3, N=186, Recruiting, Genelux Corporation | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial primary completion date
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • gemcitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • olvimulogene nanivacirepvec (GL-ONC1)
    9ms
    Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    olvimulogene nanivacirepvec (GL-ONC1)
    12ms
    Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076) (clinicaltrials.gov)
    P3, N=186, Recruiting, Genelux Corporation
    Trial completion date • Trial primary completion date
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • gemcitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • olvimulogene nanivacirepvec (GL-ONC1)
    1year
    A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer. (PubMed, Int J Gynecol Cancer)
    Expected complete accrual in 2024 with presentation of primary endpoint results in 2025. NCT05281471.
    Clinical • P3 data • Clinical Trial,Phase III • Journal
    |
    Avastin (bevacizumab) • olvimulogene nanivacirepvec (GL-ONC1)
    over1year
    Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial. (PubMed, JAMA Oncol)
    To assess antitumor activity and safety of intraperitoneal (IP) olvimulogene nanivacirepvec (Olvi-Vec) virotherapy and platinum-based chemotherapy with or without bevacizumab in patients with PRROC. These hypothesis-generating results warrant further evaluation in a confirmatory phase 3 trial. ClinicalTrials.gov Identifier: NCT02759588.
    Clinical • P2 data • Journal
    |
    Avastin (bevacizumab) • olvimulogene nanivacirepvec (GL-ONC1)
    over1year
    Correlative analysis from a phase I clinical trial of intrapleural administration of oncolytic vaccinia virus (Olvi-vec) in patients with malignant pleural mesothelioma. (PubMed, Front Immunol)
    The intrapleural administration of oncolytic vaccinia viral therapy is safe and feasible and generates regional immune response without overt systemic symptoms. https://clinicaltrials.gov/ct2/show/NCT01766739, identifier NCT01766739.
    P1 data • Clinical Trial,Phase I • Journal • Oncolytic virus
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • PD-L2 (Programmed Cell Death 1 Ligand 2) • GZMB (Granzyme B) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    olvimulogene nanivacirepvec (GL-ONC1)
    almost2years
    GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (clinicaltrials.gov)
    P1b, N=46, Completed, Genelux Corporation | Active, not recruiting --> Completed
    Trial completion • Oncolytic virus • IO biomarker
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    MUC16 elevation
    |
    Avastin (bevacizumab) • olvimulogene nanivacirepvec (GL-ONC1)
    over2years
    GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (clinicaltrials.gov)
    P1b, N=64, Active, not recruiting, Genelux Corporation | Trial completion date: Jun 2022 --> Dec 2022
    Trial completion date • Oncolytic virus • IO biomarker
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    MUC16 elevation
    |
    Avastin (bevacizumab) • olvimulogene nanivacirepvec (GL-ONC1)
    over2years
    GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (clinicaltrials.gov)
    P1b, N=64, Active, not recruiting, Genelux Corporation | Trial primary completion date: Dec 2020 --> Dec 2021
    Trial primary completion date
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    MUC16 elevation
    |
    Avastin (bevacizumab) • olvimulogene nanivacirepvec (GL-ONC1)
    almost3years
    A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer. (PubMed, Gynecol Oncol)
    Oncolytic viral therapy with intraperitoneal Olvi-Vec showed promising safety, clinical activities, and immune activation in patients with PRROC, warranting further clinical investigation.
    P1 data • Clinical Trial,Phase I • Journal • Oncolytic virus
    |
    CD8 (cluster of differentiation 8)
    |
    olvimulogene nanivacirepvec (GL-ONC1)
    almost4years
    GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (clinicaltrials.gov)
    P1b, N=64, Active, not recruiting, Genelux Corporation | Recruiting --> Active, not recruiting | Trial completion date: Nov 2020 --> May 2022 | Trial primary completion date: Jul 2020 --> Dec 2020
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Oncolytic virus • IO biomarker
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    MUC16 elevation
    |
    Avastin (bevacizumab) • olvimulogene nanivacirepvec (GL-ONC1)
    over4years
    [VIRTUAL] Phase II trial of oncolytic vaccinia virus primed immunochemotherapy in platinum-resistant/refractory ovarian cancer (PRROC) (NCT02759588) (ESMO 2020)
    Background We evaluated intraperitoneal infusion of Olvi-Vec virus followed by IV carboplatin-doublet (CD) ± bevacizumab (Bev) in heavily pretreated patients (pts) with PRROC. Funding: Genelux Corporation, San Diego, CA, USA. Clinical trial identification: NCT02759588.
    P2 data
    |
    CD8 (cluster of differentiation 8)
    |
    Avastin (bevacizumab) • carboplatin • olvimulogene nanivacirepvec (GL-ONC1)