lerapolturev (PVS-RIPO) / Istari Oncology 
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  • ||||||||||  PVS-RIPO / Istari Oncology
    Clinical, Journal, IO biomarker:  Persistent STAG2 mutation despite multimodal therapy in recurrent pediatric glioblastoma. (Pubmed Central) -  Feb 15, 2021   
    This report describes the genetic findings, obtained from whole-exome sequencing of a pediatric patient with glioblastoma who underwent multiple surgical resections and treatment with standard chemoradiation, as well as a novel recombinant poliovirus vaccine therapy...As such, this case represents a novel report following the clinical and genetic progression of a STAG2 mutated glioblastoma, including treatment with a novel and emerging immunotherapy. Although STAG2 deficiency comprises only a small subset of gliomas, this case adds clinical evidence to existing preclinical data supporting a role for STAG2 mutations in gliomagenesis and resistance to standard therapies.
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment closed, Trial completion date, Trial primary completion date:  PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) -  Jan 14, 2021   
    P1,  N=18, Active, not recruiting, 
    Although STAG2 deficiency comprises only a small subset of gliomas, this case adds clinical evidence to existing preclinical data supporting a role for STAG2 mutations in gliomagenesis and resistance to standard therapies. Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Trial completion date, Trial primary completion date:  Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (clinicaltrials.gov) -  Dec 28, 2020   
    P1b,  N=12, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: Jul 2021 --> Mar 2022 | Trial primary completion date: Jul 2020 --> Mar 2021
  • ||||||||||  nanocrystalline form of fluticasone (AC-155) / Nicox, PVS-RIPO / Istari Oncology
    [VIRTUAL] Oncolytic poliovirus as a probe for mechanisms of immune resistance in glioblastoma () -  Oct 24, 2020 - Abstract #SNO2020SNO_829;    
    This model is valuable in studying the mechanisms of intrinsic resistance and the timeline of resistance to develop in order to obtain more durable immunotherapy responses in glioblastoma. Future steps are to track inflammation induced by viral infection by RNAseq, and to find potential therapeutic interventions (including blocking PD1:PD-L1 axis) to mitigate therapy resistance in this preclinical model.
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment open, Checkpoint inhibition, IO biomarker:  LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients with Recurrent Glioblastoma (clinicaltrials.gov) -  Oct 22, 2020   
    P1,  N=10, Recruiting, 
    Future steps are to track inflammation induced by viral infection by RNAseq, and to find potential therapeutic interventions (including blocking PD1:PD-L1 axis) to mitigate therapy resistance in this preclinical model. Not yet recruiting --> Recruiting
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment change:  PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) -  Oct 22, 2020   
    P1,  N=18, Recruiting, 
    Not yet recruiting --> Recruiting N=12 --> 18
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment open:  PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) -  Sep 11, 2020   
    P1,  N=12, Recruiting, 
    Ethics Approval This study (NCT03712358) was approved by WIRB; ID 20181772. Active, not recruiting --> Recruiting
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment closed:  PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) -  Jun 18, 2020   
    P2,  N=122, Active, not recruiting, 
    Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
  • ||||||||||  PVS-RIPO / Istari Oncology
    Oncolytic poliovirus immunotherapy for breast cancer  (Board Number: P1366) -  Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_1844;    
    We observed that intratumor PVSRIPO followed by surgery effectively controls tumor growth and prevents tumor regrowth following tumor rechallenge, suggesting induction of a systemic immune response. We are now testing neoadjuvant PVSRIPO with anti-PD1/-PDL1 in murine models of cancer.
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment closed:  PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) -  Apr 7, 2020   
    P1,  N=12, Active, not recruiting, 
    We are now testing neoadjuvant PVSRIPO with anti-PD1/-PDL1 in murine models of cancer. Recruiting --> Active, not recruiting
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Trial completion date, Trial primary completion date:  PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) -  Mar 12, 2020   
    P2,  N=122, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2021 --> Aug 2023
  • ||||||||||  PVS-RIPO / Istari Oncology
    Journal:  Genetically stable poliovirus vectors activate dendritic cells and prime antitumor CD8 T cell immunity. (Pubmed Central) -  Feb 14, 2020   
    PVSRIPO vectors infect, activate, and induce epitope presentation in DCs in vitro; they recruit and activate DCs with Th1-dominant cytokine profiles at the injection site in vivo. They efficiently prime tumor antigen-specific CD8 T cells in vivo, induce CD8 T cell migration to the tumor site, delay tumor growth and enhance survival in murine tumor models.
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology, Tecentriq (atezolizumab) / Roche
    Enrollment change, Trial withdrawal, Combination therapy:  Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma (clinicaltrials.gov) -  Jan 30, 2020   
    P1b/2,  N=0, Withdrawn, 
    They efficiently prime tumor antigen-specific CD8 T cells in vivo, induce CD8 T cell migration to the tumor site, delay tumor growth and enhance survival in murine tumor models. N=31 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Opdivo (nivolumab) / BMS, lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment change, Trial withdrawal:  PVSRIPO in Combination With Nivolumab in Melanoma (clinicaltrials.gov) -  Jan 27, 2020   
    P1,  N=0, Withdrawn, 
    N=31 --> 0 | Not yet recruiting --> Withdrawn N=30 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Opdivo (nivolumab) / BMS, lerapolturev (PVS-RIPO) / Istari Oncology
    Trial initiation date:  PVSRIPO in Combination With Nivolumab in Melanoma (clinicaltrials.gov) -  Dec 19, 2019   
    P1,  N=30, Not yet recruiting, 
    N=30 --> 0 | Not yet recruiting --> Withdrawn Initiation date: Dec 2019 --> Jun 2020
  • ||||||||||  PVS-RIPO / Istari Oncology
    Genetically Stable Poliovirus Vector Platform for DIPG Immunotherapy (Ballroom Lawn) -  Oct 29, 2019 - Abstract #SNO2019SNO_1071;    
    They efficiently prime tumor antigen-specific CD8 T cells in vivo,induce CD8 T cell migration to the tumor site, delay tumor growth and enhance survival in syngeneic rodent tumor models. We are preparing a prototype PVSRIPO-derived vector delivering the H3.3(K27M) signature for clinical investigation.
  • ||||||||||  PVS-RIPO / Istari Oncology
    ATRX mutations predict response to innate based therapy in glioma. (Wildflower A) -  Oct 29, 2019 - Abstract #SNO2019SNO_897;    
    CONCLUSION Our data suggests that ATRX mutations may confer sensitivity to RNA-based innate immune signaling agonists in gliomas. This potential vulnerability can be targeted in future therapies.
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology, Tecentriq (atezolizumab) / Roche
    Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy:  Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma (clinicaltrials.gov) -  Oct 21, 2019   
    P1b/2,  N=31, Not yet recruiting, 
    This potential vulnerability can be targeted in future therapies. Trial completion date: Sep 2023 --> Jan 2024 | Initiation date: Oct 2019 --> Feb 2020 | Trial primary completion date: Sep 2023 --> Jan 2024
  • ||||||||||  Opdivo (nivolumab) / BMS, lerapolturev (PVS-RIPO) / Istari Oncology
    New P1 trial:  PVSRIPO in Combination With Nivolumab in Melanoma (clinicaltrials.gov) -  Oct 13, 2019   
    P1,  N=30, Not yet recruiting, 
  • ||||||||||  PVS-RIPO / Istari Oncology
    Journal:  Recombinant Poliovirus for Cancer Immunotherapy. (Pubmed Central) -  Sep 18, 2019   
    In this review, we explain the mechanisms of recombinant nonpathogenic poliovirus, PVSRIPO, which is currently in phase I clinical trials against recurrent glioblastoma. We focus on an unusual host:virus relationship defined by the simple and cytotoxic replication strategy of poliovirus, which generates inflammatory perturbations conducive to tumor antigen-specific immune priming.
  • ||||||||||  paclitaxel / Generic Mfg.
    Clinical, Review, Journal:  Convection-Enhanced Delivery in Malignant Gliomas: A Review of Toxicity and Efficacy. (Pubmed Central) -  Aug 22, 2019   
    With this treatment, patients who received CED of the chemotherapeutic agent paclitaxel and immunomodulator, oligodeoxynucleotides containing CpG motifs (CpG-ODN), experienced intolerable toxicity. Toward the end of this article, an ideal CED treatment procedure is proposed and the methods for quality assurance of the CED procedure are discussed.
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment change, Combination therapy:  PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) -  Jan 11, 2019   
    P2,  N=102, Recruiting, 
    Toward the end of this article, an ideal CED treatment procedure is proposed and the methods for quality assurance of the CED procedure are discussed. N=62 --> 102
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Trial initiation date, Oncolytic virus:  Examining Bioactivity of PVSRIPO in Invasive Breast Cancer (clinicaltrials.gov) -  Jan 11, 2019   
    P1,  N=6, Recruiting, 
    N=62 --> 102 Initiation date: Nov 2018 --> Feb 2019
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment open:  PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov) -  Nov 28, 2018   
    P1,  N=9, Recruiting, 
    Initiation date: Nov 2018 --> Feb 2019 Not yet recruiting --> Recruiting
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment open, Oncolytic virus:  Examining Bioactivity of PVSRIPO in Invasive Breast Cancer (clinicaltrials.gov) -  Aug 31, 2018   
    P1,  N=6, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Trial completion date:  PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) -  Mar 3, 2018   
    P1,  N=61, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Jan 2018 --> Dec 2018
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Trial primary completion date:  PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) -  Sep 12, 2017   
    P1,  N=61, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial primary completion date: Oct 2017 --> Jun 2017
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Trial initiation date, Trial primary completion date:  PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) -  Aug 3, 2017   
    P1,  N=61, Active, not recruiting, 
    Trial primary completion date: Oct 2017 --> Jun 2017 Initiation date: Jan 2012 --> Apr 2012 | Trial primary completion date: Jun 2017 --> Oct 2017
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment closed:  PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) -  Jun 14, 2017   
    P1,  N=61, Active, not recruiting, 
    Initiation date: Jan 2012 --> Apr 2012 | Trial primary completion date: Jun 2017 --> Oct 2017 Recruiting --> Active, not recruiting
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Enrollment open, Combination therapy:  PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) -  Jun 5, 2017   
    P2,  N=62, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Trial primary completion date:  PVSRIPO for Recurrent Glioblastoma (GBM) (clinicaltrials.gov) -  Feb 27, 2017   
    P1,  N=65, Recruiting, 
    Not yet recruiting --> Recruiting Trial primary completion date: Jan 2017 --> Jul 2017
  • ||||||||||  lerapolturev (PVS-RIPO) / Istari Oncology
    Combination therapy:  PVSRIPO in Recurrent Malignant Glioma (clinicaltrials.gov) -  Dec 8, 2016   
    P2,  N=62, Not yet recruiting,