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Ovarian

  • Gemogenovatucel-T Advantage in Clonal Tumor Mutation Burden–High Ovarian Cancer
    Jan 2026
    — by
    Robert L. Coleman, MD, Rodney Rocconi, MD, Bradley J. Monk, MD, Adam Walter, MD, Laura Stanbery, PhD, David Willoughby, PhD, Casey Nagel, PhD, Qi Wei, PhD, Gladice Wallraven, BS , Staci Horvath, BS, Min Tang, PhD, Donald Rao, PhD, Ernest Bognar, BS, and John Nemunaitis, MD
  • Exome sequencing shows same pattern of clonal tumor mutational burden, intratumor heterogenicity and clonal neoantigen between autologous tumor and Vigil product
    Mar 2025
    — by
    Willoughby, D., Bognar, E., Stanbery, L., Nagel, C., Wallraven, G., Pruthi, A., Bild, N., Stamper, E., Rao, D., Walter, A., Nemunaitis, J.
  • Repair Assisted Damage Detection (RADD) as a predictive biomarker for immunotherapy response in ovarian cancer
    Jan 2025
    — by
    Manoj Sonavane, Jenna Hedlich-Dwyer, Valeria L. Dal Zotto, Min Tang, John Nemunaitis, Laura Stanbery, Adam Walter, Ernest Bognar, Rodney P. Rocconi, Natalie R. Gassman
  • Gemogenovatucel-T (Vigil): bi-shRNA plasmid-based targeted immunotherapy
    Aug 2024
    — by
    Nemunaitis, J., Stanbery, L., Walter, A., Wallraven, G., Nemunaitis, A., Horvath, S., Bognar, E., Rao, D., Engle, S., Brun, S., Ghisoli, M., Rocconi, R., Monk, B., Coleman, R. L.
  • Clonal Neoantigen: Emerging “Mechanism-based” Biomarker of Immunotherapy Response
    Nov 2023
    — by
    Nemunaitis, J.; Stanbery, L.; Willoughby, D.; Bognar, E.; Brun, S.; Walter, A.; Monk, B.J.; Rocconi, R.P.; Choucair, K.; Coleman, R.L.
  • Gemogenovatucel-T (Vigil) maintenance immunotherapy: 3-year survival benefit in homologous recombination proficient (HRP) ovarian cancer
    Oct 2021
    — by
    Walter, A; Rocconi, RP; Monk, BJ; Herzog, TJ; Manning, L; Bognar, E; Wallraven, G; Aaron, P; Horvath, S; Tang, M; Stanbery, L; Coleman, RL; Nemuanitis, J
  • Long-Term Follow-Up of Gemogenovatucel-T (Vigil) Survival and Molecular Signals of Immune Response in Recurrent Ovarian Cancer
    Aug 2021
    — by
    Rocconi, R.P.; Stanbery, L.; Madeira da Silva, L.; Barrington, R.A.; Aaron, P.; Manning, L.; Horvath, S.; Wallraven, G.; Bognar, E.; Walter, A.; Nemunaitis, J.
  • Proof of principle study of sequential combination atezolizumab and Vigil in relapsed ovarian cancer
    Mar 2021
    — by
    Rocconi RP, Stevens EE, Bottsford-Miller JN, Ghamande SA, Elder J, DeMars LL, MunkarahA, Aaron P, Stanbery L, Wallraven G, Bognar E, Manley M, Horvath S, Manning L,Walter A, Galanis E, Herzog T, Monk BJ, Coleman RL, Nemunaitis J.
  • Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer
    Mar 2021
    — by
    Rocconi RP, Monk BJ, Walter A, Herzog TJ, Galanis E, Manning L, Bognar E, Wallraven G, Stanbery L, Aaron P, Senzer N, Coleman RL, Nemunaitis J.
  • Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial
    Dec 2020
    — by
    Rocconi R, Grosen E, Ghamande S, Chan J, Barve M, Oh J, Tewari D, Morris P, Stanberry L, Horvath S, Wallraven G, Bognar E, Manning L, Nemunaitis J, Shanahan D, Slomovitz B, Herzog T, Monk B, Coleman R
  • Long-term Follow-up of Phase 2A Trial Results Involving Advanced Ovarian Cancer Patients Treated with Vigil® in Frontline Maintenance
    Sep 2020
    — by
    Oh J, Barve M, Senzer N, Aaron P, Manning L, Wallraven G, Bognar E, Stanbery L, Horvath S, Manley M, Nemunaitis J, Walter A, Rocconi RP
  • Phase II Study of Vigil DNA Engineered Immunotherapy as Maintenance in Advanced Stage Ovarian Cancer. Gynecologic Oncology
    Dec 2016
    — by
    Oh J, Barve M, Matthews CM, Koon EC, Heffernan EP, Fine B, Grosen E, Bergman MK, Fleming EL, DeMars LR, West L, Spitz DL, Goodman H, Hancock KC, Wallraven G, Kumar P, Bognar E, Manning L, Pappen BO, Adams N, Senzer N, Nemunaitis J

    Phase 1 Advanced Solid Tumor

    • Clonal Neoantigen: Emerging “Mechanism-based” Biomarker of Immunotherapy Response
      Nov 2023
      — by
      Nemunaitis, J.; Stanbery, L.; Willoughby, D.; Bognar, E.; Brun, S.; Walter, A.; Monk, B.J.; Rocconi, R.P.; Choucair, K.; Coleman, R.L.

    • Vigil: Personalized Immunotherapy Generating Systemic Cytotoxic T Cell Response
      Oct 2020
      — by
      Herron J, Smith N, Stanbery L, Aaron P, Manning L, Bognar E, Wallraven G, Horvath S, Nemunaitis J

    • Case Report: Immune-mediated Complete Response in a Patient With Recurrent Advanced Ewing Sarcoma (EWS) After Vigil Immunotherapy
      May 2017
      — by
      Ghisoli M, Rutledge M, Stephens P, Mennel R, Barve M, Manley M, Oliai B, Murphy K, Manning L, Gutierrez B, Rangadass P, Walker A, Wang Z, Rao D, Adams N, Wallraven G, Senzer N, Nemunaitis J

    • Assessment of Low Dose Vigil® Engineered Autologous Tumor Cell (EATC) Immunotherapy in Patients with Advanced Solid Tumors
      Apr 2017
      — by
      Manning L, Barve M, Wallraven G, Kumar P, Taquet N, Bognar E, Mendeloff E, Oh J, Rao D, Pappen BO, Senzer N, Nemunaitis J

    • Follow-up of bi-shRNA furin / GM-CSF Engineered Autologous Tumor Cell (EATC) Immunotherapy Vigil® in patients with advanced melanoma
      Sep 2016
      — by
      Barve M, Kuhn J, Lamont J, Beitsch P, Manning L, Pappen BO, KumarP, Wallraven G, Senzer N, Nemunaitis J

    • Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer
      Dec 2011
      — by
      Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J

      Hereditary Inclusion Body Myopathy

      • Hereditary Inclusion Body Myopathy: Single Patient Response to Intravenous Dosing of GNE Gene Lipoplex
        Feb 2011
        — by
        Nemunaitis G, Jay CM, Maples PB, Gahl WA, Huizing M, Yardeni T, Tong AW, Phadke AP, Pappen BO, Bedell C, Allen H, Hernandez C, Templeton NS, Kuhn J, Senzer N, Nemunaitis J

      • Hereditary inclusion body myopathy: single patient response to GNE gene Lipoplex therapy
        Mar 2010
        — by
        Nemunaitis G, Maples PB, Jay C, Gahl WA, Huizing M, Poling J, Tong AW, Phadke AP, Pappen BO, Bedell C, Templeton NS, Kuhn J, Senzer N, Nemunaitis J

      • Safety and in vivo Expression of a GNE-Transgene: A Novel Treatment Approach for Hereditary Inclusion Body Myopathy-2
        May 2009
        — by
        Phadke AP, Jay C, Chen SJ, Haddock C, Wang Z, Yu Y, Nemunaitis D, Nemunaitis G, Templeton NS, Senzer N, Maples PB, Tong AW, Nemunaitis J

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