Key Publications
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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
Ewing’s
No items found.
Hepatocellular
No items found.
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
Long Term Follow Up: Phase I Trial of “bi-shRNA furin/GMCSF DNA/ Autologous Tumor Cell” Immunotherapy (FANG™) in Advanced Cancer
Oct 2013
— by
Senzer N, Barve M, Nemunaitis J, Kuhn J, Melnyk A, et al.
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
Head and Neck
No items found.
Lung Cancer
No items found.
Prostate Cancer
No items found.
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
Pancreatic
No items found.
Melanoma
No items found.
Low Dose
No items found.






