Key Publications
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Ovarian
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.
ENTPD1/CD39 as a predictive marker of treatment response to gemogenovatucel-T as maintenance therapy in newly diagnosed ovarian cancer
Aug 2022
— by
Rocconi, R.P., Stanbery, L., Tang, M. et al.
Network based analysis identifies TP53m-BRCA1/2wt-homologous recombination proficient (HRP) population with enhanced susceptibility to Vigil immunotherapy
Nov 2021
— by
Sliheet, E; Robinson, M; Morand, S; Choucair, K; Willoughby, D; Stanbery, L; Aaron, P, Bognar, E; Nemunaitis, J
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
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.
Pilot Study of recurrent Ewing's Sarcoma management with Vigil/Temozolomide/Irinotecan and assessment of circulating tumor (ct) DNA
Feb 2023
— by
Anderson, P., Ghisoli, M., Crompton, B. D., Klega, K. S., Wexler, L. H., Slotkin, E. K., Stanbery, L., Manning, L., Wallraven, G., Manley, M., Horvath, S., Bognar, E., & 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
Preclinical Justification of pbi-shRNA EWS/FLI1 Lipoplex (LPX) Treatment for Ewing's Sarcoma
May 2016
— by
Rao D, Jay C, Wang Z, Luo X, Kumar P, Eysenbach H, Ghisoli M, Senzer N, NemunaitisJJ
Three-year Follow up of GMCSF/bi-shRNAfurin DNA-transfected Autologous Tumor Immunotherapy (Vigil) in Metastatic Advanced Ewing's Sarcoma
Apr 2016
— by
Ghisoli M, Barve M, Mennel R, Lenarsky C, Horvath S, Wallraven G, Pappen BO, Whiting S, Rao D, Senzer N, Nemunaitis J
Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma
Mar 2015
— by
Ghisoli M, Barve M, Schneider R, Mennel R, Lenarsky C, Wallraven G, Pappen BO, LaNoue J, Kumar P, Nemunaitis D, Roth A, Nemunaitis J, Whiting S, Senzer N, Fletcher FA, Nemunaitis J
Ewing’s Sarcoma: Development of RNA Interference Based Therapy for Advanced Disease
Mar 2012
— by
Simmons O, Maples PB, Senzer N, Nemunaitis J
Hepatocellular
No items found.
Phase 1 Advanced Solid Tumor
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.
3D engineered scaffold for large-scale Vigil immunotherapy production
Jul 2024
— by
Kerneis F, Bognar E, Stanbery L, Moon S, Kim DH, Deng Y, Hughes E, Chun TH, Tharp D, Zupanc H, Jay C, Walter A, Nemunaitis J, Lahann J
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.
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.
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
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
Preclinical Biodistribution and Safety Evaluation of a pbi-shRNA STMN1 Lipoplex after Subcutaneous Delivery
Nov 2016
— by
Wang Z, Jay C, Evans C, Kumar P, Phalon C, Rao D, Senzer N, Nemunaitis J
Safety and Efficacy in Advanced Solid Tumors of a Targeted Nanocomplex Carrying the p53 Gene Used in Combination with Docetaxel: A Phase 1b Study
Sep 2016
— by
Pirollo K, Nemunaitis J, Leung PK, Nunan R, Adams J, Chang EH
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.
Immune response and survival of refractory cancer patients who received TGF-β2 antisense/GM-CSF gene modified autologous tumor cell (TAG) vaccine
Mar 2013
— by
Nemunaitis J, Senzer N, Olivares J, Kumar P, Barve M, Kuhn J, Nemunaitis T, Magee M, Yu Y, Wallraven G, Pappen BO, Maples PB
Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer
Dec 2011
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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
In vivo Safety and Antitumor Efficacy of Bifunctional Small Hairpin RNAs Specific for the Human Stathmin 1 Oncoprotein
Sep 2011
— by
Phadke AP, Jay CM, Wang Z, Chen S, Liu S, Haddock C, Kumar P, Pappen BO, Rao DD, Templeton NS, Daniels EQ, Webb C, Monsma D, Scott S, Dylewski D, Frieboes HB, Brunicardi FC, Senzer N, Maples PB, Nemunaitis J, Tong AW
Applications of HPLC-MALDI-TOF MS/MS Phosphoproteomic Analysis in Oncological Clinical Diagnostics
Jul 2011
— by
Haddock CL, Holtz B, Senzer N, Nemunaitis J
Phase I Trial of TGF-β2 Antisense GM-CSF Gene-Modified Autologous Tumor Cell (TAG) Vaccine
Jan 2011
— by
Olivares J, Kumar P, Yu Y, Maples PB, Senzer N, Bedell C, Barve M, Tong A, Pappen BO, Kuhn J, Magee M, Wallraven G, Nemunaitis J
Head and Neck
Relationships of clinical response to relevant molecular signal during Phase I testing of Aurora Kinase A inhibitor: Retrospective assessment
Aug 2015
— by
Nemunaitis J, Blend C, Bien-Willner G, Degele M, Roth A, Hayes S, Plato L, Guo A, Nemunaitis J, Jackson DB, Senzer N
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.
Immune response and survival of refractory cancer patients who received TGF-β2 antisense/GM-CSF gene modified autologous tumor cell (TAG) vaccine
Mar 2013
— by
Nemunaitis J, Senzer N, Olivares J, Kumar P, Barve M, Kuhn J, Nemunaitis T, Magee M, Yu Y, Wallraven G, Pappen BO, Maples PB
Lung Cancer
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.
Induction of Immune Responses and Clinical Efficacy in a Phase II Trial of IDM-2101, a 10-Epitope Cytotoxic T-Lymphocyte Vaccine, in Metastatic Non–Small-Cell Lung Cancer
Sep 2016
— by
Barve M, Bender J, Senzer N, Cunningham C, Greco FA, McCune D, Steis R, Khong H, Richards D, Stephenson J, Ganesa P, Nemunaitis J, Ishioka G, Pappen B, Nemunaitis M, Morse M, Mills B, Maples PB, Sherman J, Nemunaitis J
Phase II trial of Belagenpumatucel-L, a TGF-β2 antisense gene modified allogeneic tumor vaccine in advanced non small cell lung cancer (NSCLC) patients
Mar 2009
— by
Nemunaitis J, Nemunaitis M, Senzer N, Snitz P, Bedell C, Kumar P, Pappen B, Maples PB, Shawler D, Fakhrai H
Prostate Cancer
MicroRNA profile analysis of human prostate cancers
Oct 2008
— by
Tong AW, Fulgham P, Jay C, Chen P, Khalil I, Liu S, Senzer N, Eklund AC, Han J, 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
Pancreatic
KRAS mutant allele-specific expression knockdown in pancreatic cancer model with systemically delivered bi-shRNA KRAS lipoplex
May 2018
— by
Rao DD, Luo X, Wang Z, Jay CM, Brunicardi FC, Maltese WA, Manning LM, Senzer N, Nemunaitis J
Metformin Restrains Pancreatic Duodenal Homeobox-1 (PDX-1) Function by Inhibiting ERK Signaling in Pancreatic Ductal Adenocarcinoma
Jan 2016
— by
Zhou G, Yu J, Wang A, Liu SH, Sinnett-Smith J, Wu J, Sanchez R, Nemunaitis J, Ricordi C, Rozengurt E, Brunicardi FC
Melanoma
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.
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
Low Dose
3D engineered scaffold for large-scale Vigil immunotherapy production
Jul 2024
— by
Kerneis F, Bognar E, Stanbery L, Moon S, Kim DH, Deng Y, Hughes E, Chun TH, Tharp D, Zupanc H, Jay C, Walter A, Nemunaitis J, Lahann 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
