Key Publications
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Ovarian
- 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 demonstrates clinical benefit in homologous recombinationproficient (HRP) ovarian Cancer. Gynecologic Oncology. In Press
- 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. Proof of Principle Study of SequentialCombination Atezolizumab and Vigil in Relapsed Ovarian Cancer. Cancer Gene Therapy. In Press.
- 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. Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial. The Lancet Oncology, 2020 December; Volume 21, Issue 12: Pages 1661-1672
- 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. Long-term Follow-up of Phase 2A Trial ResultsInvolving Advanced Ovarian Cancer Patients Treated with Vigil® in FrontlineMaintenance. Gynecologic Oncology Reports. 2020; 17(34).
- 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 II Study of Vigil DNA Engineered Immunotherapy as Maintenance in Advanced Stage Ovarian Cancer. Gynecologic Oncology. 2016; 143: 504–510
Ewing’s
- 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. Case Report: Immune Mediated Complete Response in a Patient with Recurrent Advanced Ewing’s Sarcoma (EWS) Following Vigil® Immunotherapy. Journal of Pediatric Hematology/Oncology J Pediatr Hematol Oncol. 2017 May;39(4):e183-e186
- Rao D, Jay C, Wang Z, Luo X, Kumar P, Eysenbach H, Ghisoli M, Senzer N, NemunaitisJJ. Preclinical Justification of pbi-shRNA EWS/FLI1 Lipoplex (LPX) Treatment for Ewing’s Sarcoma. Molecular Therapy. 2016 Aug;24(8):1412-22.
- Ghisoli M, Barve M, Mennel R, Lenarsky C, Horvath S, Wallraven G, Pappen BO, Whiting S, Rao D, Senzer N, Nemunaitis J. Three Year Follow up of GMCSF/bi-shRNA(furin) DNA Transfected Autologous Tumor Immunotherapy (Vigil(™)) in Metastatic Advanced Ewing's Sarcoma. Mol Ther. 2016 Aug;24(8):1478-83
- 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. Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma. Mol Ther. 2015 Jun;23(6):1103-9. doi: 10.1038/mt.2015.43. Epub 2015 Mar 19.
- Simmons O, Maples PB, Senzer N, Nemunaitis J: Ewing’s Sarcoma: Development of RNA Interference Based Therapy forAdvanced Disease. ISRN Oncology 2012;2012:247657. 10.5402/2012/247657
Hepatocellular
Phase 1 Advanced Solid Tumor
- Herron J, Smith N, Stanbery L, Aaron P, Manning L, Bognar E, Wallraven G, Horvath S,Nemunaitis J. Vigil: PersonalizedImmunotherapy Generating Systemic Cytotoxic T cell Response. Cancer Science and Research. 2020; 3(1): 1-4.
- Pirollo K, Nemunaitis J, Leung PK, Nunan R, Adams J, Chang EH. Safety and Efficacy in Advanced Solid Tumorsof Docetaxel in Combination with a Targeted Nanocomplex Carrying the p53 Gene: A Phase Ib Study. Molecular Therapy 2016 Sept;24(9):1697-1706.
- Haddock CL, Holtz B, Senzer N, Nemunaitis J: Applications of HPLC-MALDI-TOF MS/MS Phosphoproteomic Analysis inOncological Clinical Diagnostics. Current Proteomics 2011 Jul; 8(2): 153-167.
- 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: In vivo Safety and Antitumor Efficacy of Bifunctional Small Hairpin RNAs Specific for the Human Stathmin 1 Oncoprotein. DNA and Cell Biology 2011Sep; 30(9):715-726.
- 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: Phase I Trial of TGF-β2 Antisense-GMCSF Gene Modified Autologous TumorCell (TAG) Vaccine. Clinical Cancer Research 2011 Jan 1: 17(1):183-192.
- 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. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.
- Senzer N, Barve M, Nemunaitis J, Kuhn J, Melnyk A, et al. (2013) Long Term Follow Up: Phase I Trial of “bi-shRNA furin/GMCSF DNA/Autologous Tumor Cell” Immunotherapy (FANG™) in Advanced Cancer. J Vaccines Vaccine 2013; 4: 209. doi: 10.4172/2157-7560.1000209
Head and Neck
- Manning L, Barve M, Wallraven G, Kumar P, Taquet N, Bognar E, Mendeloff E, Oh J, Rao D, Pappen BO, Senzer N, Nemunaitis J. Assessment of Low Dose Vigil® EngineeredAutologous Tumor Cell (EATC) Immunotherapy in Patients with Advanced SolidTumors. Clinics in Oncology. 2017 April 3; 2:1254.
- Nemunaitis J, Blend C, Bien-Willner G, Degele M, Roth A, Hayes S, Plato L, Guo A, Nemunaitis J, Jackson DB, Senzer N. Relationships of Clinical Response to Relevant Molecular Signal DuringPhase I Testing of Aurora Kinase A Inhibitor: Retrospective Assessment. Integrative Molecular Medicine 2015; 2(5):331-337.
- Senzer N, Barve M, Nemunaitis J, Kuhn J, Melnyk A, Beitsch P, Magee M, Oh J, Bedell C,Kumar P, Rao D, Pappen B, Wallraven G, Brunicardi FC, Maples P, Nemunaitis J.Long Term Follow Up: Phase I Trial of “bi-shRNA furin/GMCSF DNA/Autologous Tumor Cell” Immunotherapy (FANG™) in Advanced Cancer. Journal of Vaccines &Vaccination 2013; 4(8):209
- Nemunaitis J, Senzer N, Olivares J, Kumar P, Barve M, Kuhn J, Nemunaitis T, Magee M, Yu Y,Wallraven G, Pappen BO, Maples PB: Immune Response and Survival of Refractory Cancer Patients Who ReceivedTGF-β2 Antisense/GM-CSF Gene Modified Autologous Tumor Cell (TAG) Vaccine. Gene Therapy 2013 Sep; 20(9):875-9.
Lung Cancer
- Nemunaitis J, Nemunaitis M, Senzer N, Snitz P, Bedell C, Kumar P, Pappen B, Maples PB,Shawler D, Fakhrai H: Phase II Trial ofBelagenpumatucel-L, a TGF-β2 Antisense Gene Modified Allogeneic Tumor Vaccine in Advanced Non Small Cell Lung Cancer (NSCLC) Patients. Cancer Gene Therapy 2009 Aug; 16(8):620-624.
- 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: Induction of Immune Responses and ClinicalEfficacy in a Phase II Trial of IDM-2101, a 10-Epitope Cytotoxic T-LymphocyteVaccine, in Metastatic Non—Small-Cell Lung Cancer. Journal of Clinical Oncology 2008 Sept 20;26(27):4418-4425.
- Nemunaitis J, Dillman RO, Schwarzenberger PO, Senzer N, Cunningham C, Cutler J, Tong A, Kumar P, Pappen B, Hamilton C, DeVol E, Maples PB, Liu L, Chamberlin T, Shawler DL, Fakhrai H: Phase II Study of Belagenpumatucel-L,a Transforming Growth Factor Beta-2 Antisense Gene-Modified Allogeneic TumorCell Vaccine in Non-Small-Cell Lung Cancer. Journal of Clinical Oncology 2006 Oct 10; 24(29):4721-4730
Prostate Cancer
Hereditary Inclusion Body Myopathy
- Nemunaitis G, Jay CM, Maples PB, Gahl WA, Huizing M, Yardeni T, Tong AW, Phadke AP, PappenBO, Bedell C, Allen H, Hernandez C, Templeton NS, Kuhn J, Senzer N, Nemunaitis J: Hereditary Inclusion BodyMyopathy: Single Patient Response toIntravenous Dosing of GNE Gene Lipoplex. Human Gene Therapy 2011 Nov; 22(11):1331-1341
- 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: Hereditary Inclusion Body Myopathy: Single Patient Response to GNE Gene Lipoplex Therapy. The Journal of Gene Medicine2010 May; 12(5):403-412.
- 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: Safety and in vivo Expression of a GNE-Transgene: A Novel Treatment Approach for Hereditary Inclusion Body Myopathy-2. Gene Regulation and Systems Biology 2009 May8; 3:89-101.
Pancreatic
- Rao DD, Luo X, Wang Z, Jay CM, Brunicardi FC, Maltese WA, Manning LM, Senzer N, Nemunaitis J. KRAS mutant allele-specific expression knockdown in pancreatic cancer model with systemically delivered bi-shRNA KRAS lipoplex. PLOS One. 2018May;13(5): e0193644.
- Wang Z, Jay C, Evans C, Kumar P, Phalon C, Rao D, Senzer N, Nemunaitis J. Preclinical Biodistribution and Safety Evaluation of a pbi-shRNA STMN1 Lipoplex after Subcutaneous Delivery. Toxicological Sciences. 2016 November 4;155(2):400-408.
- Zhou G, Yu J, Wang A, Liu SH, Sinnett-Smith J, Wu J, Sanchez R, Nemunaitis J, Ricordi C, Rozengurt E, Brunicardi FC. Metformin Restrains Pancreatic Duodenal Homeobox-1 (PDX-1) Function byInhibiting ERK Signaling in Pancreatic Ductal Adenocarcinoma. Curr Mol Med. 2016;16(1):83-90.
