Publications

Adagrasib (MRTX849) is an oral, highly selective, small-molecule, covalent inhibitor of KRASG12C. We report results from a phase I/IB study of adagrasib in non–small-cell lung cancer, colorectal cancer, and other solid tumors harboring the KRASG12C mutation.

BETA PRIME, a phase I clinical trial, will study AdAPT-001, an oncolytic adenovirus that carries a TGF-β ‘trap’ +/- a checkpoint inhibitor with the ultimate objective to turn ‘cold’ tumors ‘hot’ and increase response rates.

Gemogenovatucel-T (Vigil) is a triple-function autologous tumor cell immunotherapy which expresses granulocyte-macrophage colony-stimulating factor and decreases expression of furin and downstream TGF-β1 and TGF-β2. Vigil has suggested survival benefit in frontline maintenance ovarian cancer patients who are BRCA-wt. In addition, Vigil demonstrates relapse-free and overall survival advantage in homologous recombination-proficient patients with OC. Further evidence of clinical benefit and safety has been demonstrated in combination with atezolizumab.

See Mary Crowley featured in the New England Journal of Medicine.

Covalent Bruton’s tyrosine kinase (BTK) inhibitors are efficacious in multiple B-cell malignancies, but patients discontinue these agents due to resistance and intolerance. We evaluated the safety and efficacy of pirtobrutinib (working name; formerly known as LOXO-305), a highly selective, reversible BTK inhibitor, in these patients. Pirtobrutinib was safe and active in multiple B-cell malignancies, including patients previously treated with covalent BTK inhibitors. Pirtobrutinib might address a growing unmet need for alternative therapies for these patients.

Cantrixil is a novel third-generation benzopyran molecule, with potent cytotoxicity against chemoresistant ovarian cancer stem cells and chemosensitive ovarian cancer cell lines. The aims of this Phase I study were to define the maximum tolerated dose, tolerability, and antitumor activity of Cantrixil when administered via an intraperitoneal (IP) port. Cantrixil was tolerable even in patients with heavily pretreated disease. This first in-human study has demonstrated the potential for prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cells to standard chemotherapy with IP-administered Cantrixil.

Telisotuzumab vedotin (Teliso-V) is an antic-Met–directed antibody-drug conjugate that has exhibited antitumor activity as monotherapy in NSCLC. Its potential activity combined with programmed cell death protein-1 inhibitors has not been previously evaluated.

Colorectal cancer is the third most diagnosed cancer in the United States. Five-year survival rates remain low and many patients will develop liver metastasis. Vigil is an immunotherapy manufactured from autologous tumor cells and transfected ex vivo with a plasmid that encodes the GM-CSF gene and bifunctional shRNA construct to knockdown furin. Here, we report two patients with colorectal cancer and resectable liver metastasis entered into a clinical trial involving Vigil in combination with standard of care modified FOLFOX-6 chemotherapy.

Telisotuzumab vedotin (Teliso-V) is an antic-Met–directed antibody-drug conjugate that has exhibited antitumor activity as monotherapy in NSCLC. Its potential activity combined with programmed cell death protein-1 inhibitors has not been previously evaluated. Combination therapy with Teliso-V plus nivolumab was well tolerated in patients with c-Metþ NSCLC with limited antitumor activity.

Entrectinib is a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, which has been shown to have anti-tumour activity against NTRK gene fusion-positive solid tumours, including CNS activity due to its ability to penetrate the blood–brain barrier. We present an integrated efficacy and safety analysis of patients with metastatic or locally advanced solid tumours harbouring oncogenic NTRK1, NTRK2, and NTRK3 gene fusions treated in three ongoing, early-phase trials.

Small cell lung cancer (SCLC) is a leading cause of cancer death worldwide, with few treatment options. Rovalpituzumab tesirine (Rova-T) is an antibody-drug conjugate that targets delta-like 3 on SCLC cells to deliver a cytotoxic payload directly to tumor cells. In this study, the cardiac safety profile of Rova-T was assessed by evaluating changes in QT interval, electrocardiogram (ECG) waveform, heart rate, and proarrhythmic adverse events (AEs) after treatment with Rova-T in patients with previously treated extensive-stage SCLC.

Sarina A. Piha-Paul, Jasgit C. Sachdev, Minal Barve, Patricia LoRusso, Russell Szmulewitz, Sapna Pradyuman Patel, Primo N. Lara, Jr., Xiaotian Chen, Beibei Hu, Kevin J. Freise, Dimple Modi, Anjla Sood, Jessica E. Hutti, Johannes Wolff, Bert H. O’Neil.

First-in-human Study of Mivebresib (ABBV-075), an Oral Pan-inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors.

Berglund AE, Rounbehler RJ, Gerke T, Awasthi S, Cheng CH, Takhar M, Davicioni E, Alshalalfa M, Erho N, Klein EA, Freedland SJ, Ross AE, Schaeffer EM, Trock BJ, Den RB, Cleveland JL, Park JY, Dhillon J, Yamoah K. Distinct Transcriptional Repertoire of the Androgen Receptor in ETS Fusion-negative Prostate Cancer. Prostate Cancer Prostatic Dis. 2018 Oct 26. doi: 10.1038/s41391-018-0103-4. [Epub ahead of print]

Sfanos KS, Markowski MC, Peiffer LB, Ernst SE, White JR, Pienta KJ, Antonarakis ES, Ross AE. Compositional Differences in Gastrointestinal Microbiota in Prostate Cancer Patients Treated with Androgen Axis-targeted Therapies. Prostate Cancer Prostatic Dis. 2018 Jul 9. doi: 10.1038/s41391-018-0061-x. [Epub ahead of print]

Kishan AU, Cook RR, Ciezki JP, Ross AE, Pomerantz MM, Nguyen PL, Shaikh T, Tran PT, Sandler KA, Stock RG, Merrick GS, Demanes DJ, Spratt DE, Abu-Isa EI, Wedde TB, Lilleby W, Krauss DJ, Shaw GK, Alam R, Reddy CA, Stephenson AJ, Klein EA, Song DY, Tosoian JJ, Hegde JV, Yoo SM, Fiano R, D'Amico AV, Nickols NG, Aronson WJ, Sadeghi A, Greco S, Deville C, McNutt T, DeWeese TL, Reiter RE, Said JW, Steinberg ML, Horwitz EM, Kupelian PA, King CR. Radical Prostatectomy, External Beam Radiotherapy, or External Beam Radiotherapy With Brachytherapy Boost and Disease Progression and Mortality in Patients With Gleason Score 9-10 Prostate Cancer. JAMA. 2018 Mar 6;319(9):896-905.

Ribas A, Medina T, Kummar S, Amin A, Kalbasi A, Drabick J, Barve M,  Daniels G, Wong D, Schmidt E, Candia A, Coffman R, Leung A, Janssen R. SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase Ib, Multicenter Study. 2018 Nov 1; [Epub ahead of print].

Karnes RJ, Sharma V, Choeurng V, Ashab HA, Erho N, Alshalalfa M, Trock B, Ross A, Yousefi K, Tsai H, Zhao SG, Tosoian JJ, Haddad Z, Takhar M, Chang SL, Spratt DE, Abdollah F, Jenkins RB, Klein EA, Nguyen PL, Dicker AP, Den RB, Davicioni E, Feng FY, Lotan TL, Schaeffer EM. Development and Validation of a Prostate Cancer Genomic Signature that Predicts Early ADT Treatment Response Following Radical Prostatectomy. Clin Cancer Res. 2018 Aug 15;24(16):3908-3916. Epub 2018 May 14.

Chesney J, Awasthi S, Curti B, Hutchins L, Linette G, Triozzi P, Tan M, Brown R, Nemunaitis J, Whitman E, Windham C, Lutzky J, Downey GF, Batty N, Amatruda T. Phase IIIb safety results from an expanded access protocol of talimogene laherparepvec for patient with unresected, stage IIIB-IVM1c melanoma. Melanoma Research. 2018 Feb; 28(1):44-51.

Burris H, Infante J, Ansell SM, Nemunaitis J, Weiss GR, Villalobos VM, Sikic BI, Taylor MH, Northfelt DW, Carson WE, Hawthorne TR, Davis TA, Yellin MJ, Keler T, Bullock T.  Safety and Activity of Varlilumab, a Novel and First-in-Class Agonist Anti-CD27 Antibody, in Patients with Advanced Solid Tumors.  Journal of Clinical Oncology. Jun 20;35(18):2028-2036.

Hanley MJ, Gupta N, Venkatakrishnan K, Bessudo A, Sharma S, O’Neil BH, Wang B, Van De Velde H, Nemunaitis J. A Phase 1 Study to Assess the Relative Bioavailability of Two Capsule Formulations of Ixazomib, an Oral Proteasome Inhibitor, in Patients with Advanced Solid Tumors or Lymphoma. Journal of Clinical Pharmacology. 2018 Jan;58(1):114-121.

Barve M, Barve R, Rao D, Rao J, Manning L, Adams N, Senzer N, Nemunaitis J. Case Report: Vigil Therapy in Pathology Defined High-Risk Differentiated Thyroid Cancer Compounded by Post Ablation High-Risk Factors. Journal of Surgical Oncology and Clinical Research. 2017; 1(1):1005.

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. 2017 May;39(4):e183-186.

Gupta N, Hanley MJ, Venkatakrishnan K, Bessudo A, Rasco DW, Sharma S, O’Neil BH, Wang B, Liu G, Ke A, Patel C, Yeo KR, Xia C, Zhang X, Esseltine DL, Nemunaitis J. Effects of strong CYP3A inhibition and induction on the pharmacokinetics of ixazomib, an oral proteasome inhibitor: results of drug-drug interaction studies in patients with advanced solid tumors or lymphoma and a physiologically-based pharmacokinetic analysis. Journal of Clinical Pharmacology. 2018 Feb;58(2):180-192.

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® Engineered Autologous Tumor Cell (EATC) Immunotherapy in Patients with Advanced Solid Tumors. Clinics in Oncology. 2017 April 3; 2:1254.

Nemunaitis J, Senzer N. Editorial: Immunotherapy, checkpoint inhibitor advance to frontline NSCLC. Translational Cancer Research. 2017;6(Suppl 1):S141-144.

Zhou X, Pant S, Nemunaitis J, Lockhart AC, Falchook G, Bauer TM, Patel M, Sarantopoulos J, Bargefrede M, Muehler A, Rangachari L, Zhang B, Venkatakrishnan K. Effects of rifampin, itraconazole and esomeprazole on the pharmacokinetics of alisertib, an investigational Aurora A kinase inhibitor in patients with advanced malignancies. Investigational New Drugs. 2017 Aug 30; [Epub ahead of print].

Manning L, Nemunaitis J. Future Directions for Immunotherapy in Ovarian Cancer. Journal of Gynecology and Women’s Health. 2017; 2(3): 555587.

Barve M, Adams N, Plato L, Dupler R, Anand R, Jones J, Brown M, Stephens PJ, Shiller SM, Senzer N, Nemunaitis J. Case Report: Immune Checkpoint Inhibitor Elicited Complete Response in a Heavily Pretreated Patient with Metastatic Endometrial Carcinoma with a High Tumor Mutation Burden (TMB). Molecular Medicine. 2017 Dec 6; 1(1):005.

Hege KM, Bergsland EK, Fisher GA, Nemunaitis JJ, Warren RS, McArthur JG, Lin AA, Schlom J, June CH, Sherwin SA.  Safety, Trafficking and Antitumor Activity of Chimeric Antigen Receptor (CAR)-T Cells Specific for TAG-72 in Patients with Metastatic Colorectal Cancer. Journal for Immunotherapy of Cancer. 2017 Mar 21; 5-22. eCollection 2017.

Juric D, de Bono J, LoRusso P, Nemunaitis J, Heath EI, Kwak EL, Mercade TM, Geuna E, de Miguel-Luken MJ, Patel C, Kuida K, Sankoh S, Westin E, Zohren F, Shou Y, Tabernero J. A First-in-Human, Phase I, Dose-Escalation Study of TAK-117, a Selective PI3Kα Isoform Inhibitor, in Patients with Advanced Solid Malignancies. Clinical Cancer Research. 2017 Sept 1;23(17):5015-5023.

Manning L, Nemunaitis J. Harnessing the immune response to target tumors. Faculty of 1000. 2017 May 18;6:710. doi: 10.12688/f1000research.10795.1. eCollection 2017. Review.

Zhou X, Nemunaitis J, Pant S, Bauer TM, Patel M, Sarantopoulos J, Lockhart AC, Goodman D, Huebner D, Mould DR, Venkatakrishnan K. Effects of Alisertib, an investigational Aurora A kinase inhibitor on the QTc interval in patients with advanced malignancies. Investigational New Drugs. 2017 Aug 18 [Epub ahead of print].

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. Molecular Therapy. 2016 Aug;24(8):1478-83.

Rao DD, Jay C, Wang Z, Luo X, Kumar P, Eysenbach H, Ghisoli M, Senzer N, Nemunaitis J. Preclinical Justification of pbi-shRNA EWS/FLI1 Lipoplex (LPX) Treatment for Ewing’s Sarcoma. Molecular Therapy. 2016 Aug; 24(8):1412-22.

Gupta N, Hanley MJ, Venkatakrishnan K, Wang B, Sharma S, Bessudo A, Hui AM, Nemunaitis J.  The Effect of a High-Fat Meal on the Pharmacokinetics of Ixazomib, an Oral Proteasome Inhibitor, in Patients With Advanced Solid Tumors or Lymphoma. J Clin Pharmacol. 2016 Oct;56(10):1288-95.

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 by Inhibiting ERK Signaling in Pancreatic Ductal Adenocarcinoma. Curr Mol Med. 2016;16(1):83-90.

Wang Z, Jay CM, Evans C, Kumar P, Phalon C, Rao DD, Senzer N, Nemunaitis J. Preclinical Biodistribution and Safety Evaluation of a pbi-shRNA STMN1 Lipoplex after Subcutaneous Delivery. Toxilogical Sciences. 2016 November 4;155(2):400-408.

Chang E, Pirollo K, Nemunaitis J, Leung PK, Nunan R, Adams J. Safety and Efficacy in Advanced Solid Tumors of Docetaxel in Combination with a Targeted Nanocomplex Carrying the p53 Gene: A Phase Ib Study. Molecular Therapy 2016 June 30;24(9):1697-1706.

Barve M, Kuhn J, Lamont J, Beitsch P, Manning L, Pappen B, Kumar P, Wallraven G, Senzer N, Nemunaitis J. Follow-up of bi-shRNAfurin /GM-CSF Engineered Autologous Tumor Cell (EATC) Immunotherapy Vigil® in patients with advanced melanoma. Biomedical Genetics and Genomics. 2016 Sept 29;1(3):81-86.

Oh J, Barve M, Matthews CM, Koon EC, Heffernan TP, 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 September 19;143:504-510.

Ghisoli M, Manning L, Senzer N, Nemunaitis J.  Review: Innovative Exploratory Clinical Approaches for Relapsed and/or Refractory Metastatic Ewing’s Sarcoma.  Pediatric Cancers - Clinics in Oncology. 2016 Sept 08;1:1079.

Yu J, Liu SH, Sanchez R, Nemunaitis J, Rozengurt E, Brunicardi FC. Pancreatic cancer actionable genes in precision medicine and personalized surgery. Surgeon. 2016 Jun 28. pii: S1479-666X(16)30021-X.

Nemunaitis J, Senzer N, Plato L.  Tumor Vaccines and Cellular Immunotherapies.  Annals of Translational Medicine. 2016 Oct; 4(Suppl1):S24. No abstract available.

Nemunaitis J, Manning L: “This is another tool in our oncology toolbox. Immunotherapy approaches engaged in clinical testing are highly visible..." of: [Iwasa S et al. Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients. Cancer Sci 2016 May; 107(5):590-600; DOI: 10.1111/cas.12919]. Faculty of 1000, 01 Jul 2016. F1000.com/726192170.

Yu J, Liu SH, Sanchez R, Nemunaitis J, Brunicardi FC. Hypoglycemia and PDX1 Targeted Therapy. J of Endocr Disord. 2016, 2(1): 1018-24.

Yu J, Liu SH, Sanchez R, Nemunaitis J, Rozengurt E, Brunicardi FC. PDX1 associated therapy in translational medicine. Ann Transl Med. 2016 Jun;4(11):214

Mita MM, Nemunaitis J, Grilley-Olson J, El-Rayes B, Bekaii-Saab T, Harvey RD, Marshall J, Zhang X, Strout V.  Phase 1 Study of CEP-37250/KHK2804, a Tumor-specific Anti-glycoconjugate Monoclonal Antibody, in Patients with Advanced Solid Tumors. Targeted Oncology. 2016 Dec;11(6):807-814.

Andtbacka RH, Agarwala SS, Ollila DW, Hallmeyer S, Milhem M, Amatruda T, Nemunaitis J, Harrington KJ, Chen L, Shilkrut M, Ross M, Kaufman HL. Cutaneous head and neck melanoma in OPTiM, a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor for the treatment of unresected stage IIIB/IIIC/IV melanoma.  Head and Neck. 2016 Dec;38(12):1752-1758. doi: 10.1002/hed.24522.

Kaufman HL, Amatruda T, Reid T, Gonzalez R, Glaspy J, Whitman E, Harrington K, Nemunaitis J, Zloza A, Wolf M, Senzer NN.  Systemic versus local responses in melanoma patients treated with talimogene laherparepvec from a multi-institutional phase II study. The Journal for Immunotherapy of Cancer. 2016 March 15;4:12.

Hong D, Kurzrock R, Wheler JJ, Naing A, Falchook GS, Fu S, Kim KB, Davies MA, Nguyen LM, George GC, Xu L, Shumaker R, Ren M, Mink J, Bedell C, Andresen C, Sachdev P, O'Brien JP, Nemunaitis J. Phase I dose-escalation study of the multikinase inhibitor lenvatinib in patients with advanced solid tumors and in an expanded cohort of patients with melanoma. Clinical Cancer Research 2015 Nov 1;21(21):4801-10.

Hong D, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Folwer N, Zhou T, Schmidt J, Jo M, Lee S, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella M VP, Mohseni M, Lawson D, Reimer C, Blakely D, Xiao X, Hsu J, Monia BP, MacLeod AR: AZD9150, a Next-Generation Antisense Oligonucleotide Inhibitor of STAT3, with Early Evidence of Clinical Activity in Lymphoma and Lung Cancer. Science Translational Medicine 2015 Nov 18;7(314):314ra185.

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. Molecular Therapy 2015 Jun;23(6):1103-9.

Giaccone G, Bazhenova LA, Nemunaitis J, Tan M, Juhász E, Ramlau R, van den Heuvel MM, Lal R, Kloecker GH, Eaton KD, Chu Q, Dunlop DJ, Jain M, Garon EB, Davis CS, Carrier E, Moses SC, Shawler DL, Fakhrai H.  A phase III study of belagenpumatucel-L, an allogeneic tumour cell vaccine, as maintenance therapy for non-small cell lung cancer. Eur J Cancer 2015 Nov;51(16):2321-9.

Wu JX, Liu SH, Nemunaitis JJ, Brunicardi FC.  Liposomal insulin promoter-thymidine kinase gene therapy followed by ganciclovir effectively ablates human pancreatic cancer in mice. Cancer Lett. 2015 Apr 10;359(2):206-10.

Barve B, Wang Z, Kumar P, Jay CM, Luo X, Bedell C, Mennel RG, Wallraven G, Brunicardi FC, Senzer N, Nemunaitis J, Rao D. Phase I Trial of bi-shRNA STMN1 BIV in Refactory Cancer. Molecular Therapy 2015 Jun;23(6):1123-30.

Berinstein NL, Karkada M, Oza AM, Odunsi K, Villella JA, Nemunaitis JJ, Morse MA, Pejovic T, Bentley J, Buyse M, Nigam R, Weir GM, MacDonald LD, Quniton T, Rajagopalan R, Sharp K, Penwell A, Sammatur L, Burzykowski T, Stanford MM, Mansour M.  Survivin-targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients.  Oncoimmunology 2015 May 7;4(8):e1026529.

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 During Phase I Testing of Aurora Kinase A Inhibitor: Retrospective Assessment. Integrative Molecular Medicine 2015;2(5):331-337.

Patnaik A, Tolcher A, Beeram M, Nemunaitis J, Weiss GJ, Bhalla K, Agrawal M, Nichols G, Middleton S, Beryozkina A, Sarapa N, Peck R, Zhi J.  Clinical pharmacology characterization of RG7112, an MDM2 antagonist, in patients with advanced solid tumors. Cancer Chemotherapy and Pharmacology 2015 Sep;76(3):587-95.

Nemunaitis J, Senzer N.  Commentary:  Shedding New Light on the Use of Imaging Technology for Glioblastoma Tumor Resection. Molecular Therapy 2015 Jul;23(7):1136-1137.

Hong DS, Kurzrock R, Falchook GS, Andresen C, Kwak J, Ren M, Xu L, George GC, Kim KB, Nguyen LM, O’Brien JP, Nemunaitis J.  Phase IB Study of Lenvatinib (E7080) in Combination With Temozolomide for Treatment of Advanced Melanoma.  Oncotarget. 2015 Dec 15;6(40):43127-34.

Hong D, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Folwer N, Zhou T, Schmidt J, Jo M, Lee S, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella M VP, Mohseni M, Lawson D, Reimer C, Blakely D, Xiao X, Hsu J, Monia BP, MacLeod AR: AZD9150, a Next-Generation Antisense Oligonucleotide Inhibitor of STAT3, with Early Evidence of Clinical Activity in Lymphoma and Lung Cancer. Science Translational Medicine 2015 Nov 18;7(314):314ra185.

Hurwitz HI, Uppal N, Wagner SA, Bendell JC, Beck JT, Wade SM, Nemunaitis JJ, Stella PJ, Pipas JM, Wainberg ZA, Manges R, Garrett WM, Hunter DS, Clark J, Leopold L, Sandor V, Levy RS, on behalf of the RECAP study investigators.  Randomized, Double-Blind, Phase II Study of Ruxolitinib or Placebo in Combination With Capecitabine in Patients With Metastatic Pancreatic Cancer for Whom Therapy With Gemcitabine Had Failed.  Journal of Clinical Oncology 2015 Dec 1;33(34):4039-47.

Berinstein NL, Karkada M, Oza AM, Odunsi K, Villella JA, Nemunaitis JJ, Morse MA, Pejovic T, Bentley J, Buyse M, Nigam R, Weir GM, MacDonald LD, Quniton T, Rajagopalan R, Sharp K, Penwell A, Sammatur L, Burzykowski T, Stanford MM, Mansour M.  Survivin-targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients.  Oncoimmunology 2015 May 7;4(8):e1026529.

Wu J, Liu S, Yu J, Zhou G, Rao D, Jay CM, Kumar P, Sanchez R, Templeton N, Senzer N, Maples P, Nemunaitis J, Brunicardi FC. Vertically Integrated Translational Studies of PDX1 as a Therapeutic Target for Pancreatic Cancer via a Novel Bifunctional RNAi Platform. Cancer Gene Therapy 2014 Feb;21(2):48-53.

Stephenson JJ, Nemunaitis J, Joy AA, Martin JC, Jou YM, Zhang D, Statkevich P, Yao SL, Zhu Y, Zhou H, Small K, Bannerji R, Edelman MJ.  Randomized phase II study of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus erlotinib in patients with non-small cell lung cancer.  Lung Cancer 2014 Feb;83(2):219-23.

Brunicardi C, Zhou G, Sinnett-Smith J, Liu S, Yu J, Wu J, Sanchez R, Pandol SJ, Abrol R, Nemunaitis J, Rozengurt E.  Down-regulation of pancreatic and duodenal homeobox-1 by somatostatin receptor subtype 5: a novel mechanism for inhibition of cellular proliferation and insulin secretion by somatostatin.  Frontiers in Physiology 2014; 5:226. doi:10.3389/fphys.2014.0022.

Smith DA, Conkling P, Richards DA, Nemunaitis JJ, Boyd TE, Mita AC, de la Bourdonnaye G, Wages D, Bexon AS.  Antitumor activity and safety of combination therapy with the Toll-like receptor 9 agonist IMO-2055, erlotinib, and bevacizumab in advanced or metastatic non-small cell lung cancer patients who have progressed following chemotherapy.  Cancer Immunology, Immunotherapy 2014 Aug;63(8):787-96.

Nemunaitis J. Genome Expression to Targeted Therapy in Cancer Management. Hereditary Genetics. May 2014; 3(2):129.

Levy B, Spira A, Becker D, Evans T, Schnadig I, Camidge DR, Bauman JE, Hausman D, Walker L, Nemunaitis J, Rudin CM, Halmos B, Bowles DW.  A Randomized, Phase II Trial of Docetaxel with or without PX-866, an Irreversible Oral Phosphatidylinositol 3-Kinase Inhibitor, in Patients with Relapsed or Metastatic Non-Small-Cell Lung Cancer.  Journal of Thoracic Oncology. 2014 Jul;9(7):1031-5.

Nemunaitis J, Barve M, Orr D, Kuhn J, Magee M, Lamont J, Bedell C, Wallraven G, Pappen BO, Roth A, Horvath S, Nemunaitis D, Kumar P, Maples PB, Senzer N. Summary of bi-shRNAfurin/GM-CSF Augmented Autologous Tumor Cell Immunotherapy (FANG™) in Advanced Cancer of the Liver.  Oncology 2014;87:21-29. doi: 10.1159/000360993.

Mahalingam D, Nemunaitis JJ, Malik L, Sarantopoulos J, Weitman S, Sankhala K, Hart J, Kousba A, Gallegos NS, Anderson G, Charles J, Rogers JM, Senzer NN, Mita AC.  Phase I study of intravenously administered ATI-1123, a liposomal docetaxel formulation in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Dec;74(6):1241-50.

Mahalingam D, Nemunaitis JJ, Malik L, Sarantopoulos J, Weitman S, Sankhala K, Hart J, Kousba A, Gallegos NS, Anderson G, Charles J, Rogers JM, Senzer NN, Mita AC.  Phase I study of intravenously administered ATI-1123, a liposomal docetaxel formulation in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Dec;74(6):1241-50.

Wu J, Liu S, Yu J, Zhou G, Rao D, Jay CM, Kumar P, Sanchez R, Templeton N, Senzer N, Maples P, Nemunaitis J, Brunicardi FC. Vertically Integrated Translational Studies of PDX1 as a Therapeutic Target for Pancreatic Cancer via a Novel Bifunctional RNAi Platform. Cancer Gene Therapy 2014 Feb;21(2):48-53.

Nemunaitis J: "Ellis et al describe and justify the…” of: [Ellis M.J et al. Connecting Genomic Alterations to Cancer Biology with Proteomics: The NCI Clinical Proteomic Tumor Analysis Consortium. Cancer Discovery, 3(10): p1108-1112] Faculty 1000, Nov 2013, F1000prime.com/718141566. 
 

Jay C, Ruoff C, Kumar P, Maass H, Spanhel B, Miller M, Arrington A, Montalvo N, Gresham V, Rao D, Evans C, Wang Z, Brunicardi FC, Liu SH, Zhou G, Senzer N, Nemunaitis J, King L, Weeks B, Clubb F, Fossum TW, Maples P. Assessment of Intravenous pbi-shRNA PDX1 Nanoparticle (OFHIRNA-PDX1) in Yucatan Swine. Cancer Gene Therapy 2013 Dec; 20(12):683-9.

Senzer N, Nemunaitis J, Nemunaitis D, Bedell C, Edelman G, Barve M, Nunan R, Pirollo KF, Rait A, Chang EH:  Phase I Study of a Systemically Delivered p53 Nanoparticle in Advanced Solid Tumors.  Molecular Therapy 2013 May; 21(5):1096-103.

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. doi: 10.4172/2157-7560.1000209.

Rao DD, Senzer N, Wang Z, Kumar P, Jay CM, Nemunaitis J:  Bifunctional Short Hairpin RNA (bi-shRNA): Design and Pathway to Clinical Application (Chapter 14).  In: siRNA Design: Methods and Protocols.  Springer Science+Business Media, LLC; Taxman DJ (ed.), pp. 259-278, 2013.

Nemunaitis J:  Cancer Targeting Vaccines:  Surrogate Measures of Activity.  Human Vaccines & Immunotherapeutics 2013 Jan;9(1):213-218.

Nemunaitis J, Small KA, Kirschmeier P, Zhang D, Zhu Y, Jou Y-M, Statkevich P, Yao S-L, Bannerji R:  A First-in-human, Phase 1, Dose-escalation Study of Dinaciclib, a Novel Cyclin-dependent Kinase Inhibitor, Administered Weekly in Subjects with Advanced Malignancies.  Journal of Translational Medicine 2013 Oct 16;11(1):259.

Nemunaitis J, Hochster HS, Lustgarten S, Rhodes R, Ebbinghaus S, Turner CD, Dodion PF, Mita MM:  A Phase 1 Trial of Oral Ridaforolimus (AP23573; MK-8669) in Combination With Bevacizumab for Patients With Advanced Cancers.  Clinical Oncology 2013 Jun; 25(6):336-342.

Belani CP, Nemunaitis JJ, Chachoua A, Eisenburg PD, Raez LE, Cuevas JD, Mather CB, Benner RJ, Meech SJ: Phase 2 Trial of Erlotinib With or Without PF-3512676 (CPG 7909, a Toll-like Receptor 9 Agonist) in Patients With Advanced Recurrent EGFR-Positive Non-Small Cell Lung Cancer. Cancer Biology and Therapy 2013 May; 14(7):557-563.

Rao DD, Wang Z, Senzer N, Nemunaitis J:  RNAi and Personalized Cancer Therapy. Discovery Medicine 2013 Feb; 15(81):101-110.

Liu S-H, Zhou G, Yu J, Wu J, Nemunaitis J, Senzer N, Dawson D, Li M, Fisher WE, Brunicardi FC: Notch1 Activation Up-Regulates Pancreatic and Duodenal Homeobox-1. Genes 2013 Jul; 4(3):358-374.

Belani CP, Nemunaitis JJ, Chachoua A, Eisenburg PD, Raez LE, Cuevas JD, Mather CB, Benner RJ, Meech SJ: Phase 2 Trial of Erlotinib With or Without PF-3512676 (CPG 7909, a Toll-like Receptor 9 Agonist) in Patients With Advanced Recurrent EGFR-Positive Non-Small Cell Lung Cancer. Cancer Biology and Therapy 2013 May; 14(7):557-563.

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 Received TGF-β2 Antisense/GM-CSF Gene Modified Autologous Tumor Cell (TAG) Vaccine. Gene Therapy 2013 Sep; 20(9):875-9.

Nemunaitis J, Mita A, Stephenson J, Mita MM, Sarantopoulos J, Padmanabhan-lyer S, Nanda N, Gleich L, Benichou AC, Craig A:  Pharmacokinetic Study of Omacetaxine Mepesuccinate Administered Subcutaneously to Patients with Advanced Solid and Hematologic Tumors.  Cancer Chemotherapy and Pharmacology 2013 Jan;71(1):35-41.

Tong AW, Senzer N, Cerullo V, Templeton NS, Hemminki A, Nemunaitis J:  Oncolytic Viruses for Induction of Anti-Tumor Immunity.  Current Pharmaceutical Biotechnology 2012; 13:1750-1760.

Le DT, Brockstedt DG, Nir-Paz R, Hampl J, Mathur S, Nemunaitis J, Sterman DH, Hassan R, Lutz E, Moyer B, Giedlin M, Louis J-L, Sugar EA, Pons A, Cox AL, Levine J, Murphy AL, Illei P, Dubensky Jr. TW, Eiden JE, Jaffee EM, Laheru DA:  A Live-attenuated Listeria Vaccine (ANZ-100) and a Live-attenuated Listeria Vaccine Expressing Mesothelin (CRS-207) for Advanced Cancers: Phase I Studies of Safety and Immune Induction.  Clinical Cancer Research 2012 Feb; 18(3):858-868.

Nemunaitis J: "Hanna et al. Describe a novel DNA plasmid (called BC-819) that enables expression…" of: [Hanna N et al. Phase 1/2a, dose-escalation, safety, pharmacokinetic and preliminary efficacy study of intratumoral administration of BC-819 in patients with unresectable pancreatic cancer.  Cancer Gene Therapy 2012; 19:374-381; doi: 10.1038/cgt.2012.10].  Faculty of 1000, 06 Jul 2012. F1000.com/717597920#eval793052830.

Liu S-H, Rao DD, Nemunaitis J, Senzer N, Zhou G, Dawson D, Gingras M-C, Wang Z, Gibbs R, Norman M, Templeton NS, DeMayo FJ, O’Malley B, Sanchez R, Fisher WE, Brunicardi FC:  PDX-1 Is a Therapeutic Target for Pancreatic Cancer, Insulinoma and Islet Neoplasia Using a Novel RNA Interference Platform.  PLoS ONE 2012; 7(8):e40452.

Nemunaitis J: "The clinical data generated in the report By Lu et al. involving 31 advanced lungs..." of: [Lu C et al. Phase I clinical trial of systemically administered TUSC2 (FUS1)-nanoparticles mediating functional gene transfer in humans. PLoS ONE 2012; 7(4):e34833; doi: 10.1371/journal.pone.0034833]. Faculty of 1000, 06 Jun 2012. F1000.com/715898029#eval791452808.

Laskin JJ, Nicholas G, Lee C, Gitlitz B, Vincent M, Cormier Y, Stephenson J, Ung Y, Sanborn R, Pressnail B, Nugent F, Nemunaitis J, Gleave ME, Murray N, Hao D:  Phase I/II Trial of Custirsen (OGX-011), an Inhibitor of Clusterin, in Combination with a Gemcitabine and Platinum Regimen in Patients with Previously Untreated Advanced Non-Small Cell Lung Cancer.  Journal of Thoracic Oncology 2012 Mar; 7(3):579-586.

Hecht JR, Farrell JJ, Senzer N, Nemunaitis J, Rosemurgy A, Chung T, Hanna N, Chang KJ, Javle M, Posner M, Waxman I, Reid A, Erickson R, Canto M, Chak A, Blatner G, Kovacevic M, Thornton M: EUS or Percutaneously Guided Intratumoral TNFerade Biologic with 5-Fluorouracil and Radiotherapy for First-Line Treatment of Locally Advanced Pancreatic Cancer: A Phase I/II Study.  Gastrointestinal Endoscopy 2012 Feb; 75(2):332-338.

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.  Molecular Therapy 2012 Mar 1; 20(3):679-686.

* FANG^TM

Strange W, Cagnina S, Bedell C, Nemunaitis J.  The Cost of Cancer Care:  Navigation Challenges to Participation in Phase I Clinical Trials.  Cancer and Clinical Oncology 2012 Nov; 1(2):86-90.

Simmons O, Maples PB, Senzer N, Nemunaitis J:  Ewing’s Sarcoma: Development of RNA Interference Based Therapy for Advanced Disease.  ISRN Oncology 2012; 2012:247657.

Nemunaitis J:  Stathmin 1: A Protein with Many Tasks. New Biomarker and Potential Target in Cancer (Editorial).  Expert Opinion on Therapeutic Targets 2012 Jul; 16(7):631-634.

Mansour M, Berinstein NL, Karkada M, Morse M, Nemunaitis JJ, Chatta G, Kaufman HL, Odunsi K, Nigam R, Sammatur L, MacDonald LD, Wier G, Stanford MM:  First-in-Man Application of a Novel Therapeutic Cancer Vaccine Formulation with the Capacity to Induce Multi-functional T Cell Responses in Ovarian, Breast and Prostate Cancer Patients.  Journal of Translational Medicine 2012 Aug 3;10:156.

Amato RJ, Stephenson J, Hotte SJ, Nemunaitis JJ, Bélanger K, Reid G, Martell R:  MG98, A Second Generation DNMT1 Inhibitor, in the Treatment of Advanced Renal Cell Carcinoma.  Cancer Investigation 2012 Jun; 30(5):415-421.

Burke JM, Lamm DL, Meng MV, Nemunaitis JJ, Stephenson JJ, Arseneau JC, Aimi J, Lemer S, Yeung AW, Kazarian T, Maslyar DJ, McKiernan JM:  A First in Human Phase 1 Study of CG0070, a GM-CSF Expressing Oncolytic Adenovirus, for the Treatment of Nonmuscle Invasive Bladder Cancer.  Journal of Urology 2012 Dec;188(6):2391-7.

Brunicardi FC, Gibbs RA, Wheeler DA, Nemunaitis J, Fisher W, Goss J, Chen C: Overview of the Development of Personalized Genomic Medicine and Surgery.  World Journal of Surgery 2011 Aug; 35(8):1693-1699.

Liu S-H, Rao DD, Nemunaitis J, Senzer N, Dawson D, Gingras M-C, Wang Z, Gibbs R, Norman M, Templeton NS, DeMayo FJ, Stehling K, Fisher WE, Brunicardi FC:  A Novel Therapeutic Strategy for Pancreatic Neoplasia Using a Novel RNAi Platform Targeting PDX-1.  Nature Precedings 2011 Jun 21 [Posted online].

Schwartzentruber DJ, Kirkwood JM, Guarino M, Richards J, Hamid O, O'Day S, Nemunaitis J, Talmadge J, Chada S, Menander K, Shafer-Weaver K, Senesac J, Thornton MO, Lewis JJ, Herberman RB. Immunotherapy of Advanced Melanoma by Intra-Tumoral Injections of Autologous, Purified Dendritic Cells Transduced with Gene Construct of Interleukin-12, with Dose-Dependent Expression Under the Control of an Oral Activator Ligand.  ASCO Annual Meetings, June 3-7, 2011.

Nemunaitis J:  Multifunctional Vaccines in Cancer: The ‘Triad’ Approach.  Expert Review of Vaccines 2011 Jun; 10(6):713-715.

Haddock CL, Holtz B, Senzer N, Nemunaitis J: Applications of HPLC-MALDI-TOF MS/MS Phosphoproteomic Analysis in Oncological 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 2011 Sep; 30(9):715-726.

Nemunaitis J, Rao DD, Liu S-H, Brunicardi FC:  Personalized Cancer Approach: Using RNA Interference Technology.  World Journal of Surgery 2011 Aug; 35(8):1700-1714.

Nemunaitis J, Senzer N, Cooper B, Nemunaitis M, Bedell C, Singer JW, Oldham FB:  Procoagulant Inhibitory Properties of Paclitaxel Polyglumex.  International Journal of General Medicine 2011; (4):5-11.

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-ß2 Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine.  Clinical Cancer Research 2011 Jan 1: 17(1):183-192.

Eager RM, Nemunaitis J:  Clinical Development Directions in Oncolytic Viral Therapy.  Cancer Gene Therapy 2011 May; 18(5):305-317.

Liu S-H, Patel S, Gingras M-C, Nemunaitis J, Zhou G, Chen C, Li M, Fisher W, Gibbs R, Brunicardi FC:  PDX-1: Demonstration of Oncogenic Properties in Pancreatic Cancer. Cancer 2011 Feb 15; 117(4):723-733.

Bendell JC, Nemunaitis J, Vukelja SJ, Hagenstad C, Campos LT, Hermann RC, Sportelli P, Gardner L, Richards DA:  Randomized Placebo-Controlled Phase II Trial of Perifosine Plus Capecitabine as Second- or Third-Line Therapy in Patients with Metastatic Colorectal Cancer.  Journal of Clinical Oncology 2011 Nov; 29(33):4394-4400.

Balentine CJ, Berger DH, Liu S-H, Chen C, Nemunaitis J, Brunicardi FC:  Defining the Cancer Master Switch.  World Journal of Surgery 2011 Aug; 35(8):1738-1745.

Wang Z, Rao DD, Senzer N, Nemunaitis J.  RNA Interference and Cancer Therapy.  Pharmaceutical Research 2011 Dec; 28(12):2983-2995.

Nemunaitis J, Roth J:  Vaccine Therapy for Lung Cancer.  In:  Lung Cancer: Prevention, Management, and Emerging Therapies.  Humana Press, Totowa, NJ; Stewart DJ (ed.), pp. 279-303, 2010.

Senzer N, Nemunaitis J, Bedell C, Nunan R, Allen H, Sleer L, Chang E. Phase I Safety and Pharmacokintetic Study of Systemic p53 Gene Therapy (SGT-53) using Immunopoplexes Targeted by Anti-Transferrin Receptor (TfR) Single Chain Antibody Fragment (scFv): Updated Results. Poster #536. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Nemunaitis G, Jay CM, Senzer N, Allen H, Phadke AP, Templeton NS, Maples PB, Nemunaitis J. A single patient, multiple intravenous (IV) infusion, clinical trial of GNE-lipoplex for therapy of Hereditary Inclusion Body Myopathy (HIBM). Oral #586. ASGCT13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Templeton NS, Shi Q, Nguyen AT, Angell Y, Deng D, Na C, Burgess K, Roberts DD, Brunicardi FC, Maples PB, Nemunaitis J. A Combinatorial Approach for Targeted, Systemic Delivery using Small Molecules and Reversible Masking to Bypass Non-Specific Uptake In Vivo. Poster #731. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Rao DD, Wang Z, Kumar P, Yu Y, Liu S, Jay CM, Templeton NS, Haddock C, Vorhies J, Tong AW, Maples PB, Senzer N, Brunicardi FC, Nemunaitis J. "bifunctional" shRNA Strategy for Cancer Gene and Cell Therapy. Poster #564. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Phadke AP, Jay CM, Maples PB, Senzer N, Nemunaitis J, Tong AW. Assessment of pre-clinical safety of GMP grade GNE-lipoplexes after repeat intravenous injections in Balb/c mice. Poster #148. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Wang Z, Liu S, Rao DD, Maples PB, Senzer N, Nemunaitis J, Brunicardi FC. Development of a Novel, RNAi-Based Therapeutic Targeting Pancreatic Duodenal Homebox-1 (PDX-1) for Insulinoma and Pancreatic Cancer. Poster #892. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Senzer N, Nemunaitis J, Bedell C, Nunan R, Allen H, Sleer L, Chang E. Phase I Safety and Pharmacokinetic Study of Systemic p53 Gene Therapy (SGT-53) using Immunolipoplexes Targeted by Anti-Transferrin Receptor (TfR) Single Chain Antibody Fragment (scFv): Updated Results. Poster #536. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Senzer N, Bedell C, Nemunaitis J:  OncoVEXGM-CSF: An Oncolytic Viral Immunotherapeutic in Melanoma.  Drugs of the Future 2010; 35(6):449.

Haddock C, Holtz RB, Senzer N, Maples PB, Nemunaitis J. Nano-flow 2D-HPLC MALDI-TOF MS/MS for differentially expressed protein analysis in breast cancer patient samples. Poster #213. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Jay CM, Haddock C, Maples PB, Nemunaitis J. Manufacturing and Stability Testing of a GNE-Lipoplex for a Clinical Trial for the Treatment of Hereditary Inclusion Body Myopathy Type (HIBM). Poster #578. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, DC.

Tong AW, Yu Y, Rao DD, Maples PB, Senzer N, Nemunaitis J. Augmentation of docetaxel anti-tumor activity by a stathmin-specific bi-functional shRNA. Poster #248. ASGCT13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Nemunaitis J, Nemunaitis J:  Head and Neck Cancer: Response to p53-Based Therapeutics. Head and Neck 2011; 33(1):131-134.  Epub 2010 Mar 10.

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 Medicine 2010 May; 12(5):403-412.

Murray N, Eager R, Nemunaitis J:  Lung Cancer Vaccines.  In: Principles and Practice of Lung Cancer: The Official Reference Text of the IASLC, Fourth Edition (Chapter 51).  The International Association for the Study of Lung Cancer.  Lippincott Williams and Wilkins; Pass H, Carbone D, Johnson D, Minna J, Turrisi A, Scagliotti G (eds.), pp. 753-766, 2010.

Levonyak N, Magee M, Nemunaitis J:  Immunological Approaches to the Treatment of Lung Cancer (Chapter 24).  In: Lung Cancer: A Multidisciplinary Approach to Diagnosis and Management.  Demos Medical Publishing, LLC; Kernstine K and Reckamp K (eds.), pp. 299-312, 2010.

Nemunaitis J, Roth J:  Gene-Based Therapies for Lung Cancer.  In:  Lung Cancer: Prevention, Management, and Emerging Therapies.  Humana Press, Totowa, NJ; Stewart DJ (ed.), pp. 305-330, 2010.

Maples PB, Kumar P, Yu Y, Wang Z, Jay CM, Pappen BO, Rao DD, Kuhn J, Nemunaitis J, Senzer N:  FANG Vaccine: Autologous Tumor Cell Vaccine Genetically Modified to Express GM-CSF and Block Production of Furin.  BioProcessing Journal 2010; 8(4):4-14.

Papavasiliou P, Fisher T, Kuhn J, Nemunaitis J, Lamont J:  Circulating Tumor Cells in Patients Undergoing Surgery for Hepatic Metastases from Colorectal Cancer.  Baylor University Medical Center Proceedings 2010; 23(1):11-14.

Tong AW, Phadke AP, Horvath S, Wold W, Nemunaitis J, Senzer N. Clinical Characterization of the Adenovirus Death Protein-potentiated Oncolytic Adenovirus VRX007. Poster #196. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Maples PB, Kumar P, Yu Y, Pappen BO, Jay CM, Wang Z, Rao DD, Kuhn J, Nemunaitis J, Senzer N. FANG Autologous Tumor Cell Vaccine Development and Manufacturing. Poster # 532. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Rao DD, Maples PB, Senzer N, Kumar P, Wang Z, Pappen BO, Yu Y, Haddock C, Jay C, Phadke AP, Chen S, Kuhn J, Dylewski D, Scott S, Monsma D, Webb C, Tong A, Shanahan D, Nemunaitis J:  Enhanced Target Gene Knockdown by a Bifunctional shRNA:  A Novel Approach of RNA Interference.  Cancer Gene Therapy 2010 Nov; 17(11): 780-791.

Simmons O, Magee M, Nemunaitis J:  Current Vaccine Updates for Lung Cancer.  Expert Review of Vaccines 2010 Mar; 9(3):323-335.

Maples PB, Kumar P, Yu Y, Pappen BO, Kuhn J, Nemunaitis J. TAG Vaccine Clinical Trial Manufacturing. Poster # 275. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF, for the IMPACT Study Investigators:  Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer. New England Journal of Medicine 2010 Jul 29; 363(5):411-422.

Templeton NS, Firozi P, Zhang W, Chen L, Quiocho FA, Worley KC, Maples PB, Nemunaitis J. Removal of clinically relevant contaminants from cGMP grade preparations of plasmid DNA: implications for non-viral gene therapy and DNA-based vaccines. Poster #574. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Wallraven G, Maples PB, Nemunaitis J. Regulatory Submission Process for Gene and Cellular Therapies. Poster #520. ASGCT13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Phadke AP, Jay CM, Rao DD, Senzer N, Maples PB, Nemunaitis J, Tong AW. Preclinical safety and toxicity assessment of Stathmin 1 bifunctional shRNA formulation following a single intravenous injection in rats. Poster #252. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Phalon C, Rao DD, Nemunaitis J:  Potential Use of RNA Interference in Cancer Therapy.  Expert Reviews in Molecular Medicine 2010 Aug 18; 12(e26):1-16.

Geevarghese SK, Geller DA, de Haan HA, Hörer M, Knoll AE, Mescheder A, Nemunaitis J, Reid TR, Sze DY, Tanabe KK, Tawfik H:  Phase I/II Study of Oncolytic Herpes Simplex Virus NV1020 in Patients with Extensively Pretreated Refractory Colorectal Cancer Metastatic to the Liver.  Human Gene Therapy 2010 Sep; 21(9):1119-1128.

Maples PB, Kumar P, Yu Y, Pappen BO, Monsma D, Scott S, Dylewski D, Webb C, Senzer N, Nemunaitis J. Xenograft Expanded FANG Autologous Tumor Cell Vaccine Development and Manufacturing for Clinical Use. Poster #487. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Nemunaitis J, Tong AW, Nemunaitis M, Senzer N, Bedell C, Adams N, Phadke AP, Zhang Y, Maples PB, Chen S, Pappen B, Burke J, Ichimaru D, Urata Y, Fujiwara T:  A Phase I Study of Telomerase-specific Replication Competent Oncolytic Adenovirus (Telomelysin) for Various Solid Tumors.  Molecular Therapy 2010 Feb; 18(2):429-434.

Roth JA, Nemunaitis J, Ji L, Ramesh R:  Tumor Suppressor Gene Therapy (Chapter 5).  In: Gene-Based Therapies for Cancer. Springer Science+Business Media, LLC; Roth JA (ed.), pp. 63-78, 2010.

Wang Z, Phalon C, Kumar P, Jay CM, Rao DD, Tong AW, Maples PB, Senzer N, Nemunaitis J. The Application of "Bi-functional" Short Hairpin RNA in A Furin-shRNA and GM-CSF (FANG) Autologous Vaccine for Cancer Therapy. Poster #245. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Liu S, Wang Z, Jay CM, Rao DD, Templeton NS, Maples PB, Senzer N, Brunicardi FC, Nemunaitis J. Systemic Administration of Bifunctional shRNA Lipoplex Targeting PDX-1 for Murine Model of Insulinoma and Pancreatic Cancer. Poster #247. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Vorhies JS, Rao DD, Senzer N, Nemunaitis J:  siRNA Versus shRNA for Personalized Cancer Therapy: Mechanisms and Applications (Chapter 4).  In: Gene-Based Therapies for Cancer. Springer Science+Business Media, LLC; Roth JA (ed.), pp. 51-62, 2010.

Senzer N, Kumar P, Kuhn J, Barve M, Bedell C, Yu Y, Tong AW, Maples PB, Nemunaitis J. Translational phase I study in advanced cancer patients of dual-function autologous (FANG) vaccine incorporating bifunctional shRNAfurin and GMCSF transgene expression. Oral #335. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Nemunaitis J, Kumar P, Senzer N, Kuhn J, Barve M, Olivares J, Edelman G, Bedell C, Yu Y, Magee M, Pappen BO, Wallraven G, Tong AW, Maples PB. Final results of phase I trial of GMCSF gene-TGFß2 antisense gene autologous tumor cell (TAG) vaccine in advanced cancer. Oral #292. ASGCT 13th Annual Meeting, May 17 - 22, 2010, Washington, D.C.

Kumar P, Jay C, Oxendine I, Nemunaitis J, Maples PB:  TAG Xenograft Vaccine: Xenograft-Expanded Autologous Tumor Vaccine Genetically Modified to Express GM-CSF and Block Production of TGFß2.  BioProcessing Journal 2009; 8(1):30-6.

Maples PB, Kumar P, Oxendine I, Jay C, Yu Y, Kuhn J, Nemunaitis J:  TAG Vaccine: Autologous Tumor Vaccine Genetically Modified to Express GM-CSF and Block Production of TGFß2.  BioProcessing Journal 2009; 8(1):38-45.