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Rationale, discovery and clinical development of NEO-201.

Arlen P, Morelli MP.

Expert Opin Biol Ther. 2019 Nov 22. doi: 10.1080/14712598.2020.1696767. [Epub ahead of print] No abstract available.


An IL-15 Superagonist, ALT-803, Enhances Antibody-Dependent Cell-Mediated Cytotoxicity Elicited by the Monoclonal Antibody NEO-201 Against Human Carcinoma Cells.

Fantini M, David JM, Wong HC, Annunziata CM, Arlen PM, Tsang KY.

Cancer Biother Radiopharm. 2019 Apr;34(3):147-159. doi: 10.1089/cbr.2018.2628. Epub 2019 Jan 2.


Preclinical Characterization of a Novel Monoclonal Antibody NEO-201 for the Treatment of Human Carcinomas.

Fantini M, David JM, Saric O, Dubeykovskiy A, Cui Y, Mavroukakis SA, Bristol A, Annunziata CM, Tsang KY, Arlen PM.

Front Immunol. 2018 Jan 4;8:1899. doi: 10.3389/fimmu.2017.01899. eCollection 2017.


Neoantigens in the immuno-oncology space.

Arlen PM.

Future Oncol. 2017 Oct;13(25):2209-2211. doi: 10.2217/fon-2017-0349. Epub 2017 Oct 4. No abstract available.


TARP vaccination is associated with slowing in PSA velocity and decreasing tumor growth rates in patients with Stage D0 prostate cancer.

Wood LV, Fojo A, Roberson BD, Hughes MS, Dahut W, Gulley JL, Madan RA, Arlen PM, Sabatino M, Stroncek DF, Castiello L, Trepel JB, Lee MJ, Parnes HL, Steinberg SM, Terabe M, Wilkerson J, Pastan I, Berzofsky JA.

Oncoimmunology. 2016 Jul 1;5(8):e1197459. doi: 10.1080/2162402X.2016.1197459. eCollection 2016 Aug.


A phase 1 dose-escalation study of NEO-102 in patients with refractory colon and pancreatic cancer.

Beg MS, Azad NS, Patel SP, Torrealba J, Mavroukakis S, Beatson MA, Wang XP, Arlen PM, Morse MA.

Cancer Chemother Pharmacol. 2016 Sep;78(3):577-84. doi: 10.1007/s00280-016-3108-5. Epub 2016 Jul 23.


A Phase II Clinical Trial of TRC105 (Anti-Endoglin Antibody) in Adults With Advanced/Metastatic Urothelial Carcinoma.

Apolo AB, Karzai FH, Trepel JB, Alarcon S, Lee S, Lee MJ, Tomita Y, Cao L, Yu Y, Merino MJ, Madan RA, Parnes HL, Steinberg SM, Rodriguez BW, Seon BK, Gulley JL, Arlen PM, Dawson NA, Figg WD, Dahut WL.

Clin Genitourin Cancer. 2017 Feb;15(1):77-85. doi: 10.1016/j.clgc.2016.05.010. Epub 2016 May 27.


Phase II trial of docetaxel, bevacizumab, lenalidomide and prednisone in patients with metastatic castration-resistant prostate cancer.

Madan RA, Karzai FH, Ning YM, Adesunloye BA, Huang X, Harold N, Couvillon A, Chun G, Cordes L, Sissung T, Beedie SL, Dawson NA, Theoret MR, McLeod DG, Rosner I, Trepel JB, Lee MJ, Tomita Y, Lee S, Chen C, Steinberg SM, Arlen PM, Gulley JL, Figg WD, Dahut WL.

BJU Int. 2016 Oct;118(4):590-7. doi: 10.1111/bju.13412. Epub 2016 Feb 19.


Docetaxel Alone or in Combination With a Therapeutic Cancer Vaccine (PANVAC) in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial.

Heery CR, Ibrahim NK, Arlen PM, Mohebtash M, Murray JL, Koenig K, Madan RA, McMahon S, Marté JL, Steinberg SM, Donahue RN, Grenga I, Jochems C, Farsaci B, Folio LR, Schlom J, Gulley JL.

JAMA Oncol. 2015 Nov;1(8):1087-95. doi: 10.1001/jamaoncol.2015.2736. Erratum in: JAMA Oncol. 2015 Nov;1(8):1171-2.


Phase I Trial of a Yeast-Based Therapeutic Cancer Vaccine (GI-6301) Targeting the Transcription Factor Brachyury.

Heery CR, Singh BH, Rauckhorst M, Marté JL, Donahue RN, Grenga I, Rodell TC, Dahut W, Arlen PM, Madan RA, Schlom J, Gulley JL.

Cancer Immunol Res. 2015 Nov;3(11):1248-56. doi: 10.1158/2326-6066.CIR-15-0119. Epub 2015 Jun 30.


A national multicenter phase 2 study of prostate-specific antigen (PSA) pox virus vaccine with sequential androgen ablation therapy in patients with PSA progression: ECOG 9802.

DiPaola RS, Chen YH, Bubley GJ, Stein MN, Hahn NM, Carducci MA, Lattime EC, Gulley JL, Arlen PM, Butterfield LH, Wilding G.

Eur Urol. 2015 Sep;68(3):365-71. doi: 10.1016/j.eururo.2014.12.010. Epub 2014 Dec 18.


The Cause and Prevention of Anastomotic Recurrence following Colectomy: An Immunohistochemical Approach for Detecting Transforming Colonocytes.

M A, J C, G C, O S, J B, A D, J S, C C, A K, J P, P A, X W, E M.

J Cancer. 2014 Oct 23;5(9):784-9. doi: 10.7150/jca.9485. eCollection 2014.


Monoclonal antibodies that target the immunogenic proteins expressed in colorectal cancer.

Arlen M, Arlen P, Coppa G, Crawford J, Wang X, Saric O, Dubeykovskiy A, Molmenti E.

World J Gastrointest Oncol. 2014 Jun 15;6(6):170-6. doi: 10.4251/wjgo.v6.i6.170. Review.


Phase I trial of a recombinant yeast-CEA vaccine (GI-6207) in adults with metastatic CEA-expressing carcinoma.

Bilusic M, Heery CR, Arlen PM, Rauckhorst M, Apelian D, Tsang KY, Tucker JA, Jochems C, Schlom J, Gulley JL, Madan RA.

Cancer Immunol Immunother. 2014 Mar;63(3):225-34. doi: 10.1007/s00262-013-1505-8. Epub 2013 Dec 7.


Recent advances revolutionize treatment of metastatic prostate cancer.

Madan RA, Arlen PM.

Future Oncol. 2013 Aug;9(8):1133-44. doi: 10.2217/fon.13.65. Review.


Optimizing the immune system to achieve control of the metastatic malignant lesion.

Arlen M, Arlen P.

J Cancer. 2013 Jun 28;4(5):427-32. doi: 10.7150/jca.6572. Print 2013.


Anti-tumor activity of a novel monoclonal antibody, NPC-1C, optimized for recognition of tumor antigen MUC5AC variant in preclinical models.

Patel SP, Bristol A, Saric O, Wang XP, Dubeykovskiy A, Arlen PM, Morse MA.

Cancer Immunol Immunother. 2013 Jun;62(6):1011-9. doi: 10.1007/s00262-013-1420-z. Epub 2013 Apr 17.


Prostate cancer vaccines: an old yet novel target, the androgen receptor.

Arlen PM.

Expert Rev Vaccines. 2013 Mar;12(3):249-51. doi: 10.1586/erv.13.17.


Nanocytology vs. Immunohistochemistry of Intestinal Colonocytes to Assess the Risk of Colon Cancer based on Field Cancerization - A Preliminary Report.

Arlen M, Saric O, Wang X, Dubeykovskiy A, Arlen P.

J Cancer. 2013;4(2):165-9. doi: 10.7150/jca.5468. Epub 2013 Feb 2.


Prostate cancer vaccines: moving therapeutic vaccination forward in the post-Provenge era.

Arlen PM, Wood LV.

Expert Rev Vaccines. 2012 Mar;11(3):287-302. doi: 10.1586/erv.11.183. Review.


Prostate cancer cell surface-associated keratin 8 and its implications for enhanced plasmin activity.

Kuchma MH, Kim JH, Muller MT, Arlen PA.

Protein J. 2012 Mar;31(3):195-205. doi: 10.1007/s10930-011-9388-z.


Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial.

Madan RA, Mohebtash M, Arlen PM, Vergati M, Rauckhorst M, Steinberg SM, Tsang KY, Poole DJ, Parnes HL, Wright JJ, Dahut WL, Schlom J, Gulley JL.

Lancet Oncol. 2012 May;13(5):501-8. doi: 10.1016/S1470-2045(12)70006-2. Epub 2012 Feb 10.


A pilot study of MUC-1/CEA/TRICOM poxviral-based vaccine in patients with metastatic breast and ovarian cancer.

Mohebtash M, Tsang KY, Madan RA, Huen NY, Poole DJ, Jochems C, Jones J, Ferrara T, Heery CR, Arlen PM, Steinberg SM, Pazdur M, Rauckhorst M, Jones EC, Dahut WL, Schlom J, Gulley JL.

Clin Cancer Res. 2011 Nov 15;17(22):7164-73. doi: 10.1158/1078-0432.CCR-11-0649. Epub 2011 Nov 8.


A pilot safety trial investigating a vector-based vaccine targeting carcinoembryonic antigen in combination with radiotherapy in patients with gastrointestinal malignancies metastatic to the liver.

Gulley JL, Madan RA, Tsang KY, Arlen PM, Camphausen K, Mohebtash M, Kamrava M, Schlom J, Citrin D.

Expert Opin Biol Ther. 2011 Nov;11(11):1409-18. doi: 10.1517/14712598.2011.615741. Epub 2011 Aug 28.


Prostate cancer immunotherapy: the role for sipuleucel-T and other immunologic approaches.

Arlen PM.

Oncology (Williston Park). 2011 Mar;25(3):261-2. Review. No abstract available.


Development of a serum biomarker assay that differentiates tumor-associated MUC5AC (NPC-1C ANTIGEN) from normal MUC5AC.

Luka J, Arlen PM, Bristol A.

J Biomed Biotechnol. 2011;2011:934757. doi: 10.1155/2011/934757. Epub 2010 Dec 16.


Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy.

Stein WD, Gulley JL, Schlom J, Madan RA, Dahut W, Figg WD, Ning YM, Arlen PM, Price D, Bates SE, Fojo T.

Clin Cancer Res. 2011 Feb 15;17(4):907-17. doi: 10.1158/1078-0432.CCR-10-1762. Epub 2010 Nov 24.


The therapeutic value of monoclonal antibodies directed against immunogenic tumor glycoproteins.

Arlen M, Arlen P, Tsang A, Wang X, Gupta R.

J Cancer. 2010 Nov 3;1:209-22.


Analysis of circulating regulatory T cells in patients with metastatic prostate cancer pre- versus post-vaccination.

Vergati M, Cereda V, Madan RA, Gulley JL, Huen NY, Rogers CJ, Hance KW, Arlen PM, Schlom J, Tsang KY.

Cancer Immunol Immunother. 2011 Feb;60(2):197-206. doi: 10.1007/s00262-010-0927-9. Epub 2010 Oct 26.


Bioluminescence imaging correlates with tumor progression in an orthotopic mouse model of lung cancer.

Madero-Visbal RA, Colon JF, Hernandez IC, Limaye A, Smith J, Lee CM, Arlen PA, Herrera L, Baker CH.

Surg Oncol. 2012 Mar;21(1):23-9. doi: 10.1016/j.suronc.2010.07.008. Epub 2010 Aug 30.


A phase I clinical study of high dose ketoconazole plus weekly docetaxel for metastatic castration resistant prostate cancer.

Figg WD, Woo S, Zhu W, Chen X, Ajiboye AS, Steinberg SM, Price DK, Wright JJ, Parnes HL, Arlen PM, Gulley JL, Dahut WL.

J Urol. 2010 Jun;183(6):2219-26. doi: 10.1016/j.juro.2010.02.020.


Phase II trial of bevacizumab, thalidomide, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer.

Ning YM, Gulley JL, Arlen PM, Woo S, Steinberg SM, Wright JJ, Parnes HL, Trepel JB, Lee MJ, Kim YS, Sun H, Madan RA, Latham L, Jones E, Chen CC, Figg WD, Dahut WL.

J Clin Oncol. 2010 Apr 20;28(12):2070-6. doi: 10.1200/JCO.2009.25.4524. Epub 2010 Mar 22.


Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer.

Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR.

J Clin Oncol. 2010 Mar 1;28(7):1099-105. doi: 10.1200/JCO.2009.25.0597. Epub 2010 Jan 25.


Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer.

Gulley JL, Arlen PM, Madan RA, Tsang KY, Pazdur MP, Skarupa L, Jones JL, Poole DJ, Higgins JP, Hodge JW, Cereda V, Vergati M, Steinberg SM, Halabi S, Jones E, Chen C, Parnes H, Wright JJ, Dahut WL, Schlom J.

Cancer Immunol Immunother. 2010 May;59(5):663-74. doi: 10.1007/s00262-009-0782-8. Epub 2009 Nov 5.


Current perspectives in prostate cancer vaccines.

Arlen PM, Gulley JL.

Anticancer Agents Med Chem. 2009 Dec;9(10):1052-7. Review.


Prostvac-VF: a vector-based vaccine targeting PSA in prostate cancer.

Madan RA, Arlen PM, Mohebtash M, Hodge JW, Gulley JL.

Expert Opin Investig Drugs. 2009 Jul;18(7):1001-11. doi: 10.1517/13543780902997928. Review.


New gene expressed in prostate: a potential target for T cell-mediated prostate cancer immunotherapy.

Cereda V, Poole DJ, Palena C, Das S, Bera TK, Remondo C, Gulley JL, Arlen PM, Yokokawa J, Pastan I, Schlom J, Tsang KY.

Cancer Immunol Immunother. 2010 Jan;59(1):63-71. doi: 10.1007/s00262-009-0723-6. Epub 2009 Jun 4.


Phase I study of oral lenalidomide in patients with refractory metastatic cancer.

Dahut WL, Aragon-Ching JB, Woo S, Tohnya TM, Gulley JL, Arlen PM, Wright JJ, Ventiz J, Figg WD.

J Clin Pharmacol. 2009 Jun;49(6):650-60. doi: 10.1177/0091270009335001.


Promising novel immunotherapies and combinations for prostate cancer.

Arlen PM, Mohebtash M, Madan RA, Gulley JL.

Future Oncol. 2009 Mar;5(2):187-96. doi: 10.2217/14796694.5.2.187. Review.


Higher incidence of Osteonecrosis of the Jaw (ONJ) in patients with metastatic castration resistant prostate cancer treated with anti-angiogenic agents.

Aragon-Ching JB, Ning YM, Chen CC, Latham L, Guadagnini JP, Gulley JL, Arlen PM, Wright JJ, Parnes H, Figg WD, Dahut WL.

Cancer Invest. 2009 Feb;27(2):221-6. doi: 10.1080/07357900802208608.


Cancer vaccines: current directions and perspectives in prostate cancer.

Mohebtash M, Gulley JL, Madan RA, Ferrara T, Arlen PM.

Curr Opin Mol Ther. 2009 Feb;11(1):31-6. Review.


A double-blind randomized crossover study of oral thalidomide versus placebo for androgen dependent prostate cancer treated with intermittent androgen ablation.

Figg WD, Hussain MH, Gulley JL, Arlen PM, Aragon-Ching JB, Petrylak DP, Higano CS, Steinberg SM, Chatta GS, Parnes H, Wright JJ, Sartor O, Dahut WL.

J Urol. 2009 Mar;181(3):1104-13; discussion 1113. doi: 10.1016/j.juro.2008.11.026. Epub 2009 Jan 23.


Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer.

Aragon-Ching JB, Jain L, Gulley JL, Arlen PM, Wright JJ, Steinberg SM, Draper D, Venitz J, Jones E, Chen CC, Figg WD, Dahut WL.

BJU Int. 2009 Jun;103(12):1636-40. doi: 10.1111/j.1464-410X.2008.08327.x. Epub 2009 Jan 9.


Therapeutic prostate cancer vaccines: a review of the latest developments.

Mohebtash M, Madan RA, Gulley JL, Arlen PM.

Curr Opin Investig Drugs. 2008 Dec;9(12):1296-301. Review.


Kinetics of serum androgen normalization and factors associated with testosterone reserve after limited androgen deprivation therapy for nonmetastatic prostate cancer.

Gulley JL, Aragon-Ching JB, Steinberg SM, Hussain MH, Sartor O, Higano CS, Petrylak DP, Chatta GS, Arlen PM, Figg WD, Dahut WL.

J Urol. 2008 Oct;180(4):1432-7; discussion 1437. doi: 10.1016/j.juro.2008.06.017. Epub 2008 Aug 16.


Safety and immunologic response of a viral vaccine to prostate-specific antigen in combination with radiation therapy when metronomic-dose interleukin 2 is used as an adjuvant.

Lechleider RJ, Arlen PM, Tsang KY, Steinberg SM, Yokokawa J, Cereda V, Camphausen K, Schlom J, Dahut WL, Gulley JL.

Clin Cancer Res. 2008 Aug 15;14(16):5284-91. doi: 10.1158/1078-0432.CCR-07-5162.


Analysis of overall survival in patients with nonmetastatic castration-resistant prostate cancer treated with vaccine, nilutamide, and combination therapy.

Madan RA, Gulley JL, Schlom J, Steinberg SM, Liewehr DJ, Dahut WL, Arlen PM.

Clin Cancer Res. 2008 Jul 15;14(14):4526-31. doi: 10.1158/1078-0432.CCR-07-5048.


Effective plague vaccination via oral delivery of plant cells expressing F1-V antigens in chloroplasts.

Arlen PA, Singleton M, Adamovicz JJ, Ding Y, Davoodi-Semiromi A, Daniell H.

Infect Immun. 2008 Aug;76(8):3640-50. doi: 10.1128/IAI.00050-08. Epub 2008 May 27.


Pilot study of vaccination with recombinant CEA-MUC-1-TRICOM poxviral-based vaccines in patients with metastatic carcinoma.

Gulley JL, Arlen PM, Tsang KY, Yokokawa J, Palena C, Poole DJ, Remondo C, Cereda V, Jones JL, Pazdur MP, Higgins JP, Hodge JW, Steinberg SM, Kotz H, Dahut WL, Schlom J.

Clin Cancer Res. 2008 May 15;14(10):3060-9. doi: 10.1158/1078-0432.CCR-08-0126.

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