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The Landscape of Early Clinical Gene Therapies outside of Oncology.

Rittié L, Athanasopoulos T, Calero-Garcia M, Davies ML, Dow DJ, Howe SJ, Morrison A, Ricciardelli I, Saudemont A, Jespers L, Clay TM.

Mol Ther. 2019 Oct 2;27(10):1706-1717. doi: 10.1016/j.ymthe.2019.09.002. Epub 2019 Sep 6. Review.


Polyfunctional anti-human epidermal growth factor receptor 3 (anti-HER3) antibodies induced by HER3 vaccines have multiple mechanisms of antitumor activity against therapy resistant and triple negative breast cancers.

Osada T, Hartman ZC, Wei J, Lei G, Hobeika AC, Gwin WR, Diniz MA, Spector N, Clay TM, Chen W, Morse MA, Lyerly HK.

Breast Cancer Res. 2018 Aug 9;20(1):90. doi: 10.1186/s13058-018-1023-x.


A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer.

Morse MA, Niedzwiecki D, Marshall JL, Garrett C, Chang DZ, Aklilu M, Crocenzi TS, Cole DJ, Dessureault S, Hobeika AC, Osada T, Onaitis M, Clary BM, Hsu D, Devi GR, Bulusu A, Annechiarico RP, Chadaram V, Clay TM, Lyerly HK.

Ann Surg. 2013 Dec;258(6):879-86. doi: 10.1097/SLA.0b013e318292919e.


Novel adenoviral vector induces T-cell responses despite anti-adenoviral neutralizing antibodies in colorectal cancer patients.

Morse MA, Chaudhry A, Gabitzsch ES, Hobeika AC, Osada T, Clay TM, Amalfitano A, Burnett BK, Devi GR, Hsu DS, Xu Y, Balcaitis S, Dua R, Nguyen S, Balint JP Jr, Jones FR, Lyerly HK.

Cancer Immunol Immunother. 2013 Aug;62(8):1293-301. doi: 10.1007/s00262-013-1400-3. Epub 2013 Apr 30.


Cancer regression and neurological toxicity cases after anti-MAGE-A3 TCR gene therapy.

Brichard VG, Louahed J, Clay TM.

J Immunother. 2013 Feb;36(2):79-81. doi: 10.1097/CJI.0b013e3182829747. No abstract available.


Evidence for phenotypic plasticity in aggressive triple-negative breast cancer: human biology is recapitulated by a novel model system.

D'Amato NC, Ostrander JH, Bowie ML, Sistrunk C, Borowsky A, Cardiff RD, Bell K, Young LJ, Simin K, Bachelder RE, Delrow J, Dawson A, Yee LD, Mrózek K, Clay TM, Osada T, Seewaldt VL.

PLoS One. 2012;7(9):e45684. doi: 10.1371/journal.pone.0045684. Epub 2012 Sep 25.


Polyclonal HER2-specific antibodies induced by vaccination mediate receptor internalization and degradation in tumor cells.

Ren XR, Wei J, Lei G, Wang J, Lu J, Xia W, Spector N, Barak LS, Clay TM, Osada T, Hamilton E, Blackwell K, Hobeika AC, Morse MA, Lyerly HK, Chen W.

Breast Cancer Res. 2012 Jun 7;14(3):R89.


Co-delivery of antigen and IL-12 by Venezuelan equine encephalitis virus replicon particles enhances antigen-specific immune responses and antitumor effects.

Osada T, Berglund P, Morse MA, Hubby B, Lewis W, Niedzwiecki D, Yang XY, Hobeika A, Burnett B, Devi GR, Clay TM, Smith J, Kim Lyerly H.

Cancer Immunol Immunother. 2012 Nov;61(11):1941-51. doi: 10.1007/s00262-012-1248-y. Epub 2012 Apr 10.


Phase 1 clinical trial of HER2-specific immunotherapy with concomitant HER2 kinase inhibition [corrected].

Hamilton E, Blackwell K, Hobeika AC, Clay TM, Broadwater G, Ren XR, Chen W, Castro H, Lehmann F, Spector N, Wei J, Osada T, Lyerly HK, Morse MA.

J Transl Med. 2012 Feb 10;10:28. doi: 10.1186/1479-5876-10-28. Erratum in: J Transl Med. 2013;11:82. Morse, Michael A [added].


Immunodominant liver-specific expression suppresses transgene-directed immune responses in murine pompe disease.

Zhang P, Sun B, Osada T, Rodriguiz R, Yang XY, Luo X, Kemper AR, Clay TM, Koeberl DD.

Hum Gene Ther. 2012 May;23(5):460-72. doi: 10.1089/hum.2011.063. Epub 2012 Mar 29.


Increasing vaccine potency through exosome antigen targeting.

Hartman ZC, Wei J, Glass OK, Guo H, Lei G, Yang XY, Osada T, Hobeika A, Delcayre A, Le Pecq JB, Morse MA, Clay TM, Lyerly HK.

Vaccine. 2011 Nov 21;29(50):9361-7. doi: 10.1016/j.vaccine.2011.09.133. Epub 2011 Oct 12.


New perspectives on zoledronic acid in breast cancer: potential augmentation of anticancer immune response.

Hamilton E, Clay TM, Blackwell KL.

Cancer Invest. 2011 Oct;29(8):533-41. doi: 10.3109/07357907.2011.605413. Epub 2011 Aug 15. Review.


Immunologic monitoring of cellular immune responses in cancer vaccine therapy.

Whiteside TL, Gulley JL, Clay TM, Tsang KY.

J Biomed Biotechnol. 2011;2011:370374. doi: 10.1155/2011/370374. Epub 2011 Jun 7. No abstract available.


Truncated ErbB2 expressed in tumor cell nuclei contributes to acquired therapeutic resistance to ErbB2 kinase inhibitors.

Xia W, Liu Z, Zong R, Liu L, Zhao S, Bacus SS, Mao Y, He J, Wulfkuhle JD, Petricoin EF 3rd, Osada T, Yang XY, Hartman ZC, Clay TM, Blackwell KL, Lyerly HK, Spector NL.

Mol Cancer Ther. 2011 Aug;10(8):1367-74. doi: 10.1158/1535-7163.MCT-10-0991. Epub 2011 Jun 14.


Antihelminth compound niclosamide downregulates Wnt signaling and elicits antitumor responses in tumors with activating APC mutations.

Osada T, Chen M, Yang XY, Spasojevic I, Vandeusen JB, Hsu D, Clary BM, Clay TM, Chen W, Morse MA, Lyerly HK.

Cancer Res. 2011 Jun 15;71(12):4172-82. doi: 10.1158/0008-5472.CAN-10-3978. Epub 2011 Apr 29.


HER2 overexpression elicits a proinflammatory IL-6 autocrine signaling loop that is critical for tumorigenesis.

Hartman ZC, Yang XY, Glass O, Lei G, Osada T, Dave SS, Morse MA, Clay TM, Lyerly HK.

Cancer Res. 2011 Jul 1;71(13):4380-91. doi: 10.1158/0008-5472.CAN-11-0308. Epub 2011 Apr 25.


MHC class I-presented tumor antigens identified in ovarian cancer by immunoproteomic analysis are targets for T-cell responses against breast and ovarian cancer.

Morse MA, Secord AA, Blackwell K, Hobeika AC, Sinnathamby G, Osada T, Hafner J, Philip M, Clay TM, Lyerly HK, Philip R.

Clin Cancer Res. 2011 May 15;17(10):3408-19. doi: 10.1158/1078-0432.CCR-10-2614. Epub 2011 Feb 7.


Depletion of human regulatory T cells.

Hobeika AC, Morse MA, Osada T, Peplinski S, Lyerly HK, Clay TM.

Methods Mol Biol. 2011;707:219-31. doi: 10.1007/978-1-61737-979-6_14.


Polyclonal immune responses to antigens associated with cancer signaling pathways and new strategies to enhance cancer vaccines.

Clay TM, Osada T, Hartman ZC, Hobeika A, Devi G, Morse MA, Lyerly HK.

Immunol Res. 2011 Apr;49(1-3):235-47. doi: 10.1007/s12026-010-8186-6.


CSPG4 protein as a new target for the antibody-based immunotherapy of triple-negative breast cancer.

Wang X, Osada T, Wang Y, Yu L, Sakakura K, Katayama A, McCarthy JB, Brufsky A, Chivukula M, Khoury T, Hsu DS, Barry WT, Lyerly HK, Clay TM, Ferrone S.

J Natl Cancer Inst. 2010 Oct 6;102(19):1496-512. doi: 10.1093/jnci/djq343. Epub 2010 Sep 17.


Ligand-independent toll-like receptor signals generated by ectopic overexpression of MyD88 generate local and systemic antitumor immunity.

Hartman ZC, Osada T, Glass O, Yang XY, Lei GJ, Lyerly HK, Clay TM.

Cancer Res. 2010 Sep 15;70(18):7209-20. doi: 10.1158/0008-5472.CAN-10-0905. Epub 2010 Sep 7.


An alphavirus vector overcomes the presence of neutralizing antibodies and elevated numbers of Tregs to induce immune responses in humans with advanced cancer.

Morse MA, Hobeika AC, Osada T, Berglund P, Hubby B, Negri S, Niedzwiecki D, Devi GR, Burnett BK, Clay TM, Smith J, Lyerly HK.

J Clin Invest. 2010 Sep;120(9):3234-41. doi: 10.1172/JCI42672. Epub 2010 Aug 2.


An adenoviral vaccine encoding full-length inactivated human Her2 exhibits potent immunogenicty and enhanced therapeutic efficacy without oncogenicity.

Hartman ZC, Wei J, Osada T, Glass O, Lei G, Yang XY, Peplinski S, Kim DW, Xia W, Spector N, Marks J, Barry W, Hobeika A, Devi G, Amalfitano A, Morse MA, Lyerly HK, Clay TM.

Clin Cancer Res. 2010 Mar 1;16(5):1466-77. doi: 10.1158/1078-0432.CCR-09-2549. Epub 2010 Feb 23.


Metastatic colorectal cancer cells from patients previously treated with chemotherapy are sensitive to T-cell killing mediated by CEA/CD3-bispecific T-cell-engaging BiTE antibody.

Osada T, Hsu D, Hammond S, Hobeika A, Devi G, Clay TM, Lyerly HK, Morse MA.

Br J Cancer. 2010 Jan 5;102(1):124-33. doi: 10.1038/sj.bjc.6605364. Epub 2009 Dec 1.


CpG oligodeoxynucleotides as TLR9 agonists: therapeutic applications in cancer.

Murad YM, Clay TM.

BioDrugs. 2009;23(6):361-75. doi: 10.2165/11316930-000000000-00000. Review.


Synergism from combined immunologic and pharmacologic inhibition of HER2 in vivo.

Morse MA, Wei J, Hartman Z, Xia W, Ren XR, Lei G, Barry WT, Osada T, Hobeika AC, Peplinski S, Jiang H, Devi GR, Chen W, Spector N, Amalfitano A, Lyerly HK, Clay TM.

Int J Cancer. 2010 Jun 15;126(12):2893-903. doi: 10.1002/ijc.24995.


Priming and activation of human ovarian and breast cancer-specific CD8+ T cells by polyvalent Listeria monocytogenes-based vaccines.

Sinnathamby G, Lauer P, Zerfass J, Hanson B, Karabudak A, Krakover J, Secord AA, Clay TM, Morse MA, Dubensky TW Jr, Brockstedt DG, Philip R, Giedlin M.

J Immunother. 2009 Oct;32(8):856-69. doi: 10.1097/CJI.0b013e3181b0b125.


Immunomodulatory gene therapy prevents antibody formation and lethal hypersensitivity reactions in murine pompe disease.

Sun B, Kulis MD, Young SP, Hobeika AC, Li S, Bird A, Zhang H, Li Y, Clay TM, Burks W, Kishnani PS, Koeberl DD.

Mol Ther. 2010 Feb;18(2):353-60. doi: 10.1038/mt.2009.195. Epub 2009 Aug 18.


Induction of Wilms' tumor protein (WT1)-specific antitumor immunity using a truncated WT1-expressing adenovirus vaccine.

Osada T, Woo CY, McKinney M, Yang XY, Lei G, Labreche HG, Hartman ZC, Niedzwiecki D, Chao N, Amalfitano A, Morse MA, Lyerly HK, Clay TM.

Clin Cancer Res. 2009 Apr 15;15(8):2789-96. doi: 10.1158/1078-0432.CCR-08-2589. Epub 2009 Apr 7.


Harmonization guidelines for HLA-peptide multimer assays derived from results of a large scale international proficiency panel of the Cancer Vaccine Consortium.

Britten CM, Janetzki S, Ben-Porat L, Clay TM, Kalos M, Maecker H, Odunsi K, Pride M, Old L, Hoos A, Romero P; HLA-peptide Multimer Proficiency Panel of the CVC-CRI Immune Assay Working Group.

Cancer Immunol Immunother. 2009 Oct;58(10):1701-13. doi: 10.1007/s00262-009-0681-z. Epub 2009 Mar 4.


Optimization of vaccine responses with an E1, E2b and E3-deleted Ad5 vector circumvents pre-existing anti-vector immunity.

Osada T, Yang XY, Hartman ZC, Glass O, Hodges BL, Niedzwiecki D, Morse MA, Lyerly HK, Amalfitano A, Clay TM.

Cancer Gene Ther. 2009 Sep;16(9):673-82. doi: 10.1038/cgt.2009.17. Epub 2009 Feb 20.


Depletion of human regulatory T cells specifically enhances antigen-specific immune responses to cancer vaccines.

Morse MA, Hobeika AC, Osada T, Serra D, Niedzwiecki D, Lyerly HK, Clay TM.

Blood. 2008 Aug 1;112(3):610-8. doi: 10.1182/blood-2008-01-135319. Epub 2008 Jun 2.


Precision and linearity targets for validation of an IFNgamma ELISPOT, cytokine flow cytometry, and tetramer assay using CMV peptides.

Maecker HT, Hassler J, Payne JK, Summers A, Comatas K, Ghanayem M, Morse MA, Clay TM, Lyerly HK, Bhatia S, Ghanekar SA, Maino VC, Delarosa C, Disis ML.

BMC Immunol. 2008 Mar 17;9:9. doi: 10.1186/1471-2172-9-9.


Replication-attenuated Human Adenoviral Type 4 vectors elicit capsid dependent enhanced innate immune responses that are partially dependent upon interactions with the complement system.

Hartman ZC, Appledorn DM, Serra D, Glass O, Mendelson TB, Clay TM, Amalfitano A.

Virology. 2008 May 10;374(2):453-67. doi: 10.1016/j.virol.2008.01.017. Epub 2008 Feb 15.


Long term disease-free survival and T cell and antibody responses in women with high-risk Her2+ breast cancer following vaccination against Her2.

Morse MA, Hobeika A, Osada T, Niedzwiecki D, Marcom PK, Blackwell KL, Anders C, Devi GR, Lyerly HK, Clay TM.

J Transl Med. 2007 Sep 6;5:42.


Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI).

Janetzki S, Panageas KS, Ben-Porat L, Boyer J, Britten CM, Clay TM, Kalos M, Maecker HT, Romero P, Yuan J, Kast WM, Hoos A; Elispot Proficiency Panel of the CVC Immune Assay Working Group.

Cancer Immunol Immunother. 2008 Mar;57(3):303-15. Epub 2007 Aug 25.


CPG-7909 (PF-3512676, ProMune): toll-like receptor-9 agonist in cancer therapy.

Murad YM, Clay TM, Lyerly HK, Morse MA.

Expert Opin Biol Ther. 2007 Aug;7(8):1257-66. Review.


Update on anti-CTLA-4 antibodies in clinical trials.

Langer LF, Clay TM, Morse MA.

Expert Opin Biol Ther. 2007 Aug;7(8):1245-56. Review.


Investigation of HIFU-induced anti-tumor immunity in a murine tumor model.

Hu Z, Yang XY, Liu Y, Sankin GN, Pua EC, Morse MA, Lyerly HK, Clay TM, Zhong P.

J Transl Med. 2007 Jul 11;5:34.


Dendritic cell vaccines.

Mosca PJ, Lyerly HK, Clay TM, Morse MA, Lyerly HK.

Front Biosci. 2007 May 1;12:4050-60. Review.


Vascular endothelial growth factor and immunosuppression in cancer: current knowledge and potential for new therapy.

Johnson BF, Clay TM, Hobeika AC, Lyerly HK, Morse MA.

Expert Opin Biol Ther. 2007 Apr;7(4):449-60. Review.


Immunotherapeutic targeting of Wilms' tumor protein.

Hutchings Y, Osada T, Woo CY, Clay TM, Lyerly HK, Morse MA.

Curr Opin Mol Ther. 2007 Feb;9(1):62-9. Review.


Dendritic cell-based immunotherapy.

Osada T, Clay TM, Woo CY, Morse MA, Lyerly HK.

Int Rev Immunol. 2006 Sep-Dec;25(5-6):377-413. Review.


Adenovirus infection triggers a rapid, MyD88-regulated transcriptome response critical to acute-phase and adaptive immune responses in vivo.

Hartman ZC, Kiang A, Everett RS, Serra D, Yang XY, Clay TM, Amalfitano A.

J Virol. 2007 Feb;81(4):1796-812. Epub 2006 Nov 22.


Recent clinical progress in virus-based therapies for cancer.

Woo CY, Osada T, Clay TM, Lyerly HK, Morse MA.

Expert Opin Biol Ther. 2006 Nov;6(11):1123-34. Review.


Role of natural killer cell function in dendritic cell-based vaccines.

Woo CY, Clay TM, Lyerly HK, Morse MA, Osada T.

Expert Rev Vaccines. 2006 Feb;5(1):55-65. Review.


Maximizing the retention of antigen specific lymphocyte function after cryopreservation.

Disis ML, dela Rosa C, Goodell V, Kuan LY, Chang JC, Kuus-Reichel K, Clay TM, Kim Lyerly H, Bhatia S, Ghanekar SA, Maino VC, Maecker HT.

J Immunol Methods. 2006 Jan 20;308(1-2):13-8. Epub 2005 Oct 21.


Immune monitoring.

Mosca PJ, Clay TM, Morse MA, Lyerly HK.

Cancer Treat Res. 2005;123:369-88. Review.


Antigen recognition and T-cell biology.

Nishimura MI, Roszkowski JJ, Moore TV, Brasic N, McKee MD, Clay TM.

Cancer Treat Res. 2005;123:37-59. Review.


The development of therapeutic and preventive vaccines for gastric cancer and Helicobacter pylori.

Chui SY, Clay TM, Lyerly HK, Morse MA.

Cancer Epidemiol Biomarkers Prev. 2005 Aug;14(8):1883-9. Review.

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