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2. Rindopepimut with Bevacizumab for Patients with Relapsed EGFRvIII-Expressing Glioblastoma (ReACT): Results of a Double-Blind Randomized Phase II Trial

Author

Reardon, David A, Desjardins, Annick, Vredenburgh, James J, O'Rourke, Donald M, Tran, David D, Fink, Karen L, Nabors, Louis B, Li, Gordon, Bota, Daniela A, Lukas, Rimas V, Ashby, Lynn S, Duic, J Paul, Mrugala, Maciej M, Cruickshank, Scott, Vitale, Laura, He, Yi, Green, Jennifer A, Yellin, Michael J, Turner, Christopher D, Keler, Tibor, Davis, Thomas A, Sampson, John H, and investigators, for the ReACT trial

Subjects
Brain Cancer, Clinical Research, Clinical Trials and Supportive Activities, Rare Diseases, Brain Disorders, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Bevacizumab, Brain Neoplasms, Cancer Vaccines, Double-Blind Method, ErbB Receptors, Glioblastoma, Humans, Neoplasm Recurrence, Local, Patients, Vaccines, Subunit, ReACT trial investigators, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeRindopepimut is a vaccine targeting the tumor-specific EGF driver mutation, EGFRvIII. The ReACT study investigated whether the addition of rindopepimut to standard bevacizumab improved outcome for patients with relapsed, EGFRvIII-positive glioblastoma.Patients and methodsIn this double-blind, randomized, phase II study (NCT01498328) conducted at 26 hospitals in the United States, bevacizumab-naïve patients with recurrent EGFRvIII-positive glioblastoma were randomized to receive rindopepimut or a control injection of keyhole limpet hemocyanin, each concurrent with bevacizumab. The primary endpoint was 6-month progression-free survival (PFS6) by central review with a one-sided significance of 0.2.ResultsBetween May 2012 and 2014, 73 patients were randomized (36 rindopepimut, 37 control). Rindopepimut toxicity included transient, low-grade local reactions. As primary endpoint, PFS6 was 28% (10/36) for rindopepimut compared with 16% (6/37) for control (P = 0.12, one-sided). Secondary and exploratory endpoints also favored the rindopepimut group including a statistically significant survival advantage [HR, 0.53; 95% confidence interval (CI), 0.32-0.88; two-sided log-rank P = 0.01], a higher ORR [30% (9/30) vs. 18% (6/34; P = 0.38)], median duration of response [7.8 months (95% CI, 3.5-22.2) vs. 5.6 (95% CI, 3.7-7.4)], and ability to discontinue steroids for ≥6 months [33% (6/18) vs. 0% (0/19)]. Eighty percent of rindopepimut-treated patients achieved robust anti-EGFRvIII titers (≥1:12,800), which were associated with prolonged survival (HR = 0.17; 95% CI, 0.07-0.45; P < 0.0001).ConclusionsOur randomized trial supports the potential for targeted immunotherapy among patients with GBM, but the therapeutic benefit requires validation due to the small sample size and potential heterogeneity of bevacizumab response among recurrent patients with GBM.See related commentary by Wick and Wagener, p. 1535.

Published
2020

3. HSP90 inhibitors induce GPNMB cell-surface expression by modulating lysosomal positioning and sensitize breast cancer cells to glembatumumab vedotin

Author

Biondini, Marco, Kiepas, Alex, El-Houjeiri, Leeanna, Annis, Matthew G., Hsu, Brian E., Fortier, Anne-Marie, Morin, Geneviève, Martina, José A., Sirois, Isabelle, Aguilar-Mahecha, Adriana, Gruosso, Tina, McGuirk, Shawn, Rose, April A. N., Tokat, Unal M., Johnson, Radia M., Sahin, Ozgur, Bareke, Eric, St-Pierre, Julie, Park, Morag, Basik, Mark, Majewski, Jacek, Puertollano, Rosa, Pause, Arnim, Huang, Sidong, Keler, Tibor, and Siegel, Peter M.

Published
2022
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6. High-Dimensional Phenotypic Mapping of Human Dendritic Cells Reveals Interindividual Variation and Tissue Specialization

Author

Alcántara-Hernández, Marcela, Leylek, Rebecca, Wagar, Lisa E, Engleman, Edgar G, Keler, Tibor, Marinkovich, M Peter, Davis, Mark M, Nolan, Garry P, and Idoyaga, Juliana

Subjects
Biomedical and Clinical Sciences, Immunology, Prevention, Biotechnology, Immunization, Emerging Infectious Diseases, Vaccine Related, Good Health and Well Being, Animals, Antibodies, Monoclonal, Antigens, CD, Antigens, Differentiation, Biological Variation, Individual, Biomarkers, Cancer Vaccines, Cytophotometry, Dendritic Cells, Female, Gene Expression, Humans, Immunophenotyping, Immunotherapy, Lymph Nodes, Mice, Mice, Inbred C57BL, Molecular Targeted Therapy, Neoplasms, Organ Specificity, Palatine Tonsil, Phenotype, Proto-Oncogene Proteins, Receptor Protein-Tyrosine Kinases, Receptors, Immunologic, Skin, Spleen, Axl Receptor Tyrosine Kinase, Axl+ dendritic cells, C-type lectins, CyTOF, antibody targeting, dendritic cells, human, interindividual variation, plasmacytoid dendritic cells, subsets, tissue specialization
Abstract

Given the limited efficacy of clinical approaches that rely on ex vivo generated dendritic cells (DCs), it is imperative to design strategies that harness specialized DC subsets in situ. This requires delineating the expression of surface markers by DC subsets among individuals and tissues. Here, we performed a multiparametric phenotypic characterization and unbiased analysis of human DC subsets in blood, tonsil, spleen, and skin. We uncovered previously unreported phenotypic heterogeneity of human cDC2s among individuals, including variable expression of functional receptors such as CD172a. We found marked differences in DC subsets localized in blood and lymphoid tissues versus skin, and a striking absence of the newly discovered Axl+ DCs in the skin. Finally, we evaluated the capacity of anti-receptor monoclonal antibodies to deliver vaccine components to skin DC subsets. These results offer a promising path for developing DC subset-specific immunotherapies that cannot be provided by transcriptomic analysis alone.

Published
2017

7. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial

Author

Weller, Michael, Butowski, Nicholas, Tran, David D, Recht, Lawrence D, Lim, Michael, Hirte, Hal, Ashby, Lynn, Mechtler, Laszlo, Goldlust, Samuel A, Iwamoto, Fabio, Drappatz, Jan, O'Rourke, Donald M, Wong, Mark, Hamilton, Mark G, Finocchiaro, Gaetano, Perry, James, Wick, Wolfgang, Green, Jennifer, He, Yi, Turner, Christopher D, Yellin, Michael J, Keler, Tibor, Davis, Thomas A, Stupp, Roger, Sampson, John H, investigators, ACT IV trial, Campian, Jian, Recht, Lawrence, Goldlust, Samuel, Becker, Kevin, Barnett, Gene, Nicholas, Garth, Desjardins, Annick, Benkers, Tara, Wagle, Naveed, Groves, Morris, Kesari, Santosh, Horvath, Zsolt, Merrell, Ryan, Curry, Richard, O'Rourke, James, Schuster, David, Mrugala, Maciej, Jensen, Randy, Trusheim, John, Lesser, Glenn, Belanger, Karl, Sloan, Andrew, Purow, Benjamin, Fink, Karen, Raizer, Jeffrey, Schulder, Michael, Nair, Suresh, Peak, Scott, Brandes, Alba, Mohile, Nimish, Landolfi, Joseph, Olson, Jon, Jennens, Ross, DeSouza, Paul, Robinson, Bridget, Crittenden, Marka, Shih, Kent, Flowers, Alexandra, Ong, Shirley, Connelly, Jennifer, Hadjipanayis, Costas, Giglio, Pierre, Mott, Frank, Mathieu, David, Lessard, Nathalie, Sepulveda, Sanchez Juan, Lövey, József, Wheeler, Helen, Inglis, Po-Ling, Hardie, Claire, Bota, Daniela, Lesniak, Maciej, Portnow, Jana, Frankel, Bruce, Junck, Larry, Thompson, Reid, Berk, Lawrence, McGhie, John, Macdonald, David, Saran, Frank, Soffietti, Riccardo, Blumenthal, Deborah, and de, Sá Barreto Costa Marcos André

Subjects
Brain Disorders, Rare Diseases, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Neurosciences, Brain Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Brain Neoplasms, Cancer Vaccines, Dacarbazine, Disease-Free Survival, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, ErbB Receptors, Female, Follow-Up Studies, Gene Expression Regulation, Neoplastic, Glioblastoma, Humans, Internationality, Kaplan-Meier Estimate, Male, Middle Aged, Patient Selection, Proportional Hazards Models, Survival Analysis, Temozolomide, Time Factors, Treatment Outcome, Vaccines, Subunit, Young Adult, ACT IV trial investigators, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundRindopepimut (also known as CDX-110), a vaccine targeting the EGFR deletion mutation EGFRvIII, consists of an EGFRvIII-specific peptide conjugated to keyhole limpet haemocyanin. In the ACT IV study, we aimed to assess whether or not the addition of rindopepimut to standard chemotherapy is able to improve survival in patients with EGFRvIII-positive glioblastoma.MethodsIn this randomised, double-blind, phase 3 trial, we recruited patients aged 18 years and older with glioblastoma from 165 hospitals in 22 countries. Eligible patients had newly diagnosed glioblastoma confirmed to express EGFRvIII by central analysis, and had undergone maximal surgical resection and completion of standard chemoradiation without progression. Patients were stratified by European Organisation for Research and Treatment of Cancer recursive partitioning analysis class, MGMT promoter methylation, and geographical region, and randomly assigned (1:1) with a prespecified randomisation sequence (block size of four) to receive rindopepimut (500 μg admixed with 150 μg GM-CSF) or control (100 μg keyhole limpet haemocyanin) via monthly intradermal injection until progression or intolerance, concurrent with standard oral temozolomide (150-200 mg/m2 for 5 of 28 days) for 6-12 cycles or longer. Patients, investigators, and the trial funder were masked to treatment allocation. The primary endpoint was overall survival in patients with minimal residual disease (MRD; enhancing tumour

Published
2017

10. Flt3 ligand augments immune responses to anti-DEC-205-NY-ESO-1 vaccine through expansion of dendritic cell subsets

Author

Bhardwaj, Nina, Friedlander, Philip A., Pavlick, Anna C., Ernstoff, Marc S., Gastman, Brian R., Hanks, Brent A., Curti, Brendan D., Albertini, Mark R., Luke, Jason J., Blazquez, Ana B., Balan, Sreekumar, Bedognetti, Davide, Beechem, Joseph M., Crocker, Andrea S., D’Amico, Leonard, Danaher, Patrick, Davis, Thomas A., Hawthorne, Thomas, Hess, Bruce W., Keler, Tibor, Lundgren, Lisa, Morishima, Chihiro, Ramchurren, Nirasha, Rinchai, Darawan, Salazar, Andres M., Salim, Bob A., Sharon, Elad, Vitale, Laura A., Wang, Ena, Warren, Sarah, Yellin, Michael J., Disis, Mary L., Cheever, Martin A., and Fling, Steven P.

Published
2020
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13. A combinatory vaccine with IMA950 plus varlilumab promotes effector memory T-cell differentiation in the peripheral blood of patients with low-grade gliomas

Author

Saijo, Atsuro, primary, Ogino, Hirokazu, additional, Butowski, Nicholas A, additional, Tedesco, Meghan R, additional, Gibson, David, additional, Watchmaker, Payal B, additional, Okada, Kaori, additional, Wang, Albert S, additional, Shai, Anny, additional, Salazar, Andres M, additional, Molinaro, Annette M, additional, Rabbitt, Jane E, additional, Shahin, Maryam, additional, Perry, Arie, additional, Clarke, Jennifer L, additional, Taylor, Jennie W, additional, Daras, Mariza, additional, Oberheim Bush, Nancy Ann, additional, Hervey-Jumper, Shawn L, additional, Phillips, Joanna J, additional, Chang, Susan M, additional, Hilf, Norbert, additional, Mayer-Mokler, Andrea, additional, Keler, Tibor, additional, Berger, Mitchel S, additional, and Okada, Hideho, additional

Published
2023
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16. Dual targeting of mast cells and TSLP with a bispecific antibody

Author

Alvarado, Diego, primary, Vitale, Laura, additional, Murphy, Michael B, additional, Wasiuk, Anna, additional, Widger, Jenifer, additional, Crocker, Andrea, additional, Patterson, Colleen, additional, Mills-Chen, Laura, additional, O’Neill, Thomas, additional, Baronas, April R, additional, McManus, Kelly M, additional, Boyer, James M, additional, Montanari, Noe Rico, additional, Lillquist, Jay, additional, Malenchek, Linda, additional, Weidlick, Jeff, additional, Goldstein, Joel, additional, Thomas, Lawrence J, additional, Marsh, Henry C, additional, and Keler, Tibor, additional

Published
2023
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17. Abstract 2963: CDX-585, a novel bispecific antibody targeting PD-1 and ILT4

Author

Thomas, Lawrence J., primary, Vitale, Laura A., additional, Murphy, Michael, additional, Xia, Collin, additional, Peng, Zeyu, additional, Ejas, Asma, additional, Patel, Montu, additional, Boyer, James, additional, Baronas, April R., additional, O'Neill, Thomas, additional, Widger, Jenifer, additional, Mills-Chen, Laura, additional, Crocker, Andrea, additional, Ma, Mark, additional, Chen, Mingjiu, additional, Davis, Hugh M., additional, Hammond, Russ A., additional, Taglienti, Cherie, additional, Yellin, Michael, additional, Goldstein, Joel, additional, Alvarado, Diego, additional, Marsh, Henry C., additional, and Keler, Tibor, additional

Published
2023
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18. Supplementary Table 1 from Development of a Novel Antibody–Drug Conjugate for the Potential Treatment of Ovarian, Lung, and Renal Cell Carcinoma Expressing TIM-1

Author

Thomas, Lawrence J., primary, Vitale, Laura, primary, O'Neill, Thomas, primary, Dolnick, Ree Y., primary, Wallace, Paul K., primary, Minderman, Hans, primary, Gergel, Lauren E., primary, Forsberg, Eric M., primary, Boyer, James M., primary, Storey, James R., primary, Pilsmaker, Catherine D., primary, Hammond, Russell A., primary, Widger, Jenifer, primary, Sundarapandiyan, Karuna, primary, Crocker, Andrea, primary, Marsh, Henry C., primary, and Keler, Tibor, primary

Published
2023
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19. Supplementary Figure 1 from Development of a Novel Antibody–Drug Conjugate for the Potential Treatment of Ovarian, Lung, and Renal Cell Carcinoma Expressing TIM-1

Author

Thomas, Lawrence J., primary, Vitale, Laura, primary, O'Neill, Thomas, primary, Dolnick, Ree Y., primary, Wallace, Paul K., primary, Minderman, Hans, primary, Gergel, Lauren E., primary, Forsberg, Eric M., primary, Boyer, James M., primary, Storey, James R., primary, Pilsmaker, Catherine D., primary, Hammond, Russell A., primary, Widger, Jenifer, primary, Sundarapandiyan, Karuna, primary, Crocker, Andrea, primary, Marsh, Henry C., primary, and Keler, Tibor, primary

Published
2023
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20. Data from Development of a Novel Antibody–Drug Conjugate for the Potential Treatment of Ovarian, Lung, and Renal Cell Carcinoma Expressing TIM-1

Author

Thomas, Lawrence J., primary, Vitale, Laura, primary, O'Neill, Thomas, primary, Dolnick, Ree Y., primary, Wallace, Paul K., primary, Minderman, Hans, primary, Gergel, Lauren E., primary, Forsberg, Eric M., primary, Boyer, James M., primary, Storey, James R., primary, Pilsmaker, Catherine D., primary, Hammond, Russell A., primary, Widger, Jenifer, primary, Sundarapandiyan, Karuna, primary, Crocker, Andrea, primary, Marsh, Henry C., primary, and Keler, Tibor, primary

Published
2023
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21. Supplementary Figure from [89Zr]ZrDFO-CR011 PET Correlates with Response to Glycoprotein Nonmetastatic Melanoma B–targeted Therapy in Triple-negative Breast Cancer

Author

Lee, Supum, primary, Cavaliere, Alessandra, primary, Gallezot, Jean-Dominique, primary, Keler, Tibor, primary, Michelhaugh, Sharon K., primary, Belitzky, Erika, primary, Liu, Michael, primary, Mulnix, Tim, primary, Maher, Stephen E., primary, Bothwell, Alfred L.M., primary, Li, Fangyong, primary, Phadke, Manali, primary, Mittal, Sandeep, primary, and Marquez-Nostra, Bernadette, primary

Published
2023
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22. Supplementary Data from [89Zr]ZrDFO-CR011 PET Correlates with Response to Glycoprotein Nonmetastatic Melanoma B–targeted Therapy in Triple-negative Breast Cancer

Author

Lee, Supum, primary, Cavaliere, Alessandra, primary, Gallezot, Jean-Dominique, primary, Keler, Tibor, primary, Michelhaugh, Sharon K., primary, Belitzky, Erika, primary, Liu, Michael, primary, Mulnix, Tim, primary, Maher, Stephen E., primary, Bothwell, Alfred L.M., primary, Li, Fangyong, primary, Phadke, Manali, primary, Mittal, Sandeep, primary, and Marquez-Nostra, Bernadette, primary

Published
2023
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23. Supplementary Table from [89Zr]ZrDFO-CR011 PET Correlates with Response to Glycoprotein Nonmetastatic Melanoma B–targeted Therapy in Triple-negative Breast Cancer

Author

Lee, Supum, primary, Cavaliere, Alessandra, primary, Gallezot, Jean-Dominique, primary, Keler, Tibor, primary, Michelhaugh, Sharon K., primary, Belitzky, Erika, primary, Liu, Michael, primary, Mulnix, Tim, primary, Maher, Stephen E., primary, Bothwell, Alfred L.M., primary, Li, Fangyong, primary, Phadke, Manali, primary, Mittal, Sandeep, primary, and Marquez-Nostra, Bernadette, primary

Published
2023
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24. Figure A1 from Rindopepimut with Bevacizumab for Patients with Relapsed EGFRvIII-Expressing Glioblastoma (ReACT): Results of a Double-Blind Randomized Phase II Trial

Author

Reardon, David A., primary, Desjardins, Annick, primary, Vredenburgh, James J., primary, O'Rourke, Donald M., primary, Tran, David D., primary, Fink, Karen L., primary, Nabors, Louis B., primary, Li, Gordon, primary, Bota, Daniela A., primary, Lukas, Rimas V., primary, Ashby, Lynn S., primary, Duic, J. Paul, primary, Mrugala, Maciej M., primary, Cruickshank, Scott, primary, Vitale, Laura, primary, He, Yi, primary, Green, Jennifer A., primary, Yellin, Michael J., primary, Turner, Christopher D., primary, Keler, Tibor, primary, Davis, Thomas A., primary, and Sampson, John H., primary

Published
2023
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25. Supplementary Data from Rindopepimut with Bevacizumab for Patients with Relapsed EGFRvIII-Expressing Glioblastoma (ReACT): Results of a Double-Blind Randomized Phase II Trial

Author

Reardon, David A., primary, Desjardins, Annick, primary, Vredenburgh, James J., primary, O'Rourke, Donald M., primary, Tran, David D., primary, Fink, Karen L., primary, Nabors, Louis B., primary, Li, Gordon, primary, Bota, Daniela A., primary, Lukas, Rimas V., primary, Ashby, Lynn S., primary, Duic, J. Paul, primary, Mrugala, Maciej M., primary, Cruickshank, Scott, primary, Vitale, Laura, primary, He, Yi, primary, Green, Jennifer A., primary, Yellin, Michael J., primary, Turner, Christopher D., primary, Keler, Tibor, primary, Davis, Thomas A., primary, and Sampson, John H., primary

Published
2023
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26. Table S2 from PD-1 Blockade and CD27 Stimulation Activate Distinct Transcriptional Programs That Synergize for CD8+ T-Cell–Driven Antitumor Immunity

Author

Buchan, Sarah L., primary, Fallatah, Mohannad, primary, Thirdborough, Stephen M., primary, Taraban, Vadim Y., primary, Rogel, Anne, primary, Thomas, Lawrence J., primary, Penfold, Christine A., primary, He, Li-Zhen, primary, Curran, Michael A., primary, Keler, Tibor, primary, and Al-Shamkhani, Aymen, primary

Published
2023
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27. Supplementary Table 1 from Phase I Study Utilizing a Novel Antigen-Presenting Cell–Targeted Vaccine with Toll-like Receptor Stimulation to Induce Immunity to Self-antigens in Cancer Patients

Author

Morse, Michael A., primary, Chapman, Robert, primary, Powderly, John, primary, Blackwell, Kimberly, primary, Keler, Tibor, primary, Green, Jennifer, primary, Riggs, Renee, primary, He, Li-Zhen, primary, Ramakrishna, Venky, primary, Vitale, Laura, primary, Zhao, Biwei, primary, Butler, Stephen A., primary, Hobeika, Amy, primary, Osada, Takuya, primary, Davis, Thomas, primary, Clay, Timothy, primary, and Lyerly, H. Kim, primary

Published
2023
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28. Figures S1-S5 from PD-1 Blockade and CD27 Stimulation Activate Distinct Transcriptional Programs That Synergize for CD8+ T-Cell–Driven Antitumor Immunity

Author

Buchan, Sarah L., primary, Fallatah, Mohannad, primary, Thirdborough, Stephen M., primary, Taraban, Vadim Y., primary, Rogel, Anne, primary, Thomas, Lawrence J., primary, Penfold, Christine A., primary, He, Li-Zhen, primary, Curran, Michael A., primary, Keler, Tibor, primary, and Al-Shamkhani, Aymen, primary

Published
2023
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29. Supplementary Material from MAPK Pathway Inhibitors Sensitize BRAF-Mutant Melanoma to an Antibody-Drug Conjugate Targeting GPNMB

Author

Rose, April A.N., primary, Annis, Matthew G., primary, Frederick, Dennie T., primary, Biondini, Marco, primary, Dong, Zhifeng, primary, Kwong, Lawrence, primary, Chin, Lynda, primary, Keler, Tibor, primary, Hawthorne, Thomas, primary, Watson, Ian R., primary, Flaherty, Keith T., primary, and Siegel, Peter M., primary

Published
2023
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30. Supplementary Tables and Figures from MAPK Pathway Inhibitors Sensitize BRAF-Mutant Melanoma to an Antibody-Drug Conjugate Targeting GPNMB

Author

Rose, April A.N., primary, Annis, Matthew G., primary, Frederick, Dennie T., primary, Biondini, Marco, primary, Dong, Zhifeng, primary, Kwong, Lawrence, primary, Chin, Lynda, primary, Keler, Tibor, primary, Hawthorne, Thomas, primary, Watson, Ian R., primary, Flaherty, Keith T., primary, and Siegel, Peter M., primary

Published
2023
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31. Data from Phase I Study Utilizing a Novel Antigen-Presenting Cell–Targeted Vaccine with Toll-like Receptor Stimulation to Induce Immunity to Self-antigens in Cancer Patients

Author

Morse, Michael A., primary, Chapman, Robert, primary, Powderly, John, primary, Blackwell, Kimberly, primary, Keler, Tibor, primary, Green, Jennifer, primary, Riggs, Renee, primary, He, Li-Zhen, primary, Ramakrishna, Venky, primary, Vitale, Laura, primary, Zhao, Biwei, primary, Butler, Stephen A., primary, Hobeika, Amy, primary, Osada, Takuya, primary, Davis, Thomas, primary, Clay, Timothy, primary, and Lyerly, H. Kim, primary

Published
2023
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32. Supplementary Figure 2 from Depletion of Dendritic Cells Delays Ovarian Cancer Progression by Boosting Antitumor Immunity

Author

Huarte, Eduardo, primary, Cubillos-Ruiz, Juan R., primary, Nesbeth, Yolanda C., primary, Scarlett, Uciane K., primary, Martinez, Diana G., primary, Buckanovich, Ronald J., primary, Benencia, Fabian, primary, Stan, Radu V., primary, Keler, Tibor, primary, Sarobe, Pablo, primary, Sentman, Charles L., primary, and Conejo-Garcia, Jose R., primary

Published
2023
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33. Supplementary Figure 1 from Depletion of Dendritic Cells Delays Ovarian Cancer Progression by Boosting Antitumor Immunity

Author

Huarte, Eduardo, primary, Cubillos-Ruiz, Juan R., primary, Nesbeth, Yolanda C., primary, Scarlett, Uciane K., primary, Martinez, Diana G., primary, Buckanovich, Ronald J., primary, Benencia, Fabian, primary, Stan, Radu V., primary, Keler, Tibor, primary, Sarobe, Pablo, primary, Sentman, Charles L., primary, and Conejo-Garcia, Jose R., primary

Published
2023
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34. Data Supplement from Depletion of Dendritic Cells Delays Ovarian Cancer Progression by Boosting Antitumor Immunity

Author

Huarte, Eduardo, primary, Cubillos-Ruiz, Juan R., primary, Nesbeth, Yolanda C., primary, Scarlett, Uciane K., primary, Martinez, Diana G., primary, Buckanovich, Ronald J., primary, Benencia, Fabian, primary, Stan, Radu V., primary, Keler, Tibor, primary, Sarobe, Pablo, primary, Sentman, Charles L., primary, and Conejo-Garcia, Jose R., primary

Published
2023
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35. Data from Depletion of Dendritic Cells Delays Ovarian Cancer Progression by Boosting Antitumor Immunity

Author

Huarte, Eduardo, primary, Cubillos-Ruiz, Juan R., primary, Nesbeth, Yolanda C., primary, Scarlett, Uciane K., primary, Martinez, Diana G., primary, Buckanovich, Ronald J., primary, Benencia, Fabian, primary, Stan, Radu V., primary, Keler, Tibor, primary, Sarobe, Pablo, primary, Sentman, Charles L., primary, and Conejo-Garcia, Jose R., primary

Published
2023
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36. Supplementary Figure 3 from Depletion of Dendritic Cells Delays Ovarian Cancer Progression by Boosting Antitumor Immunity

Author

Huarte, Eduardo, primary, Cubillos-Ruiz, Juan R., primary, Nesbeth, Yolanda C., primary, Scarlett, Uciane K., primary, Martinez, Diana G., primary, Buckanovich, Ronald J., primary, Benencia, Fabian, primary, Stan, Radu V., primary, Keler, Tibor, primary, Sarobe, Pablo, primary, Sentman, Charles L., primary, and Conejo-Garcia, Jose R., primary

Published
2023
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37. Supplementary Figure Legends from Depletion of Dendritic Cells Delays Ovarian Cancer Progression by Boosting Antitumor Immunity

Author

Huarte, Eduardo, primary, Cubillos-Ruiz, Juan R., primary, Nesbeth, Yolanda C., primary, Scarlett, Uciane K., primary, Martinez, Diana G., primary, Buckanovich, Ronald J., primary, Benencia, Fabian, primary, Stan, Radu V., primary, Keler, Tibor, primary, Sarobe, Pablo, primary, Sentman, Charles L., primary, and Conejo-Garcia, Jose R., primary

Published
2023
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38. Indoleamine 2,3-Dioxygenase-Expressing Aortic Plasmacytoid Dendritic Cells Protect against Atherosclerosis by Induction of Regulatory T Cells

Author

Yun, Tae Jin, Lee, Jun Seong, Machmach, Kawthar, Shim, Dahee, Choi, Junhee, Wi, Young Jin, Jang, Hyung Seok, Jung, In-Hyuk, Kim, Kyeongdae, Yoon, Won Kee, Miah, Mohammad Alam, Li, Bin, Chang, Jinsam, Bego, Mariana G., Pham, Tram N.Q., Loschko, Jakob, Fritz, Jörg Hermann, Krug, Anne B., Lee, Seung-Pyo, Keler, Tibor, Guimond, Jean V., Haddad, Elie, Cohen, Eric A., Sirois, Martin G., El-Hamamsy, Ismail, Colonna, Marco, Oh, Goo Taeg, Choi, Jae-Hoon, and Cheong, Cheolho

Published
2016
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39. Targeted delivery of a vaccine protein to Langerhans cells in the human skin via the C‐type lectin receptor Langerin

Author

Bellmann, Lydia, Strandt, Helen, Zelle-Rieser, Claudia, Ortner, Daniela, Tripp, Christoph H, Schmid, Sandra, Rühl, Julia, Cappellano, Giuseppe, Schaffenrath, Sandra, Prokopi, Anastasia, Spoeck, Sarah, Seretis, Athanasios, Del Frari, Barbara, Sigl, Stephan, Krapf, Johanna, Heufler, Christine, Keler, Tibor, Münz, Christian, Romani, Nikolaus, Stoitzner, Patrizia, University of Zurich, Romani, Nikolaus, and Stoitzner, Patrizia

Subjects
2403 Immunology, Vaccines, Immunology, 610 Medicine & health, Dendritic Cells, 10263 Institute of Experimental Immunology, Mice, Mannose-Binding Lectins, Langerhans Cells, 2723 Immunology and Allergy, 570 Life sciences, biology, Animals, Humans, Immunology and Allergy, Lectins, C-Type, Antigens, Skin
Abstract

Human skin is a preferred vaccination site as it harbors multiple dendritic cell (DC) subsets, which display distinct C-type lectin receptors (CLR) that recognize pathogens. Antigens can be delivered to CLR by antibodies or ligands to boost antigen-specific immune responses. This concept has been established in mouse models but detailed insights into the functional consequences of antigen delivery to human skin DC in situ are sparse. In this study, we cloned and produced an anti-human Langerin antibody conjugated to the EBV nuclear antigen 1 (EBNA1). We confirmed specific binding of anti-Langerin-EBNA1 to Langerhans cells (LC). This novel LC-based vaccine was then compared to an existing anti-DEC-205-EBNA1 fusion protein by loading LC in epidermal cell suspensions before coculturing them with autologous T cells. After restimulation with EBNA1-peptides, we detected elevated levels of IFN-γ- and TNF-α-positive CD4

Published
2022

41. 596 Results from a phase 1 study of CDX-1140, a fully human anti-CD40 agonist monoclonal antibody (mAb), in combination with pembrolizumab

Author

Sanborn, Rachel, primary, Gabrail, Nashat, additional, Carneiro, Benedito, additional, O'Hara, Mark, additional, Bordoni, Rodolfo, additional, Gordon, Michael, additional, Khalil, Danny, additional, Hauke, Ralph, additional, Taglienti, Cherie, additional, Rogalski, Mark, additional, Styles, Rachel, additional, Alvarado, Diego, additional, Maurer, Deena, additional, Crew, Linda, additional, Keler, Tibor, additional, and Yellin, Michael, additional

Published
2022
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42. 555 Clinical and pharmacodynamic biomarker results from PORTER, a multi-cohort phase 1 platform trial of combination immunotherapy for metastatic castration-resistant prostate cancer patients

Author

Galsky, Matthew, primary, Autio, Karen, additional, Wentzel, Kristopher, additional, Graff, Julie, additional, Friedlander, Terence, additional, Densmore, Julie, additional, Cabanski, Christopher, additional, Shotts, Kristin, additional, Howes, Tim, additional, Yu, Jia, additional, Eisenbeisz, Elaine, additional, Spasic, Marko, additional, Maddock, Stephen, additional, DaSilva, Diane, additional, Kumar, Dinesh, additional, Moore, Jonni, additional, Schretzenmair, Richard, additional, Lata, Jennifer, additional, Xu, Arron, additional, Reuschel, Emma, additional, Wani, Snehal, additional, Morrow, Matthew, additional, Skolnik, Jeffrey, additional, Santulli-Marotto, Sandra, additional, Padron, Lacey, additional, Butterfield, Lisa, additional, LaVallee, Theresa, additional, Bucktrout, Samantha, additional, Yellin, Michael, additional, Keler, Tibor, additional, Salvador, Lisa, additional, O'Donnell-Tormey, Jill, additional, Lucey, Vanessa, additional, Fairchild, Justin, additional, Dugan, Ute, additional, Bhardwaj, Nina, additional, Subudhi, Sumit, additional, and Fong, Lawrence, additional

Published
2022
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43. 559 Biomarker correlates of clinical response with FLT3L/nivo backbone treatment in the multi-cohort phase 1 PORTER platform trial in metastatic castration-resistant prostate cancer patients

Author

Shotts, Kristin, primary, Howes, Timothy, additional, Yu, Jia, additional, Densmore, Julie, additional, Silva, Diane Da, additional, Kumar, Dinesh, additional, Santulli-Marotto, Sandra, additional, Cabanski, Christopher, additional, Eisenbeisz, Elaine, additional, Ivison, Geoffrey, additional, Mayer, Aaron, additional, Moore, Jonni, additional, Jones, Derek, additional, Kraynyak, Kimberly, additional, Dolgoter, Alex, additional, Chen, Richard, additional, Butterfield, Lisa, additional, LaVallee, Theresa, additional, Bucktrout, Samantha, additional, Padron, Lacey, additional, Dugan, Ute, additional, Yellin, Michael, additional, Keler, Tibor, additional, O'Donnell-Tormey, Jill, additional, Fairchild, Justin, additional, Salvador, Lisa, additional, Wentzel, Kristopher, additional, Fong, Lawrence, additional, Subudhi, Sumit, additional, Bhardwaj, Nina, additional, Autio, Karen, additional, and Galsky, Matthew, additional

Published
2022
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44. Antibody 10-1074 suppresses viremia in HIV-1-infected individuals

Author

Caskey, Marina, Schoofs, Till, Gruell, Henning, Settler, Allison, Karagounis, Theodora, Kreider, Edward F, Murrell, Ben, Pfeifer, Nico, Nogueira, Lilian, Oliveira, Thiago Y, Learn, Gerald H, Cohen, Yehuda Z, Lehmann, Clara, Gillor, Daniel, Shimeliovich, Irina, Unson-O'Brien, Cecilia, Weiland, Daniela, Robles, Alexander, Kümmerle, Tim, Wyen, Christoph, Levin, Rebeka, Witmer-Pack, Maggi, Eren, Kemal, Ignacio, Caroline, Kiss, Szilard, West, Anthony P, Jr, Mouquet, Hugo, Zingman, Barry S, Gulick, Roy M, Keler, Tibor, Bjorkman, Pamela J, Seaman, Michael S, Hahn, Beatrice H, Fätkenheuer, Gerd, Schlesinger, Sarah J, Nussenzweig, Michel C, and Klein, Florian

Subjects
HIV infections -- Genetic aspects -- Development and progression -- Care and treatment, Viral proteins -- Health aspects, Monoclonal antibodies -- Patient outcomes, Biological sciences, Health
Abstract

Monoclonal antibody 10-1074 targets the V3 glycan supersite on the HIV-1 envelope (Env) protein. It is among the most potent anti-HIV-1 neutralizing antibodies isolated so far. Here we report on its safety and activity in 33 individuals who received a single intravenous infusion of the antibody. 10-1074 was well tolerated and had a half-life of 24.0 d in participants without HIV-1 infection and 12.8 d in individuals with HIV-1 infection. Thirteen individuals with viremia received the highest dose of 30 mg/kg 10-1074. Eleven of these participants were 10-1074-sensitive and showed a rapid decline in viremia by a mean of 1.52 log[sub.10] copies/ml. Virologic analysis revealed the emergence of multiple independent 10-1074-resistant viruses in the first weeks after infusion. Emerging escape variants were generally resistant to the related V3-specific antibody PGT121, but remained sensitive to antibodies targeting nonoverlapping epitopes, such as the anti-CD4-binding-site antibodies 3BNC117 and VRC01. The results demonstrate the safety and activity of 10-1074 in humans and support the idea that antibodies targeting the V3 glycan supersite might be useful for the treatment and prevention of HIV-1 infection., Author(s): Marina Caskey (corresponding author) [1]; Till Schoofs [1]; Henning Gruell [2, 3, 4]; Allison Settler [1]; Theodora Karagounis [1]; Edward F Kreider [5]; Ben Murrell [6]; Nico Pfeifer [7]; [...]

Published
2017
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46. Tissue-specific modifier alleles determine Mertk loss-of-function traits

Author

Akalu, Yemsratch T, primary, Mercau, Maria E, primary, Ansems, Marleen, additional, Hughes, Lindsey D, additional, Nevin, James, additional, Alberto, Emily J, additional, Liu, Xinran N, additional, He, Li-Zhen, additional, Alvarado, Diego, additional, Keler, Tibor, additional, Kong, Yong, additional, Philbrick, William M, additional, Bosenberg, Marcus, additional, Finnemann, Silvia C, additional, Iavarone, Antonio, additional, Lasorella, Anna, additional, Rothlin, Carla V, additional, and Ghosh, Sourav, additional

Published
2022
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47. Safety, tolerability and efficacy of agonist anti-CD27 antibody (varlilumab) administered in combination with anti-PD-1 (nivolumab) in advanced solid tumors

Author

Sanborn, Rachel E, primary, Pishvaian, Michael J, additional, Callahan, Margaret K, additional, Weise, Amy, additional, Sikic, Branimir I, additional, Rahma, Osama, additional, Cho, Daniel C, additional, Rizvi, Naiyer A, additional, Sznol, Mario, additional, Lutzky, Jose, additional, Bauman, Julie E, additional, Bitting, Rhonda L, additional, Starodub, Alexander, additional, Jimeno, Antonio, additional, Reardon, David A, additional, Kaley, Thomas, additional, Iwamoto, Fabio, additional, Baehring, Joachim M, additional, Subramaniam, Deepa S, additional, Aragon-Ching, Jeanny B, additional, Hawthorne, Thomas R, additional, Rawls, Tracey, additional, Yellin, Michael, additional, and Keler, Tibor, additional

Published
2022
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48. HIV-1 antibody 3BNC117 suppresses viral rebound in humans during treatment interruption

Author

Scheid, Johannes F., Horwitz, Joshua A., Bar-On, Yotam, Kreider, Edward F., Lu, Ching-Lan, Lorenzi, Julio C.C., Feldmann, Anna, Braunschweig, Malte, Nogueira, Lilian, Oliveira, Thiago, Shimeliovich, Irina, Patel, Roshni, Burke, Leah, Cohen, Yehuda Z., Hadrigan, Sonya, Settler, Allison, Witmer-Pack, Maggi, West, Jr., Anthony P., Juelg, Boris, Keler, Tibor, Hawthorne, Thomas, Zingman, Barry, Gulick, Roy M., Pfeifer, Nico, Learn, Gerald H., Seaman, Michael S., Bjorkman, Pamela J., Klein, Florian, Schlesinger, Sarah J., Walker, Bruce D., Hahn, Beatrice H., Nussenzweig, Michel C., and Caskey, Marina

Subjects
HIV antibodies -- Health aspects, Antiviral agents -- Dosage and administration, Drug therapy, Combination -- Methods, Host-virus relationships -- Prevention, HIV infection -- Drug therapy, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Interruption of combination antiretroviral therapy in HIV-1infected individuals leads to rapid viral rebound. Here we report the results of a phase IIa open label clinical trial evaluating 3BNC117, a broad and potent neutralizing antibody against the CD4 binding site of the HIV-1 Env protein (1), during analytical treatment interruption in 13 HIV-1-infected individuals. Participants with 3BNC117-sensitive virus outgrowth cultures were enrolled. Results show that two or four 30 mg [kg.sup.-1] 3BNC117 infusions, separated by 3 or 2 weeks, respectively, are generally well tolerated. Infusions are associated with a delay in viral rebound of 5-9 weeks after two infusions, and up to 19 weeks after four infusions, or an average of 6.7 and 9.9 weeks, respectively, compared with 2.6 weeks for historical controls (P < 0.00001). Rebound viruses arise predominantly from a single provirus. In most individuals, emerging viruses show increased resistance, indicating escape. However, 30% of participants remained suppressed until antibody concentrations waned below 20 µg [ml.sup.-1], and the viruses emerging in all but one of these individuals showed no apparent resistance to 3BCN117, suggesting failure to escape over a period of 9-19 weeks. We conclude that the administration of 3BNC117 exerts strong selective pressure on HIV-1 emerging from latent reservoirs during analytical treatment interruption in humans., A fraction of HIV-1-infected individuals develops broad and potent serologic activity against the virus. Single-cell antibody cloning methods (2) have uncovered the source of this activity as broadly neutralizing antibodies [...]

Published
2016

49. Tissue-specific modifier alleles determine Mertk loss-of-function traits

Author

Akalu, Yemsratch T., primary, Mercau, Maria E., additional, Ansems, Marleen, additional, Wagage, Sagie, additional, Hughes, Lindsey D., additional, Nevin, James, additional, Alberto, Emily, additional, Liu, Xinran, additional, He, Li-Zhen, additional, Alvarado, Diego, additional, Keler, Tibor, additional, Kong, Yong, additional, Philbrick, William M., additional, Finnemann, Silvia C., additional, Iavarone, Antonio, additional, Lasorella, Anna, additional, Rothlin, Carla V., additional, and Ghosh, Sourav, additional

Published
2022
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50. [(89)Zr]ZrDFO-CR011 positron emission tomography correlates with response to glycoprotein non-metastatic melanoma B-targeted therapy in triple negative breast cancer

Author

Lee, Supum, Cavaliere, Alessandra, Gallezot, Jean-Dominique, Keler, Tibor, Michelhaugh, Sharon K., Belitzky, Erika, Liu, Michael, Mulnix, Tim, Maher, Stephen E., Bothwell, Alfred L.M., Li, Fangyong, Phadke, Manali, Mittal, Sandeep, and Marquez-Nostra, Bernadette

Subjects
Radioisotopes, Membrane Glycoproteins, Positron-Emission Tomography, Humans, Triple Negative Breast Neoplasms, Zirconium, Melanoma, Article, Glycoproteins
Abstract

There is a need for prognostic markers to select patients most likely to benefit from antibody drug conjugate (ADC) therapy. We quantified the relationship between pre-treatment positron emission tomography (PET) imaging of glycoprotein non-metastatic melanoma B (gpNMB) with (89)Zr-labeled anti-gpNMB antibody ([(89)Zr]ZrDFO-CR011) and response to ADC therapy (CDX-011) in triple negative breast cancer (TNBC). First, we compared different PET imaging metrics and found that standardized uptake values (SUV) and tumor-to-heart SUV ratios (SUVR) were sufficient to delineate differences in radiotracer uptake in the tumor of four different cell- and patient-derived tumor models and achieved high standardized effect sizes. These tumor models with varying levels of gpNMB expression were imaged with [(89)Zr]ZrDFO-CR011 followed by treatment with a single bolus injection of CDX-011. The percent change in tumor volume relative to baseline (% CTV) was then correlated with SUV(mean) of [(89)Zr]ZrDFO-CR011 uptake in the tumor. All gpNMB-positive tumor models responded to CDX-011 over 6 weeks of treatment, except one patient-derived tumor re-grew after 4 weeks of treatment. As expected, the gpNMB-negative tumor increased in volume by 130 ± 59 % at endpoint. The magnitude of pre-treatment SUV had the strongest inverse correlation with the % CTV at 2 – 4 weeks after treatment with CDX-011 (Spearman ρ = −0.8). However, pre-treatment PET imaging with [(89)Zr]ZrDFO-CR011 did not inform on which tumor types will re-grow over time. Other methods will be needed to predict resistance to treatment.

Published
2022

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