Search Results - "Gelzleichter, Thomas"

Effects of RG7652, a Monoclonal Antibody Against PCSK9, on LDL-C, LDL-C Subfractions, and Inflammatory Biomarkers in Patients at High Risk of or With Established Coronary Heart Disease (from the Phase 2 EQUATOR Study) by Baruch, Amos, PhD, Mosesova, Sofia, PhD, Davis, John D., PhD, Budha, Nageshwar, PhD, Vilimovskij, Alexandr, MD, Kahn, Robert, MD, Peng, Kun, PhD, Cowan, Kyra J., PhD, Harris, Laura Pascasio, MPH, Gelzleichter, Thomas, PhD, Lehrer, Josh, MD, Davis, John C., MD, Tingley, Whittemore G., MD

“…RG7652 (MPSK3169A), a fully human immunoglobulin G1 (IgG1) monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9), blocks…”
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Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies by Ponce, Rafael, Abad, Leslie, Amaravadi, Lakshmi, Gelzleichter, Thomas, Gore, Elizabeth, Green, James, Gupta, Shalini, Herzyk, Danuta, Hurst, Christopher, Ivens, Inge A., Kawabata, Thomas, Maier, Curtis, Mounho, Barbara, Rup, Bonita, Shankar, Gopi, Smith, Holly, Thomas, Peter, Wierda, Dan

“…An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile…”
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Preclinical pharmacokinetic characterization of an adipose tissue-targeting monoclonal antibody in obese and non-obese animals by Rajan, Sharmila, Mandikian, Danielle, Baruch, Amos, Gelzleichter, Thomas R, Stevens, Dale, Sonoda, Junichiro, Cowan, Kyra, Boswell, C Andrew, Stefanich, Eric

“…Target receptor levels can influence pharmacokinetics (PK) or pharmacodynamics (PD) of monoclonal antibodies (mAbs), and can affect drug development of this…”
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Combined administration of RG7652, a recombinant human monoclonal antibody against PCSK9, and atorvastatin does not result in reduction of immune function by Gelzleichter, Thomas R, Halpern, Wendy, Erwin, Roy, Baruch, Amos, Leabman, Maya, Forrest, Abigail S, Satterwhite, Christina M, Peng, Kun, Chilton, Jennifer, Stevens, Dale

“…RG7652 is a human IgG1 monoclonal antibody designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9) binding to hepatic low density lipoprotein…”
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Effect of antigen binding affinity and effector function on the pharmacokinetics and pharmacodynamics of anti-IgE monoclonal antibodies by Mortensen, Deborah L., Prabhu, Saileta, Stefanich, Eric G., Kadkhodayan-Fischer, Saloumeh, Gelzleichter, Thomas R., Baker, Dana, Jiang, Jenny, Wallace, Kristin, Iyer, Suhasini, Fielder, Paul J., Putnam, Wendy S.

“…Modulating the binding affinities to IgE or changing the FcγR binding properties of anti-IgE antibodies offers an opportunity to enhance the therapeutic…”
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Preclinical pharmacokinetics, pharmacodynamics, and activity of a humanized anti‐CD40 antibody (SGN‐40) in rodents and non‐human primates by Kelley, Sean K, Gelzleichter, Thomas, Xie, Dong, Lee, Wyne P, Darbonne, Walter C, Qureshi, Ferhan, Kissler, Kim, Oflazoglu, Ezogelin, Grewal, Iqbal S

“…1 Cell‐surface expression of CD40 in B‐cell malignancies and multiple solid tumors has raised interest in its potential use as a target for antibody‐based…”
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A Soluble BAFF Antagonist, BR3-Fc, Decreases Peripheral Blood B Cells and Lymphoid Tissue Marginal Zone and Follicular B Cells in Cynomolgus Monkeys by Vugmeyster, Yulia, Seshasayee, Dhaya, Chang, Wesley, Storn, Anahid, Howell, Kathy, Sa, Susan, Nelson, Tenea, Martin, Flavius, Grewal, Iqbal, Gilkerson, Ellen, Wu, Ben, Thompson, Jeff, Ehrenfels, Barbara N., Ren, Song, Song, An, Gelzleichter, Thomas R., Danilenko, Dimitry M.

“…BAFF (also known as BLyS), a member of the tumor necrosis factor superfamily, plays a critical role in the maturation and development of B cells. BAFF has…”
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Anti-BR3 antibodies: a new class of B-cell immunotherapy combining cellular depletion and survival blockade by Lin, Wei Yu, Gong, Qian, Seshasayee, Dhaya, Lin, Zhonghua, Ou, Qinglin, Ye, Shiming, Suto, Eric, Shu, Jean, Pun Lee, Wyne, Lee, Ching-Wei V., Fuh, Germaine, Leabman, Maya, Iyer, Suhasini, Howell, Kathy, Gelzleichter, Thomas, Beyer, Joseph, Danilenko, Dimitry, Yeh, Sherry, DeForge, Laura E., Ebens, Allen, Thompson, Jeffrey S., Ambrose, Christine, Balazs, Mercedesz, Starovasnik, Melissa A., Martin, Flavius

“…Removal of pathogenic B lymphocytes by depletion of monoclonal antibodies (mAbs) or deprivation of B-cell survival factors has demonstrated clinical benefit in…”
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Latest generation estrogen receptor degraders for the treatment of hormone receptor-positive breast cancer by Chen, Ya-Chi, Yu, Jiajie, Metcalfe, Ciara, De Bruyn, Tom, Gelzleichter, Thomas, Malhi, Vikram, Perez-Moreno, Pablo D, Wang, Xiaojing

“…The selective estrogen receptor degrader (SERD) and full receptor antagonist provides an important therapeutic option for hormone receptor (HR)-positive breast…”
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Antibody-mediated activation of the FGFR1/Klothoβ complex corrects metabolic dysfunction and alters food preference in obese humans by Baruch, Amos, Wong, Chin, Chinn, Leslie W., Vaze, Anjali, Sonoda, Junichiro, Gelzleichter, Thomas, Chen, Shan, Lewin-Koh, Nicholas, Morrow, Linda, Dheerendra, Suresh, Boismenu, Richard, Gutierrez, Johnny, Wakshull, Eric, Wilson, Maria E., Arora, Puneet S.

“…Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ (FGFR1/KLB) complexes…”
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GDC-9545 (Giredestrant): A Potent and Orally Bioavailable Selective Estrogen Receptor Antagonist and Degrader with an Exceptional Preclinical Profile for ER+ Breast Cancer by Liang, Jun, Zbieg, Jason R., Blake, Robert A., Chang, Jae H., Daly, Stephen, DiPasquale, Antonio G., Friedman, Lori S., Gelzleichter, Thomas, Gill, Matthew, Giltnane, Jennifer M., Goodacre, Simon, Guan, Jane, Hartman, Steven J., Ingalla, Ellen Rei, Kategaya, Lorn, Kiefer, James R., Kleinheinz, Tracy, Labadie, Sharada S., Lai, Tommy, Li, Jun, Liao, Jiangpeng, Liu, Zhiguo, Mody, Vidhi, McLean, Neville, Metcalfe, Ciara, Nannini, Michelle A., Oeh, Jason, O’Rourke, Martin G., Ortwine, Daniel F., Ran, Yingqing, Ray, Nicholas C., Roussel, Fabien, Sambrone, Amy, Sampath, Deepak, Schutt, Leah K., Vinogradova, Maia, Wai, John, Wang, Tao, Wertz, Ingrid E., White, Jonathan R., Yeap, Siew Kuen, Young, Amy, Zhang, Birong, Zheng, Xiaoping, Zhou, Wei, Zhong, Yu, Wang, Xiaojing

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Effect of pirfenidone on gastric emptying in a rat model by Pan, Lin, Gelzleichter, Thomas, Chen, Yuan, Burg, Cindy, Limb, Susan L., Nguyen, Linda

“…Gastrointestinal (GI) adverse events (AEs) are commonly reported in patients with idiopathic pulmonary fibrosis who are treated with pirfenidone. Taking…”
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Corrigendum to ‘Effects of RG7652, a Monoclonal Antibody Against PCSK9, on Low-Density Lipoprotein Cholesterol (LDL-C), LDL-C Subfractions, and Inflammatory Biomarkers in Patients at High Risk of or with Established Coronary Heart Disease (From the Phase 2 EQUATOR Study)’ The American Journal of Cardiology 119 (2017) 1576–1583 by Baruch, Amos, Mosesova, Sofia, Davis, John D., Budha, Nageshwar, Vilimovskij, Alexandr, Kahn, Robert, Peng, Kun, Cowan, Kyra J., Harris, Laura Pascasio, Gelzleichter, Thomas, Lehrer, Josh, Davis, John C., Tingley, Whittemore G.

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Assessment of placental transfer and the effect on embryo-fetal development of a humanized monoclonal antibody targeting lymphotoxin-alpha in non-human primates by Wang, Hong, Schuetz, Chris, Arima, Akihiro, Chihaya, Yutaka, Weinbauer, Gerhard F., Habermann, Gunnar, Xiao, Jim, Woods, Cynthia, Grogan, Jane, Gelzleichter, Thomas, Cain, Gary

“…•Placental transfer of therapeutic IgG1 occurs at low level in non-human primates.•Pateclizumab did not induce maternal/fetal toxicity when dosed from GD20 to…”
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A pharmacology guided approach for setting limits on product-related impurities for bispecific antibody manufacturing by Rajan, Sharmila, Sonoda, Junichiro, Tully, Timothy, Williams, Ambrose J., Yang, Feng, Macchi, Frank, Hudson, Terry, Chen, Mark Z., Liu, Shannon, Valle, Nicole, Cowan, Kyra, Gelzleichter, Thomas

“…Introduction: bFKB1 is a humanized bispecific IgG1 antibody, created by conjoining an anti-Fibroblast Growth Factor Receptor 1 (FGFR1) half-antibody to an…”
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Nonclinical evaluation of the serum pharmacodynamic biomarkers HGF and shed MET following dosing with the anti-MET monovalent monoclonal antibody onartuzumab by Mai, Elaine, Zheng, Zhong, Chen, Youjun, Peng, Jing, Severin, Christophe, Filvaroff, Ellen, Romero, Mally, Mallet, William, Kaur, Surinder, Gelzleichter, Thomas, Nijem, Ihsan, Merchant, Mark, Young, Judy C

“…Onartuzumab, a humanized, monovalent monoclonal anti-MET antibody, antagonizes MET signaling by inhibiting binding of its ligand, hepatocyte growth factor…”
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Nicotine- or epinephrine-induced uteroplacental vasoconstriction and fetal growth in the rat by Birnbaum, S C, Kien, N, Martucci, R W, Gelzleichter, T R, Witschi, H, Hendrickx, A G, Last, J A

“…We examined the relationship between nicotine-induced vasoconstriction in pregnant rat dams and fetal growth during the third trimester of pregnancy. Pregnant…”
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Immunomodulation and lymphoma in humans by Ponce, Rafael A, Gelzleichter, Thomas, Haggerty, Helen G, Heidel, Shawn, Holdren, Matthew S, Lebrec, Herve, Mellon, R Daniel, Pallardy, Marc

“…Observational and clinical studies have associated increased cancer risks with primary or acquired immunodeficiencies, autoimmunity, and use of immunotherapies…”
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703 Gut-Homing CD4+ Lymphocytes Are Specifically Targeted in Cynomolgus Monkeys Dosed with Anti-Beta7 Antibodies by Fuh, Franklin, David, Clarissa, Hwang, Olivia, Gadkari, Shweta, Nguyen, Quyen, Takahashi, Chikara, Lutman, Jeffery, Pham, Khanh, Storn, Anahid, Howell, Kathleen, Berry, Karen, O'Byrne, Sharon, Danilenko, Dimitry M, Gelzleichter, Thomas, Wang, Hong, Stefanich, Eric, Williams, Marna

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Anti-BR3 antibodies : a new class of B-cell immunotherapy combining cellular depletion and survival blockade. Commentary by EISENBERG, Robert, WEI YU LIN, LEE, Ching-Wei V, FUH, Germaine, LEABMAN, Maya, LYER, Suhasini, HOWELL, Kathy, GELZLEICHTER, Thomas, BEYER, Joseph, DANILENKO, Dimitry, YEH, Sherry, DEFORGE, Laura E, QIAN GONG, EBENS, Allen, THOMPSON, Jeffrey S, AMBROSE, Christine, BALAZS, Mercedesz, STAROVASNIK, Melissa A, MARTIN, Flavius, SESHASAYEE, Dhaya, ZHONGHUA LIN, QINGLIN OU, SHIMING YE, SUTO, Eric, SHU, Jean, WYNE PUN LEE

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