Search Results - "Herzyk, Danuta"

An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors by Poulet, Frederique M., Wolf, Jayanthi J., Herzyk, Danuta J., DeGeorge, Joseph J.

“…This report discusses the principles of reproductive toxicity risk assessment for biopharmaceuticals blocking the PD‐1/programmed cell death ligand 1 (PD‐L1)…”
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FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations by Ackley, David, Birkebak, Joanne, Blumel, Jorg, Bourcier, Todd, de Zafra, Christina, Goodwin, Andrew, Halpern, Wendy, Herzyk, Danuta, Kronenberg, Sven, Mauthe, Robert, Shenton, Jacintha, Shuey, Dana, Wange, Ronald L.

“…The nonhuman primate (NHP) has always been a limited resource for pharmaceutical research with ongoing efforts to conserve. This is due to their inherent…”
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Cancer Immunotherapy: Factors Important for the Evaluation of Safety in Nonclinical Studies by Herzyk, Danuta J., Haggerty, Helen G.

“…The development of novel therapies that can harnass the immune system to eradicate cancer is an area of intensive research. Several new biopharmaceuticals that…”
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Characterization of MK-4166, a Clinical Agonistic Antibody That Targets Human GITR and Inhibits the Generation and Suppressive Effects of T Regulatory Cells by Sukumar, Selvakumar, Wilson, Douglas C, Yu, Ying, Wong, Jerelyn, Naravula, Saraswathi, Ermakov, Grigori, Riener, Romina, Bhagwat, Bhagyashree, Necheva, Antoaneta S, Grein, Jeff, Churakova, Tatyana, Mangadu, Ruban, Georgiev, Peter, Manfra, Denise, Pinheiro, Elaine M, Sriram, Venkataraman, Bailey, Wendy J, Herzyk, Danuta, McClanahan, Terrill K, Willingham, Aarron, Beebe, Amy M, Sadekova, Svetlana

“…GITR is a T-cell costimulatory receptor that enhances cellular and humoral immunity. The agonist anti-mouse GITR antibody DTA-1 has demonstrated efficacy in…”
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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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A T-cell-dependent antibody response study using a murine surrogate anti-PD-1 monoclonal antibody as an alternative to a non-human primate model by Plitnick, Lisa M., Hutchins, Beth, Dubey, Sheri, Li, Nianyu, Amin, Rupesh P., Born, Stephanie, Mangadu, Ruban, Phillips, Joseph H., Sriram, Venkataraman, Herzyk, Danuta J.

“…The programmed cell death 1 (PD-1) pathway represents a major immune checkpoint which may be engaged by cells in a tumor microenvironment to overcome active…”
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The T-dependent antibody response to keyhole limpet hemocyanin in rodents by Plitnick, Lisa M, Herzyk, Danuta J

“…Central to the evaluation of potential immunotoxicants is the concept that measurement of multiple parameters is required for the determination of toxicity…”
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Preclinical efficacy and safety of mepolizumab (SB-240563), a humanized monoclonal antibody to IL-5, in cynomolgus monkeys by Hart, Timothy K., Cook, Richard M., Zia-Amirhosseini, Parnian, Minthorn, Elisabeth, Sellers, Teresa S., Maleeff, Beverly E., Eustis, Scot, Schwartz, Lester W., Tsui, Ping, Appelbaum, Edward R., Martin, Elise C., Bugelski, Peter J., Herzyk, Danuta J.

“…Background: Allergic respiratory diseases are characterized by large numbers of eosinophils and their reactive products in airways and blood; these are…”
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Primary antibody response to keyhole limpet hemocyanin in rat as a model for immunotoxicity evaluation by Gore, Elizabeth R., Gower, Jill, Kurali, Edit, Sui, Jui-Lan, Bynum, Jane, Ennulat, Daniela, Herzyk, Danuta J.

“…To address current regulatory expectations on immunotoxicity testing of new chemicals, we describe an animal model that measures the primary antibody response…”
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Adequate immunotoxicity testing in drug development by Herzyk, Danuta J, Gore, Elizabeth R

“…Modulation of the immune system can lead to either immunostimulation or immunosuppression and can be either intended or unintended. While many effects on the…”
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Preclinical Safety of Recombinant Human Interleukin-18 by Herzyk, Danuta J., Bugelski, Peter J., Hart, Timothy K., Wier, Patrick J.

“…Recombinant human interleukin-18 (rHuIL-18) is currently in clinical trials for treatment of cancer. This report presents results of preclinical toxicity…”
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Immunomodulatory Effects of Anti-CD4 Antibody in Host Resistance against Infections and Tumors in Human CD4 Transgenic Mice by HERZYK, Danuta J, GORE, Elizabeth R, POLSKY, Rodd, NADWODNY, Kimberly L, MAIER, Curtis C, LIU, Susan, HART, Timothy K, HARMSEN, Allen G, BUGELSKI, Peter J

“…Classifications Services IAI Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit…”
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Summary of a workshop on nonclinical and clinical immunotoxicity assessment of immunomodulatory drugs by Piccotti, Joseph R, Lebrec, Herve N, Evans, Ellen, Herzyk, Danuta J, Hastings, Kenneth L, Burns-Naas, Leigh Ann, Gourley, Ian S, Wierda, Daniel, Kawabata, Thomas T

“…The number of anti-inflammatory and immunomodulatory drugs being developed in the pharmaceutical industry has increased considerably in the past decade. This…”
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Nonclinical safety of tildrakizumab, a humanized anti–IL-23p19 monoclonal antibody, in nonhuman primates by Santostefano, Michael, Herzyk, Danuta, Montgomery, Diana, Wolf, Jayanthi

“…Tildrakizumab (also known as MK-3222), is a high-affinity, humanized, immunoglobin G1κ monoclonal antibody targeting the p19 subunit of interleukin-23 recently…”
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Assessing immunotoxicity of pharmaceuticals: the need for enhanced testing by Herzyk, Danuta J.

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Identification of natural antibodies to interleukin-18 in the sera of normal humans and three nonhuman primate species by Soos, Jeanne M, Polsky, Rodd M, Keegan, Sean P, Bugelski, Peter, Herzyk, Danuta J

“…Natural antibodies to cytokines can be found in the sera of normal healthy individuals in the absence of specific immunostimulation. However, the function,…”
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Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis by Pallardy, Marc, Bechara, Rami, Whritenour, Jessica, Mitchell-Ryan, Shermaine, Herzyk, Danuta, Lebrec, Herve, Merk, Hans, Gourley, Ian, Komocsar, Wendy J, Piccotti, Joseph R, Balazs, Mercedesz, Sharma, Amy, Walker, Dana B, Weinstock, Daniel

“…Drug hypersensitivity reactions (DHRs) are a type of adverse drug reaction that can occur with different classes of drugs and affect multiple organ systems and…”
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Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach by Chien, Hsiao-Tzu, Prior, Helen, Andrews, Laura, van Aerts, Leon, Cauvin, Annick, Clarke, David O., Datta, Kaushik, Dempster, Maggie, Dybdal, Noel, Freebern, Wendy, de Haan, Lolke, Herzyk, Danuta, Hey, Adam, Kissner, Thomas, Kronenberg, Sven, Leach, Michael W., Lee, Donna, Schutte, Katrin, Sewell, Fiona, Trouba, Kevin, Ulrich, Peter, Weir, Lucinda, van Meer, Peter

“…To support registration of monoclonal antibodies (mAbs) for chronic indications, 6-month toxicity studies have historically been conducted. Experience with mAb…”
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IMMUNOPHARMACOLOGY OF RECOMBINANT HUMAN INTERLEUKIN-18 IN NON-HUMAN PRIMATES by Herzyk, Danuta J., Soos, Jeanne M., Maier, Curtis C., Gore, Elizabeth R., Narayanan, Padma K., Nadwodny, Kimberly L., Liu, Susan, Jonak, Zdenka L., Bugelski, Peter J.

“…Recombinant human interleukin (IL)-18 (rHuIL-18) has a potential as a therapeutic agent in cancer and is currently in drug development. Since human IL-18…”
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The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain by Prior, Helen, Andrews, Laura, Cauvin, Annick, Chien, Hsiaotzu, Clarke, David O., Datta, Kaushik, Dempster, Maggie, Dybdal, Noel, Freebern, Wendy, de Haan, Lolke, Herzyk, Danuta, Hey, Adam, Kissner, Thomas, Kronenberg, Sven, Leach, Michael W., Lee, Donna, Reid, Kirsty, Schutte, Katrin, Sewell, Fiona, Trouba, Kevin, Ulrich, Peter, van Aerts, Leon, van Meer, Peter, Weir, Lucinda

“…Assessment of reversibility from nonclinical toxicity findings in animals with potential adverse clinical impact is required during pharmaceutical development,…”
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