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Herceptin

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https://www.readbyqxmd.com/read/28296619/drifts-in-adcc-related-quality-attributes-of-herceptin%C3%A2-impact-on-development-of-a-trastuzumab-biosimilar
#1
Seokkyun Kim, Jinsu Song, Seungkyu Park, Sunyoung Ham, Kyungyeol Paek, Minjung Kang, Yunjung Chae, Heewon Seo, Hyung-Chan Kim, Michael Flores
A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the two products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biological properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019...
March 15, 2017: MAbs
https://www.readbyqxmd.com/read/28294622/tracking-antibody-distribution-with-near-infrared-fluorescent-dyes-impact-of-dye-structure-and-degree-of-labeling-on-plasma-clearance
#2
Cornelius Cilliers, Ian Nessler, Nikolas Christodolu, Greg M Thurber
Monoclonal antibodies labeled with near infrared (NIR) fluorophores have potential use in disease detection, intraoperative imaging, and pharmacokinetic characterization of therapeutic antibodies in both the preclinical and clinical setting. Recent work has shown conjugation of NIR fluorophores to antibodies can potentially alter antibody disposition at a sufficiently high degree of labeling (DoL); however, other reports show minimal impact after labeling with NIR fluorophores. In this work, we label two clinically approved antibodies Herceptin (trastuzumab) and Avastin (bevacizumab) with NIR dyes IRDye 800CW (800CW) or Alexa Fluor 680 (AF680), at 1...
March 15, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28286614/is-there-any-concordance-between-of-ihc-with-fish-in-her2-positive-breast-cancer-patients
#3
Mehrdad Payandeh, Masoud Sadeghi, Edris Sadeghi, Alireza Janbakhsh
Background: In developed or developing countries, the most common cancer in women is breast cancer with a pick in 40-50 years in Asia. Herein, we compared the association between IHC with FISH in HER2-positive breast cancer patients and affection of trastuzumab on disease free survival and overall survival (OS). Subjects and Methods: Immunohistochemical (IHC) analysis of hormone receptors and HER2 was performed in 133 patients with breast cancer between 2003 and 2014. Patients were selected for Herceptin adjuvant treatment, according to IHC 3+ or FISH+...
January 1, 2017: International Journal of Hematology-oncology and Stem Cell Research
https://www.readbyqxmd.com/read/28263844/a-high-throughput-bioluminescent-assay-to-monitor-the-deamidation-of-asparagine-and-isomerization-of-aspartate-residues-in-therapeutic-proteins-and-antibodies
#4
Kevin Hsiao, Juliano Alves, Rushikesh Patel, Monica Adams, Vishal Nashine, Said Goueli
Since the introduction of Herceptin and Rituximab in 1986 therapeutic antibodies have gained tremendous momentum in treatment of broad range of several diseases such as cancer and inflammation. Selection of the clinical candidate mAb usually starts with large-scale in vitro screening and profiling of multiple mAbs to identify candidates that show high in vitro or in vivo activity, and thus it is necessarily to identify and eliminate potentially unstable mAbs during the lead selection process. Antibodies undergo a variety of degradation reactions which may result in compromised bioactivity and safety profile...
March 2, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28247220/what-quality-of-life-issues-do-women-with-ductal-carcinoma-in-situ-dcis-consider-important-when-making-treatment-decisions
#5
Rebecca Mercieca-Bebber, Madeleine T King, Miriam M Boxer, Andrew Spillane, Zoë E Winters, Phyllis N Butow, Joan McPherson, Claudia Rutherford
PURPOSE: To explore quality-of-life (QOL) issues considered important when deciding on treatment for ductal carcinoma in situ (DCIS). METHODS: Breast Cancer Network of Australia members diagnosed with DCIS in the past 5 years (self-identified) participated in an online survey (Sep-Nov 2015). From a list of 74 QOL issues, participants selected all issues they experienced during DCIS diagnosis, treatment or recovery, then the issues they felt important to making a DCIS treatment decision, and completed the Health Literacy Questionnaire (HLQ)...
February 28, 2017: Breast Cancer: the Journal of the Japanese Breast Cancer Society
https://www.readbyqxmd.com/read/28223691/cellular-glycosylation-affects-herceptin-binding-and-sensitivity-of-breast-cancer-cells-to-doxorubicin-and-growth-factors
#6
Diluka Peiris, Alexander F Spector, Hannah Lomax-Browne, Tayebeh Azimi, Bala Ramesh, Marilena Loizidou, Hazel Welch, Miriam V Dwek
Alterations in protein glycosylation are a key feature of oncogenesis and have been shown to affect cancer cell behaviour perturbing cell adhesion, favouring cell migration and metastasis. This study investigated the effect of N-linked glycosylation on the binding of Herceptin to HER2 protein in breast cancer and on the sensitivity of cancer cells to the chemotherapeutic agent doxorubicin (DXR) and growth factors (EGF and IGF-1). The interaction between Herceptin and recombinant HER2 protein and cancer cell surfaces (on-rate/off-rate) was assessed using a quartz crystal microbalance biosensor revealing an increase in the accessibility of HER2 to Herceptin following deglycosylation of cell membrane proteins (deglycosylated cells Bmax: 6...
February 22, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28215665/11-years-follow-up-of-trastuzumab-after-adjuvant-chemotherapy-in-her2-positive-early-breast-cancer-final-analysis-of-the-herceptin-adjuvant-hera-trial
#7
David Cameron, Martine J Piccart-Gebhart, Richard D Gelber, Marion Procter, Aron Goldhirsch, Evandro de Azambuja, Gilberto Castro, Michael Untch, Ian Smith, Luca Gianni, Jose Baselga, Nedal Al-Sakaff, Sabine Lauer, Eleanor McFadden, Brian Leyland-Jones, Richard Bell, Mitch Dowsett, Christian Jackisch
BACKGROUND: Clinical trials have shown that trastuzumab, a recombinant monoclonal antibody against HER2 receptor, significantly improves overall survival and disease-free survival in women with HER2-positive early breast cancer, but long-term follow-up data are needed. We report the results of comparing observation with two durations of trastuzumab treatment at a median follow-up of 11 years, for patients enrolled in the HERA (HERceptin Adjuvant) trial. METHODS: HERA (BIG 1-01) is an international, multicentre, open-label, phase 3 randomised trial of 5102 women with HER2-positive early breast cancer, who were enrolled from hospitals in 39 countries between Dec 7, 2001, and June 20, 2005...
February 16, 2017: Lancet
https://www.readbyqxmd.com/read/28208257/hydrophilic-interaction-chromatography-hyphenated-with-mass-spectrometry-a-powerful-analytical-tool-for-the-comparison-of-originator-and-biosimilar-therapeutic-monoclonal-antibodies-at-the-middle-up-level-of-analysis
#8
Valentina D'Atri, Szabolcs Fekete, Alain Beck, Matthew Lauber, Davy Guillarme
The development and approval processes of biosimilar mAbs depend on their comparability to originators. Therefore, analytical comparisons are required to assess structural features and post-translational modifications (PTM) and thereby minimize the risk of being clinically meaningful differences between biosimilar and originator drug products. The glycosylation pattern of mAbs is considered to be an important critical quality attribute (CQA), and several analytical approaches have been proposed that facilitate characterizing and monitoring a glycosylation profile, albeit mainly at a glycan and glycopeptide level of analysis...
February 7, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28199174/role-of-troponins-i-and-t-and-n-terminal-prohormone-of-brain-natriuretic-peptide-in-monitoring-cardiac-safety-of-patients-with-early-stage-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-receiving-trastuzumab-a-herceptin-adjuvant-study-cardiac
#9
Dimitrios Zardavas, Thomas M Suter, Dirk J Van Veldhuisen, Jutta Steinseifer, Johannes Noe, Sabine Lauer, Nedal Al-Sakaff, Martine J Piccart-Gebhart, Evandro de Azambuja
Purpose Women receiving trastuzumab with chemotherapy are at risk for trastuzumab-related cardiac dysfunction (TRCD). We explored the prognostic value of cardiac markers (troponins I and T, N-terminal prohormone of brain natriuretic peptide [NT-proBNP]) to predict baseline susceptibility to develop TRCD. We examined whether development of cardiac end points or significant left ventricular ejection fraction (LVEF) drop was associated with markers' increases. Patients and Methods Cardiac marker assessments were coupled with LVEF measurements at different time points for 533 patients from the Herceptin Adjuvant (HERA) study who agreed to participate in this study...
March 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28197225/herceptin-responsive-lung-adenocarcinoma-in-the-setting-of-bilateral-synchronous-lung-primaries-and-breast-carcinoma
#10
Gerard J Fitzmaurice, Michael Moore, Waris Ahmad, Ronan J Ryan
The incidence of human epidermal growth factor receptor 2 (Her-2) mutations in lung adenocarcinoma is approximately 3%; however, its significance in the management of these lung cancers remains under investigation. We describe an incidental but unique opportunity to evaluate the response to treatment with herceptin in a patient with bilateral synchronous lung primaries in conjunction with breast carcinoma. Interval imaging following surgical resection of the squamous cell carcinoma while on herceptin treatment delineated the radiological regression of the Her-2 positive lung adenocarcinoma...
January 2017: Annals of Thoracic Medicine
https://www.readbyqxmd.com/read/28191701/near-infrared-light-and-ph-dual-responsive-targeted-drug-carrier-based-on-core-crosslinked-polyaniline-nanoparticles-for-intracellular-delivery-of-cisplatin
#11
Chaoqun You, Hongshui Wu, Mingxin Wang, Yawen Zhang, Jingwen Wang, Yanghui Luo, Lihai Zhai, Bai-Wang Sun, Xiangyang Zhang, Jin Zhu
Biodegradable polymeric nanoparticles have caused a rapidly growing interest as one of the most promising agents applied to drug delivery. Functional and core crosslinked poly (ethylene glycol) with poly (ε-caprolactone) (PEG5k-PCL10k) block copolymer and lecithin as biodegradable polymer doping polyaniline to assemble nanoparticles which were prepared at present work for targeted delivery and controlled release of cisplatin as a common anti-tumor drug. The morphology of polyaniline nanoparticles were determined by dynamic light scattering and the prepared nanoparticles show a suitable size of 83±1 nm and a uniform spherical shape...
February 13, 2017: Chemistry: a European Journal
https://www.readbyqxmd.com/read/28183282/enhanced-and-long-term-immunogenicity-of-a-her-2-neu-multi-epitope-vaccine-conjugated-to-the-carrier-crm197-in-conjunction-with-the-adjuvant-montanide
#12
Joshua Tobias, Joanna Jasinska, Karin Baier, Michael Kundi, Nicholas Ede, Christoph Zielinski, Ursula Wiedermann
BACKGROUND: We previously identified three short single peptides (P4, P6 and P7) representing different B-cell epitopes on the extracellular domain of Her-2/neu for a vaccine that was tested in a phase-I clinical trial. Here we describe the improvement of the multi peptide vaccine by fusing the single peptides to a hybrid peptide P467. METHODS: After coupling to either virosomes or to diphtheria toxoid CRM197 (CRM), the hybrid peptide was tested in different concentrations in combination with either Montanide or Aluminium hydroxide (Alum) in preclinical studies...
February 9, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28156181/formation-of-multimeric-antibodies-for-self-delivery-of-active-monomers
#13
Yaron Dekel, Yossy Machluf, Tal Gefen, Gennady Eidelshtein, Alexander Kotlyar, Yaron Bram, Ehud Shahar, Farah Reslane, Elina Aizenshtein, Jacob Pitcovski
Proteins and peptides have been used as drugs for almost a century. Technological advances in the past 30 years have enabled the production of pure, stable proteins in vast amounts. In contrast, administration of proteins based on their native active conformation (and thus necessitating the use of subcutaneous injections) has remained solely unchanged. The therapeutic anti-HER2 humanized monoclonal immunoglobulin (IgG) Trastuzumab (Herceptin) is a first line of the treatment for breast cancer. Chicken IgY is a commercially important polyclonal antibody (Ab)...
November 2017: Drug Delivery
https://www.readbyqxmd.com/read/28144135/liposomes-derivatized-with-multimeric-copies-of-kccysl-peptide-as-targeting-agents-for-her-2-overexpressing-tumor-cells
#14
Paola Ringhieri, Silvia Mannucci, Giamaica Conti, Elena Nicolato, Giulio Fracasso, Pasquina Marzola, Giancarlo Morelli, Antonella Accardo
Mixed liposomes, obtained by coaggregation of 1,2-dioleoyl-sn-glycero-3-phosphocholine and of the synthetic monomer containing a gadolinium complex ([C18]2DTPA[Gd]) have been prepared. Liposomes externally decorated with KCCYSL (P6.1 peptide) sequence in its monomeric, dimeric, and tetrameric forms are studied as target-selective delivery systems toward cancer cells overexpressing human epidermal growth factor receptor-2 (HER-2) receptors. Derivatization of liposomal surface with targeting peptides is achieved using the postmodification method: the alkyne-peptide derivative Pra-KCCYSL reacts, through click chemistry procedures, with a synthetic surfactant modified with 1, 2, or 4 azido moieties previously inserted in liposome formulation...
2017: International Journal of Nanomedicine
https://www.readbyqxmd.com/read/28137697/bulky-polar-additives-that-greatly-reduce-the-viscosity-of-concentrated-solutions-of-therapeutic-monoclonal-antibodies
#15
Alyssa M Larson, Alisha K Weight, Kevin Love, Amanda Bonificio, Charles R Wescott, Alexander M Klibanov
The viscosity of concentrated aqueous solutions of three clinical monoclonal antibodies (mAbs), Erbitux(®), Herceptin(®), and Rituxan(®) has been reduced up to over 10 fold by adding certain bulky polar additives instead of saline at isotonic levels. Since these additives are also found not to compromise mAbs' stability against aggregation induced by stresses, a drug-delivery modality switch from intravenous infusions to more convenient and inexpensive parenteral options like subcutaneous injections may become possible...
January 27, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28135097/ionic-strength-surface-charge-and-packing-density-effects-on-the-properties-of-peptide-self-assembled-monolayers
#16
Norman Leo, Juan Liu, Ian Archbold, Yongan Tang, Xiangqun Zeng
The various environmental parameters of packing density, ionic strength, and solution charge were examined for their effects on the properties of the immobilized peptide mimotope CH19 (CGSGSGSQLGPYELWELSH) that binds with the therapeutic antibody Trastuzumab (Herceptin) on a gold substrate. The immobilization of CH19 onto gold was examined with a quartz crystal microbalance (QCM). The QCM data showed the presence of intermolecular interactions resulting in the increase of viscoelastic properties of the peptide self-assembled monolayer (SAM)...
February 15, 2017: Langmuir: the ACS Journal of Surfaces and Colloids
https://www.readbyqxmd.com/read/28111342/development-of-a-highly-specific-her2-monoclonal-antibody-for-immunohistochemistry-using-protein-microarray-chips
#17
Lili Qi, Lixin Zhou, Mingmin Lu, Kehu Yuan, Zhongwu Li, Guiyin Wu, Xiaozheng Huang, Yi Shen, Min Zhao, Wei Fu, Boyang Chu, Guangli Wang, Fangfang Ren, Donghui Ma, Jian Chen
HER2 is an orphan receptor tyrosine kinase of the EGFR families and is considered to be a key tumor driver gene [1]. Breast cancer and gastric cancer with HER2 amplification can be effectively treated by its neutralizing antibody, Herceptin. In clinic, Immunohistochemistry (IHC) was used as the primary screening method to diagnose HER2 amplification [2]. However, recent evidence suggested that the frequently used rabbit HER2 antibody 4B5 cross reacted with another family member HER4 [3]. IHC staining with 4B5 also indicated that there was strong non-specific cytoplasmic and nuclear signals in normal gastric mucosal cells and some gastric cancer samples...
January 19, 2017: Biochemical and Biophysical Research Communications
https://www.readbyqxmd.com/read/28102883/exploring-prognostic-factors-for-her2-positive-metastatic-breast-cancer-a-retrospective-cohort-study-in-a-major-swiss-hospital
#18
Lilian Bringolf, Bernhard Pestalozzi, Daniel Fink, Konstantin Dedes
BACKGROUND: Trastuzumab (Herceptin®, Roche) has significantly improved the prognosis of patients with HER2-positive metastatic breast cancer. Some patients remain in remission for many years. However, there are no prognostic markers associated with long-term survival. This study aimed to analyse treatment patterns of HER2-positive metastatic breast cancer at a single institution and explore prognostic factors for long-term survival after HER2-targeted treatment. PATIENTS AND METHODS: This was a retrospective cohort study of all patients with HER2-positive metastatic breast cancer receiving first-line treatment with HER2-targeted therapy between 2004 and 2014 at the University Hospital of Zurich (n = 81)...
January 19, 2017: Swiss Medical Weekly
https://www.readbyqxmd.com/read/28099468/mir-1296-5p-inhibits-the-migration-and-invasion-of-gastric-cancer-cells-by-repressing-erbb2-expression
#19
Xia Shan, Wei Wen, Danxia Zhu, Ting Yan, Wenfang Cheng, Zebo Huang, Lan Zhang, Huo Zhang, Tongshan Wang, Wei Zhu, Yichao Zhu, Jun Zhu
The metastasis of gastric cancer, one of the most common tumors, has a molecular mechanism that is still largely unclear. Here we investigated the role of possible tumor-suppressor miR-1296-5p in the cell migration and invasion of ERBB2-positive gastric cancer. It found that miR-1296-5p was significantly down-regulated in gastric cancer tissues. Moreover, it was down-regulated in lymph node metastatic gastric cancer tissues compared with non-metastatic gastric cancer tissues. The luciferase activity of ERBB2 3'-untranslated region-based reporters constructed in SNU-216 and NUGC-4 gastric cancer cells suggested that ERBB2 was the target gene of miR-1296-5p...
2017: PloS One
https://www.readbyqxmd.com/read/28068979/first-report-on-molecular-breast-cancer-subtypes-and-their-clinico-pathological-characteristics-in-eastern-morocco-series-of-2260-cases
#20
Manal Elidrissi Errahhali, Mounia Elidrissi Errahhali, Meryem Ouarzane, Tijani El Harroudi, Said Afqir, Mohammed Bellaoui
BACKGROUND: Breast cancer is the most frequent malignancy among women in Eastern Morocco. In this paper, we provide the first report on molecular breast cancer subtypes in this region. This is the largest population-based study on breast cancer among Moroccan women. METHODS: We analyzed 2260 breast cancer cases diagnosed at the Hassan II Regional Oncology Center between October 2005 and December 2012. Clinico-pathological and therapeutic features were studied. Molecular subtypes were determined and their associations with the clinico-pathological characteristics of the tumors were examined...
January 9, 2017: BMC Women's Health
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