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GA101

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https://www.readbyqxmd.com/read/29079598/ga101-p329g-lala-a-variant-of-obinutuzumab-with-abolished-adcc-adcp-and-cdc-function-but-retained-cell-death-induction-is-as-efficient-as-rituximab-in-b-cell-depletion-and-antitumor-activity
#1
Sylvia Herter, Frank Herting, Gunter Muth, Erwin van Puijenbroek, Tilman Schlothauer, Claudia Ferrara, Kevin Brady, Sabine Lang, Marina Bacac, Ekkehard Mössner, Pablo Umana, Christian Klein
No abstract text is available yet for this article.
October 27, 2017: Haematologica
https://www.readbyqxmd.com/read/28928164/immunopet-of-malignant-and-normal-b-cells-with-89-zr-and-124-i-labeled-obinutuzumab-antibody-fragments-reveals-differential-cd20-internalization-in-vivo
#2
Kirstin A Zettlitz, Richard Tavaré, Scott M Knowles, Kristopher K Steward, John M Timmerman, Anna M Wu
Purpose: The B-cell antigen CD20 provides a target for antibody-based positron emission tomography (immunoPET). We engineered antibody fragments targeting human CD20 and studied their potential as immunoPET tracers in transgenic mice (huCD20TM) and in a murine lymphoma model expressing human CD20.Experimental Design: Anti-CD20 cys-diabody (cDb) and cys-minibody (cMb) based on rituximab and obinutuzumab (GA101) were radioiodinated and used for immunoPET imaging of a murine lymphoma model. Pairwise comparison of obinutuzumab-based antibody fragments labeled with residualizing ((89)Zr) versus non-residualizing ((124)I) radionuclides by region of interest analysis of serial PET images was conducted both in the murine lymphoma model and in huCD20TM to assess antigen modulation in vivoResults:(124)I-GAcDb and (124)I-GAcMb produced high-contrast immunoPET images of B-cell lymphoma and outperformed the respective rituximab-based tracers...
September 19, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28830332/hypersensitivity-reactions-to-obinutuzumab-in-cynomolgus-monkeys-and-relevance-to-humans
#3
Elisabeth Husar, Maria Solonets, Olaf Kuhlmann, Eginhard Schick, Hanna Piper-Lepoutre, Thomas Singer, Gaurav Tyagi
Obinutuzumab (GA101, Gazyva™, Gazyvaro®, F. Hoffmann-La Roche AG, Basel, Switzerland) is a humanized, glycoengineered type II antibody targeted against CD20. The preclinical safety evaluation required to support clinical development and marketing authorization of obinutuzumab included repeat-dose toxicity studies in cynomolgus monkeys for up to 6-month dosing with a 9-month recovery period. Results from those studies showed decreases in circulating B cells and corresponding B-cell depletion in lymphoid tissues, consistent with the desired pharmacology of obinutuzumab...
July 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28747208/ga101-obinutuzumab-monoclonal-antibody-as-consolidation-therapy-in-cll-galactic-trial-study-protocol-for-a-phase-ii-iii-randomised-controlled-trial
#4
Jamie B Oughton, Laura Collett, Dena R Howard, Anna Hockaday, Talha Munir, Kathryn McMahon, Lucy McParland, Claire Dimbleby, David Phillips, Andy C Rawstron, Peter Hillmen
BACKGROUND: Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia. Achieving minimal residual disease (MRD) negativity in CLL is an independent predictor of survival even with a variety of different treatment approaches and regardless of the line of therapy. METHODS/DESIGN: GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) is a seamless phase II/III, multi-centre, randomised, controlled, open, parallel-group trial for patients with CLL who have recently responded to chemotherapy...
July 26, 2017: Trials
https://www.readbyqxmd.com/read/28710251/role-for-zap-70-signaling-in-the-differential-effector-functions-of-rituximab-and-obinutuzumab-ga101-in-chronic-lymphocytic-leukemia-b-cells
#5
Sladjana Skopelja-Gardner, Jonathan D Jones, B JoNell Hamilton, Alexey V Danilov, William F C Rigby
Rituximab (RTX) has been the hallmark anti-CD20 mAb for the treatment of B cell neoplasms, including B cell chronic lymphocytic leukemia (B-CLL). Recently, a novel humanized anti-CD20 mAb obinutuzumab (GA101) has been implemented as first-line CLL therapy. Treatment of CLL patients with RTX is associated with CD20 loss via an FcγR-mediated process, trogocytosis. RTX-induced trogocytosis has been characterized as both the means of resistance to therapy, via loss of cell surface target proteins (antigenic modulation), as well as a process that alters B cell phenotype and function...
August 15, 2017: Journal of Immunology: Official Journal of the American Association of Immunologists
https://www.readbyqxmd.com/read/28584371/shifting-focus-in-the-therapeutics-of-immunobullous-disease
#6
Abhishek De, Asad Ansari, Nidhi Sharma, Aarti Sarda
Therapeutics of autoimmune bullous disease has seen a major shift of focus from more global immunosuppression to targeted immunotherapy. Anti CD 20 monoclonal antibody Rituximab revolutionized the therapeutics of autoimmune bullous disease particularly pemphigus. Though it is still being practiced off-label, evidences in the form of RCT and meta analysis are now available. Other novel anti CD 20 monoclonal antibodies like ofatumumab, veltuzumab, and ocrelizumab, tositumomab or obinutuzumab/GA101 may add to the therapeutic options in coming days...
May 2017: Indian Journal of Dermatology
https://www.readbyqxmd.com/read/28269762/cloning-and-molecular-characterization-of-the-cdnas-encoding-the-variable-regions-of-an-anti-cd20-monoclonal-antibody
#7
Dariush Shanehbandi, Jafar Majidi, Tohid Kazemi, Behzad Baradaran, Leili Aghebati-Maleki
BACKGROUND: CD20-based targeting of B-cells in hematologic malignancies and autoimmune disorders is associated with outstanding clinical outcomes. Isolation and characterization of VH and VL cDNAs encoding the variable regions of the heavy and light chains of monoclonal antibodies (MAb) is necessary to produce next generation MAbs and their derivatives such as bispecific antibodies (bsAb) and single-chain variable fragments (scFv). OBJECTIVE: This study was aimed at cloning and characterization of the VH and VL cDNAs from a hybridoma cell line producing an anti-CD20 MAb...
2017: Human Antibodies
https://www.readbyqxmd.com/read/28182141/obinutuzumab-in-chronic-lymphocytic-leukemia-design-development-and-place-in-therapy
#8
REVIEW
Othman Al-Sawaf, Kirsten Fischer, Anja Engelke, Natali Pflug, Michael Hallek, Valentin Goede
For decades, treatment of chronic lymphocytic leukemia (CLL) has been based on chemotherapy. This changed when the first CD20 antibody rituximab was introduced. Since 2008, the combination of chemotherapy and CD20 antibodies has become the standard of care for most patients, and a significant fraction of patients had very long-lasting remissions after chemoimmunotherapy. Despite the improvement of response rates and overall survival (OS) by the use of chemoimmunotherapy, most CLL patients will relapse eventually...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28122282/unexpected-cross-reactivity-of-anti-cathepsin-b-antibodies-leads-to-uncertainties-regarding-the-mechanism-of-action-of-anti-cd20-monoclonal-antibody-ga101
#9
Wei Wen Chien, Charlène Niogret, Romain Jugé, Loïc Lionnard, Aurélie Cornut-Thibaut, Jérôme Kucharczak, Ariel Savina, Gilles Salles, Abdel Aouacheria
GA101, also known as obinutuzumab or Gazyva (Gazyvaro), is a glycoengineered type II humanized antibody that targets the CD20 antigen expressed at the surface of B-cells. This novel anti-CD20 antibody is currently assessed in clinical trials with promising results as a single agent or as part of therapeutic combinations for the treatment of B-cell malignancies. Detailed understanding of the mechanisms of GA101-induced cell death is needed to get insight into possible resistance mechanisms occurring in patients...
April 2017: Leukemia Research
https://www.readbyqxmd.com/read/28004361/a-review-of-obinutuzumab-ga101-a-novel-type-ii-anti-cd20-monoclonal-antibody-for-the-treatment-of-patients-with-b-cell-malignancies
#10
REVIEW
Kensei Tobinai, Christian Klein, Naoko Oya, Günter Fingerle-Rowson
Obinutuzumab (GA101) is a novel, type II, glycoengineered, humanized anti-CD20 monoclonal antibody that has been developed to address the need for new therapeutics with improved efficacy in patients with lymphocytic leukemia and lymphoma of B-cell origin. Obinutuzumab has a distinct mode of action relative to type I anti-CD20 antibodies, such as rituximab, working primarily by inducing direct cell death and antibody-dependent cell-mediated cytotoxicity. Obinutuzumab is under investigation in a wide-ranging program of clinical trials in patients with B-cell malignancies...
February 2017: Advances in Therapy
https://www.readbyqxmd.com/read/27698437/intravital-imaging-reveals-improved-kupffer-cell-mediated-phagocytosis-as-a-mode-of-action-of-glycoengineered-anti-cd20-antibodies
#11
Capucine L Grandjean, Fabricio Montalvao, Susanna Celli, David Michonneau, Beatrice Breart, Zacarias Garcia, Mario Perro, Olivier Freytag, Christian A Gerdes, Philippe Bousso
Anti-CD20 monoclonal antibodies (mAbs) represent an effective treatment for a number of B cell malignancies and autoimmune disorders. Glycoengineering of anti-CD20mAb may contribute to increased anti-tumor efficacy through enhanced antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADP) as reported by in vitro studies. However, where and how glycoengineered Ab may potentiate therapeutic responses in vivo is yet to be elucidated. Here, we have performed mouse liver transplants to demonstrate that the liver is sufficient to mediate systemic B cells depletion after anti-CD20 treatment...
October 4, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27684575/anti-tumor-efficacy-study-of-the-bruton-s-tyrosine-kinase-btk-inhibitor-ono-gs-4059-in-combination-with-the-glycoengineered-type-ii-anti-cd20-monoclonal-antibody-obinutuzumab-ga101-demonstrates-superior-in-vivo-efficacy-compared-to-ono-gs-4059-in-combination
#12
Tomoko Yasuhiro, Wako Sawada, Christian Klein, Ryohei Kozaki, Shingo Hotta, Toshio Yoshizawa
The activated B-cell diffuse large B-cell-like lymphoma (ABC-DLBCL) correlates with poor prognosis. The B-cell receptor signaling pathway is known to be dysregulated in NHL/CLL and given BTK is a downstream mediator of BCR signaling, BTK constitutes an interesting and obvious therapeutic target. Given the high potency and selectivity of the BTK inhibitor, ONO/GS-4059, it was hypothesized that, the anti-tumor activity of ONO/GS-4059 could be further enhanced by combining it with the anti-CD20 Abs, rituximab (RTX) or obinutuzumab (GA101)...
March 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/27528699/complement-regulatory-proteins-cfhr1-and-cfhr3-and-patient-response-to-anti-cd20-monoclonal-antibody-therapy
#13
Laura M Rogers, Sarah L Mott, Brian J Smith, Brian K Link, Deniz Sahin, George J Weiner
Purpose: Anti-CD20 mAb therapies, including rituximab and obinutuzumab (GA101), are common treatments for follicular lymphoma. In an effort to better understand the role of complement in mAb action, we recently performed germline SNP profiling on 142 follicular lymphoma patients and found rs3766404 genotype correlated with patient response to rituximab. To assess the role of three SNP-associated complement-regulatory proteins (CFH, CFHR1, and CFHR3) in clinical response to anti-CD20 mAb, we studied two cohorts of patients treated with anti-CD20 mAb...
February 15, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/27345636/obinutuzumab-plus-bendamustine-versus-bendamustine-monotherapy-in-patients-with-rituximab-refractory-indolent-non-hodgkin-lymphoma-gadolin-a-randomised-controlled-open-label-multicentre-phase-3-trial
#14
RANDOMIZED CONTROLLED TRIAL
Laurie H Sehn, Neil Chua, Jiri Mayer, Gregg Dueck, Marek Trněný, Kamal Bouabdallah, Nathan Fowler, Vincent Delwail, Oliver Press, Gilles Salles, John Gribben, Anne Lennard, Pieternella J Lugtenburg, Natalie Dimier, Elisabeth Wassner-Fritsch, Günter Fingerle-Rowson, Bruce D Cheson
BACKGROUND: Patients with indolent non-Hodgkin lymphoma who fail to achieve adequate disease control with rituximab-based treatment have few treatment options and a poor prognosis. We aimed to assess a combination of obinutuzumab (GA101), a novel glyco-engineered type II anti-CD20 monoclonal antibody, and bendamustine in this patient population. METHODS: In this open-label, randomised, phase 3 study (GADOLIN), patients aged 18 years or older with histologically documented, CD20-positive indolent non-Hodgkin lymphoma refractory to rituximab were enrolled at 83 hospital and community sites in 14 countries in Europe, Asia, and North and Central America...
August 2016: Lancet Oncology
https://www.readbyqxmd.com/read/26993060/antitumour-activity-of-the-glycoengineered-type-ii-anti-cd20-antibody-obinutuzumab-ga101-in-combination-with-the-mdm2-selective-antagonist-idasanutlin-rg7388
#15
Frank Herting, Sylvia Herter, Thomas Friess, Gunther Muth, Marina Bacac, Jitka Sulcova, Pablo Umana, Markus Dangl, Christian Klein
OBJECTIVES: To investigate whether the glycoengineered type II anti-CD20 monoclonal antibody obinutuzumab (GA101) combined with the selective MDM2 antagonist idasanutlin (RG7388) offers superior efficacy to monotherapy in treating B-lymphoid malignancies in preclinical models. METHODS: The combined effect of obinutuzumab or rituximab plus idasanutlin on direct cell death/apoptosis induction and antibody-dependent cellular cytotoxicity (ADCC) was evaluated using p53 wild-type Z-138 and DoHH-2 lymphoma cells...
November 2016: European Journal of Haematology
https://www.readbyqxmd.com/read/26991722/managing-infusion-related-reactions-for-patients-with-chronic-lymphocytic-leukemia-receiving-obinutuzumab
#16
REVIEW
Keith Dawson, Mollie Moran, Kathleen Guindon, Hui Wan
BACKGROUND: In patients with previously untreated chronic lymphocytic leukemia (CLL) and comorbidities, treatment with the glycoengineered, type II anti-CD20 monoclonal antibody obinutuzumab (Gazyva®) (GA101) plus chlorambucil (Leukeran®) was associated with superior outcomes to rituximab (Rituxan®) plus chlorambucil, with a similar safety profile. However, a higher occurrence of infusion-related reactions (IRRs) was reported with obinutuzumab. These reactions typically require additional management...
April 2016: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/26967902/treating-chronic-lymphocytic-leukemia-with-obinutuzumab-safety-and-efficacy-considerations
#17
REVIEW
G Reda, N Orofino, R Cassin, M Sciumè, B Fattizzo, A Cortelezzi
INTRODUCTION: Obinutuzumab is a novel glycoengineered type II anti-CD20 monoclonal antibody (MoAb) with a higher affinity for CD20 epitope. It was approved by the United States Food and Drug Administration (FDA) in November 2013 for use in combination with chlorambucil for previously untreated chronic lymphocytic leukemia (CLL). AREAS COVERED: This article evaluates the safety of obinutuzumab in CLL patients, also addressing pharmacokinetics/pharmacodynamics (PK/PD), clinical use and efficacy...
June 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/26659915/rationale-for-optimal-obinutuzumab-ga101-dosing-regimen-in-b-cell-non-hodgkin-lymphoma
#18
RANDOMIZED CONTROLLED TRIAL
Guillaume Cartron, Florence Hourcade-Potelleret, Franck Morschhauser, Gilles Salles, Michael Wenger, Anna Truppel-Hartmann, David J Carlile
Obinutuzumab (GA101) is a type II, glycoengineered anti-CD20 monoclonal antibody for the treatment of hematologic malignancies. Obinutuzumab has mechanisms of action that are distinct from those of rituximab, potentially translating into improved clinical efficacy. We present the pharmacokinetic and clinical data from the phase I/II GAUGUIN and phase I GAUDI studies that were used to identify the obinutuzumab dose and regimen undergoing phase III assessment. In phase I (GAUGUIN and GAUDI), non-Hodgkin lymphoma patients received up to a maximum 9 fixed doses (obinutuzumab 50-2000 mg)...
February 2016: Haematologica
https://www.readbyqxmd.com/read/26659089/follicular-lymphoma-in-vitro-effects-of-combining-lymphokine-activated-killer-lak-cell-induced-cytotoxicity-and-rituximab-and-obinutuzumab-dependent-cellular-cytotoxicity-adcc-activity
#19
Ricardo García-Muñoz, Ascensión López-Díaz-de-Cerio, Jesus Feliu, Angel Panizo, Pilar Giraldo, Mercedes Rodríguez-Calvillo, Carlos Grande, Esther Pena, Mayte Olave, Carlos Panizo, Susana Inogés
Follicular lymphoma (FL) is a disease of paradoxes-incurable but with a long natural history. We hypothesized that a combination of lymphokine-activated killer (LAK) cells and monoclonal antibodies might provide a robust synergistic treatment and tested this hypothesis in a phase II clinical trial (NCT01329354). In this trial, in addition to R-CHOP, we alternated the administration of only rituximab with rituximab and autologous LAK cells that were expanded ex vivo. Our objective was to determine the in vitro capability of LAK cells generated from FL patients to produce cytotoxicity against tumor cell lines and to determine rituximab- and obinutuzumab-induced cytotoxicity via antibody-dependent cellular cytotoxicity (ADCC) activity...
April 2016: Immunologic Research
https://www.readbyqxmd.com/read/26565404/obinutuzumab-ga101-is-highly-effective-against-chronic-lymphocytic-leukemia-cells-in-ex-vivo-b-cell-depletion-irrespective-of-high-risk-prognostic-markers
#20
LETTER
L Ysebaert, E Laprévotte, C Klein, A Quillet-Mary
No abstract text is available yet for this article.
November 13, 2015: Blood Cancer Journal
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