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Obinutuzumab - Biotech, Pharma and Life Science Channel

03:37 EDT 26th September 2017 | BioPortfolio

A glycoengineered, fully humanized IgG1 monoclonal antibody with potential antineoplastic activity. Obinutuzumab, a third generation type II anti-CD20 antibody, selectivity binds to the extracellular domain of the human CD20 antigen on malignant human B cells. The Fc region carbohydrates of the antibody, enriched in bisected non-fucosylated glycosylation variants, contribute to its higher binding affinity for human FcgammaRIII receptors compared to non-glycoengineered antibodies, resulting in enhanced antibody-dependent cellular cytotoxicity (ADCC) and caspase-independent apoptosis. In addition, modification of elbow hinge sequences within the antibody variable framework regions may account for the strong apoptosis-inducing activity of R7159 upon binding to CD20 on target cells.

Source: http://www.cancer.gov/drugdictionary?cdrid=570643

PubMed Articles [8 Associated PubMed Articles listed on BioPortfolio]

Chemotherapy-free, triple combination of obinutuzumab, venetoclax and idasanutlin: antitumor activity in xenograft models of non-Hodgkin lymphoma.

Obinutuzumab or Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma.

Purpose Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy is the standard of care in previously untreated diffuse large B-cell lymphoma (DLBCL). Obinutuzuma...

Role for ZAP-70 Signaling in the Differential Effector Functions of Rituximab and Obinutuzumab (GA101) in Chronic Lymphocytic Leukemia B Cells.

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...

Obinutuzumab induces superior B-cell cytotoxicity to rituximab in rheumatoid arthritis and systemic lupus erythematosus patient samples.

A proportion of RA and SLE patients treated with standard doses of rituximab (RTX) display inefficient B cell deletion and poor clinical responses that can be augmented by delivering higher doses, ind...

Differences in Treatment Effect Size Between Overall Survival and Progression-Free Survival in Immunotherapy Trials: A Meta-Epidemiologic Study of Trials With Results Posted at ClinicalTrials.gov.

Purpose We aimed to compare treatment effect sizes between overall survival (OS) and progression-free survival (PFS) in trials of US Food and Drug Administration-approved oncology immunotherapy drugs ...

Obinutuzumab in chronic lymphocytic leukemia: design, development and place in therapy.

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 chemothe...

Unexpected cross-reactivity of anti-cathepsin B antibodies leads to uncertainties regarding the mechanism of action of anti-CD20 monoclonal antibody GA101.

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...

Obinutuzumab Plus Chlorambucil in a Patient with Severe Myasthenia Gravis and Chronic Lymphocytic Leukemia.

Myasthenia gravis (MG) is an autoimmune disease of the neuromuscular junction, characterized by fatigable weakness of the extraocular, bulbar, and limb musculature; prevalence is estimated at 14 to 32...

News Articles [19 Associated News Articles listed on BioPortfolio]

Roche gets EC nod for Gazyvaro to treat advanced follicular lymphoma

Roche has secured approval from the European Commission (EC) for its Gazyvaro (obinutuzumab) in combination with chemotherapy for the treatment for previously untreated advanced follicular lymphoma.

Roche to up Russian Gazyva supply through local fill/finish deal

Local manufacturer Pharmstandard will make the finished dosage form of Roche’s monoclonal antibody Gazyva (obinutuzumab) at its site in Ufa.

Roche investiert knapp 25 Mio CHF in Gazyva-Produktion in Russland

Zürich (awp) - Der Pharmakonzern Roche plant in Russland 1,5 Mrd Rubel (umgerechnet: 24,9 Mio CHF) in eine Partnerschaft zu investieren, um das Medikament Gazyva (Obinutuzumab) vor Ort zu produzier.....

FDA grants Priority Review for Genentech’s Gazyva

Genentech, a member of the Roche Group, announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva (obinutuzumab) in ...

FDA accepts Genentech’s sBLA for gazyva to treat untreated follicular lymphoma

The US Food and Drug Administration (FDA) has accepted biotechnology company Genentech’s supplemental biologics licence application (sBLA) and granted priority review for gazyva (obinutuzumab) for t...

FDA grants Priority Review for Roche’s Gazyva in previously untreated follicular lymphoma

Roche announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuz...

NDA filing for obinutuzumab in Japan

Japanese drug major Chugai Pharmaceutical has filed a new drug application to the Ministry of Health,…

Obinutuzumab vs. Rituximab for Diffuse Large B-Cell Lymphoma

Substituting obinutuzumab for rituximab during induction chemotherapy did not improve outcomes.

Market Access Impact (US) [CLL]

LONDON, Aug.8, 2017 /PRNewswire/ -- How are market barriers moving the goalposts for CLL drugs in US?Just how significantly are market barriers skewing prescribing behaviour for CLL drugs in the US? O...

Genentech Inc Medical Equipment Deals and Alliances Profile [Report Updated: 12072017] Prices from USD $250

SummaryGenentech Inc Genentech, a subsidiary of F. HoffmannLa Roche Ltd, is a biotechnology company that develops and markets medicines to address serious medical needs. Its clinical development pipe...

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Companies [1 Associated Companies listed on BioPortfolio]

Abreos Biosciences

Abreos Biosciences is focused on ligand binding assays for biologic and biosimilar drug development, activity validation, authentication, and precision dosing, as well as massivel...

Clinical Trials [54 Associated Clinical Trials listed on BioPortfolio]

Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas

This study is a multicenter phase II trial which primary objective is to assess the anti-lymphoma activity of atezolizumab associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an an...

Evaluation of Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse After First Line Immunochemotherapy With Autologous Stem Cell

The objective of the study is the evaluation of efficacy and safety of obinutuzumab preemptive treatment at the time of the molecular relapse after first line immunochemotherapy with autol...

Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas

This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutu...

Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter`s Transformation Requiring Allogeneic Stem Cell Transplantation

The primary objective of the study is to evaluate the feasibility, efficacy and safety of an obinutuzumab containing conditioning regimen for poor risk CLL patients and patients with Richt...

Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients

This research study studies the combination of ibrutinib and obinutuzumab with or without the standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients wi...

A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lym

This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with idasanutlin an...

Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome

The purpose of the study is to investigate whether combination of obinutuzumab, lenalidomide, and high dose methylprednisolone in the treatment of Richter's Syndrome. The study will evalua...

Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy

Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an ora...

A Dose Escalation Study of RO7082859, Administered After a Fixed, Single Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

This is a Phase I, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), RO7082859, adm...

Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)

This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic acti...

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An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

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