Delving into the Latest Updates on Lumiliximab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-CD23 monoclonal antibody, Gomiliximab, Gomiliximab (USAN)

+ [5]

Target

CD23

Action

antagonists

Mechanism

CD23 antagonists(Immunoglobulin epsilon Fc receptor antagonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [3]

Active Indication-

Inactive Indication

Allergic asthmaAsthmaChronic Lymphocytic Leukemia+ [2]

Originator Organization

Biogen, Inc.

Active Organization-

Inactive Organization

Biogen, Inc.

Biogen Idec Ltd.Biogen (Denmark) A/S

License Organization-

Drug Highest PhaseDiscontinuedPhase 2/3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 616719387H

Source: *****

Sequence Code 174989L

Source: *****

A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed CLL

Start Date05 Nov 2007

Sponsor / Collaborator

Biogen Idec Ltd.

NCT00391066

/ TerminatedPhase 2

A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia

This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.

Start Date01 Nov 2006

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Lumiliximab

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100 Translational Medicine associated with Lumiliximab

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100 Patents (Medical) associated with Lumiliximab

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40

Literatures (Medical) associated with Lumiliximab

01 Feb 2024·Journal of Allergy and Clinical Immunology

IgE directly affects eosinophil migration in chronic rhinosinusitis with nasal polyps through CCR3 and predicts the efficacy of omalizumab

Article

Author: Zhang, Luo ; Sun, Ying ; Cao, Feifei ; Yu, Jiaqi ; Piao, Yingshi ; Xiong, Wei ; Shen, Shen ; Li, Ying ; Wang, Yang ; Wang, Chengshuo ; Hu, Chen ; Yan, Bing

BACKGROUNDWhether IgE affects eosinophil migration in chronic rhinosinusitis with nasal polyps (CRSwNP) remains largely unclear. Moreover, our understanding of local IgE, eosinophils, and omalizumab efficacy in CRSwNP remains limited.OBJECTIVEWe investigated whether IgE acts directly on eosinophils and determined its role in omalizumab therapy.METHODSEosinophils and their surface receptors were detected by hematoxylin and eosin staining and flow cytometry. IgE and its receptors, eosinophil peroxidase (EPX), eosinophilic cationic protein, and CCR3 were detected by immunohistochemistry and immunofluorescence. Functional analyses were performed on blood eosinophils and polyp tissues. Logistic regression was performed to screen for risk factors. Receiver operating characteristic curve was generated to evaluate the accuracy.RESULTSBoth FcεRI and CD23 were expressed on eosinophils. The expression of FcεRI and CD23 on eosinophil in nasal polyp tissue was higher than in peripheral blood (both P < .001). IgE and EPX colocalized in CRSwNP. IgE directly promoted eosinophil migration by upregulating CCR3 in CRSwNP but not in healthy controls. Omalizumab and lumiliximab were found to be effective in restraining this migration, indicating CD23 was involved in IgE-induced eosinophil migration. Both IgE⁺ and EPX⁺ cells were significantly reduced after omalizumab treatment in those who experienced response (IgE⁺ cells, P = .001; EPX⁺ cells, P = .016) but not in those with no response (IgE⁺ cells, P = .060; EPX⁺ cells, P = .151). Baseline IgE⁺ cell levels were higher in those with response compared to those without response (P = .024). The baseline local IgE⁺ cell count predicted omalizumab efficacy with an accuracy of 0.811.CONCLUSIONSIgE directly promotes eosinophil migration, and baseline local IgE⁺ cell counts are predictive of omalizumab efficacy in CRSwNP.

01 Nov 2014·British Journal of HaematologyQ2 · MEDICINE

A randomized, open‐label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

Q2 · MEDICINE

Article

Author: Flinn, Ian W. ; Byrd, John C. ; N/A ; Hughes, Steven G. ; Robak, Tadeusz ; Trone, Denise ; Hellmann, Andrzej ; Shannon, Megan ; Hillmen, Peter ; Awan, Farrukh T.

SummaryLumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B‐cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open‐label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty‐seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression‐free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.

01 Jan 2012·Cancer ControlQ4 · MEDICINE

Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia

Q4 · MEDICINE

ReviewOA

Author: Pinilla-Ibarz, Javier ; Veliz, Marays

Background Recent advances in the treatment of chronic lymphocytic leukemia (CLL) have moved beyond the traditional use of alkylating agents and purine analogs into regimens combining these two chemotherapy classes with monoclonal antibodies. Methods This article reviews treatments options for patients with relapsed or refractory CLL. Results Several studies have investigated novel agents in treating patients with 17p deletion, TP53 mutation, and fludarabine-refractory CLL, as well as patients with suboptimal response to intense treatment. These investigational agents include rituximab, alemtuzumab, ofatumumab, bendamustine, high-dose methylprednisolone, lenalidomide, lumiliximab, cyclin-dependent kinase inhibitors, small modular immunopharmaceuticals, Bcl-2 inhibitors, and histone deacetylase inhibitors. While these newer drugs and combination therapies have shown promise as treatment options for CLL, additional studies are needed to determine the immunosuppression, toxicities, and infections associated with their use. Conclusions Despite improvement in initial overall response rates, most patients relapse and require further treatment. CLL remains incurable with standard therapies due to development of disease refractoriness. As such, novel approaches such as those noted above warrant continued research to improve outcomes for patients with CLL.

100 Deals associated with Lumiliximab

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External Link

KEGG	Wiki	ATC	Drug Bank
D06463	Lumiliximab	-	DB06162

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Chronic Lymphoid Leukemia	Phase 3	Australia	Biogen, Inc.	01 Nov 2006
Recurrent Chronic Lymphoid Leukemia	Phase 3	India	Biogen, Inc.	01 Nov 2006
Allergic asthma	Phase 3	United States	Biogen Idec Ltd.	-
Asthma	Phase 3	-	Biogen (Denmark) A/S	-
Chronic Lymphocytic Leukemia	Phase 3	United States	Biogen Idec Ltd.	-
Chronic Lymphocytic Leukemia	Phase 3	European Union	Biogen Idec Ltd.	-
Chronic Lymphocytic Leukemia	Phase 3	Canada	Biogen Idec Ltd.	-
Chronic Lymphocytic Leukemia	Phase 3	Australia	Biogen Idec Ltd.	-
Rhinitis, Allergic	Phase 3	-	Biogen (Denmark) A/S	-
Rhinitis, Allergic	Phase 3	United States	Biogen Idec Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2008	Phase 1/2	Recurrent Chronic Lymphoid Leukemia	-	Lumiliximab	(beuspatgyd) = olbrxfdbgi jggxmmuylq (uyvoaegrui ) View more	-	20 May 2008

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Lumiliximab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation