Delving into the Latest Updates on Rivabazumab pegol with Synapse

Overview

Basic Info

Drug Type

Fab fragment

Synonyms

Anti-PcrV mAb fragment

Target

T3SS

Mechanism

T3SS inhibitors(Type III secretion system protein inhibitors)

Therapeutic Areas

Infectious DiseasesCongenital DisordersDigestive System Disorders+ [2]

Active Indication-

Inactive Indication

Cystic FibrosisPneumonia, Ventilator-AssociatedPseudomonas aeruginosa infection+ [1]

Originator Organization

Humanigen, Inc.

Active Organization-

Inactive Organization

Humanigen, Inc.

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 319922166L

Source: *****

Sequence Code 319922165H

Source: *****

The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway Pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.

Start Date01 Dec 2012

Sponsor / Collaborator

Humanigen, Inc.

NCT00691587 / CompletedPhase 1/2

A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa

Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.

Start Date01 Apr 2008

Sponsor / Collaborator

Humanigen, Inc.

100 Clinical Results associated with Rivabazumab pegol

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100 Translational Medicine associated with Rivabazumab pegol

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100 Patents (Medical) associated with Rivabazumab pegol

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7

Literatures (Medical) associated with Rivabazumab pegol

01 Dec 2022·Saudi Pharmaceutical Journal

Molecular targets for cystic fibrosis and therapeutic potential of monoclonal antibodies

Review

Author: Al Basheer, Asmaa ; Moni, Sivakumar S

Cystic fibrosis (CF) is a genetic disease that affects the exocrine glands and is caused by cystic fibrosis transmembrane conductance regulator gene (CFTR) mutations. Lung disease is the leading cause of morbidity in patients. Target-specific treatment of CF has been achieved using monoclonal antibodies (mAbs). The purpose of this article is to discuss the possibility of treating CF with mAbs through their significant target specificity. We searched electronic databases in Web of Science, PubMed, EMBASE, Scopus, and Google Scholar from 1984 to 2021. We discussed the critical role of targeted therapy in cystic fibrosis, as it will be more effective at suppressing the molecular networks. After conducting a critical review of the available literature, we concluded that it is critical to understand the fundamental molecular mechanisms underlying CF prior to incorporating biologics into the therapy regimen. Omalizumab, Mepolizumab, Benralizumab, Dupilumab and KB001-A have been successfully screened for asthma-complicated CF, and their efficacies have been well reported. Despite the availability of effective targeted biologics, treating CF has remained a difficult task, particularly when it comes to reduction of secondary inflammatory mediators. This review emphasizes the overall views on CF, the immunological mechanism of CF, and the prospective therapeutic use of mAbs as potential targeted biologics for enhancing the overall status of human health.

01 Jul 2018·Journal of Cystic FibrosisQ2 · MEDICINE

KB001-A, a novel anti-inflammatory, found to be safe and well-tolerated in cystic fibrosis patients infected with Pseudomonas aeruginosa

Q2 · MEDICINE

Article

Author: Beckett, V V ; Milla, Carlos ; Mayer-Hamblett, N ; VanDevanter, D R ; Burns, J L ; Accurso, F J ; Konstan, M W ; Chmiel, J F ; Jain, Raksha

BACKGROUNDChronic Pseudomonas aeruginosa (Pa) airways infection, exuberant local inflammation, and progressive lung function loss are hallmarks of cystic fibrosis (CF). KB001-A is an anti-PcrV PEGylated monoclonal antibody fragment to the Type III secretion system of Pa. This 16-week study evaluated KB001-A associated effect on time-to-need for antibiotics for worsening respiratory signs and symptoms, as well as safety, and treatment-associated changes in symptom scores, inflammatory markers, and spirometry.METHODSThis was a randomized, double-blind, placebo-controlled, repeat-dose study in CF subjects with Pa. Intravenous 10mg/kg KB001-A or placebo infusions were administered at baseline and weeks 2, 4, 8, and 16, with a 4-week follow-up. Sputum inflammatory markers were assessed in a sub-study. Time-to-need for antibiotics was compared between groups by Kaplan Meier analysis and Cox proportional hazards modeling adjusting for randomization strata.RESULTSOf 182 subjects, 169 received at least one infusion of KB001-A (n=83) or placebo (n=86). KB001-A was generally safe and well-tolerated as compared to placebo, with no significant emergent adverse effects other than one serious adverse event of elevated hepatic enzymes of unclear etiology. Time to need for antibiotics did not differ between groups (HR: 1.00; 95% CI: 0.69, 1.45, p=0.995). A 3.2 increase in ppFEV₁ from placebo favoring KB001-A was observed at week 16 (95% CI: 1.12, 5.30, p=0.003). Mean changes from baseline in log₁₀ sputum neutrophil elastase (NE) had a non-significant decrease (-0.27, 95% CI: -0.58,0.04, p=0.084) while IL-8 concentrations at week 16 were significantly lower (-0.27, 95% CI: -0.55,0.00, p=0.048) among KB001-A subjects (n=16) relative to placebo (n=13).CONCLUSIONSKB001-A was safe and well-tolerated and associated with a modest FEV₁ benefit and reduction in select sputum inflammatory markers (IL-8). KB001-A was not associated with an increased time to need for antibiotics. The lack of efficacy seen with KB001-A may be due, in part, to the low levels of the type III secretion proteins previously reported in sputum of CF patients chronically infected with Pa.

03 Oct 2014·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Anti-PcrV antibody strategies against virulentPseudomonas aeruginosa

Q3 · MEDICINE

Article

Author: Haight, Matthew ; Ito, Emi ; Sawa, Teiji ; Nguyen, Vinh Huu

Pseudomonas aeruginosa is an opportunistic bacterial pathogen that causes fatal acute lung infections in critically ill individuals. Its pathogenesis is associated with bacterial virulence conferred by the type III secretion system (TTSS), through which P. aeruginosa causes necrosis of the lung epithelium and disseminates into the circulation, resulting in bacteremia, sepsis, and mortality. TTSS allows P. aeruginosa to directly translocate cytotoxins into eukaryotic cells, inducing cell death. The P. aeruginosa V-antigen PcrV, a homolog of the Yersinia V-antigen LcrV, is an indispensable contributor to TTS toxin translocation. Vaccination against PcrV ensures the survival of challenged mice and decreases lung inflammation and injury. Both the rabbit polyclonal anti-PcrV antibody and the murine monoclonal anti-PcrV antibody, mAb166, inhibit TTS toxin translocation. mAb166 IgG was cloned, and a molecular engineered humanized anti-PcrV IgG antigen-binding fragment, KB001, was developed for clinical use. KB001 is currently undergoing Phase-II clinical trials for ventilator-associated pneumonia in France and chronic pneumonia in cystic fibrosis in USA. In these studies, KB001 has demonstrated its safety, a favorable pharmacokinetic profile, and promising potential as a nonantibiotic strategy to reduce airway inflammation and damage in P. aeruginosa pneumonia.

100 Deals associated with Rivabazumab pegol

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cystic Fibrosis	Phase 2	NZ	Humanigen, Inc.	01 Dec 2012
Cystic Fibrosis	Phase 2	AU	Humanigen, Inc.	01 Dec 2012
Cystic Fibrosis	Phase 2	US	Humanigen, Inc.	01 Dec 2012
Cystic Fibrosis	Phase 2	IL	Humanigen, Inc.	01 Dec 2012
Pneumonia, Ventilator-Associated	Phase 2	FR	Humanigen, Inc.	01 Apr 2008
Pseudomonas Infections	Phase 2	FR	Humanigen, Inc.	01 Apr 2008
Pseudomonas aeruginosa infection	Phase 2	US	Humanigen, Inc.	01 Mar 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01695343 (Pubmed \| J Cyst Fibros) Manual	Phase 2	Pseudomonas aeruginosa infection \| Cystic Fibrosis	169	KB001-A	dormmsqdan(dyqkmkkzvc) = Time to need for antibiotics did not differ between groups rbuuiqtutv (ethxqvyaqx ) View more	Positive	01 Jul 2018
				Placebo