Delving into the Latest Updates on Pagibaximab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

A-110 (Applied Molecular Evolution/Biosynexus), Pagibaximab (INN/USAN)

+ [3]

Target

LTA

Mechanism

LTA inhibitors(Lipoteichoic acid inhibitors)

Therapeutic Areas

Infectious DiseasesOther DiseasesCongenital Disorders

Active Indication-

Inactive Indication

Neonatal SepsisSepsisStaphylococcal Infections

Originator Organization

Applied Molecular Evolution, Inc.

Active Organization-

Inactive Organization

Biosynexus, Inc.

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.

Start Date01 Mar 2009

Sponsor / Collaborator

Biosynexus, Inc.

NCT00631800 / CompletedPhase 2

Phase II Randomized, Double Blind, Placebo Controlled, Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110, for the Prevention of Staphylococcal Infection

The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.

Start Date01 May 2003

Sponsor / Collaborator

Biosynexus, Inc.

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100 Clinical Results associated with Pagibaximab

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100 Translational Medicine associated with Pagibaximab

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100 Patents (Medical) associated with Pagibaximab

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16

Literatures (Medical) associated with Pagibaximab

01 Jun 2019·Virologica SinicaQ2 · MEDICINE

Localization Analysis of Heterophilic Antigen Epitopes of H1N1 Influenza Virus Hemagglutinin

Q2 · MEDICINE

Article

Author: Xie, Xin ; Zhang, Jun-Jun ; Guo, Chun-Yan ; Zhang, Hai-Xiang ; Sun, Li-Jun ; Feng, Yang-Meng ; Feng, Qing ; Liang, Dao-Yan ; Li, Yan ; Li, Hui-Jin ; Hu, Jun

Previous studies have indicated that two monoclonal antibodies (mAbs; A1-10 and H1-84) of the hemagglutinin (HA) antigen on the H1N1 influenza virus cross-react with human brain tissue. It has been proposed that there are heterophilic epitopes between the HA protein and human brain tissue (Guo et al. in Immunobiology 220:941-946, 2015). However, characterisation of the two mAbs recognising the heterophilic epitope on HA has not yet been performed. In the present study, the common antigens of influenza virus HA were confirmed using indirect enzyme-linked immunosorbent assays and analysed with DNAMAN software. The epitopes were localized to nine peptides in the influenza virus HA sequence and the distribution of the peptides in the three-dimensional structure of HA was determined using PyMOL software. Key amino acids and variable sequences of the antibodies were identified using abYsis software. The results demonstrated that there were a number of common antigens among the five influenza viruses studied that were recognised by the mAbs. One of the peptides, P2 (LVLWGIHHP_191-199), bound both of the mAbs and was located in the head region of HA. The key amino acids of this epitope and the variable regions in the heavy and light chain sequences of the mAbs that recognised the epitope are described. A heterophilic epitope on H1N1 influenza virus HA was also introduced. The existence of this epitope provides a novel perspective for the occurrence of nervous system diseases that could be caused by influenza virus infection, which might aid in influenza prevention and control.

20 Sep 2016·BiochemistryQ3 · BIOLOGY

Inhibition of Inosine-5′-monophosphate Dehydrogenase from Bacillus anthracis: Mechanism Revealed by Pre-Steady-State Kinetics

Q3 · BIOLOGY

Article

Author: Hedstrom, Lizbeth ; Modi, Gyan ; Kuzmič, Petr ; Wei, Yang ; Yu, Runhan

Inosine-5'-monophosphate dehydrogenase (IMPDH) catalyzes the conversion of inosine 5'-monophosphate (IMP) to xanthosine 5'-monophosphate (XMP). The enzyme is an emerging target for antimicrobial therapy. The small molecule inhibitor A110 has been identified as a potent and selective inhibitor of IMPDHs from a variety of pathogenic microorganisms. A recent X-ray crystallographic study reported that the inhibitor binds to the NAD(+) cofactor site and forms a ternary complex with IMP. Here we report a pre-steady-state stopped-flow kinetic investigation of IMPDH from Bacillus anthracis designed to assess the kinetic significance of the crystallographic results. Stopped-flow kinetic experiments defined nine microscopic rate constants and two equilibrium constants that characterize both the catalytic cycle and details of the inhibition mechanism. In combination with steady-state initial rate studies, the results show that the inhibitor binds with high affinity (Kd ≈ 50 nM) predominantly to the covalent intermediate on the reaction pathway. Only a weak binding interaction (Kd ≈ 1 μM) is observed between the inhibitor and E·IMP. Thus, the E·IMP·A110 ternary complex, observed by X-ray crystallography, is largely kinetically irrelevant.

03 Apr 2015·Expert Opinion on Biological TherapyQ3 · MEDICINE

Anti-lipoteichoic acid monoclonal antibody (pagibaximab) studies for the prevention of staphylococcal bloodstream infections in preterm infants

Q3 · MEDICINE

Review

Author: Manisha Patel ; David A Kaufman

INTRODUCTIONAdvances in modern medicine have given very low birth weight (VLBW) infants a better chance of survival; however, these infants remain at high risk for developing nosocomial infections associated with increased morbidity and mortality. The ability of antistaphylococcal immunoglobulins, Altastaph and INH A-2, to augment the neonatal immune system to prevent infections has been studied and evaluated in a 2009 Cochrane review.AREAS COVEREDOur objective is to evaluate the safety and efficacy of a third antistaphylococcal immunoglobulin, pagibaximab, in the prevention of staphylococcal infection in preterm infants. Three studies of pagibaximab, Phases I, II and III, were examined in terms of study design, pharmacokinetics, development of sepsis and adverse effects.EXPERT OPINIONThese studies demonstrated safety and tolerability of pagibaximab with no observed reduction in sepsis. Reported adverse events in both treatment and placebo groups were similar and consistent with events commonly observed in VLBW infants. Antistaphylococcal immunoglobulins alone have been unsuccessful in preventing nosocomial infections. Further investigations need to evaluate any potential immunomodulating products in preterm animal models prior to human studies. Future studies are required to determine how to best augment the immature immune system, likely through the use of multiple immunomodulating agents to successfully prevent infections in preterm infants.

100 Deals associated with Pagibaximab

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External Link

KEGG	Wiki	ATC	Drug Bank
D08960	Pagibaximab	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sepsis	Phase 3	US	Biosynexus, Inc.	01 Mar 2009
Staphylococcal Infections	Phase 3	US	Biosynexus, Inc.	01 Mar 2009
Neonatal Sepsis	Phase 3	US	Biosynexus, Inc.	01 Nov 2001

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00646399 (CTgov)	Phase 2/3	Staphylococcal Infections	1,579	Placebo	lyyrlhtxuz(ualozihytt) = gotcuffzbz milabbyrib (pkarhkozpm, mzywcjijem - vmogubeamc) View more	-	24 Oct 2011
NCT00631800 (Pubmed \| Pediatrics)	Phase 2	Staphylococcal Infections	88	Pagibaximab 60 mg/kg	(eyiqetsvyn) = whatgindwx diqlhgpfyc (tkdrcnwhyu )	Positive	01 Aug 2011
NCT00631800 (Pubmed \| Pediatrics)	Phase 2	Staphylococcal Infections	88	Placebo	(eyiqetsvyn) = lktyxtnixc diqlhgpfyc (tkdrcnwhyu )	Positive	01 Aug 2011