Delving into the Latest Updates on MV-130 with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine

Synonyms

BACTEK-R, Bacmune, Bactek

+ [3]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Bronchial SpasmBronchiolitisCOVID-19+ [1]

Originator Organization

Inmunotek SL

Active Organization

Inmunotek SL

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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A mechanistic clinical trial with the aim to evaluate whether MV130 can induce the expression of a particular immune response (trained immunity) in peripheral blood cells. Therefore, the investigators are not evaluating efficacy in any disease or medical condition but rather assessing the immunological effect in immunogenicity of MV130 in healthy volunteers.

Start Date01 Sep 2023

Sponsor / Collaborator

Inmunotek SL

NCT04452643

/ WithdrawnPhase 3

Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel

The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.

Start Date01 Oct 2020

Sponsor / Collaborator

Inmunotek SL

100 Clinical Results associated with MV-130

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100 Translational Medicine associated with MV-130

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100 Patents (Medical) associated with MV-130

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13

Literatures (Medical) associated with MV-130

01 Jan 2023·Frontiers in immunology

Combining different bacteria in vaccine formulations enhances the chance for antiviral cross-reactive immunity: a detailed in silico analysis for influenza A virus.

Article

Author: Lafuente, Esther M ; Ras-Carmona, Alvaro ; Reche, Pedro A ; Subiza, Jose L ; Bodas-Pinedo, Andrés ; Pelaez-Prestel, Hector F

Bacteria are well known to provide heterologous immunity against viral infections through various mechanisms including the induction of innate trained immunity and adaptive cross-reactive immunity. Cross-reactive immunity from bacteria to viruses is responsible for long-term protection and yet its role has been downplayed due the difficulty of determining antigen-specific responses. Here, we carried out a systematic evaluation of the potential cross-reactive immunity from selected bacteria known to induce heterologous immunity against various viruses causing recurrent respiratory infections. The bacteria selected in this work were Bacillus Calmette Guerin and those included in the poly-bacterial preparation MV130: Streptococcus pneumoniae, Staphylococcus aureus, Staphylococcus epidermidis, Klebisella pneumoniae, Branhamella catarrhalis and Haemophilus influenzae. The virus included influenza A and B viruses, human rhinovirus A, B and C, respiratory syncytial virus A and B and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Through BLAST searches, we first identified the shared peptidome space (identity ≥ 80%, in at least 8 residues) between bacteria and viruses, and subsequently predicted T and B cell epitopes within shared peptides. Interestingly, the potential epitope spaces shared between bacteria in MV130 and viruses are non-overlapping. Hence, combining diverse bacteria can enhance cross-reactive immunity. We next analyzed in detail the cross-reactive T and B cell epitopes between MV130 and influenza A virus. We found that MV130 contains numerous cross-reactive T cell epitopes with high population protection coverage and potentially neutralizing B cell epitopes recognizing hemagglutinin and matrix protein 2. These results contribute to explain the immune enhancing properties of MV130 observed in the clinic against respiratory viral infections.

01 Jan 2022·Cell ReportsQ1 · BIOLOGY

Trained immunity induction by the inactivated mucosal vaccine MV130 protects against experimental viral respiratory infections

Q1 · BIOLOGY

ArticleOA

Author: Nieto, Antonio ; Amores-Iniesta, Joaquín ; Relaño, Carlos ; Del Fresno, Carlos ; Brandi, Paola ; Saz-Leal, Paula ; Ardavín, Carlos ; Dopazo, Ana ; Cueto, Francisco J ; Dunphy, Gillian ; Enamorado, Michel ; Casanovas, Miguel ; Sancho, David ; Quintas, Ana ; Martínez-Cano, Sarai ; Conejero, Laura ; Gómez, Manuel J ; Nistal-Villán, Estanislao ; Subiza, José Luis

MV130 is an inactivated polybacterial mucosal vaccine that confers protection to patients against recurrent respiratory infections, including those of viral etiology. However, its mechanism of action remains poorly understood. Here, we find that intranasal prophylaxis with MV130 modulates the lung immune landscape and provides long-term heterologous protection against viral respiratory infections in mice. Intranasal administration of MV130 provides protection against systemic candidiasis in wild-type and Rag1-deficient mice lacking functional lymphocytes, indicative of innate immune-mediated protection. Moreover, pharmacological inhibition of trained immunity with metformin abrogates the protection conferred by MV130 against influenza A virus respiratory infection. MV130 induces reprogramming of both mouse bone marrow progenitor cells and in vitro human monocytes, promoting an enhanced cytokine production that relies on a metabolic shift. Our results unveil that the mucosal administration of a fully inactivated bacterial vaccine provides protection against viral infections by a mechanism associated with the induction of trained immunity.

15 Aug 2021·American Journal of Respiratory and Critical Care MedicineQ1 · MEDICINE

Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial

Q1 · MEDICINE

Article

Author: Fernández-Pérez, Cristina ; Calderón, Rafael ; Subiza, José Luis ; Casanovas, Miguel ; Conejero, Laura ; Uixera, Sonia ; Palao, Maria José ; Sancho, David ; Mazón, Angel ; Calaforra, Susana ; Brandi, Paola ; Selva, Blanca ; Nieto, María ; Saz-Leal, Paula ; Nieto, Antonio

Rationale: Recurrent wheezing in children represents a severe public health concern. Wheezing attacks (WA), mainly associated with viral infections, lack effective preventive therapies. Objectives: To evaluate the efficacy and safety of mucosal sublingual immunotherapy based on whole inactivated bacteria (MV130) in preventing WA in children. Methods: A Phase 3 randomized, double-blind, placebo-controlled, parallel-group trial including a cohort of 120 children <3 years old with ⩾3 WA during the previous year was conducted. Children with a positive skin test to common aeroallergens in the area where the clinical trial was performed were excluded from the trial. Subjects received MV130 or placebo daily for 6 months. The primary endpoint was the number of WA within 1 year after the first dose comparing MV130 and placebo. Measurements and Main Results: There was a significant lower number of WA in MV130 versus the placebo group, 3.0 (interquartile range [IQR], 2.0-4.0) versus 5.0 (IQR, 3.0-7.0) (P < 0.001). As secondary outcomes, a decrease in the duration of WA and a reduction in symptoms and medication scores in the MV130 versus placebo group were found. No adverse events were reported related to the active treatment. Conclusions: Mucosal bacterial immunotherapy with MV130 shows safety and clinical efficacy against recurrent WA in children.Clinical trial registered with www.clinicaltrials.gov (NCT01734811).

100 Deals associated with MV-130

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	Dominican Republic	Inmunotek SL	10 Jun 2020
COVID-19	Phase 3	Dominican Republic	Inmunotek SL	10 Jun 2020
Pulmonary Disease, Chronic Obstructive	Phase 3	Spain	Inmunotek SL	01 Apr 2013
Bronchial Spasm	Phase 3	Spain	Inmunotek SL	01 Oct 2012
Bronchiolitis	Phase 3	Spain	Inmunotek SL	01 Oct 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EUCTR2012-003253-28-ES (ERS2021)	Phase 3	Pulmonary Disease, Chronic Obstructive	198	MV130	offdhbrlcu(vvdqadgpjj) = crvlknqcap bqoxfcgqmb (mdyptrgjpd, 5.0 - 24.0)	Positive	05 Sep 2021
				Placebo	offdhbrlcu(vvdqadgpjj) = lyeqjshruv bqoxfcgqmb (mdyptrgjpd, 7.5 - 47.0)
NCT01734811 (MV130, CTgov)	Phase 3	Bronchiolitis \| Bronchial Spasm	120	Biological vaccine (Placebo)	yiqijavgpq(xzobkoyfbz) = xkhwhndoiw bgrbnjqdng (eclrisntfe, gneccubmmg - xcnkpdwwcf) View more	-	04 Sep 2020
				Biological vaccine (Biological Vaccine)	yiqijavgpq(xzobkoyfbz) = hiffsspapx bgrbnjqdng (eclrisntfe, rhxcoaiocu - nopjpprzrz) View more