Bactek (MV130) / Inmunotek - LARVOL DELTA

Trained immunity-based mucosal immunotherapies for the prevention of respiratory infections. (PubMed, Trends Immunol) - "We discuss examples of TIbVs, including the tuberculosis vaccine Bacille Calmette-Guérin (BCG) and the polybacterial immunotherapy MV130. From our viewpoint, illustrating the mode of action and clinical evidence supports the proposal that TIbVs should be considered as next-generation vaccines to confer protection against a wide range of respiratory infections."

Journal • Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

BRONCHIECTASIS AND POTENTIAL BENEFIT OF MUCOSAL VACCINE (CHEST 2024) - "The last infectious exacerbation was on January 2023 treated with ciprofloxacin 500 mgs bid for 2 weeks...We starting management based on dual bronchodilation (Tiotropium + Olodaterol), mucolytic (erdosteine) and immunotherapy with MV130, 2 sublingual shots OD for three months...By November 2023 she visited emergency department due to a new recurrence treated with amoxicillin/clavulanate... Clinical trials are needed to clear expectations of the mucosal vaccines in the bronchiectasis field."

Bronchiectasis • Chronic Cough • Chronic Obstructive Pulmonary Disease • Cough • Immunology • Infectious Disease • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Respiratory Diseases

Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Inmunotek S.L. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Sep 2023 ➔ Jan 2025

Enrollment open • Trial completion date • Trial primary completion date • IL1B • IL6

New Agents MV130 and Nasal Mucosal Response (ISPPD 2024) - No abstract available

Infectious Disease • Pneumococcal Infections

MV130 in the Prevention of Recurrent Respiratory Tract Infections: A Retrospective Real-World Study in Children and Adults. (PubMed, Vaccines (Basel)) - "The median number of antibiotic courses also significantly decreased for both children and adults by over 80% (p < 0.001). This RWS showed that MV130 is an effective strategy for the prevention of respiratory infections and the reduction of associated antibiotic consumption."

Journal • Real-world • Real-world evidence • Retrospective data • Infectious Disease • Respiratory Diseases

Combining different bacteria in vaccine formulations enhances the chance for antiviral cross-reactive immunity: a detailed in silico analysis for influenza A virus. (PubMed, Front Immunol) - "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."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

Late Breaking Abstract - Management of RRTIs in children with the Trained Immunity-based Vaccine MV130: A retrospective study (ERS 2023) - "MV130 is an effective strategy in the prevention of RRTIs and the reduction of antibiotic uptake in children.; General respiratory patient care; Epidemiology; Imaging; Pulmonary function testing; Public health; Cell and molecular biology"

Late-breaking abstract • Retrospective data • Infectious Disease • Respiratory Diseases

Late Breaking Abstract - MV130, a Trained Immunity-based Vaccine, in the prevention of RRTIs in adults: A retrospective study (ERS 2023) - "MV130 is a potential tool for RRTI prevention and antibiotic cut down in adults.; Cell and molecular biology; General respiratory patient care; Physiology"

Late-breaking abstract • Retrospective data • Infectious Disease • Respiratory Diseases

Long-Term Benefit of Perlingual Polybacterial Vaccines in Patients with Systemic Autoimmune Diseases and Active Immunosuppression. (PubMed, Biomedicines) - "Even though the beneficial protective effects against infections of TIbV progressively decreased, they remained low for up to 3 years, with significantly reduced infections compared to the year prior to vaccination, further supporting a long-term benefit of TIbV in this setting. Moreover, an absence of infections was observed in almost half of patients."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Nephrology • Novel Coronavirus Disease • Respiratory Diseases • Rheumatoid Arthritis

The polybacterial mucosal vaccine MV130 impairs airway inflammation in a HDM-induced eosinophilic asthma model (ERS 2022) - "MV130 prevents airway inflammation and inhibit the systemic allergic response, pointing out this vaccine as a potential asthma treatment."

Allergy • Asthma • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • CD4

Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2/3 | N=180 | Active, not recruiting | Sponsor: Inmunotek S.L. | Trial completion date: Mar 2022 ➔ Mar 2023 | Trial primary completion date: Mar 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immune Modulation • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CD8

Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells (clinicaltrials.gov) - P1/2 | N=48 | Not yet recruiting | Sponsor: Inmunotek S.L. | Trial completion date: Dec 2022 ➔ Dec 2023 | Initiation date: Feb 2022 ➔ Jun 2022 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Trial completion date • Trial initiation date • Trial primary completion date • IFNG • IL10 • IL17A • IL1B • IL6

Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2/3 | N=180 | Active, not recruiting | Sponsor: Inmunotek S.L. | Trial completion date: Dec 2020 ➔ Mar 2022 | Trial primary completion date: Dec 2020 ➔ Mar 2022

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immune Modulation • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CD8

Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Inmunotek S.L.

New P1/2 trial • IFNG • IL10 • IL17A • IL1B • IL6

Trained immunity induction by the inactivated mucosal vaccine MV130 protects against experimental viral respiratory infections. (PubMed, Cell Rep) - "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."

Journal • Candidiasis • Immune Modulation • Infectious Disease • Inflammation • Respiratory Diseases • RAG1

The Bacterial Mucosal Immunotherapy MV130 Protects Against SARS-CoV-2 Infection and Improves COVID-19 Vaccines Immunogenicity. (PubMed, Front Immunol) - "Independently of the vaccine candidate and vaccination route used, intranasal prophylaxis with MV130 boosted S-specific responses, including CD8-T cell activation and the production of S-specific mucosal IgA antibodies. Therefore, the bacterial mucosal immunotherapy MV130 protects against SARS-CoV-2 infection and improves COVID-19 vaccines immunogenicity."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8

Overview of incorporation of inorganic antimicrobial materials in denture base resin: A scoping review. (PubMed, J Prosthet Dent) - "Although nanotechnology and antimicrobial medications or drugs have been successfully used to reduce Candida-associated denture stomatitis, long-term solutions are still lacking, and their disadvantages continue to outweigh their advantages."

Journal • Review • Dental Disorders • Stomatitis

Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection (clinicaltrials.gov) - P3; N=100; Active, not recruiting; Sponsor: Inmunotek S.L.; Recruiting ➔ Active, not recruiting; Trial completion date: Jul 2021 ➔ Jan 2022; Trial primary completion date: Jul 2021 ➔ Jan 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

[VIRTUAL] RCT Abstract - Randomized, double-blind, placebo-controlled, phase III clinical trial with MV130, a sublingual bacterial immunotherapy to prevent COPD exacerbations (ERS 2021) - P2/3 | "Only 2 subjects reported adverse reactions (both non-serious), one per arm. Conclusions MV130 reduces the number and severity of exacerbations in COPD patients as well as medication use with excellent safety profile."

Clinical • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases

Sublingual Bacterial Vaccination Reduces Recurrent Infections in Patients With Autoimmune Diseases Under Immunosuppressant Treatment. (PubMed, Front Immunol) - "pneumoniae IgA and IgG antibodies following MV130 vaccination. Sublingual polybacterial vaccines prevent recurrent infections in patients with SAD under treatment with immunosuppressant therapies, supporting a broad non-specific anti-infectious effect in these patients."

Clinical • Journal • Immunology • Infectious Disease • Nephrology • Pneumonia • Respiratory Diseases • Rheumatoid Arthritis

Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-blind, Placebo-controlled Trial. (PubMed, Am J Respir Crit Care Med) - P3 | "Mucosal bacterial immunotherapy with MV130 shows safety and clinical efficacy against recurrent WA in children. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01734811."

Clinical • Journal • Infectious Disease

Trained Immunity-Based Vaccine in B Cell Hematological Malignancies With Recurrent Infections: A New Therapeutic Approach. (PubMed, Front Immunol) - "On the other hand, immunological assessment of serum IgA and IgG levels demonstrated an increase in specific antibodies to MV130-contained bacteria following MV130 immunotherapy. In conclusion, MV130 may add clinical benefit reducing the rate of infections and enhancing humoral immune responses in these vulnerable patients."

Journal • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Respiratory Diseases

Involvement of Mesenchymal Stem Cells in Oral Mucosal Bacterial Immunotherapy. (PubMed, Front Immunol) - "In addition, MSCs trained with MV130 undergo functional changes, enhancing their immunomodulatory response to a secondary stimulus. Finally, we show that MSCs are able to uptake, process and retain a reservoir of the TLR ligands derived from MV130 digestion which can be subsequently transferred to dendritic cells, an additional feature that also may be associated to trained immunity."

IO Biomarker • Journal • Immune Modulation • Immunology • Infectious Disease • Inflammation • Respiratory Diseases

Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Inmunotek S.L.; N=3312 ➔ 0; Initiation date: Jul 2020 ➔ Oct 2020; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial initiation date • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Human Oral Epithelial Cells Impair Bacteria-Mediated Maturation of Dendritic Cells and Render T Cells Unresponsive to Stimulation. (PubMed, Front Immunol) - "Here, we evaluated the ability of H413 and TR146 cells, two OEC lines derived from human oral squamous cell carcinomas, and primary OECs to modulate immune responses to a cocktail of Gram and Gram bacteria known as MV130...The inhibition on T cell activation by OECs was cell-contact dependent, TGFβ independent and largely irreversible. Overall, this behavior of OECs is likely key to avoid immune system over-reaction against resident bacteria."

IO Biomarker • Journal • Immune Modulation • Inflammation • Oncology • Oral Cancer • Squamous Cell Carcinoma of Head and Neck