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Treatment of immune diseases by administration of antigen-specific formulations

An antigen, disease technology, applied in the fields of medicine and immunology, which can solve problems such as low compliance and adherence rates, difficulty in defining exact antigen doses, long treatment regimens, etc.

Pending Publication Date: 2020-11-13
ALLERO THERAPEUTICS BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Regulatory challenges can include: Difficulty defining exact antigen dosage; Presence of recombinant DNA; Inhibition of recombinant bacteria
Even if these practical and regulatory issues are overcome, for example by mixing only live, non-recombinant bacteria with the antigen, the short retention time of such formulations in the oral cavity still limits the efficacy of the treatment and requires long treatment regimens
Therefore, low adherence and persistence rates remain an issue

Method used

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  • Treatment of immune diseases by administration of antigen-specific formulations
  • Treatment of immune diseases by administration of antigen-specific formulations
  • Treatment of immune diseases by administration of antigen-specific formulations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0075] 1. A mucoadhesive carrier comprising non-living bacterial particles for administration in the oral mucosa to treat immune response-related diseases in a patient, wherein said non-living bacterial particles are associated with at least one of said immune response-causing Combination of antigens, and wherein said immune response-related disease is selected from the group consisting of celiac disease, allergic asthma, allergic rhinitis, allergic conjunctivitis, atopic dermatitis, multiple sclerosis, type I diabetes, autoimmune uveal autoimmune thyroiditis, autoimmune myasthenia gravis, rheumatoid arthritis, pemphigus vulgaris, or food allergy.

[0076] 2. A mucoadhesive carrier according to embodiment 1, wherein the carrier is a mucoadhesive patch, a biofilm or a hydrogel.

[0077] 3. A mucoadhesive patch according to embodiment 2, wherein said patch comprises electrospun fibers.

[0078] 4. A mucoadhesive carrier according to any one of embodiments 1 to 3, wherein the an...

Embodiment A1

[0092] Example A1: Determination of Loading in and In Vitro Release from Nanoreservoirs of Bacterial Particles

[0093] introduction

[0094] The ability to load BLP into prefabricated nanoreservoir layers made of different types of polymer fibers and to release BLP in vitro from these nanoreservoirs into buffers after drying was tested.

[0095] Materials and Methods

[0096] Bacterial particles: BLPs of Lactococcus lactis MG1363 were prepared essentially according to WO 02 / 101026.

[0097] Nanoreservoir layer: Using polycaprolactone (PCL, Mw 80,000 g / mol, Sigma Aldrich) or a mixture (1:1) of polycaprolactone and silk fibroin (PSF) polymers, by electrospinning Preparation of the nanoreservoir layer. Procedure as described by Masek et al. (2017, J Control Rel, 249:183-195). In this way, PCL and PSF nanoreservoir layers were obtained, in which the average pore size was about 5 μm.

[0098] Experimental setup: By placing a droplet on the surface of the reservoir layer, a 1 ...

Embodiment A2

[0103] Reservoir layers of PCL and PSF nanofibers can be used to load and release BLP, and the PSF nanoreservoir layer has the highest efficiency. Example A2: Determination of ex vivo release and penetration into oral mucosal tissues from mucoadhesive patches or hydrogels of bacterial particles combined with antigens

[0104] introduction

[0105] Tested in realistic conditions (mucosal tissue surface wetted with limited amount of water, typical mucus layer, etc.) In, the ability of mucoadhesive patches and hydrogels to target and release associated bacterial particles formulated with antigens. The release of bacterial particles formulated with antigen from mucoadhesive patches and hydrogels in a separate experiment was studied by confocal microscopy of fluorescent signals measured in cross-sections of adjacent tissues.

[0106] Materials and Methods

[0107] Bacterial particles: BLP of Lactococcus lactis MG1363 and BG of Escherichia coli Nissle 1917 were prepared essential...

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Abstract

The present invention relates to the treatment of autoimmune and allergic diseases by oromucosal administration of a formulation consisting of an optimized combination of antigen, tolerizing agent andmucoadhesive carrier for each immune disease indication.

Description

technical field [0001] The present invention relates to the fields of medicine and immunology. The present invention relates to the treatment of immune-mediated disorders (e.g., autoimmune and allergic diseases) by administering formulations consisting of antigens, tolerizing agents for each immune disease indication, agent) and mucoadhesive carrier (mucoadhesive carrier) optimal combination composition. Background technique [0002] The immune system has the task of distinguishing between self and non-self. The mucosal immune system along the respiratory, gastrointestinal, and genitourinary tracts has the additional burden of coexisting with large numbers of bacteria and innocuous antigens such as food, airborne antigens, or commensal flora. A key feature of the mucosal immune system is its ability to maintain tolerance to these antigens while retaining the ability to effectively reject the pathogen. Systemic introduction of antigen, either by injection or injury, result...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/00A61K39/35A61K39/39
CPCA61K39/0008A61K39/001A61K39/35A61K39/39A61K2039/541A61K2039/542A61K2039/543A61K2039/555A61K2039/55505A61K2039/55594A61K2039/577A61K2039/6006Y02A50/30A61K47/6903A61K9/006A61K35/741
Inventor E·R·G·波特C·J·利恩霍茨P·泽伦森
Owner ALLERO THERAPEUTICS BV
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