Immunomodulatory therapy for type 1 diabetes mellitus autoimmunity

a type 1 diabetes mellitus and autoimmunity technology, applied in the field of autoimmune diseases, can solve the problems of hypo and hyperglycemic episodes, further significant morbidity and mortality, and severe burden on individuals and society, and achieve the effects of preventing the development or progression, and reducing the risk of t1dm

Inactive Publication Date: 2021-11-18
PHAIM PHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a treatment that can prevent or delay the development of Type 1 diabetes (T1DM) in people with pre-clinical T1DM. This treatment may provide a longer symptom-free period and even prevent the onset of T1DM altogether. It also helps to protect against hypoglycemia, improve metabolic control, and reduce complications associated with diabetes. Additionally, the treatment may help to reduce the autoimmunity that causes damage to beta cells in the pancreas. Overall, this treatment has the potential to improve the day-to-day management for people with diabetes and preserve residual beta cell function.

Problems solved by technology

Despite the significant progress that has been made in its treatment, T1DM represents a severe burden on the individual and on society.
While the onset of T1DM can occur in adulthood, it is largely a problem in children and youngsters.
Short-term, and often life threatening, complications include hypo and hyperglycemic episodes often complicated with acidosis.
Long-term complications can represent further significant morbidity and mortality.
Patients may face both macro and microvascular complications, cardiovascular complications, hypertension, retinopathy, nephropathy, and neuropathy, which can be debilitating and life threatening.
These can be reduced with improved care but currently cannot be eliminated in T1DM patients.
Further sever complications include kidney failure, blindness, and amputation.

Method used

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  • Immunomodulatory therapy for type 1 diabetes mellitus autoimmunity

Examples

Experimental program
Comparison scheme
Effect test

example 1

de Synthesis

[0098]Chemistry and Manufacturing Introduction: Overlapping preproinsulin 20 amino acid peptides are designed such that each of following peptides overlaps by 10 amino acids with the preceding peptide sequence. These peptides are made as a monocomponent HPLC (C18 column) purified peptides, synthesized in a protein-core laboratory on a Protein Synthesizer Model 433A from Applied Biosystems, using amino acid preparations from Peptide International. This is a standard solid-phase peptide synthesis (SPPS) procedure, which has the following main steps:

[0099]Chain Assembly.

[0100]The assembly strategy used in the protein synthesis is ABI (Applies Biosystem Inc.)-Fmoc / Thr. The Fmoc group protects the α-amino group of the amino acid. The peptide is assembled from the C-terminus towards the N-terminus with the α-carboxyl group of the starting amino acid attached to a solid support (resin). The resin used for assembly is polystyrene bead, an insoluble support with size of 400-1000 ...

example 2

ulin Polypeptide Vaccine Formulations

[0109]A. A preproinsulin polypeptide (3P) vaccine. The 3P immune modulatory vaccine is a combination of the water-soluble preproinsulin 20-aminoacid overlapping polypeptide mixture and incomplete Freund's adjuvant solution. The injections / emulsions (the final drug products) are prepared immediately before administration in a lamina-flow protected hood, under sterile condition by using high-pressure sterile syringes as a 50 / 50 (w / w) emulsion of human preproinsulin peptides mix solution (0.5 ml) by mixing with Montanide ISA51 (0.5 ml) (Seppic Inc.).

[0110]B. A preproinsulin polypeptide (3P) vaccine. The 3P immune modulatory vaccine is a combination of the water-soluble preproinsulin 20-aminoacid overlapping polypeptide mixture and incomplete Freund's adjuvant solution. The injections / emulsions (e.g., the final drug product) are pre-prepared (e.g., in a manufacturing setting) and can have an extended expanded shelf life (e.g., years).

[0111]C. A prepr...

example 3

ulin Polypeptide Vaccine Therapies

[0114]A. Administer a composition in accordance with the present invention to a subject (e.g., of any age and / or any disease duration) who has been diagnosed with type 1 diabetes (e.g., a clinical diagnosis+at least one positive type 1 diabetes specific autoantibodies such as IAA, GAD65, Ia2, Zn transporter8 or type 1 diabetes specific T cell marker positive).

[0115]B. Administer a composition in accordance with the present invention to a subject who does not have clinical diagnosis of type 1 diabetes, but has at least one positive type 1 diabetes specific autoantibodies (e.g., IAA, GAD65, Ia2, Zn transporter8) or type 1 diabetes specific T cell marker. The subject can have normal glucose status or impaired glucose tolerance tested by oral glucose tolerance test. Such subjects can be identified by family screening of patients with type 1 diabetes, or by screening a larger population.

[0116]The section headings used herein are for organizational purpos...

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PUM

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Abstract

A composition for treating type 1 diabetes mellitus autoimmunity can include a therapeutically effective amount of two or more overlapping fragments of preproinsulin and a pharmaceutically acceptable carrier, wherein at least of the polypeptide fragments is antigenic.

Description

FIELD OF THE INVENTION[0001]The present invention relates generally to the field of autoimmune disease and specifically to the treatment, prevention, or delayed progression of Type 1 diabetes mellitus. The present invention relates more particularly to immunomodulatory therapy for type 1 diabetes mellitus autoimmunity.BACKGROUND OF THE INVENTION[0002]The onset of human Type 1 diabetes mellitus (“T1DM”) is the clinical manifestation of β-cell failure caused by T cell mediated autoimmune destruction. T1DM results in a lifelong dependence on daily insulin injections and exposure to both the acute and late complications. Despite the significant progress that has been made in its treatment, T1DM represents a severe burden on the individual and on society. T1DM is a particular burden to children and their families, representing one of the most severe, chronic childhood diseases. While the onset of T1DM can occur in adulthood, it is largely a problem in children and youngsters. There is a ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/00C07K14/62A61K38/28C07K14/47G01N33/68A61K45/06C07K14/00
CPCA61K39/0005C07K14/62A61K38/28C07K14/4713G01N33/6893A61K45/06A61K2039/57G01N2800/42A61K2039/55A61K2039/55505A61K2039/55511A61K2039/55566A61K2039/55588C07K14/001A61P37/02A61P37/06A61P3/10A61K38/04A61K39/0008C07K7/04A61K38/08C07K7/06A61P5/50
Inventor ORBAN, TIHAMERHEYMAN, JALAHEJDAUBENEY, NARADAUBENEY, PIERS
Owner PHAIM PHARM LTD
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