Ivig composition and method of treatment of antibody deficient patients

Patent metadata

Field	Value
Publication number	US-2021395343-A1
Application number	US-201917287727-A
Country	US
Kind code	A1
Filing date	Oct 28, 2019
Priority date	Oct 29, 2018
Publication date	Dec 23, 2021
Grant date	—

Abstract

The invention is in the field of therapy of antibody deficiencies such as immune diseases and inflammatory disorders. The inventors demonstrate for the first time the convergence of intestinal IgA and serum IgG responses toward the same microbial targets, under homeostatic conditions. Private anti-microbiota IgG specificities are induced in IgA-deficient patients, but are not found in IgG pools from healthy donors, partially explaining why substitutive IgG (IVIG) cannot regulate antibody deficiency-associated gut dysbiosis and intestinal translocation. Finally, in both controls and IgA-deficient patients, systemic anti-microbiota IgG responses correlate with reduced inflammation suggesting that systemic IgG responses contribute to the gut microbiota confinement. Accordingly, the invention relates to IVIGs (Intravenous immunoglobulins) composition containing at least 1% of immunoglobulins (Ig) from SIgAd (Selective IgA deficiency) patient and their use in the treatment of antibody deficiency disorders such as immune diseases, inflammatory disorders and autoimmune disease.

First claim

1 . A composition of IVIGs (Intravenous immunoglobulins) containing at least 1% of immunoglobulin G (IgG) from SIgAd (Selective IgA deficiency) patients.

2 . The composition of IVIGs according to claim 1 , wherein said composition contains between 1% to 10% of immunoglobulin G (IgG) from SIgAd (Selective IgA deficiency) patients.

3 . A method of preparation of the composition of IVIGs according to claim 1 comprising
separating plasma proteins into individual stable fractions with different biological functions by Cohn's fractionation; or
purifying immunoglobulins by ion-exchange chromatography.

4 . A method of treating an antibody deficiency disorder selected from the group consisting of an immune disease, an inflammatory disorder and an autoimmune disease, in a subject in need thereof, comprising
administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising the composition of IVIGs of claim 1 .

5 . The method according to claim 4 , wherein the immune disease is a Primary antibody deficiency or a Secondary antibody deficiency.

6 . The method according to claim 5 wherein the Primary antibody deficiency is common variable immunodeficiency (CVID).

7 . The method according to claim 4 , wherein the inflammatory disorder is selected form the group consisting of a gut inflammatory disease, sepsis and graft versus host disease.

8 . The method according to claim 7 wherein the gut inflammatory disease is inflammatory bowel disease.

9 . The method according to claim 4 , wherein the autoimmune disease is a neurological, haematological, nephrological, rheumatological and/or dermatological disease.

Assignees

• Inst Nat Sante Rech Med
• Univ Sorbonne
• Assist Publique Hopitaux Paris Aphp

Inventors

• Gorochov Guy
• Larsen Martin
• Sterlin Delphine
• Fadlallah Jehane

Classifications

• A61P37/02

  Immunomodulators · CPC title

• C07K16/06 Primary

  from serum · CPC title

• C07K2317/52

  Constant or Fc region; Isotype · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• C07K16/00 Primary

  Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies · CPC title