US2023159647A1PendingUtilityA1

Methods for treating allergy and enhancing allergen-specific immunotherapy by administering an il-4r inhibitor

Assignee: REGENERON PHARMAPriority: Jun 4, 2013Filed: Sep 23, 2022Published: May 25, 2023
Est. expiryJun 4, 2033(~6.8 yrs left)· nominal 20-yr term from priority
C07K 16/28A61P 37/00C07K 16/2866A61K 45/06A61K 2039/577A61K 2039/505C07K 2317/21A61K 38/20A61K 2039/545A61K 39/395A61K 2300/00A61P 37/08A61P 37/02C07K 2317/90
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Claims

Abstract

The present invention provides methods for treating, preventing or reducing the severity of allergic reactions. The present invention also provides methods for enhancing the efficacy and/or safety of an allergen-specific immunotherapy (SIT) regimen. The methods of the present invention comprise administering to a subject in need thereof a therapeutic composition comprising an interleukin-4 receptor (IL-4Rα) antagonist such as an anti-IL-4Rα antibody.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 - 46 . (canceled) 
     
     
         47 . A method for reducing total serum IgE level in a subject who is exposed to a food allergen, the method comprising administering an interleukin-4 receptor (IL-4R) antagonist to the subject prior to exposure to the food allergen, wherein the IL-4R antagonist is an antibody or an antigen-binding fragment thereof that binds IL-4R, wherein the antibody or antigen-binding fragment thereof comprises three HCDRs (HCDR1, HCDR2 and HCDR3) and three LCDRs (LCDR1, LCDR2 and LCDR3), wherein the HCDR1 comprises the amino acid sequence of SEQ ID NO:3, the HCDR2 comprises the amino acid sequence of SEQ ID NO:4, the HCDR3 comprises the amino acid sequence of SEQ ID NO:5, the LCDR1 comprises the amino acid sequence of SEQ ID NO:6, the LCDR2 comprises the amino acid sequence of SEQ ID NO:7, and the LCDR3 comprises the amino acid sequence of SEQ ID NO:8. 
     
     
         48 . The method of  claim 47 , wherein the method comprises administering the IL-4R antagonist to the subject from 1 day to 2 weeks prior to exposure to the allergen. 
     
     
         49 . The method of  claim 47 , wherein the method comprises administering the IL-4R antagonist to the subject 2 weeks prior to exposure to the allergen. 
     
     
         50 . The method of  claim 47 , wherein the food allergen is derived from or contained within a food item that is a dairy product, egg, celery, sesame, wheat, soy, fish, shellfish, sugar, peanut, or tree nut. 
     
     
         51 . The method of  claim 47 , wherein the food allergen is cow's milk. 
     
     
         52 . The method of  claim 47 , wherein the food allergen is peanut. 
     
     
         53 . The method of  claim 47 , wherein the IL-4R antagonist is an antibody or antigen-binding fragment thereof that comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 1 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO. 2. 
     
     
         54 . The method of  claim 47 , wherein the IL-4R antagonist is dupilumab. 
     
     
         55 . The method of  claim 47 , wherein the method comprises administering multiple doses of the IL-4R antagonist to the subject, wherein the IL-4R antagonist is administered once every week, once every two weeks, once every three weeks, or once every four weeks. 
     
     
         56 . The method of  claim 47 , wherein the IL-4R antagonist is administered in an amount from 0.05 mg to 600 mg. 
     
     
         57 . The method of  claim 47 , wherein the IL-4R antagonist is administered subcutaneously. 
     
     
         58 . The method of  claim 47 , wherein the method further comprises administering to the subject a second therapeutic agent, wherein the second therapeutic agent is selected from the group consisting of steroids, antihistamines, decongestants, and anti-IgE agents. 
     
     
         59 . The method of  claim 47 , wherein the IL-4R antagonist is contained in a syringe. 
     
     
         60 . The method of  claim 47 , wherein the IL-4R antagonist is contained in a pen delivery device. 
     
     
         61 . The method of  claim 60 , wherein the pen delivery device is prefilled.

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