Claims for Patent: 10,392,439

Summary for Patent: 10,392,439

Title:	Methods for treating allergy and enhancing allergen-specific immunotherapy by administering an IL-4R inhibitor
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-4R.alpha.) antagonist such as an anti-IL-4R.alpha. antibody.
Inventor(s):	Stahl; Neil (Carmel, NY), Orengo; Jamie M (Cortlandt Manor, NY), Murphy; Andrew J. (Croton-on-Hudson, NY), Gandhi; Namita (New York, NY), Graham; Neil (Croton-on-Hudson, NY)
Assignee:	Regeneron Pharmaceuticals, Inc. (Tarrytown, unknown)
Application Number:	14/294,544
Patent Claims:	1. A method for treating or reducing the severity of an allergic reaction, the method comprising administering a therapeutically effective amount of a pharmaceutical composition comprising an interleukin-4 receptor (IL-4R) antagonist to a subject in need thereof, wherein the IL-4R antagonist is an antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDRs) (HCDR1, HCDR2 and HCDR3) and three light chain complementarity determining regions (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, wherein the allergic reaction is triggered by a food allergen, and wherein the composition is administered to the subject less than 4 hours before allergen exposure, less than 4 hours after allergen exposure, or less than 4 hours after manifestation of one or more allergic symptoms in the subject. 2. The method of claim 1, wherein the antibody or antigen-binding fragment thereof binds IL-4R.alpha. and prevents the interaction of IL-4 and/or IL-13 with a type 1 or type 2 IL-4 receptor. 3. The method of claim 2, wherein the antibody or antigen-binding fragment thereof prevents the interaction of IL-4 with both type 1 and type 2 IL-4 receptors. 4. The method of claim 3, wherein the antibody or antigen-binding fragment thereof 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. 5. The method of claim 1, wherein the IL-4R antagonist is dupilumab or a bioequivalent thereof. 6. The method of claim 1, wherein the allergic symptoms are selected from the group consisting of urticaria, angioedema, rhinitis, asthma, vomiting, respiratory compromise, swollen lips, swollen tongue, and reduced blood pressure. 7. The method of claim 1, wherein the allergic reaction is anaphylaxis. 8. The method of claim 1, wherein the food allergen is selected from the group consisting of dairy product, egg, wheat, soy, fish, shellfish, peanut and tree nut. 9. The method of claim 1, wherein the pharmaceutical composition is administered to the subject as part of a therapeutic dosing regimen comprising once a week, once every two weeks, once every three weeks, or once a month dosing of the pharmaceutical composition. 10. The method of claim 1, wherein the pharmaceutical composition is administered to the subject in combination with a second therapeutic agent selected from the group consisting of steroids, antihistamines, decongestants, and anti-IgE agents. 11. The method of claim 2, wherein the antibody or antigen-binding fragment thereof prevents the interaction of IL-13 with a type 2 IL-4 receptor.

Details for Patent 10,392,439

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Aimmune Therapeutics, Inc.	PALFORZIA	peanut (arachis hypogaea) allergen powder	Powder	125696	01/31/2020		2039-09-04
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	03/28/2017		2039-09-04
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	10/19/2018		2039-09-04