Claims for Patent: 10,676,530

Summary for Patent: 10,676,530

Title:	Methods for treating allergy and enhancing allergen-specific immunotherapy by administering an antibody to IL-4 receptor
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, NY)
Application Number:	15/842,868
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 allergic reaction is triggered by a non-food allergen, wherein the IL-4R antagonist is an antibody or antigen-binding fragment thereof that binds IL-4R, wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDR1, HCDR2 and HCDR3) and three light chain complementarity determining regions (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. 2. The method of claim 1, wherein the pharmaceutical composition is administered to the subject before allergen exposure. 3. The method of claim 2, wherein the pharmaceutical composition is administered to the subject less than 4 hours before allergen exposure. 4. The method of claim 1, wherein the pharmaceutical composition is administered to the subject during or after allergen exposure. 5. The method of claim 4, wherein the pharmaceutical composition is administered to the subject less than 4 hours after allergen exposure. 6. The method of claim 4, wherein the pharmaceutical composition is administered to the subject following the manifestation of one or more allergic symptoms in the subject. 7. The method of claim 6, wherein the pharmaceutical composition is administered to the subject less than 4 hours after manifestation of one or more allergic symptoms in the subject. 8. The method of claim 6, 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. 9. The method of claim 1, wherein the allergic reaction is anaphylaxis. 10. The method of claim 1, wherein the non-food allergen is selected from the group consisting of dust, pollen, insect venom, mold, animal fur, animal dander, wool, latex, metals, household cleaners, detergents, drugs, therapeutic monoclonal antibodies, ragweed, grass and birch. 11. 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. 12. 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. 13. The method of claim 1, wherein the IL-4R antagonist is an antibody or antigen-binding fragment thereof that binds IL-4Ra and prevents the interaction of IL-4 and/or IL-13 with a type 1 or type 2 IL-4 receptor. 14. The method of claim 13, wherein the antibody or antigen-binding fragment thereof prevents the interaction of IL-4 with both type 1 and type 2 IL-4 receptors. 15. The method of claim 1, 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. 16. The method of claim 1, wherein the IL-4R antagonist is dupilumab or a bioequivalent thereof. 17. The method of claim 1, wherein the pharmaceutical composition is administered subcutaneously. 18. The method of claim 1, wherein the pharmaceutical composition is contained in a syringe or a pen delivery device. 19. The method of claim 18, wherein the pharmaceutical composition is contained in a syringe. 20. The method of claim 18, wherein the pharmaceutical composition is contained in a pen delivery device. 21. The method of claim 20, wherein the pen delivery device is prefilled. 22. The method of claim 10, wherein the non-food allergen is grass. 23. The method of claim 1, wherein the pharmaceutical composition comprises from 50 mg to 600 mg of the IL-4R antagonist. 24. The method of claim 23, wherein the pharmaceutical composition comprises 300 mg of the IL-4R antagonist.

Details for Patent 10,676,530

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	03/28/2017		2033-06-04
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	10/19/2018		2033-06-04
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	06/18/2020		2033-06-04
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	06/14/2021		2033-06-04
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	10/20/2021		2033-06-04