Claims for Patent: 10,669,341

Summary for Patent: 10,669,341

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:
Application Number:	15/842,865
Patent Claims:	1. A method for enhancing the efficacy and/or safety of an allergen-specific immunotherapy (SIT) regimen, the method comprising administering a therapeutically effective amount of a pharmaceutical composition comprising an interleukin-4 receptor (IL-4R) antagonist to a subject prior to or concurrent with the SIT regimen, 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 SIT regimen comprises an up-dosing phase followed by a maintenance phase. 3. The method of claim 2, wherein the SIT regimen is a rush SIT regimen. 4. The method of claim 2, wherein the pharmaceutical composition is administered to the subject at a frequency of about once a week, once every two weeks, once every three weeks, or once a month, prior to or during the up-dosing phase. 5. The method of claim 2, wherein the pharmaceutical composition is administered to the subject at a frequency of about once a week, once every two weeks, once every three weeks, or once a month, during or after the maintenance phase. 6. The method of claim 2, wherein the pharmaceutical composition is administered to the subject at a frequency of about once a week, once every two weeks, once every three weeks, or once a month, throughout the entire course of the SIT regimen. 7. The method of claim 1, wherein the SIT regimen comprises administration of a food allergen derived from a food item selected from the group consisting of dairy product, egg, wheat, soy, fish, shellfish, peanut, and tree nut. 8. The method of claim 1, wherein the SIT regimen comprises administration of a non-food allergen 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. 9. 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. 10. The method of claim 1, wherein the IL-4R antagonist is an antibody or antigen-binding fragment thereof that 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. 11. The method of claim 10, wherein the antibody or antigen-binding fragment thereof prevents the interaction of IL-4 with both type 1 and type 2 IL-4 receptors. 12. 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. 13. The method of claim 1, wherein the IL-4R antagonist is dupilumab or a bioequivalent thereof. 14. The method of claim 1, wherein the pharmaceutical composition is administered subcutaneously. 15. The method of claim 1, wherein the pharmaceutical composition is contained in a syringe or a pen delivery device. 16. The method of claim 15, wherein the pharmaceutical composition is contained in a syringe. 17. The method of claim 15, wherein the pharmaceutical composition is contained in a pen delivery device. 18. The method of claim 17, wherein the pen delivery device is prefilled. 19. The method of claim 7, wherein the SIT regimen comprises administration of a peanut allergen. 20. The method of claim 1, wherein the pharmaceutical composition is administered to the subject prior to the SIT regimen.

Details for Patent 10,669,341

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		2033-06-04
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