Claims for Patent: 10,166,286

Summary for Patent: 10,166,286

Title:	Mixed allergen compositions and methods for using the same
Abstract:	Mixed allergen compositions of two or more different allergens are provided. In some instances, the mixed allergen compositions include: a nut allergen; an animal allergen; and at least one of: a non-nut plant allergen; a biotic agent; and a vitamin. Also provided are methods of administering the mixed allergen compositions to a subject. The mixed allergen compositions find use in a variety of applications, including health maintenance, immune balance, gut balance, immune support, health improvement and therapeutic applications.
Inventor(s):	Nadeau; Kari C. (Los Altos Hills, CA)
Assignee:	The Board of Trustees of the Leland Stanford Junior University (Stanford, CA)
Application Number:	15/224,004
Patent Claims:	1. A method of treating an autoimmune disease or inflammatory disease in a human subject in need thereof, the method comprising administering to the subject a mixed allergen composition comprising: 2 to 20 different flours or powders, wherein at least one flour or powder is a nut flour selected from the group consisting of peanut, almond, walnut, cashew, hazelnut, pecan, and pistachio, at least one flour or powder is an animal powder selected from the group consisting of shrimp, cod, and salmon, and the mixed allergen composition comprises equal parts by protein weight of each flour or powder; and optionally a vitamin selected from the group consisting of vitamin D and vitamin C; wherein the composition is administered to the subject at least weekly or at least every other week. 2. The method of claim 1, further comprising allowing sufficient time for the administration of the composition to inhibit the symptoms of the autoimmune disease or inflammatory disease in the human subject. 3. The method of claim 1, wherein the method further comprises inhibiting the symptoms of one or more food allergies. 4. The method of claim 3, wherein the one or more food allergies is a single food allergy. 5. The method of claim 3, wherein the one or more food allergies is a multiple food allergy. 6. The method of claim 1, wherein the treating is prophylactically treating. 7. The method of claim 1, wherein after administration the subject has an improved immune protection against autoimmune inflammation as measured by the subject's Th1 proliferation levels in response to an allergen, as compared to levels before administration. 8. A method of reducing the incidence of, or for prophylactic treating, an inflammatory disease or an autoimmune disease in a pediatric or pregnant subject in need thereof, the method comprising administering a mixed allergen composition comprising: 2 to 20 different flours or powders, wherein at least one flour or powder is a nut flour selected from the group consisting of peanut, almond, walnut, cashew, hazelnut, pecan, and pistachio, at least one flour or powder is an animal powder selected from the group consisting of shrimp, cod, and salmon, and the mixed allergen composition comprises equal parts by protein weight of each flour or powder; and optionally a vitamin selected from the group consisting of vitamin D and vitamin C; wherein the composition is administered to the subject at least weekly or at least every other week. 9. The method of claim 8, wherein administering the composition is daily for a period of time, followed by weekly, twice weekly and/or three times a week for a period of time. 10. The method of claim 1, wherein administering comprises administering about 1 to about 10 mg (by weight protein) of the composition, or of each flour or powder, daily for about 1 week to about 30 weeks, and then about 1 to about 300 mg or more (by weight protein) weekly for about 1 to about 30 or more weeks. 11. The method of claim 1, wherein administering comprises two, three or more step-wise, increasing dose levels of the composition, wherein each dose level is about 5 to about 100% more than the preceding dose level by total weight protein level, wherein each dose level is independently administered daily or weekly for about 1 to about 30 weeks. 12. The method of claim 1, wherein the 2 to 20 different flours or powders are each selected from the group consisting of shellfish, peanut, tree nut, fish, milk, egg, legume, grain, sesame, and fruit. 13. The method of claim 12, wherein the 2 to 20 different flours or powders are each selected from the group consisting of cashew, pistachio, walnut, almond, pecan, chicken egg, cow milk, peanut, shrimp, salmon, wheat, cod, crab, soy, and sesame. 14. The method of claim 13, wherein the composition is a food product. 15. The method of claim 14, wherein the food product is pureed food product. 16. The method of claim 14, wherein the food product is infant formula. 17. The method of claim 1, wherein the human subject is a pediatric subject. 18. The method of claim 17, wherein the pediatric subject is 1 month to 7 years old. 19. The method of claim 17, wherein the pediatric subject is 1 month to 6 months, or 6 months to 7 years old. 20. The method of claim 1, wherein the composition comprises 6 to 20 different flours or powders. 21. The method of claim 8, wherein the subject has an increased risk to develop the autoimmune disease or inflammatory disease relative to the general population based on diagnostic criteria. 22. The method of claim 1, wherein at least one flour or powder is a non-nut plant flour selected from the group consisting of wheat, sesame, and oat. 23. The method of claim 1, wherein at least one flour or powder is powdered hen's egg. 24. The method of claim 1, wherein at least one flour or powder is soy. 25. The method of claim 1, wherein the composition comprises vitamin D. 26. A method of treating an autoimmune disease or inflammatory disease in a human subject in need thereof, the method comprising orally administering to the subject a mixed allergen unit composition comprising: 6 to 20 different flours or powders, wherein at least one flour or powder is a nut flour selected from the group consisting of peanut, almond, walnut, cashew, hazelnut, pecan, and pistachio, at least one flour or powder is an animal powder selected from the group consisting of shrimp, cod, salmon, milk, and egg, at least one flour or powder is a non-nut plant flour selected from the group consisting of wheat, sesame, and oat, and the unit composition comprises equal parts by protein weight of each flour or powder.

Details for Patent 10,166,286

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Aimmune Therapeutics, Inc.	PALFORZIA	peanut (arachis hypogaea) allergen powder-dnfp	Powder	125696	January 31, 2020		2036-07-29