Claims for Patent: 10,086,068

Summary for Patent: 10,086,068

Title:	Peanut formulations and uses thereof
Abstract:	The present application relates to compositions for oral immunotherapy of peanut allergies. Further, the present application relates to methods for the preparation of the compositions for immunotherapy, and their use in immunotherapy.
Inventor(s):	Walser; Bryan (Menlo Park, CA), Raff; Howard V. (Mill Valley, CA)
Assignee:	Aimmune Therapeutics, Inc. (Brisbane, CA)
Application Number:	15/276,440
Patent Claims:	1. A method for treating peanut allergy in a subject, comprising: selecting a subject having a peanut allergy; orally administering to the subject a pharmaceutical composition comprising: peanut flour comprising 0.45 mg to 550 mg peanut protein; one or more diluents in an amount of from 1% to 99% w/w of the composition; and one or more lubricants in an amount of from 0.01% to 10% w/w of the composition. 2. The method of claim 1, wherein the pharmaceutical composition is administered daily over a period of at least two weeks. 3. The method of claim 1, wherein the pharmaceutical composition is formulated for oral administration. 4. The method of claim 1, wherein the pharmaceutical composition is formulated as a capsule, a tablet, a mini-tablet, a powder, or a sprinkle. 5. The method of claim 1, wherein the pharmaceutical composition is formulated as a food product. 6. The method of claim 1, wherein the one or more diluents is selected from the group consisting of alginic acid and salts thereof; a cellulose derivative; microcrystalline dextrose; amylose; magnesium aluminum silicate; polysaccharide acids; bentonite; gelatin; polyvinylpyrrolidone/vinyl acetate copolymer; crosspovidone; povidone; starch; pregelatinized starch; tragacanth; dextrin; a sugar; dicalcium phosphate; a natural or synthetic gum; polyvinylpyrrolidone; larch arabogalactan; Veegum.RTM.; polyethylene glycol; waxes; sodium alginate; sodium starch glycolate; a cross-linked starch; a cross-linked polymer; a cross-linked polyvinylpyrrolidone; alginate; a clay; sodium starch glycolate; a natural sponge; a surfactant; a resin; citrus pulp; sodium lauryl sulfate; sodium lauryl sulfate in combination with starch; and combinations thereof. 7. The method of claim 1, wherein the one or more lubricants is selected from the group consisting of stearic acid, calcium hydroxide, talc, corn starch, sodium stearyl fumerate, alkali-metal and alkaline earth metal salts, waxes, boric acid, sodium benzoate, sodium acetate, sodium chloride, leucine, a polyethylene glycol (PEG), a methoxypolyethylene glycol, propylene glycol, sodium oleate, glyceryl behenate, glyceryl palmitostearate, glyceryl benzoate, magnesium lauryl sulfate, sodium lauryl sulfate, and combinations thereof. 8. The method of claim 1, wherein the pharmaceutical composition is formulated in a dose of 0.45 mg to 0.55 mg, 0.9 mg to 1.1 mg, 9.0 mg to 11.0 mg, 90 mg to 110 mg, 427.5 mg to 522.5 mg, or 450 mg to 550 mg of peanut protein. 9. The method of claim 1, wherein the pharmaceutical composition comprises peanut flour in a concentration from 7.2% to 16.5%. 10. A method of identifying a pharmaceutical composition for treatment of peanut allergy in a subject, comprising: determining the amounts of Ara h1, Ara h2 and Ara h6 in a sample of peanut flour by RP-HPLC; comparing the amounts of Ara h1, Ara h2 and Ara h6 in the sample to amounts of Ara h1, Ara h2 and Ara h6 in a reference standard; and identifying a pharmaceutical composition for treatment of peanut allergy in a subject, wherein the pharmaceutical composition includes: peanut flour containing at least the amounts of Ara h1, Ara h2 and Ara h6 of the reference standard, and wherein a total characterized peanut protein amount is from 0.45 mg to 550 mg peanut protein; one or more diluents in an amount of from 1% to 99% w/w of the pharmaceutical composition; one or more lubricants in an amount of from 0.01% to 10% w/w of the pharmaceutical composition. 11. A method for treating peanut allergy in a subject, comprising: selecting a subject having a peanut allergy; orally administering to the subject a pharmaceutical composition identified according to claim 10. 12. The method of claim 10, further comprising comparing samples from one or more lots of peanut flour to determine the amounts of Ara h1, Ara h2 and Ara h6 in the samples. 13. A method for treating peanut allergy in a subject, comprising: selecting a subject having a peanut allergy; orally administering to the subject a pharmaceutical composition comprising: peanut flour comprising 0.9 mg to 1100 mg peanut protein; one or more diluents in an amount of from 1% to 99% w/w of the pharmaceutical composition; and one or more lubricants in an amount of from 0.01% to 10% w/w of the pharmaceutical composition. 14. The method of claim 13, wherein the pharmaceutical composition is formulated for oral administration. 15. The method of claim 13, wherein the pharmaceutical composition is formulated as a capsule, a tablet, a mini-tablet, a powder, or a sprinkle. 16. The method of claim 13, wherein the pharmaceutical composition is formulated as a food product. 17. The method of claim 13, wherein the one or more diluents is selected from the group consisting of alginic acid and salts thereof; a cellulose derivative; microcrystalline dextrose; amylose; magnesium aluminum silicate; polysaccharide acids; bentonite; gelatin; polyvinylpyrrolidone/vinyl acetate copolymer; crosspovidone; povidone; starch; pregelatinized starch; tragacanth, dextrin, a sugar; dicalcium phosphate; a natural or synthetic gum; polyvinylpyrrolidone; larch arabogalactan; Veegum.RTM.; polyethylene glycol; waxes; sodium alginate; sodium starch glycolate; a cross-linked starch; a cross-linked polymer; a cross-linked polyvinylpyrrolidone; alginate; a clay; sodium starch glycolate; a natural sponge; a surfactant; a resin; citrus pulp; sodium lauryl sulfate; sodium lauryl sulfate in combination with starch; and combinations thereof. 18. The method of claim 13, wherein the one or more lubricants is selected from the group consisting of stearic acid, calcium hydroxide, talc, corn starch, sodium stearyl fumerate, alkali-metal and alkaline earth metal salts, waxes, boric acid, sodium benzoate, sodium acetate, sodium chloride, leucine, a polyethylene glycol (PEG), a methoxypolyethylene glycol, propylene glycol, sodium oleate, glyceryl benzoate, magnesium lauryl sulfate, sodium lauryl sulfate, and combinations thereof. 19. The method of claim 13, wherein the pharmaceutical composition is formulated in a dose of 0.9 mg to 1.1 mg, 9.0 mg to 11.0 mg 90 mg to 110 mg, 427.5 mg to 522.5 mg, 450 mg to 550 mg, or 900 mg to 1100 g of peanut protein. 20. The method of claim 13, wherein the pharmaceutical composition comprises peanut flour in a concentration from 7.2% to 16.5% w/w. 21. The method of claim 13, wherein the pharmaceutical composition is administered daily over a period of at least two weeks. 22. The method of claim 1, wherein the one or more diluents comprise 60% to 90% w/w of the pharmaceutical composition. 23. The method of claim 1, wherein the one or more diluents comprise 5% to 20% w/w of the pharmaceutical composition. 24. The method of claim 10, wherein the one or more diluents comprise 60% to 90% w/w of the pharmaceutical composition. 25. The method of claim 10, wherein the one or more diluents comprise 5% to 20% w/w of the pharmaceutical composition. 26. The method of claim 13, wherein the one or more diluents comprise 60% to 90% w/w of the pharmaceutical composition. 27. The method of claim 13, wherein the one or more diluents comprise 5% to 20% w/w of the pharmaceutical composition. 28. A method for treating a peanut allergy in a subject having a peanut allergy, comprising orally administering to the subject a pharmaceutical composition identified according to the method of claim 10. 29. A method for treating a peanut allergy in a subject having a peanut allergy, comprising: orally administering to the subject a pharmaceutical composition comprising: peanut flour comprising 0.45 mg to 1100 mg peanut protein; one or more diluents in an amount of from 1% to 99% w/w of the composition; and one or more lubricants in an amount of from 0.01% to 10% w/w of the composition. 30. The method of claim 29, wherein the peanut flour comprises 0.45 mg to 550 mg peanut protein. 31. The method of claim 29, wherein the pharmaceutical composition is administered daily over a period of at least two weeks. 32. The method of claim 29, wherein the pharmaceutical composition is formulated for oral administration. 33. The method of claim 29, wherein the pharmaceutical composition is formulated as a capsule, a tablet, a mini-tablet, a powder, or a sprinkle. 34. The method of claim 29, wherein the pharmaceutical composition is formulated as a food product. 35. The method of claim 29, wherein the pharmaceutical composition is formulated in a dose of 0.45 mg to 0.55 mg, 0.9 mg to 1.1 mg, 9.0 mg to 11.0 mg, 90 mg to 110 mg, 427.5 mg to 522.5 mg, 450 mg to 550 mg, or 900 mg to 1100 mg peanut protein. 36. The method of claim 29, wherein the pharmaceutical composition comprises peanut flour in a concentration from 7.2% to 16.5%. 37. The method of claim 29, wherein the one or more diluents comprise 60% to 90% w/w of the pharmaceutical composition. 38. The method of claim 29, wherein the one or more diluents comprise 5% to 20% w/w of the pharmaceutical composition.

Details for Patent 10,086,068

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		2036-09-26