Claims for Patent: 10,653,773

Summary for Patent: 10,653,773

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:	16/111,102
Patent Claims:	1. A method of making a pharmaceutical composition for treatment of peanut allergy in a subject, comprising: (1) assaying, in a quality control process, a composition comprising peanut flour, said assaying comprising: determining the concentrations of Ara h 1, Ara h 2, and Ara h 6 in a composition comprising peanut flour by high-performance liquid chromatography (HPLC); comparing the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the composition to the concentrations of Ara h 1, Ara h 2, and Ara h 6 in a reference standard; and identifying the composition as suitable for treatment of peanut allergy based on the comparison to the reference standard; and (2) formulating the composition comprising peanut flour identified in step (1) for oral administration. 2. The method of claim 1, wherein the HPLC is reversed-phase HPLC (RP-HPLC). 3. The method of claim 2, wherein the RP-HPLC comprises use of a C4 column. 4. The method of claim 2, wherein the RP-HPLC comprises use of a C18 column. 5. The method of claim 1, wherein the HPLC is size-exclusion chromatography HPLC (SEC-HPLC). 6. The method of claim 1, comprising using a bovine serum albumin (BSA) standard to determine the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the composition. 7. The method of claim 1, comprising determining a total protein content of the composition. 8. The method of claim 7, wherein the total protein content of the composition is determined using a BSA reference standard or a Lowry method. 9. The method of claim 1, wherein determining the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the composition comprises comparing the peak area of each of Ara h 1, Ara h 2, and Ara h 6 in an HPLC chromatogram to a total area attributable to protein in the HPLC chromatogram. 10. The method of claim 1, comprising determining a ratio of Ara h 2 to Ara h 6 in the composition. 11. The method of claim 1, comprising extracting proteins from the composition in a liquid prior to determining the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the composition by HPLC. 12. The method of claim 11, comprising filtering the liquid comprising the proteins prior to determining the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the composition by HPLC. 13. A method of making a pharmaceutical composition for treatment of peanut allergy in a subject, comprising: (1) assaying, in a quality control process, a peanut flour lot, comprising: determining the concentrations of Ara h 1, Ara h 2, and Ara h 6 in peanut flour sampled from a peanut flour lot by high-performance liquid chromatography (HPLC); comparing the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the peanut flour to the concentrations of Ara h 1, Ara h 2, and Ara h 6 in a reference standard; and identifying the peanut flour lot as suitable for making a composition for treatment of peanut allergy based on the comparison to the reference standard; and (2) formulating peanut flour from the identified peanut flour lot identified in step (1) for oral administration. 14. The method of claim 13, wherein the HPLC is reversed-phase HPLC (RP-HPLC). 15. The method of claim 14, wherein the RP-HPLC comprises use of a C4 column. 16. The method of claim 14, wherein the RP-HPLC comprises use of a C18 column. 17. The method of claim 13, wherein the HPLC is size-exclusion chromatography HPLC (SEC-HPLC). 18. The method of claim 13, comprising using a bovine serum albumin (BSA) standard to determine the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the peanut flour. 19. The method of claim 13, comprising determining a total protein content of the peanut flour. 20. The method of claim 19, wherein the total protein content of the peanut flour is determined using a BSA reference standard or a Lowry method. 21. The method of claim 13, wherein determining the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the peanut flour comprises comparing the peak area of each of Ara h 1, Ara h 2, and Ara h 6 in an HPLC chromatogram to a total area attributable to protein in the HPLC chromatogram. 22. The method of claim 13, comprising determining a ratio of Ara h 2 to Ara h 6 in the peanut flour. 23. The method of claim 13, comprising extracting proteins from the peanut flour in a liquid prior to determining the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the peanut flour by HPLC. 24. The method of claim 13, comprising filtering the liquid comprising the proteins prior to determining the concentrations of Ara h 1, Ara h 2, and Ara h 6 in the peanut flour by HPLC. 25. The method of claim 1, further comprising filling the pharmaceutical composition into a capsule. 26. The method of claim 1, wherein formulating the composition comprising mixing the composition with a diluent, a glidant, or a lubricant. 27. The method of claim 13, further comprising filling the pharmaceutical composition into a capsule. 28. The method of claim 13, wherein formulating the peanut flour comprising mixing the peanut flour with a diluent, a glidant, or a lubricant.

Details for Patent 10,653,773

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	10,653,773	2038-08-23