IP Library › Granted Patent US 12,629,414
Granted Patent B2
US 12,629,414 · App. 17/697,467 · Granted May 19, 2026

Methods and devices for the treatment of food allergies

Inventors: Harvinder Singh Gill (Lubbock, TX); Akhilesh Kumar Shakya (Lubbock, TX)
Assignee: Texas Tech University System
A61K39/35A61K9/0021A61K39/39A61M37/0015A61P37/00A61P37/02A61K2039/54A61K2039/55561A61M2037/0046A61M2037/0061
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Quick Facts
Patent No.
US 12,629,414
App. No.
17/697,467
Granted
May 19, 2026
Kind
B2
Abstract

Methods and devices are provided for treating a food allergy in a subject in need thereof. The method entails delivering an effective amount of an allergen associated with the food allergy into the subject's cutis skin layer. Delivering the allergen is carried out by inserting one or more allergen-coated solid microneedles into the subject's skin. The one or more solid microneedles each has a base, shaft and tip, and when inserted in the subject, do not extend beyond the cutis. The allergen is allowed to dissociate from the one or more microneedles while inserted in the subject's cutis. Once the allergen disassociates, the one or more microneedles is removed from the subject's skin.

Claims (25)

1 . A method for treating a food allergy in a subject in need thereof, comprising:

delivering an effective amount of a food allergen into the subject's cutis skin layer once daily during an administration period, and the delivering comprises:

(i) inserting one or more solid microneedles each comprising a base, shaft and tip into the subject's skin, wherein at least one microneedle of the one or more solid microneedles does not extend beyond the cutis once inserted, and is coated with the food allergen;

(ii) allowing the food allergen to dissociate from the one or more microneedles while inserted in the subject's cutis; and

(iii) removing the one or more solid microneedles from the subject's skin,

wherein the administration period is two days, three days, four days, five days, six days, seven days, 14 days, 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 24 months, 27 months, 30 months, 33 months or 36 months.

2 . The method of claim 1 , wherein the one or more solid microneedles extends from an adhesive substrate.

3 . The method of claim 1 , wherein the one or more solid microneedles is stainless steel.

4 . The method of claim 1 , wherein the one or more solid microneedles is present in a microneedle array extending from a common substrate.

5 . The method of claim 1 , wherein the average width of the one or more microneedles, as measured at the widest cross section of each respective microneedle of the one or more microneedles, is from about 20 μm to about 500 μm, or from about 50 μm to about 350 μm, or from about 100 μm to about 250 μm.

6 . The method of claim 1 , wherein the one or more microneedles are coated with the allergen.

7 . The method of claim 1 , wherein the one or more microneedles comprises from about 10 to about 200 microneedles.

8 . The method of claim 1 , wherein the food allergen is a peanut allergen comprising Ara h1, Ara h2, Ara h3, Ara h4, Ara h5, Ara h6, Ara h7, Ara h8, Ara h9, Ara h10, Ara h11, Ara h12, Ara h13, a peptide fragment thereof, or a combination thereof.

9 . The method of claim 1 , wherein the one or more solid microneedles is coated with an adjuvant.

10 . The method of claim 1 , wherein each microneedle of the one or more microneedles does not extend beyond the epidermis skin layer.

11 . The method of claim 1 , wherein each microneedle of the one or more microneedles does not extend beyond the dermis skin layer.

12 . The method of claim 1 , wherein at least 40% of the allergen dissociates from the at least one microneedle while inserted in the subject's cutis.

13 . The method of claim 1 , wherein the food allergen dissociates from the at least one microneedle for about 1 minute to about 10 minutes.

14 . The method of claim 1 , wherein the effective amount of the food allergen is increased over the administration period.

15 . The method of claim 14 , wherein the effective amount of the food allergen is delivered at least twice over the administration period.

16 . The method of claim 14 , wherein the effective amount of the food allergen is delivered at least three times over the administration period.

17 . The method of claim 1 , wherein the treating comprises desensitization to the allergen.

18 . The method of claim 1 , wherein treating comprises decreasing the number of food allergen specific IgE antibodies in the subject, as compared to the number of food allergen specific IgE antibodies secreted by the subject prior to the treating.

19 . The method of claim 1 , wherein treating comprises increasing the number of food allergen specific IgG antibodies in the subject, as compared to the number of food allergen specific IgE antibodies secreted prior to the treating.

20 . The method of claim 1 , wherein the food allergen is a groundnut, milk, egg, tree nut, seed, fish, shellfish, crustacean, cereal or a legume allergen.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2022
From: GILL, HARVINDER SINGH; SHAKYA, AKHILESH KUMAR
To: TEXAS TECH UNIVERSITY SYSTEM
Reel/Frame 060078/0205 →
Continuity (4)
Continuation 16616171
Provisional Application 62576176 · Oct 24, 2017
Provisional Application 62512884 · May 31, 2017
Related Publication 20220211842A1 · Jul 7, 2022
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