IP Library Granted Patent US 12,357,688
Granted Patent B2
US 12,357,688 · App. 17/752,639 · Granted Jul 15, 2025

Methods of oral immunotherapy

Inventor: Stephen G. Dilly (Brisbane, CA)
Assignee: Société des Produits Nestlé S.A.
A61K39/35A61K9/0053A61P37/08G01N33/6854A61K2039/542A61K2039/545G01N2800/52
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Quick Facts
Patent No.
US 12,357,688
App. No.
17/752,639
Granted
Jul 15, 2025
Kind
B2
Abstract

The present disclosure relates to improved oral immunotherapy methods for treating food allergies, and particularly peanut allergy. Biomarkers, such as a level of peanut-specific IgE and/or peanut-specific IgG4s are used by the methods described herein. Such methods include a method of treating a subject for a peanut allergy, methods of assessing the suitability of a treatment for a peanut allergy, a method of evaluating a symptom in a subject during the course of treatment of a peanut allergy, a method of monitoring treatment for a peanut allergy in a subject, a method of reducing the risk or incidence of an adverse event in a subject receiving treatment for a peanut allergy, a method of adjusting a dose of an allergenic peanut composition, and a method of assessing a likelihood of an allergic reaction that requires administration of epinephrine to a subject receiving treatment for a peanut allergy.

Claims (13)

1. A method of reducing the risk or incidence of an adverse event in a subject receiving treatment for a peanut allergy, comprising:

measuring a level of peanut-specific IgEs and a level of peanut-specific IgG4s in the subject;

measuring a ratio of the peanut-specific IgEs to the peanut-specific IgG4s; and

administering a reduced dose, delaying the administration of a dose, or delaying administration of an increase of a dose of an allergenic peanut composition if the level of peanut-specific IgEs is above a predetermined threshold, and if the ratio of the peanut-specific IgEs to the peanut-specific IgG4s increases during treatment compared to an earlier measurement during treatment or within 7 days of the start of treatment.

2. The method of claim 1 , wherein the treatment is oral immunotherapy.

3. The method of claim 1 , wherein the predetermined threshold of the peanut-specific IgEs is 100 KU/L.

4. The method of claim 1 , wherein the adverse event is an allergic reaction.

5. The method of claim 1 , comprising administering the dose to the subject.

6. A method of monitoring treatment for a peanut allergy in a subject, comprising:

measuring a level of peanut-specific IgEs and a level of peanut-specific IgG4s in a sample of the subject during the course of treatment; and

measuring a ratio of the peanut-specific IgE to the peanut-specific IgG4, wherein the subject undergoes heightened monitoring for an allergenic reaction if the level of peanut-specific IgEs is above a predetermined threshold, and if the ratio of the peanut-specific IgEs to the peanut-specific IgG4s increases during the course treatment compared to an earlier measurement during treatment or within 7 days of the start of treatment, and wherein the monitoring is heightened compared to a subject having a level of peanut-specific IgEs at or below the predetermined threshold.

7. The method of claim 1 , wherein the level of peanut-specific IgEs, peanut-specific IgG4s, or both, is measured by a quantitative immunoassay or fluorescence enzyme immunoassay auto-analyzer.

8. The method of claim 6 , wherein the predetermined threshold of the peanut-specific IgEs is 100 kU/L.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2022
From: DILLY, STEPHEN G.
To: AIMMUNE THERAPEUTICS, INC.
Reel/Frame 061170/0310 →
RELEASE OF SECURITY INTEREST Recorded Sep 21, 2022
From: CORTLAND CAPITAL MARKET SERVICES LLC
To: AIMMUNE THERAPEUTICS, INC.
Reel/Frame 061170/0349 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2022
From: AIMMUNE THERAPEUTICS, INC.
To: SOCIETE DES PRODUITS NESTLE S.A.
Reel/Frame 061170/0360 →
Continuity (6)
Division 16178502 · Nov 1, 2018
Provisional Application 62674478 · May 21, 2018
Provisional Application 62637903 · Mar 2, 2018
Provisional Application 62631406 · Feb 15, 2018
Provisional Application 62580999 · Nov 2, 2017
Related Publication 20220288196A1 · Sep 15, 2022
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