IP Library › Granted Patent US 12,364,721
Granted Patent B2
US 12,364,721 · App. 17/638,137 · Granted Jul 22, 2025

Compositions and methods for treatment of inflammatory and immune diseases

Inventors: David N. Cook (City of Industry, CA); Gregory McKenzie (City of Industry, CA); Julie E. Button (City of Industry, CA)
Assignee: Prolacta Bioscience, Inc.
A61K35/745A61K31/702A61P3/04A61P3/10A61P37/06
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Quick Facts
Patent No.
US 12,364,721
App. No.
17/638,137
Granted
Jul 22, 2025
Kind
B2
Abstract

Provided herein are compositions, methods, strategies, kits, and articles of manufacture that are useful, inter alia, in the treatment or prevention of diseases or conditions such as those which may be associated with inflammation, infection, allergy, immune dysfunction, or dysbiosis of the intestinal microbiome. In some aspects, the invention provides a synergistic combination of a prebiotics, e.g., a mixture of human milk oligosaccharides, and a probiotic strain, such as a strain capable of internalizing and consuming the rebiotics, e.g., B. longum subsp. infantis.

Claims (14)

1. A method of treatment, comprising:

administering a prebiotic mixture and at least one probiotic strain to treat or prevent graft versus host disease in a subject in need thereof, wherein:

the prebiotic mixture comprises a plurality of human milk oligosaccharides that comprise 2′-fucosyl-lactose, 3′-fucosyl-lactose, 3′-sialyl-lactose, 6′-sialyl-lactose, lacto-N-tetraose, lacto-N-difucohexaose I, lactodifucotetraose, lacto-N-fucopentaose I, sialylacto-N-tetraose c, sialylacto-N-tetraose b, and disialyllacto-N-tetraose; and

the least one probiotic strain comprises Bifidobacterium longum subsp. infantis.

2. The method of claim 1 , wherein the plurality of human milk oligosaccharides comprises at least 25 human milk oligosaccharides.

3. The method of claim 1 , wherein the plurality of human milk oligosaccharides comprises at least 50 human milk oligosaccharides.

4. The method of claim 1 , wherein the prebiotic mixture is, is comprises a concentrated permeate from pooled human milk, wherein the permeate is obtained from the ultrafiltration of human skim milk, wherein the human skim milk is obtained by removing cream from pooled human milk, and wherein the pooled human milk is pooled from the milk of multiple human milk donors.

5. The method of claim 1 , wherein the prebiotic mixture and the probiotic strain are administered orally.

6. The method of claim 1 , wherein the method comprises at least a first treatment phase and a second treatment phase, wherein the first treatment phase comprises administering to the subject the prebiotic mixture and the probiotic strain on the same day for at least one day, and wherein the second treatment phase begins after the end of the first treatment phase, and comprises administering the prebiotic mixture for at least one day, wherein the probiotic strain is not administered during the second treatment phase.

7. The method of claim 6 , wherein the first treatment phase is between 3 and 14 days in length and wherein the second treatment phase is between 3 and 14 days in length.

8. The method of claim 1 , wherein the probiotic strain is administered in an amount of at least 5×10 6 colony forming units (CFU) per day.

9. The method of claim 1 , wherein the prebiotic mixture is administered in an amount of at least 500 mg of total human milk oligosaccharides per day.

10. The method of claim 9 , wherein the prebiotic mixture is administered in an amount of between 0.5 g and 25 g, 1 g and 5 g, 2 g and 3 g, 3 g and 6 g, 4 g and 5 g, 5 g and 10 g, 8 g and 10 g, 10 g and 20 g, 15 g and 25 g, 15 g and 20 g, or 17 g and 19 g of total human milk oligosaccharides per day.

11. The method of claim 1 , wherein the subject is a human subject that is a child, an adolescent, or an adult.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Jun 5, 2026
From: HAYFIN SERVICES LLP, AS AGENT
To: PROLACTA BIOSCIENCE, INC.
Reel/Frame 074862/0454 →
SECURITY INTEREST Recorded Jun 5, 2026
From: PROLACTA BIOSCIENCE, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 074871/0441 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 11, 2024
From: COOK, DAVID N.; MCKENZIE, GREGORY; BUTTON, JULIE E.
To: PROLACTA BIOSCIENCE, INC.
Reel/Frame 066100/0222 →
SECURITY INTEREST Recorded Dec 21, 2023
From: PROLACTA BIOSCIENCE, INC.
To: HAYFIN SERVICES LLP, AS COLLATERAL AGENT
Reel/Frame 065935/0511 →
Continuity (5)
Provisional Application 63053224 · Jul 17, 2020
Provisional Application 63028743 · May 22, 2020
Provisional Application 63027739 · May 20, 2020
Provisional Application 62905256 · Sep 24, 2019
Related Publication 20230068960A1 · Mar 2, 2023
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