IP Library › Granted Patent US 10,813,989
Granted Patent B2
US 10,813,989 · App. 16/704,701 · Granted Oct 27, 2020

Patent

Inventors: Kathrin Ute Jansen (New York, NY); Annaliesa Sybil Anderson (Upper Saddle River, NJ); Judith Absalon (New York, NY); Jose Miguel Aste-Amezaga (Harleysville, PA); Johannes Frederik Beeslaar (Farnham, GB); David Cooper (Monroe, NY); John Erwin Farley (Chapel Hill, NC); Leah Diane Fletcher (Genesco, NY); Shannon Lea Harris (Nanuet, NY); Thomas Richard Jones (Bluffton, SC); Isis Kanevsky (New York, NY); Lakshmi Khandke (Nanuet, NY); Paul Liberator (Holmdel, NJ); John Lance Perez (Doylestown, PA); Lynn Marie Phelan (Lake Hiawatha, NJ); Gary Warren Zlotnick (San Antonio, TX)
Assignee: Pfizer Inc.
A61K39/095A61K31/7028A61K39/12A61K47/10A61K47/183A61K47/26A61K47/646A61K47/6415A61P31/00C07K14/22C07K16/1217A61K2039/545A61K2039/55A61K2039/55505A61K2039/6037A61K2039/70C12N2770/32434
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Quick Facts
Patent No.
US 10,813,989
App. No.
16/704,701
Granted
Oct 27, 2020
Kind
B2
Abstract

In one aspect, the invention relates to a composition including a factor H binding protein (fHBP) and a Neisseria meningitidis non-serogroup B capsular polysaccharide. The invention further relates to uses of a composition that includes fHBP, such as, for example, uses to elicit an immune response against N. meningitidis serogroup B strains and non-serogroup B strains. The compositions and methods described herein are directed to administration in humans, including adults, adolescents, toddlers, and infants.

Claims (19)

1. A kit comprising (a) a first composition comprising aluminum, a lipidated MenB rLP2086 subfamily A polypeptide set forth as SEQ ID NO: 1 and a lipidated MenB rLP2086 subfamily B polypeptide set forth as SEQ ID NO: 2; and (b) a second composition comprising a Neisseria meningitidis serogroup A (MenA) capsular saccharide conjugated to tetanus toxoid carrier protein (TT); a Neisseria meningitidis serogroup C (MenC) capsular saccharide conjugated to tetanus toxoid carrier protein (TT); a Neisseria meningitidis serogroup W135 (MenW) capsular saccharide conjugated to tetanus toxoid carrier protein (TT); and a Neisseria meningitidis serogroup Y (MenY) capsular saccharide conjugated to tetanus toxoid carrier protein (TT).

2. The kit according to claim 1 , wherein the first composition is a liquid composition.

3. The kit according to claim 1 , wherein the second composition is a lyophilized composition.

4. The kit according to claim 3 , wherein the lyophilized composition does not comprise polysorbate 80.

5. The kit according to claim 1 , wherein the Neisseria meningitidis serogroup A (MenA) capsular saccharide is conjugated to an adipic acid dihydrazide (ADH) linker by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry, and wherein the linker is conjugated to tetanus toxoid carrier protein (TT) by carbodiimide chemistry (MenA AH -TT conjugate).

6. The kit according to claim 1 , wherein the Neisseria meningitidis serogroup C (MenC) capsular saccharide is conjugated to an ADH linker by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry, wherein the linker is conjugated to tetanus toxoid carrier protein (TT) by carbodiimide chemistry (MenC AH -TT conjugate).

7. The kit according to claim 1 , wherein the Neisseria meningitidis serogroup W 135 (MenW) capsular saccharide directly conjugated to tetanus toxoid carrier protein (TT) by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry, in the absence of a linker (MenW-TT conjugate).

8. The kit according to claim 1 , wherein the Neisseria meningitidis serogroup Y (MenY) capsular saccharide directly conjugated to tetanus toxoid carrier protein (TT) by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry, in the absence of a linker (MenY-TT conjugate).

9. The kit according to claim 1 , wherein the first composition further comprises sodium chloride.

10. The kit according to claim 1 , wherein the first composition further comprises L-Histidine.

11. The kit according to claim 1 , wherein the first composition further comprises polysorbate 80.

12. The kit according to claim 11 , wherein the molar ratio of the polysorbate-80 to rLP2086 polypeptide is between 1.4 to 4.2.

13. The kit according to claim 1 , wherein the first composition comprises aluminum phosphate.

14. The kit according to claim 1 , wherein the first composition does not further comprise Tris-HCl.

15. The kit according to claim 1 , wherein the first composition does not further comprise sucrose.

16. The kit according to claim 1 , wherein the second composition further comprises sodium chloride.

17. The kit according to claim 1 , wherein the second composition does not comprise polysorbate-80.

18. The kit according to claim 1 , wherein the second composition comprises at least 0.010 mg polysorbate-80 and at most 0.018 mg polysorbate-80.

19. The kit according to claim 1 , wherein the second composition comprises at least 0.010 mg polysorbate-80 and at most 0.02 mg polysorbate-80.

Assignments (1)
ASSIGNEE ADDRESS CORRECTION Recorded Mar 20, 2023
From: PFIZER INC.
To: PFIZER INC.
Reel/Frame 063119/0087 →
Cited By (1)
US 12,497,432