IP Library › Granted Patent US 12,364,723
Granted Patent B2
US 12,364,723 · App. 17/417,893 · Granted Jul 22, 2025

Thermostable compositions comprising live attenuated herpes simplex virus type 1

Inventor: Enrique Alexander Flood (Simi Valley, CA)
Assignee: AMGEN INC.
A61K35/763A61K9/19A61K47/26A61K47/42C12N7/00C12N2710/16632
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Quick Facts
Patent No.
US 12,364,723
App. No.
17/417,893
Granted
Jul 22, 2025
Kind
B2
Abstract

Provided herein is a powder comprising a live, attenuated virus, recombinant human serum albumin (rHSA), a sugar other than lactose, a sugar alcohol, a source of phosphate, a source of chloride, wherein the composition is substantially free of lactose, gelatin, antibiotic, and free amino acids. In exemplary aspects, the powder is a lyophilizate of a liquid composition. Related liquid compositions, methods of preparing an oncolytic virus for administration and methods of treating melanoma are also provided herein.

Claims (40)

1. A liquid composition comprising:

a live, attenuated herpes simplex virus 1 (HSV-1);

17.5 mg/mL to 22.5 mg/mL recombinant human serum albumin (rHSA);

less than 5 mg/mL sucrose;

26 mg/mL to 32 mg/mL sorbitol;

13.5 mg/mL to 16 mg/mL potassium phosphate; and

3 mg/mL to 7 mg/mL sodium chloride,

wherein the composition is substantially free of lactose, gelatin, antibiotic, and free amino acids.

2. The liquid composition of claim 1 , comprising 20 mg/mL±2 mg/mL rHSA.

3. The liquid composition of claim 1 , comprising 3.8 mg/mL±0.38 mg/mL sucrose.

4. The liquid composition of claim 1 , comprising 29 mg/mL sorbitol.

5. The liquid composition of claim 1 , comprising 14.5 mg/mL potassium phosphate.

6. The liquid composition of claim 1 , comprising 5.7 mg/mL sodium chloride.

7. The liquid composition of claim 1 , wherein the pH of the liquid composition is 7.2 to 7.6.

8. The liquid composition of claim 7 , wherein the pH of the liquid composition is 7.4.

9. The liquid composition of claim 1 , wherein the osmolality of the liquid composition is less than 700 mOsm/kg.

10. The liquid composition of claim 9 , wherein the osmolality of the liquid composition is 525 mOsm/kg to 575 mOsm/kg.

11. The liquid composition of claim 1 , comprising not more than 0.01 mM of any of lactose, gelatin, antibiotic, and free amino acids.

12. The liquid composition of claim 1 , wherein the HSV-1 is JS1, strain 17+, strain F, or strain KOS.

13. The liquid composition of claim 1 , wherein the HSV-1 is talimogene laherparepvec, G207, OrienX010, NV1020, M032, ImmunoVEX or OncoVEX GALV/CD .

14. The liquid composition of claim 1 , wherein the HSV-1 comprises a functional deletion of both the ICP34.5 gene and the ICP47 gene.

15. The liquid composition of claim 13 , wherein the HSV-1 is talimogene laherparepvec.

16. The liquid composition of claim 1 , wherein the HSV-1 is RP-1, RP-2, or RP-3.

17. The liquid composition of claim 1 , wherein said liquid composition comprises;

talimogene laherparepvec,

20 mg/mL rHSA;

3.8 mg/mL sucrose;

29 mg/mL sorbitol;

14.5 mg/mL potassium phosphate; and

5.7 mg/mL sodium chloride,

wherein the pH of the liquid composition is 7.4.

18. The liquid composition of claim 1 , wherein upon lyophilization and reconstitution with water, the potency of the live, attenuated HSV-1 in the reconstituted product is at least 30% of the potency of the live, attenuated HSV-1 before the liquid composition is lyophilized.

19. A liquid composition consisting essentially of:

a live, attenuated HSV-1;

17.5 mg/mL to 22.5 mg/mL rHSA;

less than 5 mg/mL sucrose;

26 mg/mL to 32 mg/mL sorbitol;

13.5 mg/mL to 16 mg/mL potassium phosphate; and

3 mg/mL to 7 mg/mL sodium chloride.

20. The liquid composition of claim 19 , wherein the HSV-1 is talimogene laherparepvec.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 13, 2022
From: FLOOD, ENRIQUE ALEXANDER
To: AMGEN INC.
Reel/Frame 058996/0459 →
Continuity (2)
Provisional Application 62785307 · Dec 27, 2018
Related Publication 20220193161A1 · Jun 23, 2022
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