Granted Patent
B2
US 12,397,053 · App. 18/163,837 · Granted Aug 26, 2025
Engineered virus
Assignee:
Replimune Limited
A61K39/39558A61K35/763A61K39/3955A61K45/06A61P35/00C07K14/005C07K14/535C07K16/2818C12N7/00A61K2039/505C12N2710/16621C12N2710/16622C12N2710/16632C12N2710/16633C12N2710/16643C12N2740/13022
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Abstract
The present invention relates to oncolytic virus comprising: (i) a GM-CSF-encoding gene; and (ii) an immune co-stimulatory pathway activating molecule or an immune co-stimulatory pathway activating molecule-encoding gene.
Claims (34)
1. A method for treating injected and non-injected solid tumors in a subject in need thereof, the method comprising:
administering to the subject an effective amount of an oncolytic herpes virus comprising inserted in its genome (i) a heterologous gene encoding granulocyte-macrophage colony-stimulating factor (GM-CSF) and (ii) a heterologous gene encoding an anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody,
wherein the oncolytic virus is administered by intra-tumoral injection, wherein the administration induces the regression of injected and non-injected solid tumors, and wherein injected solid tumors are solid tumors into which the oncolytic virus is injected, and non-injected solid tumors are solid tumors which are not injected with the oncolytic virus.
2. The method of claim 1 , wherein the solid tumor is an adenocarcinoma, carcinoma, melanoma, or sarcoma.
3. The method of claim 1 , comprising administering multiple doses of 10 4 to 10 10 pfu of the oncolytic virus to the subject.
4. The method of claim 3 , wherein the multiple doses of the oncolytic virus are administered to the subject between 3 days to 3 weeks apart.
5. The method of claim 1 , wherein the method further comprises administering an anti-programmed cell death ligand 1 (PD1) antibody to the subject.
6. The method of claim 5 , comprising administering the oncolytic virus to the subject prior to administering the anti-PD1 antibody to the subject.
7. The method of claim 6 , comprising administering the oncolytic virus to the subject once prior to administering the anti-PD1 antibody to the subject.
8. The method of claim 6 , comprising administering the oncolytic virus multiple times to the subject prior to administering the anti-PD1 antibody to the subject.
9. The method of claim 5 , comprising administering the oncolytic virus and anti-PD1 antibody to the subject concurrently.
10. The method of claim 1 , wherein the herpes virus is HSV-1.
11. A method for inducing a systemic anti-tumor response to regress solid tumors in a subject in need thereof, the method comprising:
administering to the subject an effective amount of an oncolytic herpes virus comprising inserted in its genome (i) a heterologous gene encoding GM-CSF and (ii) a heterologous gene encoding an anti-CTLA-4 antibody wherein the oncolytic virus is administered by intra-tumoral injection, wherein the administration induces the systemic anti-tumor response in the subject such that injected and non-injected solid tumors are regressed, and wherein injected solid tumors are solid tumors into which the oncolytic virus is injected, and non-injected solid tumors are solid tumors which are not injected with the oncolytic virus.
12. The method of claim 11 , wherein the solid tumor is an adenocarcinoma, carcinoma, melanoma, or sarcoma.
13. The method of claim 11 , comprising administering multiple doses of 10 4 to 10 10 pfu of the oncolytic virus to the subject.
14. The method of claim 13 , wherein the multiple doses of the oncolytic virus are administered to the subject between 3 days to 3 weeks apart.
15. The method of claim 11 , wherein the method further comprises administering an anti-PD1 antibody to the subject.
16. The method of claim 15 , comprising administering the oncolytic virus to the subject prior to administering the anti-PD1 antibody to the subject.
17. The method of claim 16 , comprising administering the oncolytic virus to the subject once prior to administering the anti-PD1 antibody to the subject.
18. The method of claim 16 , comprising administering the oncolytic virus multiple times to the subject prior to administering the anti-PD1 antibody to the subject.
19. The method of claim 15 , comprising administering the oncolytic virus and anti-PD1 antibody to the subject concurrently.
20. The method of claim 11 , wherein the herpes virus is HSV-1.
21. A method for treating one or more solid tumors in a subject in need thereof, the method comprising:
administering to the subject an effective amount of an oncolytic herpes virus comprising inserted in its genome (i) a heterologous gene encoding GM-CSF and (ii) a heterologous gene encoding an anti-CTLA-4 antibody, wherein the oncolytic virus is administered by injection into a solid tumor, and wherein the administration induces regression of the solid tumors in the subject.
22. The method of claim 21 , wherein the solid tumor is an adenocarcinoma, carcinoma, melanoma, or sarcoma.
23. The method of claim 21 , comprising administering multiple doses of 10 4 to 10 10 pfu of the oncolytic virus to the subject.
24. The method of claim 23 , wherein the multiple doses of the oncolytic virus are administered to the subject between 3 days to 3 weeks apart.
25. The method of claim 21 , wherein the method further comprises administering an anti-PD1 antibody to the subject.
26. The method of claim 25 , comprising administering the oncolytic virus to the subject prior to administering the anti-PD1 antibody to the subject.
27. The method of claim 26 , comprising administering the oncolytic virus to the subject once prior to administering the anti-PD1 antibody to the subject.
28. The method of claim 26 , comprising administering the oncolytic virus multiple times to the subject prior to administering the anti-PD1 antibody to the subject.
29. The method of claim 25 , comprising administering the oncolytic virus and anti-PD1 antibody to the subject concurrently.
30. The method of claim 21 , wherein the herpes virus is HSV-1.
Assignments (2)
SECURITY INTEREST
Recorded Jan 30, 2026
From: REPLIMUNE GROUP, INC.; REPLIMUNE, INC.; REPLIMUNE LIMITED
To: HERCULES CAPITAL, INC.
Reel/Frame 073644/0641 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 3, 2023
From: COFFIN, ROBERT
To: REPLIMUNE LIMITED
Reel/Frame 062589/0924 →
Priority Claims (3)
GB 1600380
· Jan 8, 2016
· national
GB 1600381
· Jan 8, 2016
· national
GB 1600382
· Jan 8, 2016
· national
Continuity (3)
Continuation
16068830
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