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New Genetically Modified Vaccinia Virus

Abstract: [Technical Problem] The present invention provides a genetically recombinant vaccinia virus effective in preventing or treating cancer. [Solution to Problem]   Specifically, the present invention provides a vaccinia virus comprising two polynucleotides, a polynucleotide encoding IL-7 and a polynucleotide encoding IL-12; a combination kit of two vaccinia viruses, a vaccinia virus comprising a polynucleotide encoding IL-7 and a vaccinia virus comprising a polynucleotide encoding IL-12; and use of the two vaccinia viruses in combination. [Figure 4]

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
24 December 2018
Publication Number
01/2019
Publication Type
INA
Invention Field
BIOTECHNOLOGY
Status
Email
patent@depenning.com
Parent Application
Patent Number
Legal Status
Grant Date
2023-10-31
Renewal Date

Applicants

ASTELLAS PHARMA INC.
5-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 1038411
NATIONAL UNIVERSITY CORPORATION TOTTORI UNIVERSITY
101, Koyamacho-Minami 4-chome, Tottori-shi, Tottori 6808550

Inventors

1. NAKAO Shinsuke
c/o Astellas Pharma Inc., 5-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 1038411
2. KAWASE Tatsuya
c/o Astellas Pharma Inc., 5-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 1038411
3. NAKAMURA Takafumi
c/o NATIONAL UNIVERSITY CORPORATION TOTTORI UNIVERSITY, 86, Nishi-cho, Yonago-shi, Tottori 6838503

Specification

1. A vaccinia virus comprising the following (1) and
(2) :
(1) a polynucleotide encoding interleukin-7 (IL-7); and
(2) a polynucleotide encoding interleukin-12 (IL-12).
2. A pharmaceutical composition selected from the
following (1) or (2):
(1) a pharmaceutical composition comprising a vaccinia virus comprising a polynucleotide encoding IL-12 to be used in combination with a pharmaceutical composition comprising a vaccinia virus comprising a polynucleotide encoding IL-7; or
(2) a pharmaceutical composition comprising a vaccinia virus comprising a polynucleotide encoding IL-7 to be used in combination with a pharmaceutical composition comprising a vaccinia virus comprising a polynucleotide encoding IL-12.
3. A combination kit comprising the following vaccinia
viruses (1) and (2):
(1) a vaccinia virus comprising a polynucleotide encoding IL-7; and
(2) a vaccinia virus comprising a polynucleotide encoding IL-12.

4. The vaccinia virus according to claim 1, wherein the vaccinia virus is deficient in the function of vaccinia virus growth factor (VGF).
5. The vaccinia virus according to claim 1, wherein the vaccinia virus is deficient in the function of OIL.
6. The vaccinia virus according to claim 1, wherein the vaccinia virus is deficient in the functions of VGF and OIL.
7. The vaccinia virus according to claim 1, wherein the vaccinia virus has a deletion in the short consensus repeat (SCR) domains in the B5R extracellular region.
8. The vaccinia virus according to claim 1, wherein the vaccinia virus is deficient in the functions of VGF and OIL and has a deletion in the SCR domains in the B5R extracellular region.
9. The vaccinia virus according to any one of claims 1 and 4-8, wherein the vaccinia virus is a LC16mO strain.
10. A pharmaceutical composition comprising a vaccinia virus according to any one of claims 1 and 4-9 and a pharmaceutically acceptable excipient.

11. The pharmaceutical composition according to claim 2 or the kit according to claim 3, wherein the vaccinia virus is deficient in the function of VGF.
12. The pharmaceutical composition according to claim 2 or the kit according to claim 3, wherein the vaccinia virus is deficient in the function of OIL.
13. The pharmaceutical composition according to claim 2 or the kit according to claim 3, wherein the vaccinia virus is deficient in the functions of VGF and OIL.
14. The pharmaceutical composition according to claim 2 or the kit according to claim 3, wherein the vaccinia virus has a deletion in the SCR domains in the B5R extracellular region.
15. The pharmaceutical composition according to claim 2 or the kit according to claim 3, wherein the vaccinia virus is deficient in the functions of VGF and OIL and has a deletion in the SCR domains in the B5R extracellular region.
16. The pharmaceutical composition according to any one of claims 2 and 11-15 or the kit according to any one of claims 3 and 11-15, wherein the vaccinia virus is a LC16mO strain.

17. The pharmaceutical composition according to any one of claims 2 and 11-16 or the kit according to any one of claims 3 and 11-16, further comprising a pharmaceutically acceptable excipient.
18. The pharmaceutical composition or kit according to any one of claims 10-17, for preventing or treating cancer.
19. The pharmaceutical composition or kit according to claim 18, wherein the cancer is malignant melanoma, lung adenocarcinoma, lung cancer, small cell lung cancer, lung squamous carcinoma, kidney cancer, bladder cancer, head and neck cancer, breast cancer, esophageal cancer, glioblastoma, neuroblastoma, myeloma, ovarian cancer, colorectal cancer, pancreatic cancer, prostate cancer, hepatocellular carcinoma, mesothelioma, cervical cancer or gastric cancer.
20. A method for preventing or treating cancer, comprising the step of administering the vaccinia virus according to any one of claims 1 and 4-9 to a subject in need of the prevention or treatment for cancer.
21. The method according to claim 20, wherein the cancer is malignant melanoma, lung adenocarcinoma, lung cancer,

small cell lung cancer, lung squamous carcinoma, kidney cancer, bladder cancer, head and neck cancer, breast cancer, esophageal cancer, glioblastoma, neuroblastoma, myeloma, ovarian cancer, colorectal cancer, pancreatic cancer, prostate cancer, hepatocellular carcinoma, mesothelioma, cervical cancer or gastric cancer.
22. The vaccinia virus according to any one of claims 1 and 4-9, for use in preventing or treating cancer.
23. The vaccinia virus according to claim 22, wherein the cancer is malignant melanoma, lung adenocarcinoma, lung cancer, small cell lung cancer, lung squamous carcinoma, kidney cancer, bladder cancer, head and neck cancer, breast cancer, esophageal cancer, glioblastoma, neuroblastoma, myeloma, ovarian cancer, colorectal cancer, pancreatic cancer, prostate cancer, hepatocellular carcinoma, mesothelioma, cervical cancer or gastric cancer.
24. Use of the vaccinia virus according to any one of claims 1 and 4-9 for the manufacture of a pharmaceutical composition for preventing or treating cancer.
25. The use according to claim 24, wherein the cancer is malignant melanoma, lung adenocarcinoma, lung cancer, small cell lung cancer, lung squamous carcinoma, kidney

cancer, bladder cancer, head and neck cancer, breast cancer, esophageal cancer, glioblastoma, neuroblastoma, myeloma, ovarian cancer, colorectal cancer, pancreatic cancer, prostate cancer, hepatocellular carcinoma, mesothelioma, cervical cancer or gastric cancer.
26. A method for preventing or treating cancer,
comprising the step of administering
(1) a vaccinia virus comprising a polynucleotide encoding IL-7; and
(2) a vaccinia virus comprising a polynucleotide encoding IL-12
to a subject in need of the prevention or treatment for cancer.
27. The method according to claim 26, wherein the cancer is malignant melanoma, lung adenocarcinoma, lung cancer, small cell lung cancer, lung squamous carcinoma, kidney cancer, bladder cancer, head and neck cancer, breast cancer, esophageal cancer, glioblastoma, neuroblastoma, myeloma, ovarian cancer, colorectal cancer, pancreatic cancer, prostate cancer, hepatocellular carcinoma, mesothelioma, cervical cancer or gastric cancer.
28. A vaccinia virus selected from the following (1) or (2) :

(1) a vaccinia virus comprising a polynucleotide encoding IL-7, for preventing or treating cancer in combination with a pharmaceutical composition comprising a vaccinia virus comprising a polynucleotide encoding IL-12; or
(2) a vaccinia virus comprising a polynucleotide encoding IL-12, for preventing or treating cancer in combination with a pharmaceutical composition comprising a vaccinia virus comprising a polynucleotide encoding IL-7.

29. The vaccinia virus according to claim 28, wherein the cancer is malignant melanoma, lung adenocarcinoma, lung cancer, small cell lung cancer, lung squamous carcinoma, kidney cancer, bladder cancer, head and neck cancer, breast cancer, esophageal cancer, glioblastoma, neuroblastoma, myeloma, ovarian cancer, colorectal cancer, pancreatic cancer, prostate cancer, hepatocellular carcinoma, mesothelioma, cervical cancer or gastric cancer.
30. Use of a vaccinia virus selected from the following (1) or (2) :
(1) use of a vaccinia virus comprising a polynucleotide encoding IL-7 for the manufacture of a pharmaceutical composition for preventing or treating cancer to be used in combination with a pharmaceutical composition comprising a vaccinia virus comprising a polynucleotide encoding IL-12; or

(2) use of a vaccinia virus comprising a polynucleotide encoding IL-12 for the manufacture of a pharmaceutical composition for preventing or treating cancer to be used in combination with a pharmaceutical composition comprising a vaccinia virus comprising a polynucleotide encoding IL-7.
31. The use according to claim 30, wherein the cancer is malignant melanoma, lung adenocarcinoma, lung cancer, small cell lung cancer, lung squamous carcinoma, kidney cancer, bladder cancer, head and neck cancer, breast cancer, esophageal cancer, glioblastoma, neuroblastoma, myeloma, ovarian cancer, colorectal cancer, pancreatic cancer, prostate cancer, hepatocellular carcinoma, mesothelioma, cervical cancer or gastric cancer.
32. Use of (1) a vaccinia virus comprising a polynucleotide encoding IL-7 and (2) a vaccinia virus comprising a polynucleotide encoding IL-12 for the manufacture of a combination kit for preventing or treating cancer.
33. The use according to claim 32, wherein the cancer is malignant melanoma, lung adenocarcinoma, lung cancer, small cell lung cancer, lung squamous carcinoma, kidney cancer, bladder cancer, head and neck cancer, breast cancer, esophageal cancer, glioblastoma, neuroblastoma,

myeloma, ovarian cancer, colorectal cancer, pancreatic cancer, prostate cancer, hepatocellular carcinoma, mesothelioma, cervical cancer or gastric cancer.

Documents

Application Documents

# Name Date
1 201847048823.pdf 2018-12-24
2 201847048823-TRANSLATIOIN OF PRIOIRTY DOCUMENTS ETC. [24-12-2018(online)].pdf 2018-12-24
3 201847048823-STATEMENT OF UNDERTAKING (FORM 3) [24-12-2018(online)].pdf 2018-12-24
4 201847048823-SEQUENCE LISTING(PDF) [24-12-2018(online)].pdf 2018-12-24
5 201847048823-SEQUENCE LISTING [24-12-2018(online)].txt 2018-12-24
6 201847048823-PROOF OF RIGHT [24-12-2018(online)].pdf 2018-12-24
7 201847048823-PRIORITY DOCUMENTS [24-12-2018(online)].pdf 2018-12-24
8 201847048823-POWER OF AUTHORITY [24-12-2018(online)].pdf 2018-12-24
9 201847048823-FORM 1 [24-12-2018(online)].pdf 2018-12-24
10 201847048823-DRAWINGS [24-12-2018(online)].pdf 2018-12-24
11 201847048823-DECLARATION OF INVENTORSHIP (FORM 5) [24-12-2018(online)].pdf 2018-12-24
12 201847048823-COMPLETE SPECIFICATION [24-12-2018(online)].pdf 2018-12-24
13 201847048823-CLAIMS UNDER RULE 1 (PROVISIO) OF RULE 20 [24-12-2018(online)].pdf 2018-12-24
14 abstract 201847048823.jpg 2018-12-27
15 Correspondence by Agent_Form 1_PA_02-01-2019.pdf 2019-01-02
16 201847048823-FORM 3 [20-05-2019(online)].pdf 2019-05-20
17 201847048823-FORM 18 [15-05-2020(online)].pdf 2020-05-15
18 201847048823-FER.pdf 2022-09-22
19 201847048823-OTHERS [10-03-2023(online)].pdf 2023-03-10
20 201847048823-FORM-26 [10-03-2023(online)].pdf 2023-03-10
21 201847048823-FER_SER_REPLY [10-03-2023(online)].pdf 2023-03-10
22 201847048823-COMPLETE SPECIFICATION [10-03-2023(online)].pdf 2023-03-10
23 201847048823-CLAIMS [10-03-2023(online)].pdf 2023-03-10
24 201847048823-US(14)-HearingNotice-(HearingDate-12-10-2023).pdf 2023-09-08
25 201847048823-Correspondence to notify the Controller [06-10-2023(online)].pdf 2023-10-06
26 201847048823-Written submissions and relevant documents [27-10-2023(online)].pdf 2023-10-27
27 201847048823-Retyped Pages under Rule 14(1) [27-10-2023(online)].pdf 2023-10-27
28 201847048823-2. Marked Copy under Rule 14(2) [27-10-2023(online)].pdf 2023-10-27
29 201847048823-PatentCertificate31-10-2023.pdf 2023-10-31
30 201847048823-IntimationOfGrant31-10-2023.pdf 2023-10-31

Search Strategy

1 SearchstrategyE_20-09-2022.pdf

ERegister / Renewals

3rd: 27 Dec 2023

From 29/05/2019 - To 29/05/2020

4th: 27 Dec 2023

From 29/05/2020 - To 29/05/2021

5th: 27 Dec 2023

From 29/05/2021 - To 29/05/2022

6th: 27 Dec 2023

From 29/05/2022 - To 29/05/2023

7th: 27 Dec 2023

From 29/05/2023 - To 29/05/2024

8th: 27 Dec 2023

From 29/05/2024 - To 29/05/2025