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Tolerogenic Dna Vaccine

Abstract: The present invention relates to plasmids encoding insulin antigens and cytokines for use in tolerizing immunization in particular for the prevention and/or delay of e.g. type 1 diabetes.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
15 May 2019
Publication Number
21/2019
Publication Type
INA
Invention Field
PHARMACEUTICALS
Status
Email
hipq@novonordisk.com
Parent Application
Patent Number
Legal Status
Grant Date
2022-04-25
Renewal Date

Applicants

NOVO NORDISK A/S
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd

Inventors

1. CHAPLIN, Jay
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd
2. WIJARANAKULA, Michael
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd

Specification

1. A plasmid which encodes:
i. an insulin antigen; ii. TGF-3; and iii. IL-10.
2. The plasmid according to claim 1, wherein said insulin antigen is selected from the group consisting of: proinsulin, pre-proinsulin, and a functional or immuno-dominant peptide fragment thereof.
3. The plasmid according to any one of the preceding claims, wherein said insulin antigen is endosomally targeted insulin.
4. The plasmid according to any one of the preceding claims, wherein said plasmid expresses insulin antigen and TGF-3 in an amount of at least 2 fold lower than IL-10.
5. The plasmid according to any one of the preceding claims, wherein said plasmid furthermore co-expresses lnterleukin-2 (IL-2).
6. The plasmid according to any one of the preceding claims, wherein said plasmid comprises: (i) an FMDV 2A element separating the insulin antigen encoding sequence and the TGF-3 encoding sequence, (ii) an EMCV IRES element separating the TGF-3 encoding sequence and the IL-10 encoding sequence, and (iii) a 2A element separating the IL-10 encoding sequence and the IL-2 encoding sequence.
7. The plasmid according to any one of the preceding claims, wherein the TGF-3 encoding sequence encodes constitutively active TGF-3-
8. The plasmid according to any one of the preceding claims, wherein said plasmid comprises: (i) an endosomally targeted pre-pro-insulin encoding sequence, (ii) an FMDV 2A element, (iii) a TGF-3 encoding sequence, (iv) an EMCV IRES element, (v) an IL-10 encoding sequence, (vi) a P 2A element, (vii) an IL-2 encoding sequence, (viii) a polyadenylation / termination element, (ix) a selection gene, (x) an origin of

replication, (xi) a eukaryotic promoter element, (xii) a eukaryotic translational start sequence, (xiii) an endosomal sorting sequence, and (xiv) optionally an intron.
9. A DNA immuno-therapy vaccine comprising a plasmid according to any one of the preceding claims.
10. The DNA immuno-therapy vaccine according to claim 9, or a plasmid according to any one of claims 1-8, for use in delaying or preventing type I diabetes.
11. The DNA immuno-therapy vaccine according to claim 9, or a plasmid according to any one of claims 1-8, for subcutaneous administration.
12. The DNA immuno-therapy vaccine according to claim 9, or a plasmid according to any one of claims 1-8, for intra-muscular administration.
13. A pharmaceutical composition comprising the DNA immuno-therapy vaccine according to claim 9, or a plasmid according to any one of claims 1-8, wherein said pharmaceutical composition comprises a saline solution and/or a buffer and/or a chelator.
14. The pharmaceutical composition according to claim 13, wherein said buffer does not comprise any virus, lipid co-packing agent, or condensation agent.
15. The pharmaceutical composition according to any one of claims 13-14, wherein said composition furthermore comprises a GLP-1R agonist.

Documents

Application Documents

# Name Date
1 201947019298.pdf 2019-05-15
2 201947019298-STATEMENT OF UNDERTAKING (FORM 3) [15-05-2019(online)].pdf 2019-05-15
3 201947019298-SEQUENCE LISTING(PDF) [15-05-2019(online)].pdf 2019-05-15
4 201947019298-SEQUENCE LISTING [15-05-2019(online)].txt 2019-05-15
5 201947019298-PRIORITY DOCUMENTS [15-05-2019(online)].pdf 2019-05-15
6 201947019298-POWER OF AUTHORITY [15-05-2019(online)].pdf 2019-05-15
7 201947019298-FORM 18 [15-05-2019(online)].pdf 2019-05-15
8 201947019298-FORM 1 [15-05-2019(online)].pdf 2019-05-15
9 201947019298-FIGURE OF ABSTRACT [15-05-2019(online)].jpg 2019-05-15
10 201947019298-DRAWINGS [15-05-2019(online)].pdf 2019-05-15
11 201947019298-DECLARATION OF INVENTORSHIP (FORM 5) [15-05-2019(online)].pdf 2019-05-15
12 201947019298-COMPLETE SPECIFICATION [15-05-2019(online)].pdf 2019-05-15
13 Correspondence by Agent_Form-5, POA, PCT AND SEQUENCE LISTING(CD)_20-05-2019.pdf 2019-05-20
14 201947019298-Proof of Right (MANDATORY) [06-11-2019(online)].pdf 2019-11-06
15 201947019298-FORM 3 [06-11-2019(online)].pdf 2019-11-06
16 201947019298-FORM-26 [18-12-2019(online)].pdf 2019-12-18
17 201947019298-FORM 3 [27-04-2020(online)].pdf 2020-04-27
18 201947019298-FORM 3 [20-10-2020(online)].pdf 2020-10-20
19 201947019298-FORM 3 [19-04-2021(online)].pdf 2021-04-19
20 201947019298-Information under section 8(2) [05-10-2021(online)].pdf 2021-10-05
21 201947019298-FORM 3 [05-10-2021(online)].pdf 2021-10-05
22 201947019298-FER.pdf 2021-10-18
23 201947019298-FER_SER_REPLY [20-12-2021(online)].pdf 2021-12-20
24 201947019298-DRAWING [20-12-2021(online)].pdf 2021-12-20
25 201947019298-COMPLETE SPECIFICATION [20-12-2021(online)].pdf 2021-12-20
26 201947019298-CLAIMS [20-12-2021(online)].pdf 2021-12-20
27 201947019298-US(14)-HearingNotice-(HearingDate-03-03-2022).pdf 2022-01-30
28 201947019298-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [24-02-2022(online)].pdf 2022-02-24
29 201947019298-US(14)-ExtendedHearingNotice-(HearingDate-04-04-2022).pdf 2022-03-14
30 201947019298-Correspondence to notify the Controller [28-03-2022(online)].pdf 2022-03-28
31 201947019298-Information under section 8(2) [31-03-2022(online)].pdf 2022-03-31
32 201947019298-FORM 3 [31-03-2022(online)].pdf 2022-03-31
33 201947019298-Written submissions and relevant documents [13-04-2022(online)].pdf 2022-04-13
34 201947019298-Annexure [13-04-2022(online)].pdf 2022-04-13
35 201947019298-PatentCertificate25-04-2022.pdf 2022-04-25
36 201947019298-IntimationOfGrant25-04-2022.pdf 2022-04-25
37 201947019298-PROOF OF ALTERATION [21-12-2022(online)].pdf 2022-12-21
38 201947019298-FORM-26 [12-01-2023(online)].pdf 2023-01-12
39 201947019298-RELEVANT DOCUMENTS [11-09-2023(online)].pdf 2023-09-11
40 201947019298-FORM-26 [28-12-2023(online)].pdf 2023-12-28

Search Strategy

1 2021-06-2308-19-31E_23-06-2021.pdf

ERegister / Renewals

3rd: 07 Jun 2022

From 01/11/2019 - To 01/11/2020

4th: 07 Jun 2022

From 01/11/2020 - To 01/11/2021

5th: 07 Jun 2022

From 01/11/2021 - To 01/11/2022

6th: 29 Oct 2022

From 01/11/2022 - To 01/11/2023

7th: 31 Oct 2023

From 01/11/2023 - To 01/11/2024

8th: 28 Oct 2024

From 01/11/2024 - To 01/11/2025

9th: 25 Oct 2025

From 01/11/2025 - To 01/11/2026