IP Library Granted Patent US 10,907,138
Granted Patent B2
US 10,907,138 · App. 16/811,484 · Granted Feb 2, 2021

TATk-CDKL5 fusion proteins, compositions, formulations, and use thereof

Inventors: Elisabetta Ciani (Bologna, IT); Franco Laccone (Stockerau, AT)
Assignee: Alma Mater Studiorum—Università di Bologna
C12N9/12C07K14/4737C07K14/4738C12N9/1205A61K38/00C07K2319/01C07K2319/10C07K2319/21C07K2319/41C07K2319/60C12N2501/405C12Y207/11022
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Quick Facts
Patent No.
US 10,907,138
App. No.
16/811,484
Granted
Feb 2, 2021
Kind
B2
Abstract

Disclosed herein are compositions and formulations containing a TATk-CDKL5 fusion protein. Also disclosed are methods of producing a TATk-CDKL5 fusion protein from vectors containing a TATk-CDKL5 cDNA and methods of transducing cells with the vectors containing a TATk-CDKL5 cDNA and the TATk-CDKL5 fusion protein.

Claims (18)

1. A recombinant nucleic acid comprising:

a CDKL5 nucleic acid sequence, wherein the CDKL5 nucleic acid sequence encodes a CDKL5 polypeptide sequence, wherein the CDKL5 polypeptide sequence comprises SEQ ID NO: 2 or SEQ ID NO: 16; and

a TATk nucleic acid sequence, wherein the TATk nucleic acid sequence encodes a TATk polypeptide sequence, wherein the TATk polypeptide sequence has 90% to 100% sequence identity to SEQ ID NO: 4 and wherein the TATk nucleic acid sequence is operatively coupled to the CDKL5 nucleic acid sequence and/or the TATk polypeptide sequence is operatively coupled to the CDKL5 polypeptide sequence.

2. The recombinant nucleic acid of claim 1 , wherein the CDKL5 nucleic acid has 90% to 100% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 15.

3. The recombinant nucleic acid of claim 1 , wherein the TATk nucleic acid sequence has 90% to 100% sequence identity to SEQ ID NO: 3.

4. The recombinant nucleic acid of claim 1 , wherein the nucleic acid encodes a fusion protein that increases neurite growth, elongation, branch number, or branch density in the brain of a subject as compared to a control.

5. The recombinant nucleic acid of claim 1 , wherein the nucleic acid encodes a fusion protein that reduces neuron apoptosis in the brain of a subject as compared to a control.

6. The recombinant nucleic acid of claim 1 , wherein the recombinant nucleic acid further comprises a nucleic acid sequence encoding a protein tag, wherein the nucleic acid sequence encoding the protein tag is operatively coupled to the CDKL5 nucleic acid sequence.

7. The recombinant nucleic acid of claim 6 , wherein the protein tag is selected from the group consisting of: chitin binding protein (CBP), maltose binding protein (MBP), glutathione-S-transferase (GST), poly(His), thioredoxin (TRX), poly(NANP), a FLAG-tag, V5-tag, Myc-tag, HA-tag, S-tag, SBP-Tag, Sftag 1, Softag 3, Tc tag, Xpress tag, Strep-tag, Isopeptag, Spy Tag, Ty tag, Biotin Carboxyl Carrier Protein (BCCP), and Nus tag.

8. The recombinant nucleic acid of claim 1 , wherein the recombinant nucleic acid further comprises a nucleic acid sequence encoding a reporter protein, wherein the nucleic acid sequence encoding the reporter protein is operatively coupled to the CDKL5 nucleic acid sequence.

9. The recombinant nucleic acid of claim 8 , wherein the reporter protein is selected from the group consisting of: a fluorescent protein, beta-galactosidase, a luciferase protein, an antibiotic-resistance protein, p-glucuronidase, and alkaline phosphatase.

10. A vector comprising the recombinant nucleic acid of claim 1 .

11. The vector of claim 10 , wherein the vector is suitable for expression in a bacterial cell.

12. The vector of claim 10 , wherein the vector is suitable for expression in a mammalian cell.

13. A method comprising transfecting cells with the recombinant nucleic acid of claim 1 .

14. The method of claim 13 , wherein the recombinant nucleic acid is contained in a vector.

15. The method of claim 13 , wherein the cells comprise bacterial cells.

16. The method of claim 13 , wherein the cells comprise mammalian cells.

Assignments (2)
RELEASE OF SECURITY INTEREST Recorded Apr 27, 2026
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: AMICUS THERAPEUTICS, INC.
Reel/Frame 075494/0030 →
SECURITY INTEREST Recorded Oct 6, 2023
From: AMICUS THERAPEUTICS, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 065177/0196 →