IP Library Granted Patent US 12698511
Granted Patent B2
US 12698511 · App. 18/000,612 · Granted Aug 4, 2026

Codon-optimized nucleic acid encoding SMN1 protein

Inventors: Dmitriy Aleksandrovich Madera (Moscow, RU); Pavel Mikhailovich Gershovich (Saint Petersburg, RU); Anna Sergeevna Veselova (Saint Petersburg, RU); Tatiana Evgenievna Shugaeva (Moscow, RU); Maria Andreevna Lomunova (Saint Petersburg, RU); Margarita Aleksandrovna Shkliaeva (Saint Petersburg, RU); Dmitry Valentinovich Morozov (Saint Petersburg, RU)
Assignee: JOINT STOCK COMPANY “BIOCAD”
C12N15/86C07K14/47C12N2750/14122C12N2750/14143C12N2800/22
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Quick Facts
Patent No.
US 12698511
App. No.
18/000,612
Granted
Aug 4, 2026
Kind
B2
Abstract

The present application relates to the fields of genetics, gene therapy, and molecular biology. More specifically, the present invention relates to an isolated codon-optimized nucleic acid that encodes the SMN1 protein (survival motor neuron protein), an expression cassette and a vector based thereon, as well as an AAV9 (adeno-associated virus serotype 9)-based recombinant virus for increasing the expression of the SMN1 gene in target cells, and use thereof.

Claims (26)

1 . A codon-optimized nucleic acid that encodes a SMN1 protein (survival motor neuron protein), the SMN1 protein comprising the amino acid sequence of SEQ ID NO: 1, the nucleic acid including the nucleic acid sequence of SEQ ID NO: 2.

2 . An expression cassette that includes the codon-optimized nucleic acid of claim 1 , including the following elements in the 5′-end to 3′-end direction:

a left (first) ITR (inverted terminal repeats);

a CMV (cytomeqalovirus) enhancer;

a CMV (cytomeqalovirus) promoter;

an intron of the hBG1 gene (hemoglobin subunit gamma 1 gene);

the codon-optimized nucleic acid including the nucleic acid sequence of SEQ ID NO: 2;

an hGH1 polyadenylation signal (human growth hormone gene polyadenylation signal); and

a right (second) ITR.

3 . The expression cassette of claim 2 that includes a nucleic acid comprising the nucleic acid sequence of SEQ ID NO: 4.

4 . An expression vector that includes the codon-optimized nucleic acid of claim 1 .

5 . An AAV9 (adeno-associated virus serotype 9)-based recombinant virus for increasing the expression of the SMN1 gene in target cells, the AAV9-based recombinant virus including a capsid and the expression cassette of claim 2 .

6 . The AAV9-based recombinant virus of claim 5 , wherein the capsid comprises the AAV9 protein VP1.

7 . The AAV9-based recombinant virus of claim 6 , wherein the capsid comprises the AAV9 protein VP1 having the amino acid sequence of SEQ ID NO: 5.

8 . The AAV9-based recombinant virus of claim 6 , wherein the capsid comprises the AAV9 protein VP1 having the amino acid sequence of SEQ ID NO: 5 with one or more point mutations.

9 . The AAV9-based recombinant virus of claim 5 , wherein the capsid comprises the AAV9 protein VP1 having the amino acid sequence of SEQ ID NO: 5 or the amino acid sequence of SEQ ID NO: 5 with one or more point mutations, and wherein the expression cassette includes the following elements in the 5′-end to 3′-end direction:

a CMV enhancer;

a CMV promoter;

an intron of the hBG1 gene;

the codon-optimized nucleic acid including the nucleic acid sequence of SEQ ID NO: 2;

an hGH1 polyadenylation signal; and

a right ITR.

10 . The AAV9-based recombinant virus of claim 5 , wherein the capsid includes the AAV9 protein VP1 having the amino acid sequence of SEQ ID NO: 5 or the amino acid sequence of SEQ ID NO: 5 with one or more point mutations, and wherein the expression cassette includes a nucleic acid with SEQ ID NO: 4.

11 . A pharmaceutical composition for delivering the SMN1 gene to target cells, including the AAV9-based recombinant virus of claim 5 , in combination with one or more pharmaceutically acceptable excipients.

12 . A method for delivering the SMN1 gene to one or more target cells comprising introducing the AAV9-based recombinant virus of claim 5 into the one or more target cells.

13 . A method for delivering the SMN1 gene to one or more target cells comprising introducing the composition of claim 11 into the one or more target cells.