IP Library › Granted Patent US 12,403,203
Granted Patent B2
US 12,403,203 · App. 18/911,506 · Granted Sep 2, 2025

Muscle targeting complexes and uses thereof for treating dystrophinopathies

Inventors: Romesh R. Subramanian (Framingham, MA); Mohammed T. Qatanani (Waltham, MA); Timothy Weeden (Waltham, MA); Cody A. Desjardins (Waltham, MA); Brendan Quinn (Waltham, MA); John Najim (Waltham, MA)
Assignee: Dyne Therapeutics, Inc.
A61K47/6849A61K47/6807A61K47/6889A61P21/00
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Quick Facts
Patent No.
US 12,403,203
App. No.
18/911,506
Filed
Oct 10, 2024
Granted
Sep 2, 2025
Kind
B2
Art Unit
1643
USPC
424/181.1
Abstract

Aspects of the disclosure relate to complexes comprising a muscle-targeting agent covalently linked to a molecular payload. In some embodiments, the muscle-targeting agent specifically binds to an internalizing cell surface receptor on muscle cells. In some embodiments, the molecular payload promotes the expression or activity of a functional dystrophin protein. In some embodiments, the molecular payload is an oligonucleotide, such as an antisense oligonucleotide, e.g., an oligonucleotide that causes exon skipping in a mRNA expressed from a mutant DMD allele.

Claims (21)

1. A composition comprising complexes comprising an anti-transferrin receptor (TfR) antibody covalently linked to at least one oligonucleotide, wherein the antibody is a Fab and comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 101 and a light chain comprising the amino acid sequence of SEQ ID NO: 90, and wherein each anti-TfR antibody of the complexes is on average covalently linked to 1 to 3 oligonucleotides, and wherein the oligonucleotide induces dystrophin exon 55 skipping, wherein the complexes of the composition comprise a structure of:

wherein n is 3 and m is 4, wherein L1 comprises a spacer that is a substituted or unsubstituted aliphatic, substituted or unsubstituted heteroaliphatic, substituted or unsubstituted carbocyclylene, substituted or unsubstituted heterocyclylene, substituted or unsubstituted arylene, substituted or unsubstituted heteroarylene, —O—, —N(R A )—, —S—, —C(═O)—, —C(═O)O—, —C(═O) NR A —, —NR A C(═O)—, —NR A C(═O)R A —, —C(═O)R A —, —NR A C(═O)O—, —NR A C(═O)N(R A )—, —OC(═O)—, —OC(═O)O—, —OC(═O)N(R A )—, —S(O) 2 NR A —, —NR A S(O) 2 —, or a combination thereof, wherein each R A is independently hydrogen or substituted or unsubstituted alkyl.

2. The composition of claim 1 , wherein the heavy chain of the antibody comprises an N-terminal pyroglutamate.

3. The composition of claim 1 , wherein the equilibrium dissociation constant (K D ) of binding of the antibody to the transferrin receptor is in a range from 10 −11 M to 10 −6 M.

4. The composition of claim 1 , wherein the oligonucleotide is 15-35 nucleotides in length.

5. The composition of claim 1 , wherein the oligonucleotide comprises a region of complementarity to a dystrophin RNA, wherein the region of complementarity is 12-35 nucleotides in length.

6. The composition of claim 1 , wherein the oligonucleotide comprises a region of complementarity to the target sequence of an oligonucleotide as set forth in any one of SEQ ID NOs: 131, 307, and 398-401, wherein the region of complementarity is 12-35 nucleotides in length.

7. The composition of claim 1 , wherein the oligonucleotide comprises the nucleotide sequence of any one of SEQ ID NOs: 131, 307, and 398-401, wherein any one or more of the thymine bases (T's) in the oligonucleotide may optionally be a uracil base (U), and wherein any one or more of the uracil bases (U's) in the oligonucleotide may optionally be a thymine base (T).

8. The composition of claim 1 , wherein the oligonucleotide comprises one or more modified nucleosides.

9. The composition of claim 1 , wherein the oligonucleotide is a phosphorodiamidate morpholino oligomer.

10. The composition of claim 1 , wherein L1 comprises a structure of:

wherein the piperazine moiety links to the oligonucleotide, wherein L2 comprises

11. The composition of claim 10 , wherein L2 comprises

12. A method of inducing dystrophin exon 55 skipping in muscle cells of a subject, the method comprising administering to the subject the composition of claim 1 .

13. The method of claim 12 , wherein the subject is human.

14. The method of claim 12 , wherein the subject is a cynomolgus.

15. The method of claim 12 , wherein the subject expresses a dystrophin pre-mRNA comprising a frameshift mutation.

16. The method of claim 12 , wherein the complex is intravenously administered to the subject.

17. The method of claim 12 , wherein the subject is amenable to dystrophin exon 55 skipping.

18. The method of claim 12 , wherein the subject has Duchenne muscular dystrophy.

19. The method of claim 12 , wherein the heavy chain of the antibody comprises an N-terminal pyroglutamate.

Assignments (2)
SECURITY INTEREST Recorded Jun 27, 2025
From: DYNE THERAPEUTICS, INC.
To: HERCULES CAPITAL, INC., AS AGENT
Reel/Frame 071777/0300 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 23, 2024
From: SUBRAMANIAN, ROMESH R.; QATANANI, MOHAMMED T.; WEEDEN, TIMOTHY; DESJARDINS, CODY A.; NAJIM, JOHN; QUINN, BRENDAN
To: DYNE THERAPEUTICS, INC.
Reel/Frame 069227/0650 →
Continuity (7)
Continuation 18592729 · Mar 1, 2024
Continuation 18349631 · Jul 10, 2023
Continuation 18592695 · Mar 1, 2024
Continuation 18349631 · Jul 10, 2023
Continuation 17811370 · Jul 8, 2022
Provisional Application 63220262 · Jul 9, 2021
Related Publication 20250032634A1 · Jan 30, 2025
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