IP Library › Granted Patent US 12,594,295
Granted Patent B2
US 12,594,295 · App. 18/049,210 · Granted Apr 7, 2026

CFTR mRNA compositions and related methods and uses

Inventors: Michael Heartlein (Waltham, MA); Braydon Charles Guild (Concord, MA); Frank DeRosa (Waltham, MA); Carsten Rudolph (Planegg, DE); Christian Plank (Planegg, DE); Lianne Smith (Waltham, MA)
Assignees: TRANSLATE BIO, INC.; ETHRIS GMBH
A61K31/713A61K9/0073A61K9/0078A61K9/1271A61K9/5123A61K31/7105A61K31/7115A61K47/6935A61K48/005C07K14/705C12N9/14A61K9/127A61K48/00C07H21/02C07H21/04C07K14/4712C12N15/63C12N15/88C12Y306/03049
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Quick Facts
Patent No.
US 12,594,295
App. No.
18/049,210
Granted
Apr 7, 2026
Kind
B2
Abstract

Materials, formulations, production methods, and methods for delivery of CFTR mRNA for induction of CFTR expression, including in the mammalian lung are provided. The present invention is particularly useful for treating cystic fibrosis.

Claims (21)

1 . A pharmaceutical composition comprising an mRNA-loaded nanoparticle,

wherein the mRNA is an in vitro transcribed mRNA, wherein the coding sequence of the mRNA is at least 95% identical to SEQ ID NO: 9, and

wherein the mRNA encodes a human cystic fibrosis transmembrane conductance regulator (CFTR) protein comprising the amino acid sequence of SEQ ID NO: 1.

2 . The pharmaceutical composition of claim 1 , wherein the coding sequence of the mRNA is at least 98% identical to SEQ ID NO: 9.

3 . The pharmaceutical composition of claim 1 , wherein the coding sequence of the mRNA is set forth by SEQ ID NO: 9.

4 . The pharmaceutical composition of claim 1 , wherein the mRNA comprises a 5′ untranslated region (UTR) and/or a 3′ UTR.

5 . The pharmaceutical composition of claim 4 , wherein the 5′-UTR comprises SEQ ID NO: 4 and/or the 3′-UTR comprises SEQ ID NO: 5.

6 . The pharmaceutical composition of claim 4 , wherein the mRNA further comprises a poly-A tail.

7 . The pharmaceutical composition of claim 4 , wherein the mRNA further comprises a 5′ cap.

8 . The pharmaceutical composition of claim 1 , wherein the mRNA comprises at least one nonstandard nucleobase.

9 . The pharmaceutical composition of claim 8 , wherein the nonstandard nucleobase is chosen from one or more of 5-methyl-cytidine, pseudouridine, and 2-thio-uridine.

10 . The pharmaceutical composition of claim 1 , wherein the composition is formulated to be administered to the lung by aerosolization.

11 . The pharmaceutical composition of claim 10 , wherein the composition is formulated to be administered to the lung by nebulization.

12 . The pharmaceutical composition of claim 1 , wherein the composition further comprises a pharmaceutically acceptable carrier.

13 . The pharmaceutical composition of claim 1 , wherein the nanoparticle comprises one or more organic cations.

14 . The pharmaceutical composition of claim 13 , wherein the one or more organic cations are selected from the group consisting of polyethyleneimine (PEI), protamine, PEGylated protamine, poly-L-lysine (PLL), PEGylated PLL, a cationic lipid and combinations thereof.

15 . The pharmaceutical composition of claim 1 , wherein the nanoparticle comprises a polymer.

16 . The pharmaceutical composition of claim 15 , wherein the polymer comprises branched PEI with a molecular weight ranging from 10 kDa to 40 kDa.

17 . The pharmaceutical composition of claim 1 , wherein the nanoparticle is a liposome.

18 . A method of inducing CFTR expression in epithelial cells in a lung of a mammal, wherein the method comprises contacting the epithelial cells in the lung of the mammal with the composition of claim 1 .

19 . A nebulization or aerosolization apparatus comprising the pharmaceutical composition of claim 1 .

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 11, 2026
From: HEARTLEIN, MICHAEL; GUILD, BRAYDON CHARLES; DEROSA, FRANK; SMITH, LIANNE
To: SHIRE HUMAN GENETIC THERAPIES, INC.
Reel/Frame 074043/0423 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 11, 2026
From: RUDOLPH, CARSTEN; PLANK, CHRISTIAN
To: ETHRIS GMBH
Reel/Frame 074043/0919 →
Continuity (7)
Division 16540960 · Aug 14, 2019
Division 15625648 · Jun 16, 2017
Division 14876071 · Oct 6, 2015
Division 14307322 · Jun 17, 2014
Continuation PCTUS2014028849 · Mar 14, 2014
Provisional Application 61783663 · Mar 14, 2013
Related Publication 20230302039A1 · Sep 28, 2023
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