IP Library › Granted Patent US 12,208,165
Granted Patent B2
US 12,208,165 · App. 17/811,808 · Granted Jan 28, 2025

Dry powder composition comprising long-chain RNA

Inventors: Fabian Johannes Eber (Stuttgart, DE); Benyamin Yazdan Panah (Tübingen, DE); Stefanie Sewing (Tübingen, DE); Thomas Ketterer (Gomaringen, DE); Thorsten Mutzke (Reutlingen, DE); Tilmann Roos (Kusterdingen, DE); Michael Sonntag (Tübingen, DE); Michael Wiggenhorn (Munich, DE); Katharina Kolland (Augsburg, DE)
Assignee: CureVac SE
A61K9/16A61K9/1682A61K39/145A61K48/005A61K48/0091A61P31/00A61P31/04A61P31/12A61P33/02A61P35/00A61P37/06A61P37/08A61K2039/53A61K48/00
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Quick Facts
Patent No.
US 12,208,165
App. No.
17/811,808
Granted
Jan 28, 2025
Kind
B2
Abstract

The present invention is directed to a storage-stable formulation of long-chain RNA. In particular, the invention concerns a dry powder composition comprising a long-chain RNA molecule. The present invention is furthermore directed to methods for preparing a dry powder composition comprising a long-chain RNA molecule by spray-drying. The invention further concerns the use of such a dry powder composition comprising a long-chain RNA molecule in the preparation of pharmaceutical compositions and vaccines, to a method of treating or preventing a disorder or a disease, to first and second medical uses of such a dry powder composition comprising a long-chain RNA molecule and to kits, particularly to kits of parts, comprising such a dry powder composition comprising a long-chain RNA molecule.

Claims (18)

1. A dry powder composition comprising a long-chain RNA molecule that is 500 to 20,000 nucleotides in length and is formulated with a cationic or polycationic compound, wherein the long-chain RNA molecule comprises at least one open reading frame (ORF) encoding a protein, wherein:

(i) said dry powder has a residual moisture content of less than 2%-5% (w/w); and

(ii) comprises a plurality of particles having a median particle size, in a volume weighted distribution of the composition, in a range from 1 μm and 20 μm.

2. The dry powder composition according to claim 1 , said dry powder having a residual moisture content of less than 4% (w/w).

3. The dry powder composition according to claim 1 , wherein the median particle size in a volume weighted distribution is at least 1 μm.

4. The dry powder composition according to claim 1 , wherein the particles have an average sphericity in a range from 0.7 to 1.0.

5. The dry powder composition according to claim 1 , wherein the long-chain RNA molecule is an mRNA molecule.

6. The dry powder composition according to claim 1 , wherein the long-chain RNA molecule comprises at least one nucleotide modification.

7. The dry powder composition according to claim 1 , wherein the dry powder composition comprises at least one further excipient.

8. The dry powder composition according to claim 1 , wherein the long-chain RNA molecule is in a complex with a cationic or polycationic lipid.

9. A pharmaceutical composition comprising the dry powder composition according to claim 8 .

10. The pharmaceutical composition of claim 9 , further comprising at least one pharmaceutically acceptable excipient.

11. The pharmaceutical composition of claim 10 , wherein the dry powder is formulated for administration by inhalation.

12. The pharmaceutical composition of claim 10 , wherein the dry powder is formulated for pulmonary delivery.

13. The dry powder composition of claim 9 , wherein upon reconstitution of the dry powder in a suitable solvent, the complexed long-chain RNA molecule is present in the solvent in the form of nanoparticles having a size of about 50 to 500 nm.

14. The dry powder composition of claim 10 , wherein the at least one excipient comprises a free carbohydrate.

15. The dry powder composition of claim 14 , wherein the at least one excipient comprises lactose, sucrose or trehalose.

16. The dry powder composition of claim 15 , wherein the at least one excipient comprises sucrose.

Assignments (2)
CHANGE OF NAME Recorded Feb 13, 2023
From: CUREVAC AG
To: CUREVAC SE
Reel/Frame 062718/0191 →
CHANGE OF NAME Recorded Feb 10, 2023
From: CUREVAC AG
To: CUREVAC SE
Reel/Frame 062703/0541 →
Priority Claims (2)
EP 15001517 · May 20, 2015 · regional
WO PCT/EP2015/002019 · Oct 13, 2015 · international
Continuity (4)
Division 16998259 · Aug 20, 2020
Division 16679536 · Nov 11, 2019
Division 15575284
Related Publication 20220387320A1 · Dec 8, 2022
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