US 11,534,405 B2 · Dry powder composition comprising long-chain RNA

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-freeze 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.

Claims18

Dependent claims

A method for producing an RNA powder, wherein the method comprises the following steps:

a) providing a template DNA comprising a nucleic acid sequence encoding an RNA comprising at least 200 nucleotides in length;
b) in vitro transcribing the template DNA in order to obtain a liquid comprising the RNA;
c) purifying the liquid comprising the RNA obtained in step b);
d) formulating the RNA of step c) to form a complex with a cationic or polycationic compound to produce a formulated RNA;
and
e) drying the liquid formulated RNA of step d) by spray-freeze drying to produce an RNA powder, wherein the powder comprises a plurality of particles having a mean diameter of about 100 μm to about 200 μm and a residual moisture content of 3% (w/w) or less.

3 more elements

Dependencies are inferred from the claim text.

Facts

Application

16/904,993Filed 18 Jun 2020 · continuation

Priority

EP 1500151720 May 2015

Published

US 2021/0030683 A14 Feb 2021

Granted

27 Dec 2022

Term ends

Not estimatedThe source records don’t support an estimate.

Classification13 codes

A61K 9/1682
Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,…:…
A61K 9/19
Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles: lyophilised , i.e.…
A61K 31/7105
Compounds having three or more nucleosides or nucleotides: natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine,…
A61K 48/005
Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy:…

Family

PCT/EP2016/000843Parent of this continuation · filed 20 May 2016

US 2021/0030683 A1Pre-grant publication · published 4 Feb 2021

Application15/575,301Parent of this continuation

US 10,729,654 B2Parent of this continuation

US 2019/0133950 A1Published application

US 11,534,405 B2This patent

From the US filing history. Foreign family members aren’t listed.

Dry powder composition comprising long-chain RNA

Life of this patent

Dry powder composition comprising long-chain RNA

Life of this patent

Abstract

Claims18