公开(公告)号：US20230099898A1

公开(公告)日：2023-03-30

申请号：US17904937

申请日：2021-02-26

Applicant: BioNTech SE ,  Johannes Gutenberg-Universitat Mainz

Inventor： Heinrich HAAS ,  Sara NOGUEIRA ,  Peter LANGGUTH ,  Christian SIEWERT ,  Vera CORNET

IPC: A61K9/16 ,  C12N15/88 ,  A61K31/7105

Abstract: The present disclosure relates to RNA particles for delivery of RNA to target tissues after administration, in particular after parenteral administration such as intramuscular, intravenous, subcutaneous or intratumoral administration, and compositions comprising such RNA particles. The present disclosure, in particular, relates to RNA particles comprising RNA, at least one cationic or cationically ionizable lipid or lipid-like material, and at least one cationic polymer, wherein the particles do not have a core-shell structure.

公开(公告)号：US20220362388A1

公开(公告)日：2022-11-17

申请号：US17621136

申请日：2020-07-01

Applicant: BIONTECH SE

Inventor： Heinrich HAAS ,  Jorge MORENO HERRERO ,  Anne Marion Genevieve SCHLEGEL ,  Stephanie ERBAR

IPC: A61K47/56 ,  A61K47/54 ,  A61K9/00

Abstract: The present invention relates to compositions comprising RNA, preferably messenger RNA (mRNA), more preferably self-amplifying RNA (saRNA), and polymers, in particular cationic polymers, such as polyethylenimine (PEI), poly-L-Lysin (PEL), polyvinylamine (PVA) or polyallylamine (PAA), where individual RNA molecules are present in solution. In the formulations, the RNA is preferentially present in the form of monomers, dimers, timers or oligomers, but not as aggregates comprising a large number of RNA molecules per aggregate, in particular large polyplex nanoparticles. The formulations display improved transfection efficacy and they can be used for delivery of RNA to a subject, where they have an improved dose response relationship in comparison to formulations where large aggregates in the form of polyplex nanoparticles are present.

公开(公告)号：US20230241223A1

公开(公告)日：2023-08-03

申请号：US17913743

申请日：2021-03-24

Applicant: BIONTECH SE

Inventor： Heinrich HAAS ,  Sara NOGUEIRA ,  Anne SCHLEGEL

IPC: A61K47/54 ,  A61K47/64 ,  A61K47/69 ,  A61K9/00

CPC classification number: A61K47/543 ,  A61K9/0019 ,  A61K47/646 ,  A61K47/6911 ,  A61K47/6929

Abstract: The present disclosure relates to RNA particles for delivery of RNA to target tissues after administration, in particular after parenteral administration such as intravenous, intramuscular, subcutaneous or intratumoral administration, and compositions comprising such RNA particles. The RNA particles in one embodiment comprise single-stranded RNA such as mRNA which encodes a peptide or protein of interest, such as a pharmaceutically active peptide or protein. The RNA is taken up by cells of a target tissue and the RNA is translated into the encoded peptide or protein, which may exhibit its physiological activity.

公开(公告)号：US20240408032A1

公开(公告)日：2024-12-12

申请号：US18689727

申请日：2022-09-09

Applicant: BioNTech SE

Inventor： Hossam HEFESHA ,  Heinrich HAAS ,  Ferdia BATES ,  Christian HOTZ ,  Katalin KARIKÓ

IPC: A61K9/51 ,  A61K9/00 ,  A61K38/19 ,  A61K38/20 ,  A61K38/21

Abstract: The present disclosure relates to RNA particles comprising phospholipids with a phosphatidylserine head group for delivering RNA to target tissues after administration, in particular after parenteral, intratumoral, or peritumoral administration, and compositions comprising such RNA particles. The present disclosure also relates to methods for preparing RNA particles described herein.

公开(公告)号：US20240269321A1

公开(公告)日：2024-08-15

申请号：US18246533

申请日：2021-09-30

Applicant: BioNTech SE

Inventor： Heinrich HAAS ,  Sebastian HÖRNER ,  Thomas Michael HILLER ,  Tobias KIND ,  Tijana BACIC

IPC: A61K48/00 ,  A61K47/26 ,  A61K47/54 ,  A61K47/69

CPC classification number: A61K48/0033 ,  A61K47/26 ,  A61K47/543 ,  A61K47/547 ,  A61K47/548 ,  A61K47/6911

Abstract: The present disclosure relates to methods for preparing RNA lipoplex particles for delivery of RNA to target tissues after parenteral administration, in particular after intravenous administration, and compositions comprising such RNA lipoplex particles. The present disclosure also relates to methods which allow preparing RNA lipoplex particles in an industrial GMP-compliant manner. Furthermore, the present disclosure relates to methods and compositions for storing RNA lipoplex particles without substantial loss of the product quality and, in particular, without substantial loss of RNA activity.

公开(公告)号：US20220381748A1

公开(公告)日：2022-12-01

申请号：US17627066

申请日：2020-07-17

Applicant: BioNTech SE

Inventor： Heinrich HAAS ,  Tijana BACIC ,  Jens SCHUMACHER

IPC: G01N30/00 ,  G01N15/02 ,  G01N30/74

Abstract: The present disclosure relates generally to the field of analyzing a nucleic acid, such as RNA, in particular to the determination of at least one parameter of a sample composition comprising a nucleic acid, especially RNA, and optionally particles.

公开(公告)号：US20220143069A1

公开(公告)日：2022-05-12

申请号：US17593391

申请日：2020-04-01

Applicant: BIONTECH SE

Inventor： Heinrich HAAS ,  Sebastian HÖRNER ,  Thomas Michael HILLER

IPC: A61K31/7105 ,  A61K47/18 ,  A61K47/02 ,  A61K47/26 ,  A61K47/22

Abstract: The present disclosure relates to methods for preparing RNA lipoplex particles for delivery of RNA to target tissues after parenteral administration, in particular after intravenous administration, and compositions comprising such RNA lipoplex particles. The present disclosure also relates to methods which allow preparing RNA lipoplex particles in an industrial GMP-compliant manner. Furthermore, the present disclosure relates to methods and compositions for storing RNA lipoplex particles without substantial loss of the product quality and, in particular, without substantial loss of RNA activity.