公开(公告)号：US12281322B2

公开(公告)日：2025-04-22

申请号：US17494601

申请日：2021-10-05

Applicant: BIONTECH SE ,  TRON-Translationale Onkologie an der Universitätsmedizin der Johanne Gutenberg-Universität Mainz gem

Inventor： Tim Beissert ,  Ugur Sahin ,  Mario Perkovic

IPC: C12N15/86

Abstract: The present invention embraces a RNA replicon that can be replicated by a replicase of alphavirus origin. The RNA replicon comprises sequence elements required for replication by the replicase, but these sequence elements do not encode any protein or fragment thereof, such as an alphavirus non-structural protein or fragment thereof. Thus, in the RNA replicon according to the invention, sequence elements required for replication by the replicase and protein-coding region(s) are uncoupled. According to the present invention the uncoupling is achieved by the removal of at least one initiation codon compared to a native alphavirus genomic RNA. In particular, the RNA replicon comprises a 5′ replication recognition sequence, wherein the 5′ replication recognition sequence is characterized in that it comprises the removal of at least one initiation codon compared to a native alphavirus 5′ replication recognition sequence. The replicase of alphavirus origin may be encoded by an open reading frame on the RNA replicon or on a separate RNA molecule. The present invention enables efficient and safe expression of a protein of interest in a cell or organism, but is not associated with undesired production of fragments of alphavirus non-structural protein. Methods of protein production in vitro and in vivo, as well as medical uses, are provided herein.

公开(公告)号：US12168051B2

公开(公告)日：2024-12-17

申请号：US17931215

申请日：2022-09-12

Applicant: BIONTECH SE ,  TRON—TRANSLATIONALE ONKOLOGIE AN DER UNIVERSITÄTSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITÄT

Inventor： Mahjoub Bihi ,  Ugur Sahin ,  Mustafa Diken ,  Thorsten Klamp

IPC: A61K48/00 ,  A61K39/145 ,  C12N15/11 ,  A61K38/00 ,  A61K39/00

Abstract: The present invention relates to methods and compositions for stimulating an immune response. In particular, the present invention relates to immunostimulatory RNA molecules comprising sequences derived from an Influenza A virus nucleoprotein-encoding RNA molecule that act as adjuvants and/or immunostimulatory agents to enhance host immune responses.

公开(公告)号：US20240366751A1

公开(公告)日：2024-11-07

申请号：US18526938

申请日：2023-12-01

Applicant: BioNTech SE

Inventor： Alexander Muik ,  Asaf Poran ,  Kena Anne Swanson ,  Qi Yang ,  Hui Cai ,  Ugur Sahin ,  Kayvon Modjarrad

IPC: A61K39/215 ,  A61K39/00 ,  C07K14/005

Abstract: This disclosure relates to the field of RNA to prevent or treat coronavirus infection. In particular, the present disclosure relates to methods and agents for vaccination against coronavirus infection and inducing effective coronavirus antigen-specific immune responses such as antibody and/or T cell responses.

公开(公告)号：US12133899B2

公开(公告)日：2024-11-05

申请号：US17988742

申请日：2022-11-16

Applicant: BioNTech SE

Inventor： Ugur Sahin ,  Alptekin Güler ,  Andreas Kuhn ,  Alexander Muik ,  Annette Vogel ,  Kerstin Walzer ,  Sonja Witzel ,  Stephanie Hein ,  Özlem Türeci

IPC: A61K48/00 ,  A61K9/00 ,  A61K9/127 ,  A61K9/51 ,  A61K31/7088 ,  A61K31/7105 ,  A61K31/711 ,  A61K31/7115 ,  A61K31/712 ,  A61K39/00 ,  A61K39/12 ,  A61K39/215 ,  A61P31/14 ,  A61P35/00 ,  B82Y5/00 ,  C12N7/00 ,  C12N15/11 ,  C12N15/67 ,  C12N15/88 ,  C12P19/34 ,  A61K38/00

Abstract: This disclosure relates to the field of RNA to prevent or treat coronavirus infection. In particular, the present disclosure relates to methods and agents for vaccination against coronavirus infection and inducing effective coronavirus antigen-specific immune responses such as antibody and/or T cell responses. Specifically, in one embodiment, the present disclosure relates to methods comprising administering to a subject RNA encoding a peptide or protein comprising an epitope of SARS-CoV-2 spike protein (S protein) for inducing an immune response against coronavirus S protein, in particular S protein of SARS-CoV-2, in the subject, i.e., vaccine RNA encoding vaccine antigen.

公开(公告)号：US11814411B2

公开(公告)日：2023-11-14

申请号：US17144591

申请日：2021-01-08

Applicant: BIONTECH SE ,  GENMAB A/S

Inventor： Ugur Sahin ,  Friederike Gieseke ,  Isil Altintas ,  David Satijn ,  Paul Parren

IPC: C07K16/28

CPC classification number: C07K16/2878 ,  C07K2317/31 ,  C07K2317/565 ,  C07K2317/75 ,  C07K2317/92

Abstract: The present invention relates to binding agents binding to receptors of the TNF superfamily, in particular binding agents binding to at least two different receptors of the TNF superfamily, as well as to their use in medicine. The present invention further relates to nucleic acid molecules encoding such binding agents, to cells comprising such nucleic acid molecules and to pharmaceutical compositions and kits.

公开(公告)号：US11779659B2

公开(公告)日：2023-10-10

申请号：US17565842

申请日：2021-12-30

Applicant: BioNTech SE

Inventor： Ugur Sahin ,  Gábor Boros ,  Azita Josefine Mahiny ,  Jonas Reinholz ,  Katalin Karikó

IPC: A61K48/00 ,  A61P35/00 ,  A61K31/7088 ,  A61K39/00 ,  A61K39/12 ,  A61K9/127 ,  A61K39/215 ,  C12N7/00 ,  A61P31/14 ,  A61K9/00 ,  A61K9/51 ,  A61K31/7105 ,  A61K31/7115 ,  A61K31/712 ,  B82Y5/00 ,  C12N15/11 ,  C12N15/67 ,  C12N15/88 ,  C12P19/34 ,  A61K31/711 ,  A61K38/00

CPC classification number: A61K48/0066 ,  A61K9/0019 ,  A61K9/1271 ,  A61K9/5123 ,  A61K9/5146 ,  A61K31/7088 ,  A61K31/711 ,  A61K31/712 ,  A61K31/7105 ,  A61K31/7115 ,  A61K39/0011 ,  A61K39/12 ,  A61K39/215 ,  A61K48/0033 ,  A61P31/14 ,  A61P35/00 ,  B82Y5/00 ,  C12N7/00 ,  C12N15/11 ,  C12N15/67 ,  C12N15/88 ,  C12P19/34 ,  A61K38/00 ,  A61K2039/53 ,  A61K2039/54 ,  A61K2039/545 ,  A61K2039/55555 ,  C12N2770/18022 ,  C12N2770/18034 ,  C12N2770/18071 ,  C12N2770/20034 ,  C12N2840/00

Abstract: Disclosed herein are RNA polynucleotides comprising a 5′ Cap, a 5′ UTR comprising a cap proximal sequence disclosed herein, and a sequence encoding a payload. Also disclosed herein are compositions and medical preparations comprising the same, and methods of making and using the same.

公开(公告)号：US20230226217A1

公开(公告)日：2023-07-20

申请号：US18071705

申请日：2022-11-30

Applicant: TRON-Translationale Onkologie an der Universitatsmedizin der Johannes Gutenberg-Universitat Mainz ad ,  BioNTech SE

Inventor： Ugur Sahin ,  Heinrich Haas ,  Sebastian Kreiter ,  Mustafa Diken ,  Daniel Fritz ,  Martin Meng ,  Lena Mareen Kranz ,  Kerstin Reuter

IPC: A61K48/00 ,  A61K39/00 ,  A61K9/127

CPC classification number: A61K48/0033 ,  A61K9/1272 ,  A61K39/0011 ,  A61K48/0025 ,  A61K2039/53 ,  A61K2039/55555

Abstract: The present invention is in the field of immunotherapy, in particular tumor immunotherapy. The present invention provides pharmaceutical formulations for delivering RNA to antigen presenting cells such as dendrite cells (DCs) in the spleen after systemic administration. In particular, the formulations described herein enable to induce an immune response after systemic administration of antigen-coding RNA.

公开(公告)号：US20230201817A1

公开(公告)日：2023-06-29

申请号：US18085206

申请日：2022-12-20

Applicant: BioNTech Delivery Technologies GmbH ,  BioNTech SE

Inventor： Christian Reinsch ,  David Estapé Izquierdo ,  Sierk Poetting ,  Ugur Sahin ,  Alexander Muik ,  Asaf Poran ,  Martin Lang ,  Oliver Hennig ,  Karsten Pietron-Kattmann ,  Manfred Brunen ,  Rainer Kröner ,  Mario Büttner ,  Sven Stegmann ,  Kristin Hoffmann

IPC: B01L1/00 ,  G16B30/00 ,  G16B50/30 ,  G16B20/20 ,  A61K39/215 ,  B01F25/25 ,  B01D61/14

CPC classification number: B01L1/52 ,  A61K39/215 ,  B01D61/145 ,  B01D61/147 ,  B01D61/149 ,  B01F25/25 ,  G16B20/20 ,  G16B30/00 ,  G16B50/30 ,  A61K2039/53

Abstract: A portable system for producing a formulation comprising lipid nanoparticle (LNP)-encapsulated RNA includes: a first sub-system comprising multiple drug substance formulation modules, the first sub-system comprising: a transcription module for forming an RNA solution via in vitro transcription; and a second sub-system operatively downstream of the first sub-system comprising multiple drug product formation modules, the second sub-system comprising: an LNP formulation module for producing a first RNA-LNP preparation from the RNA solution, wherein each of the transcription module and the LNP formulation module is contained within a separate standard shipping container.

公开(公告)号：US11660338B2

公开(公告)日：2023-05-30

申请号：US16749012

申请日：2020-01-22

Applicant: BIONTECH SE ,  TRON-TRANSLATIONALE ONKOLOGIE AN DER UNIVERSITATSMEDIZIN DER JOHANNES Gutenberg-Universitat Mainz Gemeinnutzige GmbH

Inventor： Ugur Sahin ,  Heinrich Haas ,  Sebastian Kreiter ,  Yves Hüsemann ,  Mustafa Diken ,  Kerstin Reuter ,  Hossam Hefesha

IPC: A61K39/39 ,  C12N15/88 ,  A61K9/50 ,  A61K9/127 ,  A61K31/675 ,  A61K39/00

CPC classification number: A61K39/39 ,  A61K9/1271 ,  A61K9/1277 ,  A61K9/5073 ,  A61K31/675 ,  A61K39/0011 ,  C12N15/88 ,  A61K2039/55505 ,  A61K2039/55511 ,  A61K2039/55516 ,  A61K2039/55555 ,  A61K2039/55561 ,  A61K2039/572 ,  C12N2810/10

Abstract: The present invention relates to RNA decorated particles such as RNA decorated lipid particles, preferably to RNA decorated liposomes. Further, the present invention relates to a pharmaceutical composition comprising RNA decorated particles such as RNA decorated lipid particles, preferably RNA decorated liposomes. Said pharmaceutical composition is useful for inducing an immune response. It is also useful in a prophylactic and/or therapeutic treatment of a disease involving an antigen. Furthermore, the present invention relates to a method for producing the RNA decorated particles such as RNA decorated lipid particles, preferably RNA decorated liposomes.

公开(公告)号：US20220313811A1

公开(公告)日：2022-10-06

申请号：US17717645

申请日：2022-04-11

Applicant: BIONTECH SE ,  TRON - TRANSLATIONALE ONKOLOGIE AN DER UNIVERSITÄTSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITÄT MAINZ

Inventor： Ugur Sahin ,  Heinrich Haas ,  Annette Vogel ,  Daniel Zucker ,  Stephanie Erbar ,  Kerstin Walzer ,  Anne Schlegel ,  Sebastian Hörner ,  Sebastian Kreiter ,  Mustafa Diken ,  Jorge Moreno Herrero

IPC: A61K39/12 ,  A61K9/00 ,  A61K9/19 ,  A61K47/18 ,  A61K47/26 ,  A61K47/34

Abstract: The present invention relates to compositions comprising polyplex formulations for delivery of RNA to a target organ or a target cell after parenteral administration, in particular after intramuscular administration. More precisely, the present invention relates to formulations for administration of RNA such as self-replicating RNA, in particular by intramuscular injection. In more detail, the formulations comprise polyplex particles from single stranded RNA and a polyalkyleneimine. The RNA may encode a protein of interest, such as a pharmaceutically active protein. Furthermore, the present invention relates to pharmaceutical products, comprising said RNA polyplex formulations for parenteral application to humans or to animals. The present invention relates as well to manufacturing of such pharmaceutical products, comprising, optionally, steps of sterile filtration, freezing and dehydration.