The present invention is inter alia directed to amphiphilic pH-sensitive polymers, wherein the polymer is soluble in an aqueous environment at a trigger physiological pH. Such polymers are suitable for encapsulation of a cargo, such as a biologically active constituent, to protect the cargo from undesirable interactions with co-formulated substances, such as in a parenteral formulation. The present invention is also directed to self-assembled particles, compositions, immunogenic compositions, and vaccines comprising such. Self-assembled particles, compositions, immunogenic compositions, and vaccines provided herein are suitable for use in medicine, in particular for the treatment or prevention of an infection, caused directly or indirectly by a pathogen.
Described are methods of delaying the onset or progression of dementia or mild cognitive impairment in a subject comprising administering to the subject a Varicella Zoster Virus glycoprotein E (VZV gE) polypeptide or a recombinant nucleic acid encoding a VZV gE polypeptide.
A61P 25/28 - Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
4.
EPSTEIN-BARR VIRUS ANTIGEN-ENCODING MESSENGER RIBONUCLEIC ACID AND ANTIGEN PROTEIN VACCINES
Provided are a pharmaceutical composition comprising a delivery vehicle and at least two Epstein-Barr virus (EBV) antigen-encoding messenger ribonucleic acid (mRNA) constructs. Methods of treatment, methods of making, uses of the pharmaceutical composition, and pharmaceutical compositions comprising at least two or more EBV antigens are provided. All contemplate treating and preventing (i.e. reducing the likelihood of a symptom or a severity of a symptom of) EBV infections and EBV-associated diseases, such as infectious mononucleosis, multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus.
The present invention relates to aqueous RNA compositions that are suitable for storage, comprising Tris, a saccharide, and phosphate anions. The present invention also relates to methods of producing such aqueous RNA compositions, as well as their use in therapy and prevention of infectious diseases.
The present invention relates to the field of modified nanoparticles, immunogenic compositions and vaccines comprising the modified nanoparticles, their manufacture and the use of such compositions in medicine.
The present invention relates to the field of modified nanoparticle subunits, immunogenic compositions and vaccines comprising the modified nanoparticles, their manufacture and the use of such compositions in medicine.
The present invention is inter alia directed to immunogenic compositions comprising: (a) a first hemagglutinin (HA) antigen or a first nucleic acid, suitably mRNA, encoding the first HA antigen wherein the first HA antigen is derived from a strain of Influenza virus; and (b) a second HA antigen or a second nucleic acid, suitably mRNA, encoding the second HA antigen wherein the second HA antigen is derived from a strain of Influenza virus, wherein (a) and (b) are different, and wherein the ratio of (a):(b) is greater than 5:1. The present invention is also directed to vaccines and kits or kits-of-parts comprising such. Immunogenic compositions, vaccines and kits-of-parts provided herein are suitable for use as a medicament, in particular, for use in the treatment or prophylaxis of an infection with an Influenza virus, suitably an Influenza A and/or Influenza B.
Candida albicansCandida albicans') protein. The modified Sap2 protein can be used as a carrier protein for other antigens, particularly saccharide antigens or other antigens lacking T cell epitopes.
Candida albicansCandida albicans) protein. The modified Als3 protein can be used as a carrier protein for other antigens, particularly saccharide antigens or other antigens lacking T cell epitopes.
The present invention relates to immunogenic compositions comprising outer membrane vesicles (OMVs) adsorbed to an aluminium hydroxide adjuvant, whereby the aluminium hydroxide adjuvant is quenched. The present invention also relates to the use of the immunogenic compositions for providing protection against diseases caused by Gram-negative bacteria. The present invention also relates to a method for reducing particle aggregation and/or average particle diameter in compositions comprising OMVs and an aluminium hydroxide adjuvant.
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 39/39 - Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
A61K 47/00 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient
The present invention relates to conjugates comprising polysaccharides comprising 3- deoxy-D-manno-actulosonic acid (KDO) moieties, particularly conjugates produced using random conjugation methods, methods for preparing such conjugates, immunogenic compositions and vaccines comprising the conjugates, and methods of treatment or medical uses using the compositions and vaccines.
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
The present invention relates to immunogenic compositions comprising antigens from Salmonella enterica serovar Typhimurium (S. Typhimurium), Salmonella enterica serovar Enteritidis (S. Enteritidis), and Salmonella enterica serovar Typhi (S. Typhi). The present invention further relates to methods and uses of compositions comprising GMMA for boosting an immune response to an S. Typhi antigen, vaccines comprising the immunogenic compositions and methods and uses of the immunogenic compositions.
The present invention provides lyophilised pharmaceutical compositions and processes of making said lyophilised pharmaceutical compositions. More particularly, the present invention provides lyophilised pharmaceutical compositions comprising lipid nanoparticles encapsulating a nucleic acid payload wherein the lyophilised pharmaceutical composition is in the form of a plurality of lyophilised beads (LyoBeads) and processes for making said compositions. The present invention further provides the use of said lyophilised pharmaceutical compositions in medicine.
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
inter alia inter alia, an RSV-F protein comprising at least two mutations relative to SEQ ID NO: 1 or 3 within a region of the protein corresponding to positions 474-523 of SEQ ID NO: 1 or 3; wherein the at least two mutations introduce, through substitution or insertion, a pair of C residues into the region, which form a disulphide bond.
Provided herein are methods, immunogenic combinations, immunogenic compositions, and uses thereof directed to co-administration of an immunogenic composition comprising a recombinant RSV antigen comprising a soluble F protein comprising at least one modification that stabilizes the prefusion conformation of the F protein; and an immunogenic composition comprising at least one glycoconjugate from each of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F.
inter aliainter alia directed to immunogenic compositions for use in the treatment or prophylaxis of an infection with an Influenza virus, wherein the immunogenic composition comprises: (a) a first nucleic acid encoding a hemagglutinin (HA) antigen of a strain of a first subtype of Influenza A virus; (b) a second nucleic acid encoding a HA antigen of a strain of a second subtype of Influenza A virus; (c) a third nucleic acid encoding a HA antigen of a first strain of Influenza B virus; and (d) optionally, a fourth nucleic acid encoding a HA antigen of a second strain of Influenza B virus, wherein an immune response is elicited against HA antigens of said strains of first and second subtypes of Influenza A virus, said first and, optionally, second strains of Influenza B virus and at least one further HA antigen subtype of Influenza A virus, being different from any of the HA antigen subtypes of Influenza A virus encoded by a nucleic acid present in the composition.
The present invention is inter alia directed to immunogenic compositions comprising: (a) a first hemagglutinin (HA) antigen or a first nucleic acid, suitably mRNA, encoding the first HA antigen wherein the first HA antigen is derived from a strain of subtype H3 of Influenza A virus; and (b) a second HA antigen or a second nucleic acid, suitably mRNA, encoding the second HA antigen wherein the second HA antigen is derived from a strain of subtype H1 of Influenza A virus, wherein the ratio of (a):(b) is comprised between 1.5:1 and 20:1. The present invention is also directed to vaccines and kits or kits-of-parts comprising such. Immunogenic compositions, vaccines and kits-of-parts provided herein are suitable for use as a medicament, in particular, for use in the treatment or prophylaxis of an infection with an Influenza virus, suitably an Influenza A and/or Influenza B.
inter alia inter alia, a recombinant nucleic acid encoding a respiratory syncytial virus fusion (RSV-F) protein comprising a cytoplasmic tail; wherein, relative to a cytoplasmic tail according to SEQ ID NO: 3 or 4, 2-20 residues are deleted from the cytoplasmic tail of the RSV-F protein.
The present disclosure provides inter alia, a recombinant ribonucleic acid (RNA) encoding a respiratory syncytial virus fusion (RSV-F) protein comprising an F2 and an F1 domain; wherein the RSV-F protein further comprises, relative to a wild-type RSV-F sequence, the substitution of a residue for a C residue in both of the F2 and F1 domains.
The present invention provides lyophilised pharmaceutical compositions and methods of making said lyophilised pharmaceutical compositions. More particularly, the present invention provides lyophilised pharmaceutical compositions comprising nucleic acid and lipid carrier particles and methods of making said lyophilised pharmaceutical compositions. The provided lyophilised compositions have improved critical quality attributes (CQAs) and the provided methods prevent the need for a deep-freeze cold chain. The present invention further provides the use of said lyophilised pharmaceutical compositions in medicine.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 9/19 - Particulate form, e.g. powders lyophilised
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
A61K 31/713 - Double-stranded nucleic acids or oligonucleotides
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
The present invention relates to the field of immunogenic compositions and vaccines, their manufacture, host cells which can be used in their manufacture and the use of such immunogenic compositions and vaccines in medicine. More particularly, it relates to an immunogenic composition comprising a Klebsiella pneumoniae O1v1 O-antigen polysaccharide conjugate, a Klebsiella pneumoniae O2a O-antigen polysaccharide conjugate, a Klebsiella pneumoniae O2afg O-antigen polysaccharide conjugate and a Klebsiella pneumoniae O3b O-antigen polysaccharide conjugate, wherein each of the Klebsiella pneumoniae O1v1, O2a, O2afg and O3b O-antigen polysaccharides are individually conjugated to a carrier protein (e.g. a detoxified Exotoxin A of Pseudomonas aeruginosa (EPA)) wherein the Klebsiella pneumoniae O3b O-antigen polysaccharide conjugate is present in said immunogenic composition at a higher saccharide dose than at least one of the Klebsiella pneumoniae O1v1 O-antigen polysaccharide conjugate, Klebsiella pneumoniae O2a O-antigen polysaccharide conjugate or Klebsiella pneumoniae O2afg O-antigen polysaccharide conjugate.
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
C07K 14/21 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Pseudomonadaceae (F)
The present invention relates to liquid chromatography methods (e.g., HPLC) that facilitate high resolution separation of mRNA formulated in lipid nanoparticles (LNPs) from impurities. In aspects, the disclosure relates to a mobile phase with two or more eluents that separates constituents of a mixture into one or more peaks, wherein at least one of the peaks is a well- defined impurity peak that can be quantified to accurately determine the amount of the impurity in the mixture.
A61K 31/00 - Medicinal preparations containing organic active ingredients
B01D 15/16 - Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
B01D 15/32 - Bonded phase chromatography, e.g. with normal bonded phase, reversed phase or hydrophobic interaction
B01D 15/42 - Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
C12N 15/10 - Processes for the isolation, preparation or purification of DNA or RNA
C12N 15/88 - Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using liposome vesicle
The present invention relates to immunogenic compositions comprising Clostridioides difficile (C. difficile) immunogens. More particularly the present invention relates to immunogenic compositions comprising a first immunogen and a second immunogen the first immunogen comprising a C. difficile toxin A CROP domain fragment and a C. difficile toxin B CROP domain fragment and the second immunogen comprising a fragment of C. difficile toxin B which comprises at least 100 contiguous amino acids of the delivery and receptor binding domain (DRBD) of toxin B. The present invention further relates to nucleic acids encoding C. difficile polypeptides and the use of said immunogenic compositions and nucleic acids in medicine.
The present invention provides improved RNA-LNP formulations with lower amounts of RNA adduct, As well as methods and uses to reduce the amount of RNA adduct in RNA- LNP formulations, in particular mRNA-LNP formulations.
A61K 9/19 - Particulate form, e.g. powders lyophilised
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 47/20 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A composition for treating chronic hepatitis B infection comprising mRNA encoding a hepatitis B virus antigen, wherein the mRNA is encapsulated in a lipid nanoparticle (LNP).
The present invention relates to vaccination against respiratory syncytial virus (RSV), in particular to the use of a vaccine formulation comprising an RSV fusion (F) protein (RSV F protein) antigen and an adjuvant in methods of inducing an immune response and in methods of prevention of RSV infection and disease in older adults.
Compositions and methods are described for inducing an immune response against extra-intestinal pathogenic Escherichia coli (ExPEC) to thereby provide immune protection against diseases associated with ExPEC. In particular, compositions are described comprising conjugates of E. coli polysaccharide antigen O1, 02, 04, 06, 08, 015, 016, 018, 025, and 075 and further comprising 0153 or 021 or both 0153 and 021 covalently bound to a carrier protein for the prevention of invasive ExPEC disease.
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
The present invention is directed to nucleic acids suitable for use in treatment or prophylaxis of an infection with a coronavirus, such as a Coronavirus SARS-CoV-2 variant, or a disorder related to such an infection, such as COVID-19. The present invention is also directed to compositions, and vaccines. The compositions and vaccines comprise at least one of said nucleic acid sequences, and nucleic acid sequences in association with a lipid nanoparticle (LNP). The invention is also directed to first and second medical uses of the nucleic acids, the composition, the vaccine, and the kit, and to methods of treating or preventing a coronavirus infection, such as a Coronavirus infection from a SARS-CoV-2 variant.
The present invention relates to compositions comprising at least one Group A Streptococcus antigen, an aluminium salt and (a) a TLR7 agonist, or (b) a benzonapthyridine compound. The present invention further relates to methods of making an immunogenic composition comprising at least one antigen, an aluminium salt and (a) a TLR7 agonist, and/or (b) a benzonapthyridine compound. The present invention also relates to vaccines comprising the compositions, and methods of using and uses of the compositions.
ALMA MATER STUDIORUM – UNIVERSITÀ DI BOLOGNA (Italy)
Inventor
Cappelli, Luigia
Cozzi, Roberta
Abstract
The present invention relates to chimeric polypeptides comprising a scaffold polypeptide and one or more exogenous polypeptides, wherein the scaffold polypeptide comprises a backbone protein 2a (BP-2a) Domain 3 (D3) polypeptide in which at least one endogenous loop has been partially or wholly replaced by an exogenous polypeptide. The present invention also relates to nanoparticles, outer membrane vesicles, pharmaceutical compositions, vaccines, arrays and kits comprising said chimeric polypeptides, methods of their production, and uses thereof in therapy and antibody screening.
The present invention relates inter alia to a method of making a composition comprising aluminium hydroxide particles wherein the method comprises reacting an aluminium ion- containing compound with a hydroxide ion-containing compound in a micro-fluidic or milli- fluidic (MF) system.
inter aliainter alia directed to immunogenic compositions comprising: (a) a first hemagglutinin (HA) antigen or a first nucleic acid, suitably mRNA, encoding the first HA antigen wherein the first HA antigen is derived from a strain of Influenza virus; and (b) a second HA antigen or a second nucleic acid, suitably mRNA, encoding the second HA antigen wherein the second HA antigen is derived from a strain of Influenza virus, wherein (a) and (b) are different, and wherein the ratio of (a):(b) is comprised between 1.5:1 and 5:1. The present invention is also directed to vaccines and kits or kits-of-parts comprising such. Immunogenic compositions, vaccines and kits-of-parts provided herein are suitable for use as a medicament, in particular, for use in the treatment or prophylaxis of an infection with an Influenza virus, suitably an Influenza A and/or Influenza B.
inter alia inter alia, a respiratory syncytial virus fusion (RSV-F) protein in the pre-fusion conformation, which is mutated relative to wild-type RSV-F according to SEQ ID NO: 1; wherein the RSV-F protein comprises at least one mutation relative to the wild-type in a region corresponding to positions 217-239 of SEQ ID NO:1; wherein the at least one mutation introduces, through substitution or insertion, a residue comprising a hydrogen bond donor and/or acceptor moiety in its side chain.
The present disclosure provides inter alia, a respiratory syncytial virus fusion (RSV-F) protein in the pre-fusion conformation, which is mutated relative to the wild-type RSV-F according to SEQ ID NO: 1 and comprises (a), (b) and (c): (ai) at least one mutation relative to the wild-type in a region corresponding to positions 38-60 of SEQ ID NO:1, wherein the at least one mutation increases the hydrophobicity of the region relative to positions 38-60 of SEQ ID NO:1; and/or (aii) at least one mutation relative to the wild-type in a region corresponding to positions 296-318 of SEQ ID NO:1, wherein the at least one mutation increases the hydrophobicity of the region relative to positions 296- 318 of SEQ ID NO:1, and/or introduces, through substitution or insertion, a residue selected from M, F, I and V into the region; (b) at least one mutation relative to the wild-type in a region corresponding to positions 208-216 of SEQ ID NO:1, wherein the at least one mutation increases the hydrophobicity of the region relative to positions 208-216 of SEQ ID NO:1, and/or introduces, through substitution or insertion, a P residue into the region; and (c) at least one mutation relative to the wild-type in a region corresponding to positions 345-352 of SEQ ID NO:1, wherein the at least one mutation introduces, through substitution or insertion, a glycosylation site into the region.
BordetellaNeisseriaNeisseria gonorrhoeaeNeisseria gonorrhoeae. Also provided are OMVs purified by the processes described herein and immunogenic compositions, such as vaccines, comprising the same.
B01D 15/12 - Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the preparation of the feed
B01D 15/38 - Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups , e.g. affinity, ligand exchange or chiral chromatography
inter aliainter alia to a continuous process for producing an immunogenic composition using a micro-fluidic or milli-fluidic (MF) system and filling one or more vessels with the immunogenic composition.
A61K 39/00 - Medicinal preparations containing antigens or antibodies
B01F 25/433 - Mixing tubes wherein the shape of the tube influences the mixing, e.g. mixing tubes with varying cross-section or provided with inwardly extending profiles
41.
RECOMBINANT RNA MOLECULES COMPRISING UNTRANSLATED REGIONS OR SEGMENTS ENCODING SPIKE PROTEIN FROM THE OMICRON STRAIN OF SEVERE ACUTE RESPIRATORY CORONAVIRUS-2
Provided herein are 3' and 5' UTRs that provide an amount, duration, or both of protein expression from a recombinant RNA. Compositions of matter, methods, or uses of said 3' and 5' UTRs are provided. Provided herein are RNA segments that encode a SARS-CoV-2 omicron spike protein, which provide for omicron-strain-specific immunogenic compositions. Compositions of matter, methods, or uses of said RNA segments that encode a SARS-CoV-2 omicron spike protein are provided.
C12P 19/56 - Preparation of O-glycosides, e.g. glucosides having an oxygen atom of the saccharide radical directly bound to a condensed ring system having three or more carbocyclic rings, e.g. daunomycin, adriamycin
C12P 19/14 - Preparation of compounds containing saccharide radicals produced by the action of a carbohydrase, e.g. by alpha-amylase
A61K 31/704 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin, digitoxin
A61K 39/39 - Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
Olivier, Aurélie Chantal Marceline Louise Julienne
Van Der Wielen, Marie
Pirçon, Jean-Yves Marc Noël
Abstract
The present invention relates to vaccination against respiratory syncytial virus (RSV), in particular to the use of a vaccine formulation comprising an RSV F fusion protein (RSV F protein) antigen and an adjuvant in methods of prevention of RSV infection and disease in older adults.
The present invention relates to an improved immunogenic composition against N. meningitidis serogroups A, C, W135 and Y in solid form, and to a reconstituted vaccine against N. meningitidis serogroups A, B, C, W135, Y obtained by reconstitution with a liquid immunogenic composition of Men B antigens. Kits and methods for the prevention and treatment of meningococcal infection and disease with the immunogenic composition or the reconstituted vaccine are also provided.
N. meningitidisN. meningitidisN. meningitidis serogroups A, B, C, W135, and Y comprising the liquid composition. Kits and methods for the prevention and treatment of meningococcal infection and disease with the immunogenic composition or the reconstituted vaccine are also provided.
C07K 14/22 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Neisseriaceae (F), e.g. Acinetobacter
46.
NUCLEIC ACID BASED VACCINE ENCODING AN ESCHERICHIA COLI FIMH ANTIGENIC POLYPEPTIDE
Described are modified Varicella Zoster Virus glycoprotein E (VZV gE) proteins having improved stability and/or immunogenicity compared to a non-modified VZV gE. Also described are associated nucleic acids, immunogenic compositions, and methods of using such modified VZV gE proteins in the treatment or prevention of shingles.
The present invention discloses an engineered bacteriophage comprising a polynucleotide encoding a heterologous protein under the control of a repressible promoter. Also disclosed are processes for producing the engineered bacteriophage, pharmaceutical compositions comprising the engineered bacteriophage and methods of treatment using the engineered bacteriophage.
The present invention provides immunogenic compositions and vaccines comprising isolated gonococcal outer membrane vesicles (OMVs). Said isolated gonococcal OMVs display lipooligosaccharide (LOS) glycan structures comprising an oligosaccharide alpha-chain elongating from Hep I having at least four hexose monosaccharides (4Hex or 5Hex) and wherein said LOS is detoxified. The present invention relates to the use of said immunogenic compositions and vaccines in medicine and, more particularly, the use of said immunogenic compositions and vaccines in immunizing a subject against Neisseria gonorrhoeae infection.
A61K 39/39 - Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
C07K 14/22 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Neisseriaceae (F), e.g. Acinetobacter
The present invention relates to Shigella outer membrane vesicles comprising at least one heterologous O-antigen, a recombinant Shigella bacterium comprising at least one heterologous O-antigen, methods for preparing the outer membrane vesicles or recombinant Shigella bacterium, plasmids for use in the methods, immunogenic compositions, vaccines and methods of treatment.
The present invention relates to the field of immunogenic compositions and vaccines, their manufacture, host cells which can be used in their manufacture and the use of such immunogenic compositions and vaccines in medicine. More particularly, it relates to Klebsiella pneumoniae O-antigens, conjugates comprising a K. pneumoniae O-antigen, host cells suitable for their production and immunogenic compositions or vaccines containing at least one Klebsiella pneumoniae O-antigen. The present invention particularly relates to a form of Klebsiella pneumoniae O1v1 O-antigen polysaccharide or O1v2 O-antigen polysaccharide which is produced in the absence of a wbbZ gene.
C12N 1/00 - Microorganisms, e.g. protozoaCompositions thereofProcesses of propagating, maintaining or preserving microorganisms or compositions thereofProcesses of preparing or isolating a composition containing a microorganismCulture media therefor
53.
BACTERIAL IMMUNIZATION USING QBETA HAIRPIN NANOPARTICLE CONSTRUCTS
The present disclosure provides protein nanoparticles, constructs, and compositions for use in inducing an immunogenic response against a bacterial polysaccharide. Also provided are polynucleotides encoding the protein nanoparticles, host cells capable of expressing the protein nanoparticles, and methods of producing the protein nanoparticles.
The invention relates to a method for producing saponins containing a quillaic acid triterpenoid aglycone, said method comprising at least the following steps: i) culturing plant cells capable of naturally synthesizing saponins containing a quillaic acid triterpenoid aglycone in a cell culture medium comprising a source of nitrogen, ii) depleting the culture medium from any nitrogen source, iii) eliciting the production of saponins with at least one elicitor, and iv) recovering the saponins produced.
The invention uses ELISA or similar assays for analysing a meningococcal vaccine. The assay uses antibodies which bind to meningococcal proteins within the vaccine, and in particular monoclonal antibodies which are bactericidal for meningococcus and/or which recognise conformational epitopes within the meningococcal proteins. By performing the assay on a series of dilutions of a test vaccine, and by comparing the results with those obtained using a reference vaccine of known potency, it is possible to determine the relative potency of the test vaccine. This value can be used as a parameter for determining whether a manufactured batch of a vaccine is suitable for release to the public, or whether it has experienced a production failure and so should not be used.
IN VITRO POTENCY ASSAY FOR PROTEIN-BASED MENINGOCOCCAL VACCINES USING A PLURALITY OF MONOCLONAL ANTIBODIES AND ANTIGENS IMMOBILIZED TO COLOUR-CODED BEADS
This invention provides a multiplex binding assay for analysing a meningococcal vaccine and assessing in vitro relative potency of the same (IVRP). The invention also provides monoclonal antibodies which bind to meningococcal proteins within the vaccine, and in particular monoclonal antibodies which are bactericidal for meningococcus and/or which recognise conformational epitopes within the meningococcal proteins.
G01N 33/537 - ImmunoassayBiospecific binding assayMaterials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
C07K 16/12 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from bacteria
G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
G01N 33/84 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving inorganic compounds or pH
G01N 33/96 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood or serum control standard
58.
COMPOSITIONS AND METHODS FOR IMPROVING THE IMMUNE RESPONSE TO SARS-COV2
The present disclosure provides compositions comprising at least one bacterial cell that expresses at least one SARS-CoV2 microbiota-derived cross-reactive antigen (SARS-CoV2 mCRAg). The present disclosure provides specific SARS-CoV2 mCRAgs, and the bacterial cells that express the polypeptides that comprise the SARS-CoV2 mCRAgs and compositions thereof. The present specification provides methods for screening for SARS-CoV2 mCRAgs. Further, the present disclosure also comprises prevention methods, treatment methods, pharmaceutical and nutraceutical compositions and kits, and vaccines that comprise or utilize the SARS-CoV2 mCRAgs provided herein.
The present application relates to an adjuvant composition comprising: (i) a STING agonist of Formula (I) or a pharmaceutically acceptable salt thereof (I); and (ii) aluminium hydroxide, aluminium phosphate, aluminium oxyhydroxide, or aluminium hydroxyphosphate; immunogenic compositions comprising the adjuvant composition, their use in methods of immunising a subject, and related aspects thereof.
inter aliainter alia to particles comprising aluminium hydroxide and (a) a stabilising excipient selected from the list consisting of: octoxynol-9, polysorbate 20, polysorbate 80, sucrose, mannose, polyvinylpyrrolidone and glycine; and/or (b) histidine.
This application discloses a method for purifying pDNA, particularly pDNA that that can be used to produce RNA, the RNA preferably encoding a therapeutic or immunogenic peptide or polypeptide. The pDNA can be grown in a bacteria such as E. coli by culturing or fermenting bacteria containing the plasmid and obtaining and purifying the pDNA. The present method allows the pDNA to be obtained in high yield and with high purity. In one embodiment of the invention, the level of all non-pDNA materials can be significantly reduced by the process. In some embodiments, the ratio of supercoiled plasmid DNA (scDNA) to non-supercoiled pDNA (non-scDNA, such as open circular plasmid DNA (ocDNA)) can be increased by one or more process steps that separate or allow for separation of scDNA and ocDNA or process steps that increase the amount of scDNA to ocDNA.
The present disclosure provides T7 RNA polymerase variants, the use of which increases transcription efficiency and improves the quality and yield of the enzyme. Also provided are polynucleotides encoding the T7 RNA polymerase variants, host cells capable of expressing the T7 RNA polymerase variants, and methods of using the T7 RNA polymerase variants for high-efficiency transcription.
Provided herein are RNA that: are collectively self-amplifying in an intracellular environment, comprise N1-methylpseudouridines and uridines, and have a mole percentage or mole proportion of the N1-methylpseudouridines to the total of the uridines and the N1-methylpseudouridines or a mole ratio of the N1-methylpseudouridines to the uridines.
C12N 15/63 - Introduction of foreign genetic material using vectorsVectorsUse of hosts thereforRegulation of expression
C07H 21/02 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with ribosyl as saccharide radical
C12N 15/85 - Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
The present invention relates to immunogenic compositions and their use in providing protection against illness caused by infection with Shigella. The immunogenic compositions comprise Shigella GMMA with particular doses of O-antigen.
Compositions and methods are provided for stabilization of RNA encapsulated by lipid nanoparticles during lyophilization. Novel lyophilization processes are provided. These techniques may be used to prevent the need for cold chain storage.
Compositions and methods are provided for stabilization of RNA encapsulated by lipid nanoparticles during lyophilization. The compositions and methods involve the use of empty lipid nanoparticles to stabilize the lyophilized composition. These techniques may be used to prevent the need for cold chain storage and may also simplify the procedure at the clinic for reconstituting the vaccine to prepare an injectable composition.
Recombinant influenza B strain haemagglutinin antigens, polynucleotides encoding the antigens and immunogenic compositions comprising the antigens and polynucleotides.
A potency release assay for measuring the potency of drug product composition comprising self-amplifying mRNA (SAM) that encodes at least one immunogenic polypeptide or at least one therapeutic peptide and a non-viral delivery system is described. In one embodiment the drug product is a vaccine comprising SAM and a non-viral delivery system such as SAM/lipid nanoparticle (LNP) delivery system, a Cationic Nanoemulsion (CNE) delivery system, or another SAM delivery system. It is demonstrated that the potency of a SAM drug product can be assessed in an in vitro system, at the RNA amplification stage (agnostic assay), by measuring the amount of double-stranded RNA (dsRNA) in cells which have been transfected with the SAM in the drug product. Thus, dsRNA can be used as a surrogate endpoint for potency. It is demonstrated that there is a very high correlation between total dsRNA in a cell culture transfected with the SAM and the potency of the SAM based drug product.
The present invention relates to immunisation using carrier-formulated mRNA in conjunction with an adjuvant comprising a STING agonist, and to related aspects.
The present invention relates to a process for the production of purified O-polysaccharide – Exoprotein A (O-EPA) bioconjugates. In particular, the process comprises a purification of said bioconjugate comprising the steps of a first anion exchange chromatography prior to a hydroxyapatite chromatography followed by a hydrophobic interaction chromatography and subsequently a second anion exchange chromatography.
UNITED STATES OF AMERICA, as represented by THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)
Inventor
Vassilev, Ventzislav Bojidarov
Mallett, Corey
Rouxel, Ronan
Blais, Normand
Kanekiyo, Masaru
Graham, Barney Scott
Abstract
The present invention relates to a carrier-formulated mRNA comprising at least one coding sequence encoding an influenza HA stem polypeptide, and to related aspects.
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
A61K 31/7115 - Nucleic acids or oligonucleotides having modified bases, i.e. other than adenine, guanine, cytosine, uracil or thymine
The present invention relates to carrier-formulated mRNA comprising at least one coding sequence encoding an influenza HA stem polypeptide, and to related aspects.
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A61K 31/7105 - Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
A61K 31/7115 - Nucleic acids or oligonucleotides having modified bases, i.e. other than adenine, guanine, cytosine, uracil or thymine
UNITED STATES OF AMERICA, as represented by THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)
Inventor
Vassilev, Ventzislav Bojidarov
Mallett, Corey
Rouxel, Ronan
Blais, Normand
Kanekiyo, Masaru
Graham, Barney, Scott
Abstract
The present invention relates to influenza virus immunisation using at least one influenza HA stem polypeptide in conjunction with squalene emulsion adjuvants, and to related aspects.
A protein language natural language processing (NLP) system is trained to predict specific biophysiochemical properties. Amino acids of proteins are tokenized and masked. A first neural network is trained on a library of amino acid sequences in an unsupervised or self-supervised manner. The information obtained from the first phase of training is applied in a subsequent training operation via transfer learning, to a second neural network. In aspects, an annotated compact dataset is used to fine-tune the second neural network in a second phase of training, and in a supervised manner, to predict biophysiochemical properties of proteins, including TCR-epitope binding.
Haemophilus influenzaeMoraxella catarrhalisMoraxella catarrhalis, for use in subjects having chronic obstructive pulmonary disease (COPD), in particular for reducing the frequency of severe exacerbations (i.e. severe AECOPDs).
The present disclosure provides mutated PglB oligosaccharyltransferase enzymes that have the ability to efficiently catalyze the transfer of a saccharide from a lipid carrier to an asparagine reissue in a glycosylation motif on a protein. Also provided are polynucleotides encoding the mutated PglB oligosaccharyltransferase enzymes, host cells capable of expressing the engineered PglB oligosaccharyltransferase enzymes, and methods of using the engineered PglB oligosaccharyltransferase enzymes to make N-glycosylated proteins. Also provided are N-glycosylated proteins that are made using the engineered PglB oligosaccharyltransferase enzymes.
Described are methods for the preparation of a HPV vaccine composition by, for example (i) adsorbing one or more HPV antigen(s) on a metallic salt and, then (ii) adding a non adsorbed glycolipid based TLR4 ligand to the mixture obtained in (i). Resulting HPV vaccine compositions and uses thereof are also described.
The present invention relates to a nucleic acid encoding a HSV2 Fc receptor or immunogenic fragment or variant thereof for use in generating a cross reactive immune response against HSV1 in a subject. Also provided is a nucleic acid encoding a HSV1 Fc receptor or immunogenic fragment or variant thereof for use in generating a cross reactive immune response against HSV2 when administered to a subject.
The present invention relates to a HSV2 Fc receptor or immunogenic fragment or variant thereof for use in generating a cross reactive immune response against HSV1 in a subject. Also provided is a HSV1 Fc receptor or immunogenic fragment or variant thereof for use in generating a cross reactive immune response against HSV2 when administered to a subject.
Compounds useful as components of immunogenic compositions for the induction of an immunogenic response in a subject against infection, methods for their use in treatment, and processes for their manufacture are provided herein. The compounds comprise a nucleic acid construct comprising a sequence which encodes an interferon effector.
The present invention is directed to a nucleic acid suitable for use in treatment or prophylaxis of an infection with a coronavirus, preferably with a Coronavirus SARS-CoV-2, or a disorder related to such an infection, preferably COVID- 19. The present invention is also directed to compositions, polypeptides, and vaccines. The compositions and vaccines preferably comprise at least one of said nucleic acid sequences, preferably nucleic acid sequences in association a lipid nanoparticle (LNP). The invention is also directed to first and second medical uses of the nucleic acid, the composition, the polypeptide, the combination, the vaccine, and the kit, and to methods of treating or preventing a coronavirus infection, preferably a Coronavirus infection.
The present invention relates to antibiotic agents for use in the treatment of patients presenting with an exacerbation of chronic obstructive pulmonary disease (COPD). More particularly the present invention relates to antibiotic agents for use in the treatment of COPD exacerbations in patients that, through analysis, have been identified as having an increased concentration of the IL-1α and TNF-α cytokine biomarkers in a biological sample taken from said patient. The present invention is further directed to methods of diagnosing and methods of treating a patient presenting with an exacerbation of COPD, said methods including identifying the patient is suffering from an exacerbation that is associated with a bacterial infection.
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
A61K 31/43 - Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula , e.g. penicillins, penems
A61K 31/496 - Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
A61K 31/5383 - 1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
A61K 31/545 - Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula , e.g. cephalosporins, cefaclor, cephalexine
A61K 31/7036 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 31/7048 - Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin
A61K 31/7052 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
rpsrpsrpsA operon and/or 30S ribosomal protein S1 and to native outer membrane vesicles (nOMVs) obtained or obtainable from said genetically modified bacterial cells.
C12P 19/56 - Preparation of O-glycosides, e.g. glucosides having an oxygen atom of the saccharide radical directly bound to a condensed ring system having three or more carbocyclic rings, e.g. daunomycin, adriamycin
C12P 19/14 - Preparation of compounds containing saccharide radicals produced by the action of a carbohydrase, e.g. by alpha-amylase
C07J 63/00 - Steroids in which the cyclopenta[a]hydrophenanthrene skeleton has been modified by expansion of only one ring by one or two atoms
A61K 39/39 - Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
C12N 9/42 - Hydrolases (3.) acting on glycosyl compounds (3.2) acting on beta-1, 4-glucosidic bonds, e.g. cellulase
C12N 9/24 - Hydrolases (3.) acting on glycosyl compounds (3.2)
The present invention is directed to novel, modified FimH polypeptides, nucleic acids encoding them, and the use of the polypeptides and nucleic acids in the treatment and/or prevention of disease, in particular, urinary tract infection (UTI).
Streptococcus pyogenesStreptococcus pyogenesStreptococcus pyogenes197197; or (c) a variant, fragment and/or fusion of (a) or (b), improved conjugation methods, and uses of said conjugates for preventing or treating disease.
The present invention relates to the field of neisserial vaccine compositions (particularly gonococcal vaccine compositions) and the use of such compositions in medicine. More particularly, the present invention relates to genetically modified gonococci of strain FA1090 and outer membrane vesicles obtained therefrom. The invention also provides a process for preparing the genetically modified gonococci of the invention as well as immunogenic compositions and vaccines comprising the outer membrane vesicles of the invention.
C07K 14/22 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Neisseriaceae (F), e.g. Acinetobacter
C07K 14/22 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Neisseriaceae (F), e.g. Acinetobacter
A61K 39/00 - Medicinal preparations containing antigens or antibodies
94.
COVID-19 VACCINES WITH TOCOPHEROL-CONTAINING SQUALENE EMULSION ADJUVANTS
Provided are novel vaccines for prophylactic treatment of SARS-CoV-2 infections and COVID-19 and methods of making the vaccines, wherein the vaccines contain an oil-in-water emulsion comprising tocopherol and squalene.
The application discloses a truncated Fusobacterium nucleatum Fusobacterium adhesin A (FadA) protein wherein at least a signal peptide which is at least 80%, 85%, 90% or 95% identical to SEQ ID NO:8 is deleted from the N-terminus of the FadA protein. Polynucleotides and vectors encoding the truncated FadA protein and bacteriophage comprising a gene encoding FadA as well of methods of treating or preventing disease such as colorectal cancer or periodontitis are also disclosed in the application.
The present invention relates to antigen binding protein, and in particular monoclonal antibodies, with bind to a HSV gEgI heterodimer, and to the use of such in detection and potency assays or in therapy.
The present invention relates to antigen binding protein, and in particular monoclonal antibodies, with bind to a HSV gEgI heterodimer, and to the use of such in detection and potency assays and in therapy.
The present invention relates to the field of modified proteins, immunogenic compositions and vaccines comprising the modified proteins, their manufacture and the use of such compositions in medicine. More particularly, it relates to a modified EPA (Exotoxin A of Pseudomonas aeruginosa) protein. The modified EPA can be used as a carrier protein for other antigens, particularly saccharide antigens or other antigens lacking T cell epitopes.
A61K 47/68 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
C07K 14/21 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Pseudomonadaceae (F)
A61K 39/385 - Haptens or antigens, bound to carriers
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
A61K 39/385 - Haptens or antigens, bound to carriers
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
C07K 14/21 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Pseudomonadaceae (F)
patents
