Abstract: The Sequence Listing associated with this application is provided in text form in lieu of a paper copy, and is hereby incorporated by reference into the specification. The name of the text file containing the Sequence Listing is SequenceListing.txt. The text file is 36.3 KB, and was created on Sep. 30, 2020.

Abstract: The present invention relates to an immunoglobulin-binding protein, wherein at least one asparagine residue has been mutated to an amino acid other than glutamine or aspartic acid, which mutation confers an increased chemical stability at pH-values of up to about 13-14 compared to the parental molecule. The protein can for example be derived from a protein capable of binding to other regions of the immunoglobulin molecule than the complementarity determining regions (CDR), such as protein A, and preferably the B-domain of Staphylococcal protein A. The invention also relates to a matrix for affinity separation, which comprises an immunoglobulin-binding protein as ligand coupled to a solid support, in which protein ligand at least one asparagine residue has been mutated to an amino acid other than glutamine.

Abstract: The present invention relates to an immunoglobulin-binding protein, wherein at least one asparagine residue has been mutated to an amino acid other than glutamine or aspartic acid, which mutation confers an increased chemical stability at pH-values of up to about 13-14 compared to the parental molecule. The protein can for example be derived from a protein capable of binding to other regions of the immunoglobulin molecule than the complementarity determining regions (CDR), such as protein A, and preferably the B-domain of Staphylococcal protein A. The invention also relates to a matrix for affinity separation, which comprises an immunoglobulin-binding protein as ligand coupled to a solid support, in which protein ligand at least one asparagine residue has been mutated to an amino acid other than glutamine.

Abstract: An isolated protein or peptide selected from the group consisting of Bordetella colonization factor A (BcfA) protein and antigenic fragments thereof is described, along with an isolated nucleic acid encoding the same, antibodies that bind to the same, methods of producing an immune response in a mammalian subject in need thereof by administering the proteins, peptides or antibodies, and pharmaceutical compositions comprising the same.

Abstract: The invention is directed to compositions and methods for generating or enhancing the immune system of a patient against infection by a pathogen, and in particular MTB. Compositions of the invention contain one or more non-naturally occurring antigens that generate an effective cellular or humoral immune response to MTB and/or antibodies that are specifically reactive to mycolic acid or to the surface of MTB. The greater activity of the immune system generated by a vaccine of the invention involve an conjugation of peptides to increase in the generation of memory T cells that provide for a greater and/or longer lived or extended response to an MTB infection. Preferably a response involves an increased generation of antibodies that enhance immunity against MTB infection and promote an enhanced phagocytic response.

Abstract: A method for diagnosing Lyme disease status in a mammal is provided. The method entails, in a biological sample obtained or derived from a mammal, determining antibodies to Borrelia burgdorferi (B. burgdorferi) outer surface proteins (Osp) OspA, OspC, and OspF. Based upon determining the OspA, OspC, and OspF antibodies, the mammal can be diagnosed as vaccinated, not vaccinated, infected or not infected with B. burgdorferi. Mammals that have early, intermediate or chronic B. burgdorferi infection can also be identified. The method is particularly suited for use with horses and dogs. Isolated or recombinant B. burgdorferi antigens and compositions that contain them are also provided.

Abstract: This disclosure relates to combination therapies comprising anti-Pseudomonas Psl and PcrV binding molecules and related compositions, for use in prevention and treatment of Pseudomonas infection.

Abstract: The present invention is directed to a monoclonal antibody that binds specifically to a Staphylococcus aureus glucosaminidase and inhibits in vivo growth of S. aureus. Also disclosed are monoclonal antibody binding portions, recombinant or hybridoma cell lines, pharmaceutical compositions containing the monoclonal antibody or binding portions thereof, and methods of treating S. aureus infection and osteomyelitis, and methods for introducing an orthopedic implant into a patient using the monoclonal antibody, binding portion, or pharmaceutical composition of the present invention.

Abstract: The invention provides anti-wall teichoic acid antibodies and antibiotic conjugates thereof, and methods of using the same.

Abstract: The invention provides anti-wall teichoic acid antibodies and antibiotic conjugates thereof, and methods of using the same.

Abstract: This present invention describes the derivation and selection of antibodies capable of neutralising the major exotoxins; TcdA and TcdB of Clostridium difficile. The invention also describes novel neutralisation and antigen binding properties of individual Mabs and mixtures thereof.

Abstract: The invention provides a two-step chromatography process for small and large-scale purification of proteins, specifically monoclonal antibodies, using only four buffer solutions made from a mother solution.

Abstract: Compositions and methods for the treatment or prevention of Staphyloccus aureus infection in a subject are provided. Antibody compositions comprising monoclonal antibodies to alpha-hemolysin protein are also provided. The methods provide administering a composition to the subject in an amount effective to reduce or eliminate or prevent relapse S. aureus bacterial infection and/or induce an immune response to Staphylococcus aureus alpha-hemolysin.

Abstract: The invention concerns a peptide or arrangement of peptides forming a Staphylococcus aureus epitope binding site comprising a first amino acid sequence and a second amino acid sequence, wherein the first amino acid sequence is at least 88% identical to sequence SEQ ID NO:1 and wherein the second amino acid sequence is at least 88% identical to sequence SEQ ID NO: 2.

Abstract: The disclosure relates to an anti-Pseudomonas PSL binding molecule and uses thereof, in particular, in prevention and treatment of Pseudomonas infection. Furthermore, the disclosure provides compositions and methods for preventing and treating Pseudomonas infection.

Abstract: The present invention relates to an isolated antigen from Streptomyces coelicolor that is useful for developing, inter alia, vaccines against pathogenic bacteria of humans and animals. The present invention also relates to vaccines and antibodies developed using the isolated antigen. The present invention also relates to methods of using the antigen, vaccines, and antibodies of the present invention to detect, treat, and prevent infection and diseases associated with pathogenic bacteria.

Abstract: The present invention provides PBP2a peptide antigens for generating antibodies against MRSA, and provides high-affinity binding agents that detect MRSA by selective immunoreactivity with PBP2a. The antibodies are useful in methods and systems for detecting MRSA, including biosensor systems, or as components of diagnostic or detection kits. The antibodies, in some embodiments, have therapeutic value against MRSA infection.

Abstract: Hybridoma cell lines which produce and secrete monoclonal antibodies which selectively bind to Mycobacterium avium subspecies paratuberculosis have been produced. Cells of M. avium subspecies paratuberculosis in biological samples may be detected and quantified by contacting the sample with the antibodies to form a M. avium subspecies paratuberculosis/antibody immunocomplex when M. avium subspecies paratuberculosis is present, which immunocomplex may then be detected. The monoclonal antibodies also may be incorporated into kits for the detection and quantification of M. avium subspecies paratuberculosis.

Abstract: Compositions and methods are provided that are useful to treat respiratory diseases such as whooping cough. Further, compositions and methods of immunizing are provided.

Abstract: The present invention features, inter alia, compositions and methods for the treatment of cancer and infectious disease. The compositions include engineered proteins that specifically bind a metal chelate and may be bispecific. For example, the engineered proteins may bind (a) a target (e.g., a cellular protein) on a cancerous cell or a pathogen and (b) a metal chelate comprising DOTA, or an active variant thereof, and a metal ion such as a radionuclide. By virtue of the multiple binding sites, the engineered protein effectively delivers a metal chelate to a cell one wishes to destroy.

Abstract: The present invention concerns methods and compositions for treating or preventing a bacterial infection, particularly infection by a Staphylococcus bacterium. The invention provides methods and compositions for providing a passive immune response against the bacteria. In certain embodiments, the methods and compositions involve an antibody, such as a recombinant antibody, that binds IsdA and/or IsdB polypeptides.

Abstract: A polypeptide, designated as “Streptococcus uberis Adhesion Molecule” (SUAM), and fragments of SUAM, prevent internalization and adherence of Streptococcus uberis and other streptococcal pathogens to cells. The SUAM polypeptide and fragments may be used diagnostically and therapeutically. Nucleic acid sequences encoding the SUAM polypeptide and fragments are included in the invention.

Abstract: Disclosed herein are compositions and methods for the isolation and purification of antibodies from a sample matrix. In particular, the present invention relates to compositions and methods for isolating and purifying antibodies exhibiting weak binding strength and low binding capacity for Protein A resin. In certain embodiments, the methods herein employ a kosmotropic salt solution, an affinity chromatographic step, and may include one or more additional chromatography and/or filtration steps to achieve the desired degree of purification. The present invention is also directed toward pharmaceutical compositions comprising one or more antibodies purified by a method described herein.

Abstract: The present invention relates to antibodies immunologically specific for an attaching and effacing Escherichia coli (AEEC) virulence-associated protein, products, compositions and methods and to their use thereof in the prevention of an AEEC infection in a mammal. The antibody of the invention is immunologically specific for an AEEC virulence-associated protein and is capable of preventing an in vivo AEEC intestinal infection when administered to a mammal. The antibody of the invention is preferably useful for preventing the development of A/E intestinal lesions associated with the AEEC. This is achieved by preferably using IgY antibodies immunologically specific for one or more AEEC virulence-associated proteins, such as Eae, Tir, EspA and Paa.

Abstract: The present specification discloses SNAP-25 compositions, methods of making ?-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, ?-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, methods of detecting BoNT/A activity, and methods of detecting neutralizing ?-BoNT/A antibodies.

Abstract: The present invention relates to a method of separating one or more immunoglobulin containing proteins from a liquid. The method includes first contacting the liquid with a separation matrix comprising ligands immobilised to a support; allowing the immunoglobulin containing proteins to adsorb to the matrix by interaction with the ligands; followed by an optional step of washing the matrix containing the immunoglobulin containing proteins adsorbed thereon; and recovering said immunoglobulin containing proteins by contacting the matrix with an eluent which releases the proteins.

Abstract: The invention concerns antibodies or fragments thereof that are directed against a Staphylococcus aureus epitope.

Abstract: A novel and rapid diagnostic method for anthrax infection is provided. Three B. anthracis gene products are described, as well as antibodies against the same, which may be used for the detection and monitoring of anthrax infection. Kits for the diagnosis of anthrax are also provided.

Abstract: The present invention provides a Mycoplasma pneumoniae community acquired respiratory distress syndrome (CARDS) toxin, biologically active fragments/domains of the CARDS toxin, antibodies to the CARDS toxin and nucleic acids encoding the CARDS toxin. Also provided are methods of diagnosing, treating and/or preventing infection by Mycoplasma pneumoniae using the compositions provided herein.

Abstract: The present invention provides compositions including antibodies that specifically bind at least one siderophore receptor polypeptide from a gram positive microbe. The present invention also provides methods of making and methods of using such compositions.

Abstract: Isolated peptides of the Bacillus anthracis Anthrax Toxin Lethal factor Protein pX01-107, antibodies specific for the peptides and methods of stimulating the immune response of a subject to produce antibodies to the Bacillus anthracis Anthrax Toxin Lethal factor Protein pX01-107 are disclosed. Also disclosed are isolated peptides of the Small Pox Virus Surface Antigen S Precursor Protein, antibodies specific for the peptides and methods of stimulating the immune response of a subject to produce antibodies to the Small Pox Virus Surface Antigen S Precursor Protein.

Abstract: The present invention relates to an antibody against a protein specifically expressed in methicillin-resistant strains of Staphylococcus aureus (MRSA), and a method and a kit for detecting MRSA. The present invention enables a fast and accurate detection of MRSA by using both a PBP2a-specific antibody for the detection of PBP2a and a Protein A-specific antibody for the detection of Protein A.

Abstract: An antigenic composition comprises several antigenic components derived from antigens of Streptococcus equi subsp. equi or subsp. zooepidemicus, wherein at least one component is a fusion protein or polypeptide comprising two or more such antigens or fragments thereof. The antigenic composition may be used for immunization of mammals against S. equi subsp. equi and/or subsp. zooepidemicus. A vaccine composition comprising the antigenic composition as immunizing component is also disclosed.

Abstract: Provided herein are reagents, compositions, and therapies with which to treat Clostridium difficile infection and related disease conditions and pathologies, such as Clostridium difficile-associated diarrhea, resulting from infection by Clostridium difficile bacteria and the enterotoxins produced by these bacteria. In particular, antibodies or antigen-binding fragments thereof that bind specifically to toxin A and/or toxin B of C difficile and neutralize the activities of these toxins; compositions comprising such antibodies; and methods of using the antibodies and the compositions are provided.

Abstract: The present disclosure relates to monoclonal antibodies that bind poly-?-D-glutamic acid (?DPGA), which is present on the surface of Bacillus anthracis. The disclosure also provides chimeric forms of the monoclonal antibodies, humanized forms of the monoclonal antibodies, and fragments thereof, as well as nucleic acids encoding the antibodies and fragments thereof. Pharmaceutical compositions including such antibodies are also disclosed herein. The disclosure further provides prophylactic, therapeutic, and diagnostic methods of using the disclosed antibodies.

Abstract: Monoclonal antibodies which can bind to the SdrF protein of Staphylococcus epidermidis are provided which can be useful in the treatment and protection against infection from staphylococcal bacteria such as Staphylococcus epidermidis. The monoclonal antibodies of the invention are advantageous in that they can also recognize binding domains and subdomains of the S. epidermidis SdrF protein in addition to the protein itself. Suitable compositions and passive vaccines based on the monoclonal antibodies of the invention, as well as methods for their use, are also provided.

Abstract: Disclosed herein are isolated and purified Staphylococcus aureus bi-component leukocidin, referred to herein as LukAB, and its components LukA and LukB, antibodies specific to LukA, antibodies specific to LukB, therapeutic compositions containing LukA and/or LukB, or anti-LukA and/or anti-LukB antibodies, uses of the compositions to treat acute inflammatory conditions or S. aureus infection, methods for identifying inhibitors of LukAB-mediated cytotoxicity of human phagocytes, and methods for using LukAB as a marker to predict severity of S. aureus infection.

Abstract: Isolated human monoclonal antibodies which bind to Anthrax protective antigen are disclosed. The human antibodies can be produced in a non-human transgenic animal, e.g., a transgenic mouse, capable of producing multiple isotypes of human monoclonal antibodies by undergoing V-D-J recombination and isotype switching. Also disclosed are derivatives of the human antibodies (e.g., bispecific antibodies and immunoconjugates), pharmaceutical compositions comprising the human antibodies, non-human transgenic animals and hybridomas which produce the human antibodies, and therapeutic and diagnostic methods for using the human antibodies.

Abstract: The vaccine that is protective against pathogenic bacterial species, typically staphylococcal species, and including methods to prepare said vaccine and to culture pathogenic bacteria.

Abstract: The present invention relates to methods for the control of virulence of infectious bacteria by modulating the extra-cellular concentration of bacterial cell signalling molecules. Derivatives of cell signalling molecules are conjugated to suitable carrier proteins and used to isolate high affinity receptors recognising the native signal molecule(s). By binding to signalling molecules, the receptors reduce and maintain extra-cellular concentrations of signal molecules below the threshold level that would otherwise result in certain opportunistic pathogens adopting a virulent form, and can transform virulent organisms to non-virulent states. These receptors have applications for the treatment of individuals with susceptibility to infection, the treatment of patients with existing infections, in disease monitoring and management, and in related applications where the host for infection is an animal or plant.

Abstract: The invention relates to a method for in vitro seriological diagnosis of Whipple's disease, whereby the bacteria responsible for the disease are isolated and established in a culture and brought into contact with the serum or biological fluid of an infected patient. The invention also relates to useful oligonucleotides with a probe and a primer for amplifying, sequencing and detecting the gene rpoB of the bacteria, Tropheryma whippelii.

Abstract: The present invention encompasses monoclonal and chimeric antibodies that bind to lipoteichoic acid of Gram positive bacteria. The antibodies also bind to whole bacteria and enhance phagocytosis and killing of the bacteria in vitro and enhance protection from lethal infection in vivo. The mouse monoclonal antibody has been humanized and the resulting chimeric antibody provides a previously unknown means to diagnose, prevent and/or treat infections caused by gram positive bacteria bearing lipoteichoic acid. This invention also encompasses a peptide mimic of the lipoteichoic acid epitope binding site defined by the monoclonal antibody. This epitope or epitope peptide mimic identifies other antibodies that may bind to the lipoteichoic acid epitope. Moreover, the epitope or epitope peptide mimic provides a valuable substrate for the generation of vaccines or other therapeutics.

Abstract: The present invention discloses crystal structure of Staphylococcus aureus Clumping factor A (ClfA) in complex with fibrinogen (Fg) derived peptide. Also, the present invention also discloses the use of this structure in the design of ClfA targeted vaccines and therapeutic agents (including monoclonal antibodies). In addition, the present invention discloses isolated and purified engineered Staphylococcus clumping factor A protein (ClfA) with a stabilized, closed conformation and immunogenic compositions thereof including methods of treating a Staphylococcus infection in an individual.

Abstract: The present invention relates to methods and systems for administering antibody therapeutic agents. The methods include administering one or more (e.g., two or three) binding agents, wherein each of the binding agents has one or more monomers that have a binding region that is specific to a portion of a disease agent and one or more copies of a tag. The binding agents can be specific to one or more portions of the same or different disease agents. The tag is the same for each of the binding agents. The methods include administering an anti-tag antibody, wherein the anti-tag antibody has an anti-tag region that is specific to the tag, and can have an immunoglobulin (e.g., IgA, IgD, IgE, IgG, and IgM). Disease agents include bacteria, bacterial proteins, viruses, viral proteins, cancer cells, and proteins or toxins produced therefrom or from other sources such as snakes, insects, plants, etc.

Abstract: Provided herein are compositions and methods for eliciting an immune response against Streptococcus pneumoniae. More particularly, the compositions and methods relate to immunogenic polypeptides, including fragments of PhtD and variants thereof, and nucleic acids, vectors and transfected cells that encode or express the polypeptides. Methods of making and using the immunogenic polypeptides are also described.

Abstract: The invention relates to the field of the diagnosis of and vaccination against Streptococcal infections, and to the detection of virulence markers of Streptococci. The invention discloses a method for modulating virulence of a Streptococcus comprising modifying a genomic fragment of the Streptococcus, wherein the genomic fragment comprises at least a functional part of a fragment identifiable by hybridization in Streptococcus suis to a nucleic acid or fragment thereof.

Abstract: The present invention is related to nucleic acids coding for adhesion factors of group B streptococcus, adhesion factors of group B streptococcus and uses thereof. More particularly, the present invention is related to a polypeptide being such adhesion factors and comprising an amino acid sequence, whereby the amino acid sequence is selected from the group comprising SEQ ID NO 11 to SEQ ID NO 20, and the use of such polypeptide for the manufacture of a vaccine.

Abstract: Isolated monoclonal antibodies that bind and/or neutralize anthrax protective antigen (PA) are disclosed as well as hybridomas secreting such antibodies. The invention also provides anti-PA fragments of the antibodies of the invention and recombinantly produced antibodies. Also provided are pharmaceutical compositions containing the antibodies or antibody fragments and uses and methods involving same.

Abstract: The disclosure provides specific and sensitive anti-toxin B antibodies and fragments thereof suitable for diagnosing Clostridium difficile infection. The antibodies and fragments recognize an epitope in the C-terminal 250-amino-acid region of toxin B of C. difficile, including epitopes defined by protein repeat sequences in this region of toxin B. This disclosure also provides the toxin B-specific epitope in the C-terminal 250-amino-acid region of toxin B of C. difficile for use in vaccine development as well as in the treatment of CDI disease and in treatment of the relapse of CDI disease. Also provided are toxin B polypeptides lacking the cytotoxic domain useful in treating or preventing CDI disease. PCR-based diagnostic assays targeting the 750-nucleotide region at the 3? end of tcdB are also provided.

Abstract: Disclosed is a monoclonal antibody having very high affinity to anthrax toxin and potent toxin-neutralizing activity. Also disclosed are a composition for neutralizing anthrax toxin comprising the antibody and a kit for detecting anthrax toxin.