Abstract: The present invention relates to neutralizing antibodies of the human pituitary adenylate cyclase activating polypeptide type I receptor (PAC1) and pharmaceutical compositions comprising such antibodies. Methods of treating or preventing headache conditions, such as migraine and cluster headache, using the neutralizing antibodies are also described.

Abstract: A method for treatment, prevention, or reduction of one-time or recurring viral outbreaks, for suppression of development or growth of chronic viral infections, or for prevention or treatment of viral infections, the method including, administering a synthetic lysine analog or mimetic, where the synthetic lysine analog or mimetic antagonizes or competes with an amino acid or other biological agent required by a virus to replicate or spread. Additionally, a composition to treat, prevent, or reduce one-time or recurrent viral outbreaks, suppress development or growth of chronic viral infections, or to prevent or treat viral infections, the composition including, a synthetic lysine analog or mimetic, where the synthetic lysine analog or mimetic antagonizes or competes with an amino acid or other biological agent required by a virus to replicate or spread.

Abstract: The present invention relates to polypeptides comprising at least one single domain antibody directed against vWF, vWF A1 domain, A1 domain of activated vWF, vWF A3 domain, gpIb and/or collagen, homologues of said polypeptides, and/or functional portions of said polypeptides, for the treatment for conditions which require a modulation of platelet-mediated aggregation and which overcomes the problems of the prior art. A further aspect of the invention is methods of production of said polypeptides, methods to coat devices with such polypeptides used in medical procedures (e.g. PCTA, stenting), methods and kits for screening for agents that modulate platelet-mediated aggregation and kits for the diagnosis of diseases related to platelet-mediated aggregation.

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: Compositions and methods of the present invention prevent, inhibit or reduce the toxic effects of proteins and toxins secreted from microbes. A method for neutralizing microbial protein products in a subject comprises administering a composition to the subject, said composition comprising plasma-derived IgM and optionally one or more excipients in a pharmaceutical carrier, wherein the composition is administered in an amount effective to neutralize the microbial protein products.

Abstract: A culture medium for culturing Clostridium difficile under aerobic culture conditions, the medium includes a nutrient medium that promotes growth of Clostridium difficile and amounts of thioglycolic and L-cystine effective to consume oxygen in the culture medium and facilitate growth of Clostridium difficile.

Abstract: Processes are described for the preparation of F-benzoxazinorifamycin I: and intermediates for conjugation with an antibody.

Abstract: The invention provides compositions and methods for utilizing synthetic human milk oligosaccharides as prebiotics.

Abstract: Monoclonal antibodies or antigen-binding fragments thereof, that bind to Clostridium difficile (C. difficile ) toxin A or toxin B and methods of using the same to detect or treat C. difficile infections and/or C. difficile -associated disease. C. difficile is a gram positive, anaerobic bacterium that causes gastrointestinal disease in humans. The bacteria are transmitted through feces and spread to food and other surfaces when people who are infected do not thoroughly wash their hands.

Abstract: The present invention relates to a composition which includes antibodies against one or more specified virus, bacteria and/or pathogen for use to improve dog health, wherein the composition is administered before 24 hours of age of the dog or between 24 hours and up to 90 days of age of the dog.

Abstract: Herein provided are compositions, methods of manufacture and methods of use pertaining to anti-alpha toxin antibodies and fragments.

Abstract: The present invention relates to methods and compositions for preventing and treating Staphylococcus aureus in a subject. Therapeutic compositions of the present invention comprise leukocidin E and/or D proteins or polypeptides and anti-leukocidin E and/or D antibodies. The invention further relates to methods of identifying inhibitors of LukE/D cytotoxicity and inhibitors of LukE/D-leukocyte binding.

Abstract: Provided are methods of reducing milk somatic cell count using L-arginine supplementation of lactating ruminant animals during gestation, and/or during the lactation phase post parturition to decrease somatic cell count in milk produced by the animals.

Abstract: The invention relates to methods of producing, and compositions comprising, an isolated alpha (2?8) or (2?9) oligosialic acid derivative bearing a non-reducing end enriched for one or more de-N-acetyl residues and resistant to degradation by exoneuraminidase. A representative production method involves: (i) treating an alpha (2?8) or (2?9) oligosialic acid precursor having a reducing end and a non-reducing end with sodium borohydride under conditions for de-N-acetylating the non-reducing end; and (ii) isolating alpha (2?8) or (2?9) oligosialic acid derivative having one or more de-N-acetylated residues and a non-reducing end that is resistant to degradation by exoneuraminidase. Isolated alpha (2?8) or (2?9) oligosialic acid derivatives that comprise a non-reducing end de-N-acetyl residue are provided, as well as antibodies specific for the derivatives, compositions comprising the derivatives, kits, and methods of use including protection against and detection of E. coli K1 and N.

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: 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 present invention relates to enterococcal cell wall components and their uses in the prevention and therapy of bacterial infection.

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: Virion-associated peptidoglycan hydrolases have a potential as antimicrobial agents due to their ability to lyse Gram positive bacteria on contact. Full-length HydH5, a virion-associated peptidoglycan hydrolase from the Staphylococcus aureus bacteriophage vB_SauS-phi-IPLA88, and two truncated derivatives, containing only the CHAP domain, exhibited high lytic activity against live S. aureus cells. Three different fusion proteins were created and showed higher staphylolytic activity than the parental enzyme or its deletion construct. Parental and fusion proteins lysed S. aureus cells in zymograms, plate lysis and turbidity reduction assays. In plate lysis assays, HydH5 and its derivative fusions lysed bovine and human S. aureus, S. aureus MRSA N315 strain, and human Staphylococcus epidermidis strains.

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: The present invention relates to monoclonal antibodies that bind or neutralize anthrax lethal factor (LF), edema factor (EF), and/or protective antigen (PA). The invention provides such antibodies, fragments of such antibodies retaining anthrax toxin-binding ability, fully human or humanized antibodies retaining anthrax toxin-binding ability, and pharmaceutical compositions including such antibodies. The invention further provides for isolated nucleic acids encoding the antibodies of the invention and host cells transformed therewith. Additionally, the invention provides for prophylactic, therapeutic, and diagnostic methods employing the antibodies and nucleic acids of the invention.

Abstract: The present invention relates to a streptococcal octapeptide AXYLXXLN, and preferably to the octapeptide AXYLZZLN, designated as peptide associated with rheumatic fever (PARF) that, through its interaction with human collagen, plays a crucial role in the pathogenesis of rheumatic fever. PARF therefore represents a marker for rheumatic fever associated strains and provides a target for therapies, and in particular preventive therapies.

Abstract: The present invention discloses isolated nucleic acid molecules encoding a hyperimmune serum reactive antigen or a fragment thereof as well as hyperimmune serum reactive antigens or fragments thereof from S. agalactiae, and methods for isolating such antigens and specific uses thereof.

Abstract: The present invention relates to monoclonal antibodies capable of recognizing and binding to the PBP2-a protein and to other proteins having sequences homologous to PBP2-a, including pathogenic species such as the methyciline-resistant Staphylococcus Aureus (MRSA), coagulase-negative Staphilococcus, Staphylococcus sciuri and Enterococcus, and any other bacteria containing the PBP2-a protein or homologous sequences. The invention also relates to the use of the monoclonal antibodies capable of recognizing and binding to the PBP2-a protein and to other proteins having sequences homologous to PBP2-a in a complementary immunodiagnostic test for detecting resistance to beta-lactam antibiotics.

Abstract: The invention relates to compositions and methods to prevent enteric infection in a subject at risk of such infection. In particular, the invention relates to the prevention of recurrence of infection by Clostridium difficile.

Abstract: Methods and compositions pertaining to botulinum neurotoxin (BoNT) light chain epitopes are provided. In particular, the methods and compositions relate to the use of real and mimetic BoNT light chain epitopes for generating an immune response in a subject, and for immunization against BoNT toxicity. Methods and compositions for detecting, isolating, and purifying BoNT epitopes and anti-BoNT antibodies are also provided.

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 current invention provides high-affinity antibodies to the Pseudomonas aeruginosa PcrV protein that have reduced immunogenicity when administered to treat Pseudomonas aeruginosa infections.

Abstract: A method for preserving a polypeptide comprising: (a) providing an aqueous solution of (i) the polypeptide, (ii) one or more sugars, and (iii) a compound of formula (I) or a physiologically acceptable salt or ester thereof and/or a compound of formula (II) or a physiologically acceptable salt or ester thereof; and (b) drying the solution to form a composition incorporating the polypeptide.

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 provides compositions and methods for the targeted bacteriostatic and antibacterial agents and for treatment of sepsis caused by infectious diseases, such as bacterial and fungal diseases. In one aspect, the invention provides methods and compositions for decreasing the levels of LPS in the circulation of an individual, e.g., a human patient with sepsis, e.g., gram negative septic shock. In one aspect, the invention is directed to chimeric proteins comprising the MD-2 polypeptide and an opsinizing agent, e.g., antibody Fc domains, or equivalent. In one aspect, the invention is directed to chimeric proteins comprising fragments or altered form of MD-2 polypeptide and an opsinizing agent, e.g., antibody Fc domains, or equivalent. The invention also provides pharmaceutical compositions comprising the chimeric polypeptides of the invention, and methods of making and using them, including methods for ameliorating or preventing sepsis.

Abstract: The present invention relates to combination vaccines and/or the combined use of immunogenic compositions for the treatment and/or prophylaxis of cattle against microbiological infections, wherein the infections are caused by M. bovis and at least one further cattle relevant pathogen. The combination vaccine as described herein comprises at least one M. bovis antigen, preferably the attenuated, avirulent M. bovis as provided herewith and one or more further immunologically active components effective for the treatment and/or prophylaxis of infections caused by a further pathogen of cattle.

Abstract: The present invention relates to monoclonal antibodies that bind or neutralize anthrax protective antigen (PA) toxin. The invention provides such antibodies, fragments of such antibodies retaining anthrax PA toxin-binding ability, fully human or humanized antibodies retaining anthrax PA toxin-binding ability, and pharmaceutical compositions including such antibodies. The invention further provides for isolated nucleic acids encoding the antibodies of the invention and host cells transformed therewith. Additionally, the invention provides for prophylactic, therapeutic, and diagnostic methods employing the antibodies and nucleic acids of the invention.

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 characterization and isolation of F20G75, F20G76 and F20G77, anti-PA monoclonal antibodies which also have neutralizing activities is described. The monoclonal antibodies may be used as a pharmaceutical composition for treating individuals suspected of or at risk of or having a Bacillus anthracis infection. The monoclonal antibodies bind to a specific region comprising amino acids 311-316 of PA, ASFFDI or a larger fragment comprising amino acids 301-330 of PA, SEVHGNAEVHASFFDIGSSVSAGFSNSNSS. Vaccines comprising these peptides may be used to immunize individuals against Bacillus anthracis infection.

Abstract: The present invention provides monoclonal antibodies which are highly specific for Bacillus spores. Also provided are peptides derived from those monoclonal antibodies. Both the antibodies and peptides are highly specific and can discriminate between spores of potentially lethal organisms such as Bacillus anthracis and other harmless but closely related bacilli and provide a very powerful tool in the construction of detection instruments as counter measures.

Abstract: In this application are described fully human monoclonal antibodies which specifically recognize F1 or V antigen of Y. pestis and epitopes recognized by these monoclonal antibodies. Also provided are mixtures of antibodies of the present invention, as well as methods of using individual antibodies or mixtures thereof for the detection, prevention, and/or therapeutical treatment of plague infections in vitro and in vivo.

Abstract: The present invention relates to novel nucleic acid molecules for producing target polypeptides in plant cells. More specifically, the novel nucleic acid molecules comprise a minireplicon derived from a Closteroviridae virus and heterologous polynucleotides encoding the target polypeptides. Also provided are compositions comprising the target polypeptides and uses thereof.

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: Disclosed are compositions, kits, and methods for inducing an immune response against disease. The dosage of antigen contained or utilized in the presently disclosed compositions, kits, and methods is substantially lower than dosages conventionally used in the field. The compositions, kits, and methods may be utilized to induce a cell-mediated response, such as a T-helper cell response, and/or a humoral response against a pathogen or a disease. In some embodiments, the compositions, kits, and methods may be utilized to induce preferentially a Th1 response versus other types of immune responses such as a Th2 response.

Abstract: This invention provides methods of treating patients having a Staphylococcus infection where the patient also has a low level of Pseudomonas aeruginosa. The methods comprise administering an antagonist of the Pseudomonas Type III Secretion System, e.g., an anti-PcrV antibody antagonist.

Abstract: The present invention provides a method of treatment or prophylaxis of enteric disease caused by Gram negative bacteria. The method includes the step of administering a vaccine or a hyperimmune material raised against said vaccine to an individual. The vaccine comprises one or more cell wall antigens reactive in a manner characteristic of O group serotypes, or reactive in a manner characteristic of lipopolysaccharide associated antigens, and at least some of said antigens are separated from bacterial cell walls or wall fragments. The invention also provides composition containing hyperimmune material as well as uses of the composition and vaccine.

Abstract: Described are human binding molecules specifically binding to enterococci and having killing activity against enterococci, nucleic acid molecules encoding the human binding molecules, compositions comprising the human binding molecules and methods of identifying or producing the human binding molecules. The molecules can be used in the diagnosis, prophylaxis, and/or treatment of a condition resulting from Enterococcus.

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 provides an antibody which binds to B. anthracis with toxin, formulations for administration of such antibodies intramuscularly, and methods of administering such antibodies prophylactically or therapeutically.

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