Abstract: The present invention provides novel immunotherapeutic compositions and methods useful for treating or preventing microbial infections, weakened immune systems, diseases in which cells have become obligately anaerobic and cellular proliferative disorders including cancer. The immunotherapeutics herein use benzaldehyde derivatives, precursors and intermediaries alone or in combination with additional therapeutic agents to stimulate the immune system and inhibit cellular proliferation.

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 invention relates to antigenic compositions and to methods for immunising animals using same. The antigenic compositions comprises a lipid formulation most usually in solid form, and at least one antigenic component. A preferred antigenic component is a living organism. In a preferred embodiment the composition is formulated for oral administration.

Abstract: The polynucleotides of the present invention are complementary to the Initiation Sites of microbes. Invading organisms, sensing the pH and nutrient deprivation of a physiologic environment quickly release these nucleotides triggering rapid growth and mutation—attributes to successfully establishing a nidus of infection. They also stimulate neutrophil functions. Accordingly, the nucleotides, compositions and methods of the present invention may be used to enhance, restore or stimulate an immune response or system of an animal, e.g. to prevent an infection caused by a microorganism, ameliorate an infection caused by a microorganism, or kill an invading microorganism that causes infection or re-establish balance to an immune system. In particular, the polynucleotides, compositions and methods of the present invention may be used to treat or prevent bacterial infections and auto-immune diseases in a mammal in need thereof.

Abstract: This invention relates to compositions and methods useful for treating various cancers. Therapeutic combinations and methods of use thereof are also covered in the present application.

Abstract: The invention relates to improved methods of producing and recovering B. anthracis protective antigen (PA), especially modified PA which is protease resistant, and to methods of using of these PAs or nucleic acids encoding these PAs for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of, B. anthracis bacterial infections and which are useful to prevent and/or treat illnesses caused by B. anthracis, such as inhalation anthrax, cutaneous anthrax and gastrointestinal anthrax.

Abstract: The invention relates to a composition of spores of nonpathogenic bacteria of the Bacillus genus, adsorbed onto a matrix made up of at least one water-insoluble adsorbent compound and a cellulose derivative, which can be obtained by the fluidized air bed technique, useful in the pharmaceutical, veterinary and nutrition fields.

Abstract: Transcutaneous immunization can deliver antigen to the immune system through the stratum corneum without physical or chemical penetration to the dermis layer of the skin. This delivery system induces an antigen-specific immune response. Use of skin-active adjuvants is preferred. Although perforation of intact skin is not required, superficial penetration or micropenetration of the skin can act as an enhancer; similarly, hydration may enhance the immune response. This system can induce antigen-specific immune effectors after epicutaneous application of a formulation containing one or more antigen and adjuvant. The formulation may initiate processes such as antigen uptake, processing, and presentation; Langerhans cell activation, migration from the skin to other immune organs, and differentiation to mature dendritic cells; contacting antigen with lymphocytes bearing cognate antigen receptors on the cell surface and their stimulation; and combinations thereof.

Abstract: An anthrax vaccine with alhydrogel as the adjuvant is presented in a composition formulated by mixing rPA with colloidal alhydrogel (alum) adjuvant to produce the final product, comprising 200 ?g/ml rPA bound to 0.26% alhydrogel in phosphate buffered saline (PBS), said formulation containing an optimal concentration of phosphate. Methods of using the vaccines to treat or prevent infections are also presented.

Abstract: Formulations of anthrax protective antigen are provided that are stable in storage for prolonged periods. Methods of using the formulations to prepare vaccine are also provided. Vaccines comprising the formulations are useful, for example, to protect against anthrax infection.

Abstract: The use of oxidatively transformed carotenoid or a component thereof to enhance the immune response in a subject for the treatment of infection or to enhance the immune response to an antigen in a subject being immunized. Also disclosed are pharmaceutical compositions and kits containing the oxidatively transformed carotenoid.

Abstract: The invention relates to a preservation composition, a formulation comprising a preservation mixture of glutamate, a saccharide, and a polymer. Said preservation mixture is advantageously used for the preservation of a biological compound.

Abstract: The present invention is directed to diagnostic tools and therapies using antibodies to Bacillus anthracis. Specifically, the present invention is directed to a B. anthracis-specific monoclonal antibody that binds to the EA1 antigen (corresponding to the eag gene) of the S-layer (surface layer) of spores. This monoclonal antibody may be used in a variety of applications, including to specifically detect and diagnose B. anthracis. Preferably, antibodies are monoclonal and bind to a surface protein, such as EA1 protein, on the spores of B. anthracis, and not to spores of either B. cereus or B. thuringiensis. Antibodies can be incorporated into detection kits using, for example, colloidal particle based lateral flow detection system. Such detection kits can distinguish anthrax spores from non-pathogenic varieties of spores. In addition, the invention is directed to B.

Abstract: Antitoxin and vaccine compositions based on nodavirus VLPs are provided. Anthrax antitoxin and vaccine compositions are provided. Methods of treating toxins with VLP-based antitoxins are provided. Methods of raising an immune response with immunogen decorated VLPs are provided.

Abstract: Improved (safer and more effective) methods of therapy using TNF-R agonists, e.g., CD40 agonists are provided. These methods provide for the addition of an amount of a type 1 interferon and/or a TLR agonist that is effective to prevent or reduce the toxicity (liver toxicity) that may otherwise result in some patients of the TNF-R agonist is used as a monotherapy (without the type 1 interferon and/r TLR agonist).

Abstract: The present invention relates to two-component lantibiotics isolated from Bacillus sp. Methods for producing said lantibiotics are provided, wherein dehydration and cyclization of the peptides is carried out by two substrate-specific modifying enzymes. Given the antimicrobial activity of the instant lantibiotics, methods for preventing or treating bacterial infections are also provided.

Abstract: An aqueous composition which comprises a protein or other biological molecule and also (i) optionally comprises one or more metal ions at a concentration of 0.01 to 20 mM; (ii) comprises excipients which are weak ligands; and (iii) is substantially free of excipients which are medium-strength ligands or strong ligands.

Abstract: The present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: The present invention relates to vaccines that are made in transgenic soybeans for use in humans, animals of agricultural importance, pets, and wildlife. These vaccines are used as vaccines against viral, bacterial, fungal, parasitic or prion related diseases, cancer antigens, toxins, and autologous or self proteins. The transgenic soybeans of the instant invention also can be used for inducing tolerance to allergens or tolerance to autoimmune antigens, wherein an individual shows hypersensitivity to said allergen or has developed autoimmunity to autologous or self proteins, respectively. The invention also relates to prophylactically treating individuals and/or populations prior to showing hypersensitivity to allergens. Other aspects of the invention include using the transgenic soybeans as an oral contraceptive, and the expression of protein adjuvants in transgenic soybeans.

Abstract: The invention relates to methods and compositions for the prevention and treatment of disease caused by B. anthracis or a bacterium which produces toxins or toxin components homologous to the virulence factors produced by B. anthracis or to the toxins or toxin components themselves, in the absence of bacteria. The methods and compositions of the invention comprise a combination of at least two antibodies, preferably monoclonal antibodies, most preferably human monoclonal antibodies, each of which binds with high affinity to a different epitope of one or more bacterial antigens.

Abstract: The present invention provides compositions comprising modified bacterial toxins and methods for using the modified bacterial toxins for targeting particular cell populations and for treating diseases.

Abstract: The present invention relates to a method for treating an infection or disease or lesion, in particular an HPV infection. Furthermore, it relates to a vaccine for treating a Human Papillomavirus (HPV) infection or an associated disease or lesion in a subject.

Abstract: Vaccines comprising TRAP polypeptides and Salmonella enteritidis vectors comprising TRAP polypeptides are provided. The vaccines may also include a CD 154 polypeptide capable of binding to CD4Q. Also provided are methods of enhancing an immune response against Apicomplexan parasites and methods of reducing morbidity associated with infection with Apicomplexan parasites.

Abstract: Compositions and methods effective for eliciting an immune response for preventing or reducing infection or improving clinical outcomes caused by Bacillus anthracis are provided. The compositions include a naturally occurring or synthetic protein, peptide, or protein fragment containing all or an active portion of an antigenic epitope associated with anthrax toxin proteins optionally combined with a pharmaceutically acceptable carrier. The preferred antigenic epitopes correspond to immunogenic regions of protective antigen, lethal factor or edema factor, either individually or in combination. In addition, methods and compositions containing antibodies for reducing the effects of anthrax toxins are described. The methods involve administering to a human or animal the compositions described herein in a dosage sufficient to elicit an immune response or treat the anthrax infection.

Abstract: Described herein are compositions that include a selected antigen, a TLR4 ligand and a TLR7/TLR8 ligand, wherein the antigen and TLR ligands are encapsulated in nanoparticles. Co-administration of both a TLR4 ligand and a TLR7/TLR8 ligand results in the synergistic induction of humor and cellular immunity as evidenced by an increase in pro-inflammatory cytokine production, an increase in the number of CD8+ T effector and T memory cells, an increase in titer of antigen-specific antibodies, an increase in antibody affinity, an increase in the proliferation of naïve B cells and/or a significant enhancement in the persistence of antibody and T cell responses. The compositions and methods provided herein can be used to stimulate an immune response such as an immune response to a pathogen or a tumor.

Abstract: The present invention relates to compounds which inhibit bacterial gyrase and pharmaceutically acceptable compositions comprising said compounds. These compounds, and compositions thereof, are useful in treating bacterial infection. Accordingly, the present invention also relates to methods for treating bacterial infections in mammals. The present invention also relates to a method for preparing these compounds.

Abstract: Disclosed are novel synthetically-modified B. thuringiensis chimeric crystal proteins having improved insecticidal activity against coleopteran, dipteran and lepidopteran insects. Also disclosed are the nucleic acid segments encoding these novel peptides. Methods of making and using these genes and proteins are disclosed as well as methods for the recombinant expression, and transformation of suitable host cells. Transformed host cells and transgenic plants expressing the modified endotoxin are also aspects of the invention.

Abstract: A polypeptide absorbable into digestive organs, which is linked with a bioactive polypeptide, and assists absorption of the bioactive polypeptide into digestive organs when it is orally taken; a fusion polypeptide comprising the polypeptide absorbable into digestive organs and the bioactive polypeptide; and an oral composition comprising the fusion polypeptide are provided.

Abstract: This invention provides methods and compositions for stabilizing proteins and vaccines in dried formulations. In particular, a cavitation method and compositions of preparing a dried vaccine are provided that stabilize the viability of live bacteria and live virus vaccines at room temperature.

Abstract: The present invention relates to conjugates of oligosaccharides of formula 1, wherein R is a linker to a carrier protein and optionally comprises up to three further saccharides, 5 and which are useful for vaccination, methods of synthesis of such conjugates, antibodies against this antigen, hybridoma producing monoclonal antibodies against this antigen, assays using these antibodies for the detection of B. anthracis spores and kits comprising these antibodies, and a vaccine for the prevention of B. anthracis infection comprising the conjugates of oligosaccharides of formula 1. Monoclonal antibodies 10 according to the invention selectively bind to B. anthracis, but not to related bacteria such as B. subtilis, B. cereus and other bacteria of this group such as B. thuringiensis.

Abstract: The invention overcomes the deficiencies of the prior art by providing antibody compositions having improved affinities for Bacillus anthracis antigens. The compositions have important thereapeutic and diagnostic applications, including treatment or detection of infection by Bacillus anthracis.

Abstract: Anthrax toxin, comprising of protective antigen (PA), lethal factor (LF) and edema factor (EF) is a major virulent factor of B. anthracis. Protective antigen, PA is the main component of all the vaccines against anthrax. The protective efficacy of PA is greatly increased if small quantities of LF of EF are incorporated into the vaccines. An ideal vaccine against anthrax should contain PA, LF and EF together, but this combination would be toxic. Therefore, the biologically inactive mutant preparations of PA, LF and EF may be used together for better immunoprotection. The present invention describes the method for generation of recombinant vaccine against anthrax, comprising of non-toxic, mutant anthrax toxin proteins. The procedure involves site-directed mutagenesis of the native genes of the toxin proteins, the expression and purification of the mutant proteins and finally characterization of these proteins.

Abstract: The present invention relates to the use of polypeptides related to a Bacillus licheniformis polypeptide (amino acids 1-85 of SEQ ID NO: 2) as antimicrobial agents, for example in pharmaceutical applications, including veterinary applications, as well as for preservation, cleaning and disinfection of various surfaces, objects and substances. The polypeptides may in particular be used to treat textiles or laundry, e.g., in detergents, for reducing microbes on textile or laundry, and/or for odor reduction. The invention also relates to use of Bacillus strains producing these polypeptides as antimicrobial agents. Examples of microorganism inhibited by Lento are Gram positive bacterial strains, such as Bacillus cereus, and various species of Corynebacterium, Enterococcus, Micrococcus, Streptococcus, and Staphylococcus.

Abstract: The invention particularly relates to inhibition of the cleavage of protective antigen (PA) of Bacillus anthracis, which subsequently leads to inhibition of activity of anthrax toxin.

Abstract: Polyelectrolyte nanoparticle compositions for biomedical applications are provided comprising at least two carrier domains comprising multivalent ionic domains and an agent exhibiting biological activity when contained within the nanoparticle or on the nanoparticle surface. The multivalent ionic domains may be contained in two separate molecules or in separate but linked domains of a single molecule. The nanoparticle optionally can further comprise an exposed targeting ligand and/or protective surface. The nanoparticle can be contacted to cells or administered directly to an animal for biomedical applications including therapeutics and immune response. The nanoparticle may alternatively be comprised of a carrier material capable of delivering various medically important antigens as vaccine.

Abstract: Provided are immunogenic compositions and methods for eliciting an immune response against B. anthracis and other bacteria that contain 3-methyl-3-hydroxybutyrate- or 3-hydroxybutyrate-substituted saccharides. Conjugates of 3-methyl-3-hydroxybutyrate- or 3-hydroxybutyrate-substituted saccharides elicit an effective immune response against B. anthracis spores in mammalian hosts to which the conjugates are administered.

Abstract: An evolvable production strain of B. subtilis exhibiting continuous or high level expression during protein evolution is described. An evolved Bacillus subtilis pstS promoter facilitates screening and production of secreted proteins.

Abstract: The present invention discloses a composition comprising an immunogenic sequence or a fragment thereof and TEM8 or a fragment thereof, where the TEM8 or the fragment functions as an adjuvant and enhances the eilicitation of immune responses mediated by the immunogenic sequence or the fragment thereof. Also disclosed herein is the use of such compositions in the treatment of cancer or pathogen associated diseases.

Abstract: The invention provides processes for improving the ability of a peptide to stimulate an immune response, comprising exposing the peptide to a chemical modifying agent. It further provides compositions comprising an antigenic peptide, wherein the peptide has been treated with a chemical modifying agent to improve its ability to stimulate an immune response. It also provides methods of stimulating an immune response in a mammal, comprising administering to the mammal an effective amount of a vaccine.

Abstract: Free-living microbes are provided in which the nucleic acid has been modified so that the microbe is attenuated for proliferation and/or which comprise genetic mutations that attenuate the ability of the microbe to repair its nucleic acid. Methods of using the modified microbes for the loading, activation, and/or maturation of antigen-presenting cells are also provided. Vaccine compositions comprising the modified microbes and/or the antigen-presenting cells and methods of using the vaccines are also provided. The microbes may be further modified to include heterologous antigens, such as tumor antigens or infectious disease antigens, for use as a vaccine against cancer or infectious diseases.

Abstract: Immunogenic compositions comprising growth regulatable recombinant intracellular pathogens that have been transformed to express recombinant immunogenic antigens of the same or other intracellular pathogens are provided. Exemplary immunogenic compositions include, but are not limited to, growth regulatable and growth limited recombinant intracellular pathogen immunogenic compositions.

Abstract: The present invention provides novel peptides which specifically targets and binds to dendritic cells. Also provided are fusion compositions comprising these peptides and a non-dendritic protein of fragments thereof. Further provided are DNA sequences encoding these peptides and fusion compositions. Methods of using the peptides or fusion compositions to promote an immune responses in an individual via administration also are provided.

Abstract: Compositions and methods for intranasal delivery of antigens for immunization of a mammal are disclosed. Antigens include, peptides, proteins, peptidomimetics, DNA, RNA, carbohydrates and phospholipids. The compositions contain at least one antigen and a permeation enhancer.

Abstract: The present composition combines an RNAIII-inhibiting peptide (RIP) with an antimicrobial peptide, such as a cathelicidin, that is capable of binding and neutralizing lipidic and polyanionic components of bacterial cell envelope. In another embodiment, the RIP is combined with an antibiotic, with or without an antimicrobial peptide. The present composition is advantageously used in a method of treatment of bacterial sepsis.

Abstract: The invention relates to improved methods of producing and recovering B. anthracisprotective antigen (PA), especially modified PA which is protease resistant, and to methods of using of these PAs or nucleic acids encoding these PAs for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of, B. anthracis bacterial infections and which are useful to prevent and/or treat illnesses caused by B. anthracis, such as inhalation anthrax, cutaneous anthrax and gastrointestinal anthrax.

Abstract: The main drawback in the use of most nucleoside anticancer agents originates from their hydrophilic nature, of which property requires a high and frequent dosage for an intravenous administration. Unlike other nucleoside anti-tumor agents, troxacitabine appears to predominantly enter tumor cells by passive diffusion rather then by using nucleoside transporters, although this may be model dependent. Accordingly, in the present work, a small library of twenty troxacitabine prodrugs has been synthesized using a parallel approach in order to evaluate the relationship between the lipophilicity of the prodrugs and their antitumor activity. Biological evaluation of the prodrugs on two non-small cell lung cancer cell lines (A549 and SW1573) and in pancreatic cell lines clearly showed better antitumor activity than that of troxacitabine, with IC50 values in the nanomolar range.

Abstract: An immunogenic reagent which produces an immune response which is protective against Bacillus anthracis, said reagent comprising one or more polypeptides which together represent up to three domains of the full length Protective Antigen (PA) of B. anthracis or variants of these, and at least one of said domains comprises domain 1 or domain 4 of PA or a variant thereof. The polypeptides of the immunogenic reagent as well as full length PA are produced by expression from E. coli. High yields of polypeptide are obtained using this method. Cells, vectors and nucleic acids used in the method are also described and claimed.

Abstract: Disclosed is a newly identified and characterized type III secretion system in Aeromonas salmonicida. The invention also encompasses the use of components of the novel secretion system in immunoprotection against A. salmonicida infection, as well as other diagnostic and therapeutic uses thereof.

Abstract: The invention provides nucleic acids, and variants and fragments thereof, obtained from strains of Bacillus thuringiensis encoding polypeptides having pesticidal activity against insect pests, including Lepidoptera. Particular embodiments of the invention provide isolated nucleic acids encoding pesticidal proteins, pesticidal compositions, DNA constructs, and transformed microorganisms and plants comprising a nucleic acid of the embodiments. These compositions find use in methods for controlling pests, especially plant pests.

Abstract: The present invention discloses compositions derived from an isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain, suitable for topical application to the skin or mucosal membranes of a mammal, which are utilized to inhibit the growth of bacterium, yeast, fungi, virus, and combinations thereof. The present invention also discloses methods of treatment and therapeutic systems for inhibiting the growth of bacterium, yeast, fungi, virus, and combinations thereof, by topical application of therapeutic compositions which are comprised, in part, of isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain.