Abstract: This invention relates to a novel target for production of immune and non-immune based therapeutics and for disease diagnosis. More particularly, the invention provides therapeutic antibodies against VSIG1, ILDR1, LOC253012, AI216611, C1ORF32 or FXYD3 antigens, which are predicted co-stimulatory family members and which are differentially expressed in cancers including, lung cancer, ovarian cancer, and colon cancer, and diagnostic and therapeutic usages. The use of these antibodies for modulating B7 costimulation and related therapies such as the treatment of autoimmunity are also provided. This invention further relates to the discovery of extracellular domains of VSIG1 and its variants, FXYD3 and its variants, ILDR1 and its variants, LOC253012 and its variants, AI216611 and its variants, and C1ORF32 and its variants awhich are suitable targets for immunotherapy, cancer therapy, and drug development.

Abstract: The present invention relates to the field of recombinant toxin protein production in bacterial hosts. In particular, the present invention relates to production processes for obtaining high levels of a recombinant CRM197, Diphtheria Toxin, Pertussis Toxin, Tetanus Toxoid Fragment C, Cholera Toxin B, Cholera holotoxin, and Pseudomonas Exotoxin A, from a bacterial host.

Abstract: The invention relates to a chimeric monomer-dimer hybrid protein wherein the protein comprises a first and a second polypeptide chain, the first polypeptide chain comprising at least a portion of an immunoglobulin constant region and a biologically active molecule, and the second polypeptide chain comprising at least a portion of an immunoglobulin constant region without the biologically active molecule of the first chain. The invention also relates to methods of using and methods of making the chimeric monomer-dimer hybrid protein of the invention.

Abstract: The present invention relates to immunogenic compositions comprising CMV antigens and methods for preparing compositions that contain CMV antigens. The invention also relates to methods for inducing an immune response to CMV.

Abstract: A procine circovirus type-2 (PCV2) immunogenic composition includes an antigenic peptide. The antigenic peptide is a non-arginine-rich peptide of a PCV2 open reading frame 2 (ORF2) and/or a recombinant fusion protein having the non-arginine-rich peptide of the PCV2 ORF2, a PE peptide, and a KDEL signal peptide. The number of arginines of the non-arginine-rich peptide of the PCV2 ORF2 is not greater than half of the number of arginines of the arginine-rich domain of the N terminal of the PCV2 ORF2.

Abstract: The invention relates to a promoter selected from a group of nucleic acids consisting of: (a) A nucleic acid having a nucleotide sequence as set out in SEQ ID NO: 1; (b) A nucleic acid having a nucleotide sequence derived from the nucleic acid set out in (a), comprising at least one nucleotide addition, deletion, substitution and/or inversion as compared to the nucleotide sequence of (a) and having essentially the same expression characteristics as the nucleic acid of (a); (c) A nucleic acid sequence having at least 70% identity with the nucleic acid of (a) and having essentially the same expression characteristics as the nucleic acid of (a); and (d) A nucleic acid capable of hybridizing to a nucleic acid of (a), (b) or (c) and having essentially the same expression characteristics as the nucleic acid of (a).

Abstract: This disclosure relates to modified Streptococcus pneumonia pneumolysm (PLY) proteins which lack hemolytic activity and can be used as immunogens in an immunogenic composition or vaccine against invasive pneumococcol diseases caused by S.

Abstract: A process for obtaining an adapted strain of Pseudomonas includes the following steps: deleting the genes ExoS, ExoT, aroA and IasI in an initial Pseudomonas strain cultivated in a LB medium; progressively cultivating this strain in a chemically defined medium based on a glucose minimal medium supplemented with magnesium and calcium; wherein the adapted strain presents the same toxicity and secretion capacities than the initial strain, and its doubling time when cultivated in the chemically defined medium is less than 60 minutes. An adapted strain is furthermore treated to become ‘killed but metabolically active’.

Abstract: The present invention provides an expression vector for cell-surface expression of proteins.

Abstract: The present invention discloses the identification and isolation of novel MHC class II epitopes derived from the cancer antigen, NY ESO-1. The novel MHC class II epitopes from NY-EsO-1 are recognized by CD4+ T lymphocytes in an HLA class II restricted manner, in particular HLA-DR or HLA-DP restricted. The products of the gene are promising candidates for immunotherapeutic strategies for the prevention, treatment and diagnosis of patients with cancer.

Abstract: Mutant ras oncogene peptides may induce specific anti-ras cellular immune responses in vaccinated patients. Moreover, a human CD8+ CTL epitope(s) reflecting a specific point mutation in the K-ras oncogene at codon 12 was identified. The mutant ras peptide has implications for both active and passive immunotherapies in selected carcinoma patients. A nested 10-mer peptide was identified [i.e., ras5-14(Asp12)], which was shown to bind to HLA-A2 and display specific functional capacity for expansion of the in vivo-primed CD8+ CTL precursors.

Abstract: The present invention discloses a codon-optimized gene encoding major capsid protein L1 of human papilloma virus, which is capable, after transduced into a yeast cell, of efficiently expressing the major capsid protein L1 of human papilloma virus. The present invention also discloses an immunogenic macromolecule which is essentially produced by expression of said codon-optimized gene encoding the major capsid protein L1 of human papilloma virus in a yeast cell. The present invention further discloses the use of said immunogenic macromolecule and a composition comprising said immunogenic macromolecule.

Abstract: The present invention relates to an Epstein-Barr virus-like particle (EB-VLP) substantially free of Epstein-Barr Virus (EBV) DNA. The present invention also relates to a polynucleotide comprising an EBV genome a) lacking at least one expressible gene selected from the group consisting of the BFLF1 gene, the BBRF gene, the BGRF1 gene, the BDRF1 gene, the BALF3 gene, the BFRF1A gene, and the BFRF1 gene, and b) producing the EB-VLP of the invention in a suitable host cell. The present invention further relates to a vector and a host cell comprising the polynucleotide of the invention as well to a method of manufacturing said EB-VLPs, a method of manufacturing a vaccine thereof, a vaccine and a composition comprising said EB-VLPs.

Abstract: The present invention provides bivalent oral vaccines against infectious pancreatic necrosis virus (IPNV) and infectious salmon anemia virus (ISAV). Yeast cells comprise an expression vector comprising (i) a polynucleotide sequence encoding a VP2 capsid protein of IPNV and (ii) a polynucleotide sequence encoding one or more antigenic epitopes of hemaglutinin of ISAV. The yeast cells express sub-viral particles (SVP) comprising a VP2 capsid protein of IPNV and one or more antigenic epitopes of hemaglutinin of ISAV. The yeast cells and SVP may be administered in an effective amount to increase the amount of antibodies against IPNV and ISAV in the fish, preferably Salmonidae. The yeast cells and SVP may be in the form of fish food for administering to the fish orally.

Abstract: The present invention relates to a cell line in which an expression construct is introduced into a genomic DNA, the expression construct including: (a) a promoter operable in animal cells and heterologous to adenoviruses; and (b) a modified adenovirus E1 coding gene sequence of SEQ ID NO:1 operatively linked to the promoter. According to the present invention, the cell line of the present invention is a novel cell line which is less likely to produce a replication competent adenovirus (RCA). The adenovirus producing cell line of the present invention has a low possibility of producing RCA due to homologous recombination, when compared with conventional cell lines. Therefore, this makes it possible to regulate the required amount of virus during gene therapy using the adenovirus and prevent tissue damage and toxic effects caused by overproduction of the adenovirus.

Abstract: Disclosed are compositions and methods for increasing the longevity of a cell culture and permitting the increased production of proteins, preferably recombinant proteins, such as antibodies, peptides, enzymes, growth factors, interleukins, interferons, hormones, and vaccines. Cells transfected with an apoptosis-inhibiting gene or vector, such as a triple mutant Bcl-2 gene, can survive longer in culture, resulting in extension of the state and yield of protein biosynthesis. Such transfected cells exhibit maximal cell densities that equal or exceed the maximal density achieved by the parent cell lines. Transfected cells can also be pre-adapted for growth in serum-free medium, greatly decreasing the time required to obtain protein production in serum-free medium. In certain methods, the pre-adapted cells can be used for protein production following transformation under serum-free conditions. The method preferably involves eukaryotic cells, more preferably mammalian cells.

Abstract: Influenza virus-like particles (VLPs) comprising the structural proteins HA, NA, M1 and M2 are described. VLPs are also generated containing M1 alone, as are VLPs with M1 and any one or two of HA, NA and M2. VLPs with HA from one influenza subtype and NA from a different influenza subtype are also described, as are VLPs in which a portion or all of HA or NA is replaced by a heterologous moiety not produced by influenza virus, so as to comprise chimeric VLPs.

Abstract: The present invention relates to a composition or composition of bilayer lipid vesicles displaying an influenza virus antigen and carbohydrate, and the production thereof in Nicotiana tabacum plants. Also disclosed herein are pharmaceutical compositions comprising said lipid vesicles for use in the treatment or prophylaxis of viral infections.

Abstract: Recombinant Bordetella pertussis strains derived from parent strain Tohama are provided. The new strains are obtained by homologous recombination using a allelic exchange vector pSS4245, which allows the replacement of sections of the bacterial chromosome without leaving any accessory mutations. The segment encoding PT subunit S1 is replaced to introduce two mutations causing inactivation of the toxic activity of PT. This strain can be further modified to express increased amounts of rPT and/or PRN. A second copy of the ptx cluster of the five PT structural genes of the ptx-ptl operon with their promoter and the ptl terminator and containing the above mutations can be inserted elsewhere on the chromosome. In addition, a second copy of the PRN gene can be inserted on the chromosome. In both cases, abandoned gene loci are selected as the insertion site to avoid the introduction of unwanted genetic alterations.

Abstract: The invention features stabilized human immunodeficiency virus (HIV) envelope (Env) trimers. The invention also features vaccines, nucleic acids, and vectors to deliver and/or facilitate production of the stabilized HIV Env trimers. In addition, the invention features methods of making and using the stabilized HIV Env trimers of the invention.

Abstract: The present invention provides compositions relating to viral capsomeres which comprise foreign immunogenic sequences for use in pharmaceutical compositions and methods of producing such compositions, and related isolated or purified protein and nucleic acid molecules, vectors, host cells, compositions, and methods of use to augment an immune response, immunise an animal and prophylactically or therapeutically treat a disease, disorder or condition. The viral capsomere may be derived from a polyomavirus and comprise an immunogen of interest at the N-terminus and further at the C-terminus and/or at one or more exposed loops of the capsomere.

Abstract: The invention provides HSV antigens that are useful for the prevention and treatment of HSV infection. Disclosed herein are antigens and/or their constituent epitopes confirmed to be recognized by T-cells derived from herpetic lesions or from uterine cervix. T-cells having specificity for antigens of the invention have demonstrated cytotoxic activity against cells loaded with virally-encoded peptide epitopes, and in many cases, against cells infected with HSV. The identification of immunogenic antigens responsible for T-cell specificity provides improved anti-viral therapeutic and prophylactic strategies. Compositions containing antigens or polynucleotides encoding antigens of the invention provide effectively targeted vaccines for prevention and treatment of HSV infection.

Abstract: An assembly capable of capturing and purifying expressed biological products during or at the end of a bioreaction cycle is disclosed wherein a binding resin is kept separated from the contents of the bioreactor allowing capturing, harvesting and purification of biological products in a bioreactor; the invention additionally provides means of removing undesirable metabolic products as well as provides for efficient loading of chromatography columns.

Abstract: Alternative and improved approaches to the heterologous expression of the proteins of Neisseria meningitidis and Neisseria gonorrhoeae are disclosed. These approaches typically affect the level of expression, the ease of purification, the cellular localization, and/or the immunological properties of the expressed protein.

Abstract: The present invention relates to recombinant DNA molecules which encode chimeric polypeptides of differing allergens of Parietaria judaica which can be used for the prevention and treatment of allergies, in particular pollen allergies. Specifically, chimeric polypeptides composed of fragments of the allergens Par j 1 and Par j 2 having hypoallergenic characteristics are described. Methods for producing these recombinant polypeptides in heterologous expression systems are also described. Efficient methods of purifying the chimeric proteins are also described.

Abstract: A vaccine composition comprising a protein, which can be detected in Haemophilus influenzae, having an amino acid sequence as described in SEQ ID NO: 1, or a fragment thereof, is described. The fragment comprises an amino acid sequence having at least 15 contiguous amino acids from the amino acid sequence of SEQ ID NO: 1, and the fragment (if necessary when coupled to a carrier) is capable of raising an immune response which recognises the polypeptide of SEQ ID NO: 1.

Abstract: The present invention provides a system for receiving biological sequence information and activating the synthesis of a biological entity. The system has a receiving unit for receiving a signal encoding biological sequence information transmitted from a transmitting unit. The transmitting unit can be present at a remote location from the receiving unit. The system also has an assembly unit connected to the receiving unit, and the assembly unit assembles the biological entity according to the biological sequence information. Thus, according to the present invention biological sequence information can be digitally transmitted to a remote location and the information converted into a biological entity, for example a protein useful as a vaccine, immediately upon being received by the receiving unit and without further human intervention after preparing the system for receipt of the information.

Abstract: The disclosure provides fusion proteins containing N-terminal signal peptides fused to immunogenic polypeptides. The immunogenic polypeptides may be from viruses, bacteria, or fungi. The disclosure also provides elevated expression of the immunogenic polypeptides using the N-terminal signal peptide. The N-terminal signal peptides enhance synthesis of the protein, particularly where the protein is neither a secretory nor a transmembrane peptide. The fusion proteins may be used to diagnose disease and to induce immune responses.

Abstract: Disclosed are immunomodulatory polypeptides that elicit an unusual induced cytokine profile, compositions comprising such polypeptides, compositions comprising antibodies that specifically bind to such polypeptides, and methods of using the same, including in cancer treatment, in the treatment of autoimmune diseases, in organ transplantation and for reducing graft rejection, for promoting fertility, and for identifying a neutrophil subset and/or other cellular subset including by flow cytometry. Pharmaceutical compositions and kits, and treatment methods are also disclosed.

Abstract: Disclosed are a cell line that expresses protein of Seq. No. 1, and a method for screening an anticancer compound of uterine cervical cancer by using the same. The stable cell line that expresses oncoprotein E6 of a human papillomavirus type 16 variant strain is used to determine a difference in amounts of expression of tumor suppressor genes, such as p53, between E6 protein of the reference strain and E6 protein of a variant strain, thereby screening an anticancer compound of uterine cervical cancer, etc. Further, it is possible to develop an anticancer agent of uterine cervical cancer.

Abstract: The present invention relates to the preparation and use of variants of the group 5 allergen of the Pooideae which are characterised by reduced IgE reactivity compared with the known wild-type allergens and at the same time by substantially retained reactivity with T lymphocytes. These hypoallergenic allergen variants can be employed for the specific immunotherapy (hyposensitisation) of patients having grass pollen allergy or for the preventative immunotherapy of grass pollen allergies.

Abstract: The invention relates to compositions and methods for the preparation, manufacture and therapeutic use of polynucleotides, primary transcripts and mmRNA molecules.

Abstract: The present invention relates to proteins and/or fragments and derivatives thereof and their use as vaccines and in biotechnological methods. The vaccines particularly include immunogenic proteins in Treponema spp. isolated from digital dermatitis in cattle. The present invention further relates to antibodies raised against said proteins or fragments thereof, and the use of said proteins in diagnostic methods in which antibodies are detected as a sign of digital dermatitis in cattle.

Abstract: Methods and compositions are provided for delivering a polynucleotide encoding a gene of interest to a target cell using a virus. The virus envelope comprises a cell-specific binding determinant that recognizes and binds to a component on the target cell surface, leading to endocytosis of the virus. A separate fusogenic molecule is also present on the envelope and facilitates delivery of the polynucleotide across the membrane and into the cytosol of the target cell. The methods and related compositions can be used for treating patients having suffering from a wide range of conditions, including infection, such as HIV; cancers, such as non-Hodgkin's lymphoma and breast cancer; and hematological disorders, such as severe combined immunodeficiency.

Abstract: Disclosed are compositions, including vaccines, and methods for vaccinating an animal against hepatitis C virus (HCV) and for treating or preventing hepatitis C viral infection in an animal. The invention includes a variety of novel HCV fusion proteins that can be used directly as a vaccine or in conjunction with a yeast-based vaccine vehicle to elicit an immune response against HCV in an animal. The invention also includes the use of the HCV fusion gene and protein described herein in any diagnostic or therapeutic protocol for the detection and/or treatment or prevention of HCV infection.

Abstract: A method of producing a protein of interest (POI) by culturing a recombinant eukaryotic cell line comprising an expression construct comprising a regulatable promoter and a nucleic acid molecule encoding a POI under the transcriptional control of said promoter, comprising the steps a) cultivating the cell line with a basal carbon source repressing the promoter, b) cultivating the cell line with a limited amount of a supplemental carbon source de-repressing the promoter to induce production of the POI at a transcription rate of at least 15% as compared to the native pGAP promoter, and c) producing and recovering the POI; and further an isolated regulatable promoter and a respective expression system.

Abstract: The present invention relates to a fermentation process comprising a fermentation step of growing a strain of Corynebacterium diphtheriae in medium in a fermenter under conditions of agitation sufficient to maintain a homogenous culture and limited aeration such that pO2 within the culture falls to less than 4% for the majority of the fermentation step.

Abstract: The embodiments described herein provide for immunogenic portions of Streptococcus pneumoniae surface protein A and surface protein C lacking alpha helical structure.

Abstract: The present invention relates to a vaccine comprising a particle, said particle comprising (i) at least one Epstein-Barr virus (EBV) structural polypeptide, (ii) at least one EBV lytic polypeptide, (iii) membrane lipids, said particle being devoid of EBV DNA, wherein (a) the B-cell transformation capacity of one or more EBV polypeptides required for B-cell transformation as comprised in said particle is disabled while their immunogenicity is maintained; and/or (b) said particle is devoid of one or more EBV polypeptides required for B-cell transformation. Furthermore, the invention relates to a method for generating a particle, to a cell obtained in the method of the invention, a kit comprising the vaccine or the particle generated according to the method of the invention. Also, the invention relates to the use of the vaccine or the particle generated according to the method of the invention for generating CD8+ cells specific for an EBV antigen.

Abstract: The present disclosure generally provides non-naturally-occurring polynucleotide sequences that facilitate high-level expression of one or more gene products (e.g., polypeptides, RNA) of interest in Neisseria meningitidis. Methods of use of such sequences, e.g., use in vaccine production, are also provided.

Abstract: The present invention relates to polynucleotides encoding immunogenic HIV polypeptides. Uses of the polypeptides in applications including immunization, generation of packaging cell lines, and production of HIV polypeptides are also described. Polynucleotides encoding antigenic HIV polypeptides are described, as are uses of these polynucleotides and polypeptide products therefrom, including formulations of immunogenic compositions and uses thereof.

Abstract: The present invention relates to the production of malaria transmission blocking vaccines in single-celled green algae, particularly algae of the genus Chlamydomonas, e.g., Chlamydomonas reinhardtii; the immunogenic Plasmodium polypeptides produced and compositions comprising them; and methods for preventing, ameliorating, reducing, delaying, treating and blocking the transmission of malaria by administration of immunogenic Plasmodium polypeptides produced in an algal host cell.

Abstract: The present invention discloses a codon-optimized gene encoding major capsid protein L1 of human papilloma virus, which is capable, after transduced into a yeast cell, of efficiently expressing the major capsid protein L1 of human papilloma virus. The present invention also discloses an immunogenic macromolecule which is essentially produced by expression of said codon-optimized gene encoding the major capsid protein L1 of human papilloma virus in a yeast cell. The present invention further discloses the use of said immunogenic macromolecule and a composition comprising said immunogenic macromolecule.

Abstract: Disclosed are immunogenic conjugates having the general formula: M2e-Cys-S—CH2—C(O)—NH—CH2—CH2-C(O—)NH-Lys-Pr, were M2e is the influenza M2 ectodomain (M2e) peptide; Cys is a cysteine amino acid residue present in the M2e peptide; S the sulfur present in the cysteine amino acid residue; CH2-CO—NH—CH2-CH2-CO the linking group; NH the amine group present in a lysine residue of the carrier; Lys is a lysine amino acid residue and Pr the carrier protein. Also disclosed are isolated immunogens that include an immunogenic fragment of an influenza HA protein including the polybasic cleavage site, wherein the immunogenic fragment of the influenza HA protein has been modified to remove an N-terminal leader amino acid sequence and a C-terminal transmembrane domain. Also disclosed are methods producing an influenza vaccine specific for an identified influenza strain.

Abstract: The present invention encompasses influenza vaccines, in particular avian influenza vaccines. The vaccine may be a subunit vaccine based on the hemagglutinin of influenza. The hemagglutinin may be expressed in plants including duckweed. The invention also encompasses recombinant vectors encoding and expressing influenza antigens, epitopes or immunogens which can be used to protect animals against influenza. It encompasses also a vaccination regimen compatible with the DIVA strategy, including a prime-boost scheme using vector and subunit vaccines.

Abstract: The present invention encompasses influenza vaccines, in particular avian influenza vaccines. The vaccine may be a subunit vaccine based on the hemagglutinin of influenza. The hemagglutinin may be expressed in plants including duckweed. The invention also encompasses recombinant vectors encoding and expressing influenza antigens, epitopes or immunogens which can be used to protect animals against influenza. It encompasses also a vaccination regimen compatible with the DIVA strategy, including a prime-boost scheme using vector and subunit vaccines.

Abstract: The present invention relates to attenuated, immunogenic West Nile virus chimeras built on a dengue virus backbone for the production of immunogenic, live, attenuated West Nile virus vaccines.

Abstract: The present invention provides a recombinant soluble trimeric hemagglutinin (rHA) protein comprising a hemagglutinin ectodomain and an oligomerization domain. The rHA is produced as a soluble homotrimer, and may further comprises a signal peptide and/or an endoplasmic reticulum (ER) retention signal. The invention is also directed to nucleic acids encoding the rHA of the invention, as well as vectors and chimeric constructs comprising the nucleic acid. Methods of producing the rHA are also provided. The rHA described herein may be used to formulate influenza vaccines, or may be used to enrich existing vaccines.

Abstract: The present application provides methods of producing soluble Treponema pallidum protein Tp0453 (such as the fragment shown in SEQ ID NO: 3). For example, the protein can be expressed from the pET28a vector in a cell and the resulting soluble Tp0453 protein isolated from the cell. Also provided are the isolated soluble Tp0453 protein, as well as Tp0453-Tp0326 chimeric proteins (e.g., SEQ ID NO: 11), and methods of using the proteins to detect antibodies specific for T. pallidum subsp. pallidum, for example to diagnose syphilis. Devices and kits that incorporate Tp0453 protein and Tp0453-Tp0326 chimeric proteins, such as lateral flow devices, are also disclosed. Kits that include the soluble Tp0453 protein and kits that include solid substrates containing the soluble Tp0453 protein are also provided.

Abstract: Disclosed is a novel HIV gene comprising a set of open reading frames encoded with the template as the plus strand of the proviral DNA, and located in the region of HIV-1 long terminal repeat. The genes encode a set of antisense proteins, (HAPs) as well as smaller proteins, related to, and containing structural motif resembling that of chemokine proteins. Depending upon the ribosomal frameshift, a plurality of proteins may be translated from the antisense RNA. The smaller proteins have similarity with chemokine SDF-1 and may play a role as a cofactor with gp120 in the binding to and entry of HIV to a target cell.