Abstract: A pharmaceutical composition for use in the treatment of osteoporosis by oral administration of the composition is provided herein. The composition comprises parathyroid hormone or a fragment thereof; and SNAC (sodium 8-N-(2-hydroxybenzoyl)aminocaprylate). Further disclosed are uses of the composition in the preparation of a medicament and methods of treating osteoporosis utilizing the composition.

Abstract: The present application relates to the use of pertussis toxin, and its derivatives, analogs, salts and pharmaceutical equivalents. In one embodiment, the invention provides a method of treating or preventing a neurological disease or injury by administering pertussis toxin to the individual.

Abstract: Disorders such as headaches can be treated by administration of a botulinum toxin to a patient suffering therefrom, such as a migraine headache. A combined a fixed site/fixed dose and an optional follow the pain variable dosage and injection site paradigm is disclosed for optimizing clinical effectiveness of botulinum toxin administration for patients suffering headache, particularly chronic migraine.

Abstract: Protein replacement therapy for patients with hemophilia or other inherited protein deficiencies is other complicated by pathogenic antibody responses, including antibodies that neutralize the therapeutic protein or that predispose to potentially life-threatening anaphylactic reactions by formation of IgE. Using murine hemophilia B as a model, we have developed a prophylactic protocol against such responses that is non-invasive and does not include immune suppression or genetic manipulation of the patient's cells. Oral delivery of coagulation factor IX (F.IX) expressed in chloroplasts, bioencapsulated in plant cells, effectively blocked formation of inhibitory antibodies in protein replacement therapy. Inhibitor titers were mostly undetectable and up to 100-fold lower in treated mice when compared to controls. Moreover, this treatment eliminated fatal anaphylactic reactions that occurred after 4 to 6 exposures to intravenous F. IX protein. While only 20-25% of control animals survived after 6-8 F.

Abstract: The present invention relates to a combination product, composition(s) and kit of parts comprising at least (i) a therapeutic vaccine and (ii) one or more immune checkpoint modulator(s). The present invention also concerns a method for treating a proliferative or an infectious disease as well as a method for eliciting or stimulating and/or re-orienting an immune response, wherein said methods comprise administering to a subject in need thereof said combination product or said composition(s).

Abstract: A method of treating prostate cancer by intradermally injecting a person with a composition comprising (a) a recall antigen and (b) prostate specific antigen (PSA) or peptides that are fragments of PSA is provided. The recall antigen may be Candida extract, Trichophyton antigens, or mumps antigen, or other recall antigen.

Abstract: The present invention is directed to methods and agents used for treating cancer in Toll-Like Receptor 5-expressing tissues by providing a Toll-Like Receptor agonist such as flagellin. The present invention also relates to protecting the liver from a liver toxicity using a Toll-like receptor agonist.

Abstract: The present disclosure encompasses immunogenic/therapeutic compositions including Globo series antigens (SSEA-4, Globo H or SSEA-3) glycoconjugates and therapeutic adjuvants (OBI-821 or OBI-834) as well as methods of making and using the same to treat proliferative diseases such as cancer. The therapeutic conjugates include an antigen linked to a carrier. In particular, the therapeutic conjugates include a SSEA-4, Globo H or SSEA-3 moiety and a KLH moiety subunit linked via a linker. The therapeutic compositions are in part envisaged to act as cancer vaccines (single valent, bi-valent or tri-valent vaccines) for boosting the body's natural ability to protect itself, through the immune system from dangers posed by damaged or abnormal cells such as cancer cells. Exemplary immune response can be characterized by reduction of the severity of disease, including but not limited to, prevention of disease, delay in onset of disease, decreased severity of symptoms, decreased morbidity and delayed mortality.

Abstract: An immunogenic composition that includes a glycoconjugate containing a fusion protein composed of an immunoglobulin gamma Fc domain fused to a tumor-associated antigen, the fusion protein being cross-linked to an azido-modified stage-specific embryonic antigen 4 conjugated to diphtheria toxoid cross-reactive material 197; and ?-galactosylceramide C34 or ?-glucosylceramide C34. Also provided are methods for treating cancer by administering the immunogenic composition to a patient.

Abstract: A chimeric antigen receptor containing (i) a single chain Fv that specifically binds to stage-specific embryonic antigen 4 and (ii) an endodomain from CD3? or Fc?RI?. Also provided is a nucleic acid encoding the chimeric antigen receptor and an expression vector that contains the nucleic acid operably linked to a promoter that is active in T cells. Furthermore, two similar methods for treating a tumor are disclosed. The first method includes (i) obtaining T cells from a subject, (ii) transducing the T cells in vitro with an expression vector encoding a chimeric antigen receptor that contains an scFv specifically recognizing stage-specific embryonic antigen 4, (iii) expanding the transduced T cells in vitro, and (iv) infusing the expanded transduced T cells into the subject.

Abstract: Two methods for treating a tumor are disclosed. The first method includes (i) obtaining NK cells or NKT cells from a subject, (ii) transducing the NK cells or NKT cells in vitro with an expression vector encoding a chimeric antigen receptor that contains an scFv specifically recognizing stage-specific embryonic antigen 4, (iii) expanding the transduced NK cells or NKT cells in vitro, and (iv) infusing the expanded transduced NK cells or NKT cells into the subject. The second method includes, in place of step (ii) above, transducing the NK cells or NKT cells in vitro with an expression vector encoding a chimeric antigen receptor that is specific for a tumor antigen other than stage-specific embryonic antigen 4, and further requires a step of administering an antibody against stage-specific embryonic antigen 4.

Abstract: A method for treating a tumor in a subject by administering at least three of the following treatment modalities: (i) an antibody, (ii) T cells bearing a first chimeric antigen receptor (CAR), (iii) NK cells bearing a second CAR, and (iv) NKT cells bearing a third CAR. The antibody binds specifically to stage-specific embryonic antigen 4 and each CAR contains a scFv that also binds specifically to SSEA4.

Abstract: A method for treating a tumor includes administering (i) a vaccine that contains stage-specific embryonic antigen 4 conjugated to a carrier, (ii) an antibody that binds specifically to SSEA-4, and (iii) immune cells expressing a chimeric antigen receptor that specifically binds to SSEA-4. The tumor, which expresses SSEA-4, can be a breast, colon, gastrointestinal, kidney, lung, liver, ovarian, pancreatic, rectal, stomach, testicular, thymic, cervical, prostate, bladder, skin, nasopharyngeal, esophageal, oral, head and neck, bone, cartilage, muscle, lymph node, bone marrow, or brain tumor.

Abstract: The present invention provides a particle comprising a fusion protein, wherein the fusion protein comprises at least one NANP repeat (SEQ ID NO: 7), some or all of the C-terminus of the CS protein from Plasmodium falciparum and a hepatitis B surface antigen, and wherein the particle comprises no, or substantially no, free hepatitis B surface antigen protein, and uses thereof.

Abstract: Compositions effective for treating or preventing an anthrax infection in a subject in need thereof and recombinant proteins included in the compositions are provided. Methods for producing recombinant proteins in plants are described. Transgenic plants engineered to produce recombinant proteins as well as genetic constructs comprising nucleic acids encoding recombinant proteins thereof are also described. Methods of protecting subjects against anthrax infection with plant-derived compositions are provided.

Abstract: The disclosure relates to generally to the field of toxin inactivation. More specifically, it relates to clostridial toxins, methods of inactivating these toxins and compositions (e.g., vaccines) comprising toxoids (e.g., produced by these methods). Provided are methods of producing a C. difficile toxoid comprising inactivating a C. difficile toxin with formaldehyde. Toxoids prepared by these methods are stable at high temperature (e.g., 37° C.) and remain non-cytotoxic with minimal residual formaldehyde.

Abstract: The present invention relates to chimeric protein vaccines and methods of use thereof in the treatment of Staphylococcus aureus. One embodiment of the present invention provides a method of generating an immune response in a mammal, that includes administering to the mammal, a composition having a chimeric protein having at least one of: a portion of a cholera toxin, a portion of a heat-labile toxin, and a portion of a shiga toxin; and an antigen having at least one of: an antigenic material from S. aureus and an antigenic material from a S. aureus-specific polypeptide.

Abstract: Here we show that SEG/SEI presented from a HLA-DQ8 (HLA-DQB*0302 and HLA-DQA*0301) platform prevent the de novo outgrowth (vaccination) of Lewis lung carcinoma (LLC) and B16-F10 melanoma and retard the growth of established tumors with no significant toxicity. Vaccination of DQ8 tg mice with irradiated LLC or B16-F10 melanoma followed by SEG/SEI immunization and live tumor challenge resulted in 100 and 66% survival respectively for 200 days compared to a median survival of 20 days for untreated controls (p<0.001). In vaccination studies, DQ8 tg mice showed a surge in IFN? serum levels reaching 3000 fold above baseline devoid of a parallel spike in TNF? levels above baseline levels. Presentation of the SEG/SEI superantigen from a MHC-DQ8 platform, therefore, augments the therapeutic index of these SAgs inducing a tumoricidal response against Lewis lung carcinoma and B16 melanoma accompanied by a sharp increase of therapeutic IFN? levels absent toxic levels of TNF?.

Abstract: Nucleic acid molecules which encode an MRSA PBP2a protein or a fragment thereof which comprises at least 245 amino acid are disclosed. Compositions comprising the nucleic acid molecules are disclosed. Novel proteins which comprise a MRSA PBP2a protein or a fragment thereof which comprises at least 245 amino acid are disclosed are disclosed. Methods of inducing an immune response against MRSA PBP2a are disclosed, as are methods of treating an individual who has been diagnosed with MRSA and methods of preventing MRSA infection in an individual.

Abstract: Meningococcal protein NMB 1870 has been described in the prior art. The inventors have found that NMB 1870 is an effective antigen for eliciting anti-meningococcal antibody responses, and that it is expressed across all meningococcal serogroups. Forty-two different NMB 1870 sequences have been identified, and these group into three variants. Serum raised against a given variant is bactericidal within the same variant group, but is not active against strains which express one of the other two variants i.e. there is intra-variant cross-protection, but not inter-variant cross-protection. For maximum cross-strain efficacy, therefore, the invention uses mixture comprising different variants of NMB 1870.

Abstract: Disclosed herein is a Chlamydia-activated B cell (CAB) platform. Also disclosed is a method of enhancing a population of B cells, comprising exposing said B cells to Chlamydia spp. under conditions suitable to enhance the population of B cells, such that expansion and differentiation of said B cells takes place, and said B cells are exposed or crosslinked to an antigen. Also disclosed are methods of producing said CABs, and treating a subject in need thereof with said CABs.

Abstract: A flavivirus virus-like particle and methods of making and using that particle, and antibodies raised to a plurality of those particles, are provided.

Abstract: Methods of thermally inactivating a rotavirus are provided according to the present invention which include exposing the rotavirus to a temperature in the range of about 50° C.-80° C., inclusive, for an incubation time sufficient to render the rotavirus incapable of replication or infection. The thermally inactivated rotavirus is antigenic and retains a substantially intact rotavirus particle structure. Vaccine compositions and methods of vaccinating a subject against rotavirus are provided which include generation and use of thermally inactivated rotavirus.

Abstract: The disclosure relates to HCMV ribonucleic acid (RNA) vaccines, as well as methods of using the vaccines and compositions comprising the vaccines.

Abstract: Immune-polyelectrolyte multilayers (iPEMs) that can be made entirely from immune signal compounds are provided. iPEMs are formed from first layer of a first immune signal compound, and a second layer of the first immune signal compound or a second immune signal compound disposed on the first layer of the first immune signal compound. The immune signal compounds are peptides, polypeptides, nucleic acids, charged derivatives thereof. Combinations of the immune signal compounds may be in adjacent layers. The first immune signal compound and the second immune signal compound have oppositely charged domains. iPEMs can be formed on or include a substrate, such as a sacrificial substrate, which allows for the formation of a three-dimensional void which can hold various other compounds for use in modulating immune responses. The iPEMs are for use in either stimulating an immune response to one or more antigens, or inducing tolerance to one or more antigens.

Abstract: Compositions of a modulator of cell metabolism, typically targeting cellular glycolysis, preferably with a targeting moiety, attached directly or indirectly to the inhibitor, or to a nanoparticle or other delivery vehicle thereof, and methods of use for treating cancer, proliferative disorders, neurodegenerative diseases, autoimmune disorders, or inflammatory diseases are provided. Pharmaceutical compositions including the targeted modulator and a pharmaceutically acceptable carrier are also provided. The pharmaceutical compositions can be administered to a subject in need thereof in an effective amount to reduce one or symptoms of the cancer, proliferative disorders, neurodegenerative diseases, autoimmune disorders, or inflammatory diseases alone or prior to or in conjunction with a further therapy such as radiotherapy.

Abstract: This invention describes novel adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37° C. that can be produced at remarkably low costs. This invention describes novel vaccine compositions and formulations to treat and prevent urinary tract infections caused by gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli. This invention also describes methods of administration of said novel vaccine compositions and formulations and methods of treatment to prevent and treat urinary tract infections caused by gram-negative bacteria including E. coli and multi-drug resistant E. coli.

Abstract: Compounds, particularly, glucopyranosyl lipid adjuvant (GLA) compounds, having the following structure (I) are provided: or a pharmaceutically acceptable salt thereof, wherein L1. L2, L3, L4, L5, L6, L7, L8, L9, L10, Y1,Y2, Y3, Y4, R1, R2, R3 , R4, R5, R6, are as defined herein. Pharmaceutical compositions, vaccine compositions, and related methods for inducing or enhancing immune responses, are also provided.

Abstract: A method of treating or preventing a disease associated with a secondary infection in a subject infected with a pathogen is provided. The method comprises administering to the subject a therapeutically effective amount of an anti-pathogenic agent directed towards the pathogen and a therapeutically effective amount of an agent which down-regulates at least one extracellular matrix-associated polypeptide.

Abstract: An effective combined dose of an anti-CD47 agent and an anti-TNF agent is administered to the subject in a dose and for a period of time effective to stabilize, prevent or reduce atherosclerotic plaque in the individual.

Abstract: The current invention relates to a new pharmaceutical formulation, in particular to a pharmaceutical formulation comprising a protein, more particularly an antibody as an active ingredient.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: Disclosed herein are antibody-drug conjugates having the general formula A-L-D, wherein A represents a neutralizing antibody specific for human immunodeficiency virus (HIV), L represents a linker, and D represents a cytotoxic moiety, pharmaceutical compositions comprising the antibody-drug conjugates, and methods of treating HIV with the antibody-drug conjugates after activation of latent reservoir cells.

Abstract: The present invention provides compositions comprising energy (e.g., light) absorbing submicron particles (e.g., nanoparticles comprising a silica core and a gold shell) and methods for delivering such particles via topical application. This delivery is facilitated by application of mechanical agitation (e.g. massage), acoustic vibration in the range of 10 Hz-20 kHz, ultrasound, alternating suction and pressure, and microjets.

Abstract: The present invention relates to combinations of a DGAT inhibitor and a peroxisome proliferator-activator receptor (PPAR) agonist or a prodrug thereof. The invention further relates to methods for preparing such combinations, pharmaceutical compositions comprising said combinations as well as the use as a medicament of said combinations. The present invention also relates to novel DGAT inhibitors. The invention further relates to methods for preparing such compounds, pharmaceutical compositions comprising said compounds as well as the use as a medicament of said compounds.

Abstract: The invention is comprised in the field of biomedicine, and more specifically, the field of tissue engineering. The invention specifically relates to the use of multiple magnetic domain particles that have a mean diameter greater than 25 nm, to compositions and biomaterials comprising same, and to an in vitro method for producing an artificial tissue with the magnetic particles, to the artificial tissue that can be produced by said method, and to the use of said artificial tissue for partially or completely increasing, restoring or replacing the functional activity of a damaged organ or tissue.

Abstract: The present invention provides a method for suppressing bitterness of a quinoline derivative.

Abstract: Compositions, devices, and methods for transdermal administration of active agents provided in their salt form instead of neutral form are provided.

Abstract: This disclosure provides improved lipid-based compositions, including lipid nanoparticle compositions, and methods of use thereof for delivering agents in vivo including nucleic acids and proteins. These compositions are not subject to accelerated blood clearance and they have an improved toxicity profile in vivo.

Abstract: The invention relates to a liquid formulation comprising propylene glycol and an effective amount of an inodilator, an angiotensin converting enzyme inhibitor, or a combination of an inodilator and an angiotensin converting enzyme inhibitor and to use of the formulation for treating cardiac disease and/or hypertension.

Abstract: Compositions and methods for treating disordered tissues, such as caused by pathogens and/or by toxins. The treatment compositions include an anti-infective active agent, a liquid carrier, and benzocaine in an amount so that the treatment composition penetrates more quickly into disordered tissue compared to the treatment composition in the absence of the benzocaine. In addition, the benzocaine can increase residence time of the anti-infective active in the treatment area. The preferred anti-infective active agent can be an organohalide, such as a quaternary ammonium halide compound, an example of which is benzalkonium chloride. The treatment compositions and methods may employ the use of an applicator adapted for use in promoting penetration of the treatment composition and/or agitation of the disordered tissue to further enhance penetration.

Abstract: Provided are an aqueous liquid preparation showing improved stability of N-[5-({2-[(cyclopropylcarbonyl)amino]imidazo[1,2-b]pyridazin-6-yl}oxy)-2-methylphenyl]-1,3-dimethyl-1H-pyrazole-5-carboxamide or a salt thereof in the aqueous liquid preparation, a method of stabilizing the compound in an aqueous liquid, and a stabilizer of the compound in an aqueous liquid. An aqueous liquid preparation containing the above-mentioned compound and ethylenediaminetetraacetic acid (EDTA) or a salt thereof or a hydrate thereof; a stabilizing method of the compound in an aqueous liquid, including adding the compound and EDTA or a salt thereof or a hydrate thereof to the aqueous liquid; a stabilizer of the above-mentioned compound in an aqueous liquid, which contains EDTA or a salt thereof or a hydrate thereof; and a stabilizer of the compound in an aqueous liquid, which contains EDTA or a salt thereof or a hydrate thereof, and castor oil in combination.

Abstract: The invention provides stabilized aqueous pharmaceutical etanercept compositions suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: Provided are salt-free antibody and other protein formulations that are substantially isosmotic and of low viscosity. Also provided are methods for the treatment of diseases using the disclosed formulations.

Abstract: A pharmaceutical dosage form having a breaking strength of at least 300 N, said dosage form comprising: an opioid (A) selected from Oxymorphone, Oxycodone, Tapentadol, Hydromorphone, Hydrocodone, Morphine, and physiologically acceptable salts thereof; wherein the weight content of the opioid (A) is from 5.0 to 35 wt.-%; an anionic polysaccharide (B) selected from croscarmellose, carmellose, crosslinked carboxymethyl starch, carboxymethyl starch, and physiologically acceptable salts thereof; wherein the weight content of the anionic polysaccharide (B) is within from 5.0 to 35 wt.-%; and a polyalkylene oxide (C) having a weight average molecular weight of at least 200,000 g/mol; wherein the weight content of the polyalkylene oxide (C) is from 20 to 80 wt.-%; wherein all wt.-%'s are based on a total weight of the dosage form, and the opioid (A) is present in a controlled-release matrix comprising the anionic polysaccharide (B) and the polyalkylene oxide (C).

Abstract: The invention relates to compositions of epinephrine formulation in an aqueous solution that enhances the chemical stability of epinephrine and consequently extends the product shelf life. The formulation comprises epinephrine or a salt thereof, a tonicity modifier, and a complexing agent, in an aqueous solution adjusted to a pH of about 2-7. A process for manufacturing and methods of using the formulation for the medicinal products are also provided.