Abstract: The present invention relates to a pharmaceutical combination for inducing one or more immune responses and/or for enhancing effectiveness of vaccination in the host, which is capable of inducing cross-protection against multiples strains and/or serotypes of a virus. In one embodiment, the pharmaceutical combination is able to generate protection in food producing animals, such as cattle, sheep, goats, swine and other cloven-hoofed animals with fewer vaccination campaigns.

Abstract: An influenza vaccine lacks at least three of: a mercurial preservative; an antibiotic; formaldehyde; and egg-derived materials. In some embodiments, the vaccine includes none of these four components.

Abstract: The invention provides compositions comprising liposomes, an antigen capable of inducing a humoral immune response, a carrier comprising a continuous phase of a hydrophobic substance, and an adjuvant that activates or increases the activity of TLR2. The invention also provides uses for such compositions in inducing a humoral response and methods for their use in the treatment of a disease, disorder or ailment ameliorated by a humoral immune response.

Abstract: In contrast to known regimens where pandemic-associated antigens are given 3-4 weeks apart for immunisation, according to the invention two doses of a pandemic-associated antigen are administered to a human 1 week apart, 2 weeks apart or 6 weeks apart. Thus the invention provides a method for immunizing a human, comprising steps of: (a) administering to the man a first vaccine comprising antigen from a pandemic-associated influenza virus strain; and then 1/2/6 week(s) later, (b) administering to the same human a second influenza vaccine comprising antigen from the pandemic-associated influenza virus strain.

Abstract: An influenza vaccine comprising an influenza hemagglutinin-containing antigen which is subjected to a treatment at a suitable low pH or other suitable conditions to obtain a suitable degree of loss of potency, and the method of making it are provided. The vaccine not only induces an increased cross-reactive immune response and cross protection, but can also induce a strain-specific immune response and protection like current inactivated vaccines. A method of administering influenza vaccines is also provided to induce an increased cross-reactive immune response and cross protection, which is especially suitable for use in emergency situations such as a pandemic.

Abstract: The present invention provides a system for analyzing interactions between glycans and interaction partners that bind to them. The present invention also provides HA polypeptides that bind to umbrella-topology glycans, and reagents and methods relating thereto.

Abstract: A buffer free, acid stable, low dose volume rotavirus vaccine is disclosed. The vaccine is available in dose volume of less than 1 ml per dose for oral administration and it is without any buffer. The vaccine also does not require pre or post administration of any antacid at the time of oral administration of the vaccine to the subject to neutralize the stomach acid. The vaccine exemplifies nominal drop in vaccine titer at pH 2-4 for a time span of 30 minutes. The vaccine is stable at ?20° C. for at least 60 months.

Abstract: Vectors, vaccines, vaccine compositions and vaccine combinations for use as therapeutics against HPV18 and/or HPV16 are described.

Abstract: A method and system for the treatment of honey bees (Apis mellifera), bats, and butterflies protects them from various life threatening conditions, including Colony Collapse Disorder, white nose syndrome, etc. and in particular, provides honey bees, bats and butterflies with the ability to assimilate and degrade pesticides such as neonicotinoids and fipronil.

Abstract: Stable aqueous formulations of adjuvant comprising a TLR7/8 agonist or a TLR4 agonist with a helper lipid that are adsorbed to alum are provided. Compositions and methods of using the formulations for stimulating an immune response are also provided.

Abstract: Described herein are dry vaccine compositions and methods of freezing aluminum-containing vaccines such that when converted into a dried powder, the dry vaccine can be readily reconstituted to form a stable liquid vaccine without significant loss of activity.

Abstract: Disclosed herein is a vaccine comprising an antigen and one or more bimolecular adjuvant. Also disclosed herein are methods for increasing an immune response in a subject. The methods may comprise administering the vaccine to the subject in need thereof.

Abstract: The invention features new a method for treating inflammatory bowel disease, including Crohn's Disease (CD) or ulcerative colitis in a human patient, comprising administering to a patient a combination therapy comprising an anti-?4?7 antibody, a TNF? antagonist, and an immunomodulator.

Abstract: The present invention concerns compositions and methods of use of bispecific antibodies comprising at least one binding site for Trop-2 (EGP-1) and at least one binding site for CD3. The bispecific antibodies are of use for inducing an immune response against a Trop-2 expressing tumor, such as carcinoma of the esophagus, pancreas, lung, stomach, colon, rectum, urinary bladder, breast, ovary, uterus, kidney or prostate. The methods may comprising administering the bispecific antibody alone, or with one or more therapeutic agents such as antibody-drug conjugates, interferons (preferably interferon-?), and/or checkpoint inhibitor antibodies. The bispecific antibody is capable of targeting effector T cells, NK cells, monocytes or neutrophils to induce leukocyte-mediated cytotoxicity of Trop-2+ cancer cells. The cytotoxic immune response is enhanced by co-administration of interferon, checkpoint inhibitor antibody and/or ADC.

Abstract: Methods and systems are described for a rapid and sustainable change in the pigment melanin content of melanocytes of the iris stroma, thereby to change the color of the eye. Also described are nanoparticle compositions for lightening or darkening the pigmented tissues or treating a pigmented tissue disease.

Abstract: The present disclosure concerns Bcl-xL inhibitors having low cell permeability, antibody drug conjugates (ADCs) comprising the inhibitors, synthons useful for synthesizing the ADCs, compositions comprising the inhibitors or ADCs, and various methods of using the inhibitors and ADCs.

Abstract: Disclosed herein are compositions comprising an NSAID such as meloxicam in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of conditions such as arthritis.

Abstract: Disclosed herein are compositions comprising an NSAID such as meloxicam in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of conditions such as pain.

Abstract: The present invention provides a pharmaceutical composition comprising an aqueous solution of an ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition. The invention further provides a method of treating a condition chosen from pain, inflammation, fever, and/or patent ductus arteriosis, comprising administering to a patient in need thereof an effective amount of an aqueous solution a ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition, as well as a method for manufacturing the composition.

Abstract: Compositions comprising a fluorescein component and benoxinate component and the corresponding uses of these compositions are described herein. These compositions have improved storage life and the fluorescein component and/or benoxinate component minimally degrade after 12 to 18 months of storage.

Abstract: Radiopaque hydrogels, in particular radiopaque hydrogel microspheres comprising a polymer having 1,2-diol or 1,3-diol groups acetalised with radiopaque species.

Abstract: Compositions, specifically a jelly, are provided the use of which composition as an auxiliary means eases the taking of oral medication in solid form, which composition comprises iota-carrageenan as a jellifying agent and citric acid as a salivating agent, characterized in that the composition further comprises maltodextrin. In another aspect, the composition comprises a calcium sequestrant for adjusting Ca-ion activity of the composition. In one embodiment, the composition comprises iota-carrageenan in 0.7-1.0% in mass, citric acid in 0.06-0.07% in mass, maltodextrin in 1.5% in mass, all relative to the total mass of the composition, and an amount of a calcium sequestrant such that the Ca-ion activity of the composition is between 20 ppm and 80 ppm.

Abstract: Capsaicinoid formulations and methods of treatment are disclosed herein which can be utilized to treat/attenuate pain in mammals. Typically, administration is via injection at a discrete site to provide pain relief for an extended period of time. The formulations are administered in a pharmaceutically acceptable vehicle. The formulations include an analgesic agent in an amount sufficient to attenuate the burning and hyperalgesic effects of capsaicinoid administration. The invention also includes a method of treating pain by administering a corticosteroid followed by administration of a capsaicinoid.

Abstract: The present invention relates to covalent conjugates of BET inhibitors and alpha amino acid esters, processes for their preparation, compositions containing them, and to their use in the treatment of various disorders in particular inflammatory and autoimmune diseases, such as rheumatoid arthritis; and cancers.

Abstract: The present invention relates to the use of a compound containing a moiety of formula (I) as a reagent for linking a compound of formula R1—H which comprises a first functional moiety of formula F1 to a second functional moiety of formula F2 wherein X, X?, Y, R1, F1 and F2 are as defined herein. The present invention also provides related processes and products. The present invention is useful for creating functional conjugate compounds, and specifically conjugates in which at least one of the constituent molecules carries a thiol group.

Abstract: The present invention relates to fluorocarbon vectors for the delivery of influenza antigens to immunoresponsive target cells. It further relates to fluorocarbon vector-influenza antigen constructs and the use of such vectors associated with antigens as vaccines and immunotherapeutics in animals, including humans.

Abstract: An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. Methods of making the coated complex and the liquid suspension are described.

Abstract: Abstract of the Disclosure Provided herein are compositions that include a dendrimer to which a drug and a binding peptide are conjugated. The binding peptide may be configured to bind to a receptor that is overexpressed by a diseased cell, such as a cancer cell. The compositions may include a hydrogel in which the dendrimer-drug conjugate is dispersed. Methods of drug delivery and kits also are provided.

Abstract: This invention provides a polymer-bonded CA4 pharmaceutical compound and a preparation method therefor. The polymer-bonded CA4 drug provided in this invention has a structure represented by formula (I). With respect to the bonded pharmaceutical compound provided by this invention, CA4 is grafted onto a specific polymer carrier, so that the resultant bonded drug may be enriched in tumor vessels and the active drug is slowly released. Therefore, an efficacy of destroying tumor vessels is exerted at a tumor site for a long period, an excellent tumor inhibition effect is achieved, and the problem of poor therapeutic effects due to short action time of CA4P is effectively solved, and thus it has a broad prospect of development in the field of tumor treatment. Additionally, the preparation method provided in this invention is simple and has wide sources of raw materials, and it is possible to achieve scale production and industrialization.

Abstract: The present invention provides a formulation having excellent solubility and/or stability of a macromolecular drug, and more specifically, a pharmaceutical composition containing a macromolecular drug, a dissolution-enhancing and/or stabilizing agent, and an aqueous solvent, wherein the dissolution-enhancing and/or stabilizing agent is at least one selected from the group consisting of (1) proteins, (2) synthetic polymers, (3) sugars or sugar alcohols, (4) inorganic salts, (5) amino acids, (6) phospholipids, (7) aliphatic alcohols, (8) medium-chain fatty acids, and (9) mucopolysaccharides.

Abstract: Described herein is a mono-end PEGyated functional upstream domain (FUD), pharmaceutical compositions, and its use to inhibit fibrosis such as organ fibrosis, idiopathic pulmonary fibrosis and fibrosis associated with cancer. Also included are methods of probing for injured or repairing tissue in an individual in need thereof using the mono-end PEGyated-FUD.

Abstract: The present invention provides stable pharmaceutical compositions of pegylated carfilzomib compounds, methods for preparing the compositions, and uses of the compositions for treating cancer, including hematologic malignancies such as multiple myeloma. The compositions can be stored in frozen form or lyophilized to dry solid form.

Abstract: The present disclosure relates to materials and methods of conjugating a water soluble polymer to a therapeutic protein.

Abstract: The present invention provides hyaluronic acid derivatives into which a certain cationic group and a certain hydrophobic group are introduced, the hyaluronic acid derivatives including one or more repeating units represented by the formula (Ia) and one or more repeating units represented by the formula (Ib).

Abstract: Described herein are polymeric drug-carrying nanogels that are capable of targeting to P-selectin for the treatment of cancer and other diseases and conditions associated with P-selectin. Furthermore, in certain embodiments, the nanogels presented here offer a drug release mechanism based on acidic pH in the microenvironment of a tumor, thereby providing improved treatment targeting capability and allowing use of lower drug doses, thereby reducing toxicity.

Abstract: Provided herein are small molecules comprising a first domain that binds to ASH1L and a second domain that facilitates ASH1L degradation. In particular, ASH1L-targeting proteolysis targeting chimeras (PROTACs) and methods of use thereof for the treatment of disease (e.g., acute leukemia, solid cancers and other diseases dependent on activity of ASH1L) are provided.

Abstract: Disclosed herein are drug delivery molecules that comprise a ligand that targets a cell surface molecule; a membrane penetration domain; and a payload binding domain; and pharmaceutical compositions comprising the same. Also disclosed are methods of treating cancer, inhibiting the progression of cancer, preventing cancer metastasis, and delivering a therapeutic compound to the brain in a subject in need thereof, the methods comprising identifying a subject in need thereof; providing a composition comprising the drug delivery molecule as disclosed herein; and administering an effective amount of the composition to the subject.

Abstract: Disclosed herein are modified C-terminal fragments of FGF21 optimized for binding to Klotho ? or antagonizing FGF21 activity. FGF21 peptides modified to comprise modifications to the C-terminal amino acid sequence are disclosed that have enhanced activity at the FGF21 receptor. Additionally, conjugates formed between the optimized FGF21 peptide fragments and insulin like peptides or nuclear hormone receptor ligands are provided.

Abstract: Low-generation dendrimers containing a high density of surface hydroxyl groups, and methods of synthesis thereof are provided. In particular, oligo ethylene glycol (OEG)-like dendrimers with a high surface functional groups at relatively low generations (e.g. ˜120 hydroxyls in the third generation, with a size of just 1-2 nm) is described. Dendrimer formulations including one or more prophylactic, therapeutic, and/or diagnostic agents, and methods of use thereof are also described. The formulations are suitable for topical, enteral, and/or parenteral delivery for treating one or more diseases, conditions, and injuries in the eye, the brain and nervous system (CNS), particularly those associated with pathological activation of microglia and astrocytes.

Abstract: An immune-modulating biomaterial comprising a hydrogel scaffold coupled to D-amino acid containing peptides having unexpected properties in vivo is described. For example, certain inflammatory reactions in vivo are significantly increased around the D-peptide containing particles of hydrogel scaffold as compared to particles that contain both L and D peptides or L peptides alone. In addition, these D-peptide compositions are further observed to enhance wound healing and improve the tensile strength of healed tissues. For these and other reasons, the D-amino acid hydrogel materials disclosed herein are useful in a number of methodologies that seek to modulate the immune response and/or wound healing.

Abstract: Provided herein are functionalized nanoparticles and compositions containing functionalized nanoparticles. The functionalized nanoparticles include a first metal nanoparticle functionalized with a drug and a targeting biomolecule, and a second metal nanoparticle functionalized with an siRNA and a targeting biomolecule. The compositions include the first metal nanoparticle and the second metal nanoparticle. Kits and methods of drug delivery also are provided.

Abstract: Disclosed herein are compositions and methods for treating cancer in a subject. This involves administering an oncolytic virus containing a heterologous DNA sequence encoding one or more immunomodulatory and/or immunostimulatory polypeptide(s) of interest to the subject under conditions effective to enhance an anti-tumor immune response in the subject, and to treat cancer. It also relates to a method of enhancing the delivery to and distribution within a tumor mass of therapeutic viruses.

Abstract: In some aspects, the disclosure relates to methods and compositions for modulation of miR-122 expression in a cell or a subject. In some embodiments, methods and compositions described by the disclosure are useful for the treatment of liver-associated diseases (e.g., chronic liver disease, alcoholic liver disease).

Abstract: Compositions for the prevention, treatment and/or reversal of hearing loss include vectors encoding an Islet-1 (Isl1) nucleic acid sequence. The over-expression of Isl1 molecules in ear cells, for example, hair cells, results in the treatment of hearing loss due to age, noise exposure or any idiopathic causes.

Abstract: Described herein are constructs used for liver-specific expression of a transgene.

Abstract: The present disclosure provides, inter alia, formulation compositions comprising modified nucleic acid molecules which may encode a protein, a protein precursor, or a partially or fully processed form of the protein or a protein precursor. The formulation composition may further include a modified nucleic acid molecule and a delivery agent. The present invention further provides nucleic acids useful for encoding polypeptides capable of modulating a cell's function and/or activity.

Abstract: This application relates to compositions and methods for excising trinucleotide repeats (TNRs) contained within intron 3 of TCF4, such as is seen in subjects having Fuchs endothelial corneal dystrophy (FECD), PSC, and Schizophrenia. Compositions comprising guide sequences targeting the alpha 2 subunit of collagen VIII are also disclosed for treatment of mutations therein that may contribute to FECD.

Abstract: The present invention encompasses engineered nucleases which recognize and cleave a recognition sequence within the int22h-1 sequence of a Factor VIII gene. The present invention also encompasses methods of using such engineered nucleases to make genetically-modified cells, and the use of such cells in a pharmaceutical composition and in methods for treating hemophilia A. Further, the invention encompasses pharmaceutical compositions comprising engineered nuclease proteins, nucleic acids encoding engineered nucleases, or genetically-modified cells of the invention, and the use of such compositions for treating of hemophilia A.

Abstract: Provided herein are methods and related compositions or kits for administering viral transfer vectors in combination with synthetic nanocarriers comprising an immunosuppressant and an anti-IgM agent.

Abstract: Provided herein are methods for expression of a transgene in the presence of neutralizing antibodies by administering a recombinant adeno-associated virus (rAAV) virion in an amount capable of evading the neutralizing antibodies.