Abstract: The present invention is directed in part to pharmaceutical compositions for storage and administration comprising a) a HER2/neu antibody (“margetuximab”), b) buffering agents, and c) stabilizers, wherein said margetuximab is stable. The invention in part provides, containers and kits comprising such pharmaceutical compositions. The invention is directed in part to the use of such pharmaceutical compositions, containers, and kits containing margetuximab in the treatment of HER2/neu-positive cancer (i.e., a cancer that expresses HER2), including breast cancer or gastric cancer or GEJ cancer.

Abstract: The present disclosure provides a recombinant fusion protein containing an extracellular Ig-like domain of a signal-regulator protein (SIRP), linked via a linker, to a paratope of an Ig-like anti-HER2 antibody at the N-terminus of a heavy chain or a light chain constituting the paratope. The present disclosure also provides a polynucleotide encoding the recombinant fusion protein, an expression vector containing the polynucleotide, a method for producing the recombinant protein and a method for treating a disease caused by over-expression of CD47 and/or HER2.

Abstract: The present invention relates methods of treatment using BMP6 antagonists.

Abstract: The present invention relates to conjugates including a chelating moiety of a metal complex thereof and a therapeutic or targeting moiety, methods for their production, and uses thereof.

Abstract: The present disclosure provides compositions and methods for extended release of certain types of antibodies in vivo. It was discovered that such antibodies are able to initiate reversible gelation of hyaluronic acid (HA) by creating a depot that dissociates over time to release the antibody without any impact on its physical and chemical properties as well as its biological activity. As certain tissues and organs, such as eyes, joints and skins, contain HA, local injection of the antibodies to these tissues or organs will result in embedding of the antibody in gel formed from the HA, which becomes a repository of slow-released antibodies. In addition, slow-released formulations can be prepared with antibodies mixed with HA, optionally with other polymers.

Abstract: The present invention relates to a method for preparing a fusion protein having an IgG Fc domain and, specifically, to a method for preparing a fusion protein having an IgG Fc domain, the method additionally comprising a step of culturing cells, which produce the fusion protein, at a decreased culture temperature, thereby increasing cell growth and cell viability so as to increase fusion protein productivity and inhibiting aggregate generation so as to improve quality and production yield.

Abstract: The present invention relates to methods and pharmaceutical compositions for the treatment of tissue lesions. The inventors showed that CCR2 is expressed on FMCs, especially on a subpopulation of progenitor cells, that they call “fetal myeloid progenitor cells” (FMPCs), and mediates the recruitment of these cells to maternal wound tissue. Moreover, the inventors reported that recruited FMCs/FMPCs improve maternal skin wound healing by organizing blood vessel endothelium and secreting pro-angiogenesis peptides, particularly chemokine CXCL1, to enhance angiogenesis in wound. In particular, the present invention relates to CCR2 agonists for use in the treatment of tissue lesions in a subject in need thereof.

Abstract: The disclosure features methods for treating craniosynostosis in a patient (e.g., a patient having hypophosphatasia (HPP) and exhibiting or likely to have increased intracranial pressure (ICP)) by administering a soluble alkaline phosphatase (sALP) to the patient, e.g., in combination with a cranial surgery, e.g., a cranial vault remodeling procedure.

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: Compositions including a CD180 binding ligand and a linked Hepatitis B antigen and their use are disclosed. The Hepatitis B antigen includes Hepatitis B virus pre-S1 and/or pre-S2 region of the HBV envelope protein (HBVpreS1/S2Ag), L-HBsAg, MHBsAg, S-HBsAg, or antigenic fragments or mutants thereof.

Abstract: The present invention relates to modified citrullinated enolase peptides that can be used as targets for cancer immunotherapy. These peptides can be used as vaccines or as targets for monoclonal antibody (mAb) therapy. Such vaccines cur mAbs may be used in the treatment of cancer.

Abstract: A peptide that binds to the Si spike protein of Middle East Respiratory syndrome coronavirus or MERS-CoV and a method for inhibiting infection of a subject exposed to or having MERS-CoV by administering the peptide.

Abstract: The present disclosure is directed to a method of treating neurological disorder comprising peripheral administration to a patient in need thereof a DN-TNF polypeptide that inhibits the activity of soluble TNF- but not transmembrane TNF-?.

Abstract: The present invention relates to compositions and methods for the immunomodulation mediated by the interaction of PD-L2 and RGMb.

Abstract: A method for producing a recombinant polypeptide, comprising: (a) providing a 100 L to 25,000 L fed-batch bioreactor comprising (i) cells capable of expressing the recombinant polypeptide asfotase alfa (SEQ ID NO: 1), and (ii) a culture medium suitable for conducting such expression, the culture medium comprising about 25 ?M to about 300 ?M zinc; (b) culturing the cells under conditions suitable to express the recombinant asfotase alfa wherein the pH of the culture medium is about 6.7 to about 7.1, and wherein zinc is added into said culture medium such that the zinc concentration in the culture medium is maintained at a concentration of about 25 ?M to about 300 ?M of zinc.

Abstract: The present invention provides bispecific antibody constructs of a specific Fc modality characterized by comprising a first domain binding to BCMA, a second domain binding to an extracellular epitope of the human and/or the Macaca CD3? chain and a third domain, which is the specific Fc modality. Moreover, the invention provides a polynucleotide, encoding the antibody construct, a vector comprising this polynucleotide, host cells, expressing the construct and a pharmaceutical composition comprising the same.

Abstract: The present disclosure provides variant PD-L1 immunomodulatory polypeptides, and fusion polypeptides comprising the variant immunomodulatory peptides. The present disclosure provides T-cell modulatory multimeric polypeptides, and compositions comprising same, where the T-cell modulatory multimeric polypeptides comprise a variant immunomodulatory polypeptide of the present disclosure. The present disclosure provides nucleic acids comprising nucleotide sequences encoding the T-cell modulatory multimeric polypeptides, and host cells comprising the nucleic acids. The present disclosure provides methods of modulating the activity of a T cell; the methods comprise contacting the T cell with a T-cell modulatory multimeric polypeptide of the present disclosure.

Abstract: The invention relates to IL-22 polypeptides, IL-22 Fc fusion proteins and IL-22 agonists, composition comprising the same, methods of making and methods of using the composition for the treatment of diseases. The invention also relates to IL-22 receptor associated reagents and methods of use thereof.

Abstract: Provided is a composition for activating neurogenesis, use of the composition, and a method for preventing, improving, inhibiting the development of, and/or treating a disease or the like of the central nervous system and or the peripheral nervous system using the composition.

Abstract: A method is used for treating bone metastasis diseases in subjects. The method preferably depends on whether the subject shows certain specific proteins levels in one or more body fluids prior to or during treatment. The treatment includes the administration of at least one pan ?v integrin inhibitor to a subject, a medicament for use in said new methods, and a method of predicting the outcome of a treatment with at least one pan ?v integrin inhibitor based on the specific protein levels in one or more body fluids of the subject.

Abstract: The present invention relates to glycosylated immunoglobulin variable domains, and in particular to glycosylated immunoglobulin single variable domains (the latter also being referred to herein by means of the abbreviation “ISF” or “ISVD”). The present invention relates to glycosylated immunoglobulin heavy-chain variable domains (also referred to herein as “VH domains”), and in particular to glycosylated immunoglobulin heavy-chain ISVD's. The invention in particular relates to immunoglobulin (single) variable domains that are glycosylated in such a way that the binding of said immunoglobulin (single) variable domains by so-called “pre-existing antibodies” is prevented and/or reduced (i.e. partially or essentially completely) compared to the same immunoglobulin (single) variable domain without the glycosylation of the invention being present.

Abstract: The present invention relates to the field of biomedicine and antibody engineering. Specifically, it relates to mono and multispecific multivalent single chain polypeptide molecules and derivatives thereof, preferably to multispecific single chain (tandem) trimerbodies with defined stoichiometry, to nucleic acid sequences and vectors encoding thereof, and host cells expressing the same. It further relates to methods of producing thereof, pharmaceutical compositions, kits, methods of treatment, use as diagnostics or imaging reagents and combination therapies using thereof.

Abstract: The present invention provides compositions and methods for generating a genetically modified T cells comprising a chimeric antigen receptor (CAR) having an antigen binding domain, a transmembrane domain, a costimulatory signaling region, and a CD3 zeta signaling domain, wherein the T cell exhibits prolonged exponential expansion in culture that is ligand independent and independent of the addition of exogenous cytokines or feeder cells.

Abstract: A method for preventing and/or treating fibrosis associated with an eye-related disease or disorder includes administering an effective amount of a multikinase inhibitor to a subject in need thereof. The multikinase inhibitor is nintedanib, lenvatinib, a combination thereof, or a salt thereof. The eye-related disease or disorder is corneal transparency, corneal scar formation, secondary cataract formation, glaucoma filtration surgery, ocular surgical procedures and implants, photorefractive keratectomy, laser in situ keratomileusis, formation and contraction of pre- and epiretinal membranes, proliferative vitreoretinopathy, subretinal fibrosis/scarring, retinal gliosis, or formation of choroidal membranes.

Abstract: Provided herein are immunomodulatory proteins that exhibit neutralizing activity of BAFF and APRIL (or BAFF/APRIL heterotrimers). The immunomodulatory proteins provided herein include variant domains of Transmembrane Activator and CAML Interactor (TACI). Among provided immunodulatory proteins are TACI-Fc fusion proteins. Also provided are nucleic acid molecules encoding the immunomodulatory proteins. The immunomodulatory proteins provide therapeutic utility for a variety of immunological diseases, disorders or conditions. Also provided are compositions and methods for making and using such proteins.

Abstract: Methods and kits for mitigating a toxic effect of at least one of vesicants and caustic gases in a subject in need thereof are described. In particular, an effective amount of a thrombopoietin (TPO) mimetic, such as RWJ-800088 or romiplostim, is used to mitigate the toxic effect of the vesicant or caustic gas.

Abstract: The present invention relates to a new antibody anti-nectin-4. Nectin-4 is a tumor-associated antigen overexpressed in several cancers and notably in 30%, 49% and 86% of breast, ovarian and lung carcinomas, respectively, which are tumors of bad prognosis. Treatments remain still elusive. That's why the inventors developed a new targeted therapy based on an antibody having specificity to nectin-4 (called 14A5.2 mab). Indeed, the inventors selected this antibody for its intrinsic prophylactic anti-metastatic properties and also for the treatment of localized primary and metastatic cancer. More, the 14A5.2 mab could be indicated for the treatment of cancer resistant to ASG-22ME (from Astellas company). Thus, the invention relates to the 14A5.2 mab and its uses thereof.

Abstract: Embodiments of the disclosure include methods and compositions for producing NKT cells effective for immunotherapy and also methods and compositions for providing an effective amount of NKT cells to an individual in need of immunotherapy. In specific embodiments, the NKT cells are CD62L+ and have been exposed to one or more costimulatory agents to maintain CD62L expression. The NKT cells may be modified to incorporate a chimeric antigen receptor, in some cases.

Abstract: The present invention relates, in part, to, chimeric proteins which include the extracellular domain of colony stimulating factor 1 receptor (CSF1R) and their use in the treatment of diseases, such as immunotherapies for cancer and/or an inflammatory disease.

Abstract: The present disclosure relates to multispecific molecule comprising a binding domain specific to the antigen CD22 and a binding domain specific to the antigen CD79a and/or CD79b, compositions comprising the same and use of both in treatment, for example the treatment of autoimmune disease.

Abstract: A pharmaceutical composition includes an NAG-1 inhibitor as an active ingredient for inhibiting resistance against an anticancer drug of an ovarian cancer patient and a method of diagnosing prognosis of resistance against an anticancer drug of an ovarian cancer patient by using the NAG-1 inhibitor. It is found by controlling NAG-1 protein that NAG-1, which is overexpressed in an ovarian cancer patient and in an ovarian cancer stem cell having resistance against an anticancer drug, plays a key role in a chronic inflammatory reaction and resistance against an anticancer drug, and in this regard, NAG-1 can be used as a target gene for effective tumor therapy.

Abstract: The present invention relates to novel antibodies and fragments that bind to a V-domain Ig Suppressor of T cell Activation (VISTA), and methods of making and using same. Methods of use include methods of treatment of cancer, including leukemias, lymphomas, solid tumors and melanomas.

Abstract: Stable lyophilized therapeutic protein compositions and their methods of manufacture are provided. Specifically, the use of water as a solid cake plasticizer and protein stabilizer is described. Also, the inclusion of a multicomponent stabilizer comprising a larger molecular entity and a smaller molecular entity is described. Also, the inclusion of post-drying annealing under certain conditions improves protein stability. Proteins are predicted to remain stable over 24 months at 25° C.

Abstract: A method of treating a human having a condition or disease related to a bone defect characterized by at least one of: increased level of an alkaline phosphatase ligand, particularly PPi, PLP, or PEA; and decreased alkaline phosphatase activity, compared to a human without said condition or disease, comprising administering to the human a therapeutically effective amount of a polypeptide comprising the amino acid sequence of SEQ ID NO: 1, wherein the polypeptide is administered through at least one subcutaneous injection to the human in a frequency of fewer than three times each week.

Abstract: Provided herein are variant CD80 polypeptides, immunomodulatory proteins comprising variant CD80 polypeptides, and nucleic acids encoding such proteins. The immunomodulatory proteins provide therapeutic utility for a variety of immunological and oncological conditions. Compositions and methods for making and using such proteins are provided.

Abstract: The disclosure features methods for treating hypophosphatasia (HPP) in a patient (e.g., an adult having HPP, such as an adult having pediatric-onset HPP, or an adolescent having HPP) exhibiting decreased pyrophosphate (PPi) or pyridoxal 5?-phosphate (PLP) concentrations in, e.g., a plasma sample, physical impairments, or decreased walking ability by administering a soluble alkaline phosphatase (sALP) to the patient.

Abstract: The present invention relates to an antibody-drug-conjugate. From one aspect, the invention relates to an anti-body-drug-conjugate comprising an antibody capable of binding to a Target, said antibody being conjugated to at least one drag selected from derivatives of dolastatin 10 and auristatins. The invention also comprises method of treatment and the use of said anti-body-drag-conjugate for the treatment of cancer.

Abstract: Methods for the treatment or prevention of disease, such as fatty liver disease and obesity, are described including the modulation the amount of CTRP1 in a subject. Novel mouse strains are also described.

Abstract: The present disclosure belongs to the field of pharmaceutical preparations and relates to the design of a series of lipophilic derivatives by using wild-type penetrating peptide penetratin. These penetratin derivatives have a strong ability to penetrate the ocular tissues and do not cause ocular tissue toxicity. As ocular absorption enhancers, non-invasive routes could be used to achieve intraocular drug delivery and increase the ocular bioavailability of drugs. These penetratin derivatives and the ophthalmic drug delivery system constructed by them are used for eye drop administration, which could replace the intraocular injection with poor patients compliance, which greatly enhances the convenience and safety of the treatment of intraocular and fundus diseases.

Abstract: The present invention relates to a composition for treatment or prevention of infectious inflammatory diseases comprising tryptophanyl-tRNA synthetase as an active ingredient, and a composition for immune enhancement. More specifically, the present invention relates to a pharmaceutical composition for treatment or prevention of infectious inflammatory diseasess comprising tryptophanyl-tRNA synthetase as an active ingredient, a food composition for preventing or improving, a veterinary composition for preventing or treating, and a composition for immune enhancement comprising a tryptophanyl-tRNA synthetase as an active ingredient, respectively. The composition of the present invention can be effectively used for preventing or treating diseases of humans and animals caused by infection from bacteria, viruses or fungi and the like by inhibiting infections such as bacterial, viral, and fungal infections at an early stage particularly through activating innate immune response.

Abstract: The present invention provides NRP1 as a cell surface marker for isolating human cardiomyogenic ventricular progenitor cells (HVPs), in particular progenitor cells that preferentially differentiate into cardiac ventricular muscle cells. Additional HVP cell surface markers identified by single cell sequencing are also provided. The invention provides in vitro methods of the separation of NRP1+ ventricular progenitor cells, and the large scale expansion and propagation thereof. Large clonal populations of isolated NRP1+ ventricular progenitor cells are also provided. Methods of in vivo use of NRP1+ ventricular progenitor cells for cardiac repair or to improve cardiac function are also provided. Methods of using the NRP1+ ventricular progenitor cells for cardiac toxicity screening of test compounds are also provided.

Abstract: The present invention is directed to a combination therapy involving the administration of a first molecule that specifically binds to human B7-H3 and a second molecule that specifically binds to human PD-1 to a subject for the treatment of cancer and/or inflammation. The invention also concerns pharmaceutical compositions that comprise a first molecule that specifically binds to human B7-H3 and a second molecule that specifically binds to human PD-1 that are capable of mediating, and more preferably enhancing, the activation of the immune system against cancer cells that are associated with any of a variety of human cancers. The invention also relates to the use of such pharmaceutical compositions to treat cancer and other diseases in recipient subjects.

Abstract: The invention relates generally to multispecific antibodies and to multispecific activatable antibodies that specifically bind to two or more different antigens or epitopes, as well as to methods of making and using these multispecific antibodies and/or multispecific activatable antibodies in a variety of therapeutic, diagnostic and prophylactic indications.

Abstract: The invention features multi-specific fusion protein complexes with one domain comprising IL-15 or a functional variant and a binding domain specific to IL-7 or IL-21.

Abstract: The present disclosure involves optimized methods for production of hiologically active proteins termed optimally manufactured stradomers. The present disclosure further provides compositions and methods useful in the treatment of diseases and conditions including autoimmune diseases, inflammatory diseases, or infectious diseases.

Abstract: Disclosed herein are Complement factor H (CFH) inhibitors, such as anti-CFH antibodies and small molecules, and methods of using said inhibitors.

Abstract: The present invention relates to the use of anti-CD3 and anti-CD25 antibodies for the management and treatment of inflammatory diseases and psycho-immune disorders, such as depression, autism (ASD) and attention deficit/hyperactivity disorder (ADHD).

Abstract: Provided herein are variant CD80 polypeptides, immunomodulatory proteins comprising variant CD80 polypeptides, and nucleic acids encoding such proteins. The immunomodulatory proteins provide therapeutic utility for a variety of immunological and oncological conditions. Compositions and methods for making and using such proteins are provided.

Abstract: The present disclosure is directed to epitope-tagged antibodies, as well as methods of employing the epitope-tagged antibodies for detecting one or more targets in a biological sample, e.g. a tissue sample.

Abstract: The invention provides compositions and methods for treating cardiac dysfunction, particularly cachexia-associated or RAGE-associated cardiac dysfunction, using an anti-RAGE agent. The invention also provides compositions and methods for identifying therapeutic agents useful for disrupting (slowing, reducing, reversing, or preventing). The methods comprise designing or identifying agents that bind to functional sites identified on the RAGE polypeptide, wherein binding of agents to the functional site(s) inhibit RAGE-mediated cachetogenic signaling.