Abstract: Livestock animals and progeny thereof comprising at least one edited chromosomal sequence that alters expression or activity of a somatostatin receptor (SSTR) protein are provided. Livestock animal cells that contain such edited chromosomal sequences are also provided. The livestock animals have improved growth performance and weight gain. Methods for producing livestock animals with increased growth performance are also provided.

Abstract: This invention provides an agonist antibody to a human thrombopoietin receptor (human c-Mpl), and pharmaceutical compositions comprising the same for use in treatment of thrombocytopenia. The disclosed agonist antibody comprises (1) antibody constant regions comprising heavy and light chain constant regions, each of which may optionally contain domain substitutions, or may contain deletions, substitutions, additions, or insertions of amino acid residues, and (2) antibody variable regions capable of binding to and activating a human thrombopoietin receptor. The-agonist antibody further induces colony formation at a concentration of 10,000 ng/ml or lower, and has a maximal activity at least 50% higher than that of PEG-rHuMGDF and an 50% effective concentration (EC50) of 100 nM or less.

Abstract: Disclosed are compositions and methods for producing fusion proteins with reduced immunogenicity. Fusion proteins of the invention include a junction region having an amino acid change that reduces the ability of a junctional epitope to bind to MHC Class II, thereby reducing its interaction with a T-cell receptor. Methods of the invention involve analyzing, changing, or modifying one or more amino acids in the junction region of a fusion protein in order to identify a T-cell epitope and reduce its ability to interact with a T cell receptor. Compositions and methods of the invention are useful in therapy.

Abstract: Provided herein are glycovariant Fc fusion proteins having increased serum half lives. Also provided are methods for increasing the serum half life of an Fc fusion protein by introducing one or more non-endogenous glycosylation sites.

Abstract: The present invention relates to LRP6 constructs that bind to LRP6 receptor. The LRP6 constructs comprise at least one LRP6 binding moiety and a half-life extender molecule such that the LRP6 construct inhibit the Wnt signaling pathway without potentiation of the Wnt signal. The LRP6 constructs also have an increased half-life to provide more time for the therapeutic benefit.

Abstract: Transplacental enzyme replacement therapy (ERT) is disclosed for deficiency of a polypeptide such as a tissue-nonspecific alkaline phosphatase (TNSALP) by administering a pharmaceutical composition that comprises a water-soluble TNSALP portion, e.g., C-terminus-truncated TNSALP peptide-bonded to an IgG1 antibody Fc portion, to a pregnant animal whose fetus or embryo is in need of such therapy. Also contemplated is a method for treating a metabolic disorder, such as HPP, in a fetus or embryo where a fusion protein that comprises a Fc fragment of an IgG1 antibody peptide-bonded to TNSALP is administered to a pregnant mother. The protein crosses the placenta of the mother and enters the fetal blood stream. The protein is taken up into fetal tissue such that the TNSALP restores normal metabolic activity in the fetus.

Abstract: A recombinant expression vector, comprising extracellular soluble domain genes of DLK1 and IgG antibody Fc domain genes, is constructed, and DLK1-Fc fusion protein is expressed and purified at 293E cell. The invention confirmed the efficacy as a drug for inhibiting cancer metastasis by confirming markedly reduced migration of cancer cells by DLK1-Fc fusion protein and also computing pharmacokinetic parameters. DLK1-Fc fusion protein has relatively higher stability than non-fusion protein, significantly reduces migration of various cancer cell lines, and provides superior cancer metastasis inhibition effect even at small concentration. Accordingly, DLK1-Fc fusion protein can be used efficaciously as an effective ingredient of a composition for inhibiting cancer metastasis.

Abstract: Exemplary embodiments disclosed herein include a microorganism that produces, secretes and injects recombinant antibodies into eukaryote cells said the described microorganisms can be used to prepare pharmaceutical compositions for the treatment of human or veterinary diseases.

Abstract: A number of human beta-glucuronidase variants having higher enzymatic activity at physiological pH as compared with wild-type beta-glucuronidase and uses thereof in prodrug therapy. Also disclosed herein is a method for identifying enzyme variants having elevated enzymatic activity using a mammalian surface display system.

Abstract: The invention provides antibodies, including chimeric human antibodies, recombinant antibodies, synthetic antibodies, and the nucleic acids encoding them, and methods for making and using these immunoglobulins. The invention provides recombinant and synthetic polypeptide and nucleic acid embodiments of these polypeptides and/or antibodies. The invention also provides polypeptides comprising, or consisting of, consensus human framework regions, or “Independently Consensused Frameworks (ICFs)”, nucleic acids encoding them, and libraries and kits comprising these ICFs and/or antibodies of the invention, individually and in combinatorial libraries and combinations.

Abstract: The present invention provides chimeric and humanized versions of anti-CD19 mouse monoclonal antibodies. The invention further relates to pharmaceutical compositions, immunotherapeutic compositions, and methods using therapeutic antibodies that bind to the human CD19 antigen and that may mediate ADCC, CDC, and/or apoptosis for the treatment of B cell diseases and disorders, such as, but not limited to, B cell malignancies, for the treatment and prevention of autoimmune disease, and for the treatment and prevention of graft-versus-host disease (GVHD), humoral rejection, and post-transplantation lymphoproliferative disorder in human transplant recipients.

Abstract: Antibodies that specifically bind to toxins of C. difficile, antigen binding portions thereof, and methods of making and using the antibodies and antigen binding portions thereof are provided herein.

Abstract: Antibodies that specifically bind to toxins of C. difficile, antigen binding portions thereof, and methods of making and using the antibodies and antigen binding portions thereof are provided herein.

Abstract: The present invention relates to novel methods of identifying and producing an anti-platelet autoantibody. More preferably, the invention relates to identification and production of a human monoclonal anti-platelet autoantibody. Moreover, the invention relates to methods for treating or alleviating a disease, disorder or condition mediated by an anti-platelet autoantibody specifically binding with a platelet, or a component thereof, such as, but not limited to, idiopathic thrombocytopenic purpura, among others. Preferably, the antibody is an unglycosylated H44L4 Fab.

Abstract: The present invention relates to a method for producing antibodies and to antibodies produced by this method. In one embodiment the invention relates to a method for producing an antibody that binds to a polypeptide of a first species, the method comprising immunizing a mammal of a second species with cells derived from a transgenic mammal of the second species, wherein the polypeptide of the first species is expressed on the surface of the cells derived from the transgenic mammal.

Abstract: Divalent antibody fragments are described, each of which has one or more interchain bridges containing a synthetic or naturally occurring polymer selected from a polyalkylene, polyakenylene, polyoxyalkylene or polysaccharide. Each bridge may be the residue of a homo- or heterobifunctional cross-linking reagent and serves to link two heavy chains in each antibody fragment via the sulphur atoms of cysteine residues present in the chains. Each fragment may be attached to one or more effector or reporter molecules, and is of use in therapy or diagnostics where it has markedly improved binding and/or pharmacokinetic properties when compared to other antibody fragments which have the same number and type of polymer molecules but in which the polymer molecules are randomly attached.

Abstract: The inventors have discovered that hematologic disorders, e.g., both neoplastic (hematologic cancers) and non-neoplastic conditions, can be treated by the induction of mixed chimerism using myeloreductive, but not myeloablative, conditioning. Methods of the invention reduce GVHD, especially GVHD associated with mismatched allogeneic or xenogeneic donor tissue, yet provide, for example, significant graft-versus-leukemia (GVL) effect and the like.

Abstract: The invention relates to the use of a monovalent antibody fragment directed against the EC2 domain of the Fc?RI receptor for the treatment of inflammatory diseases.

Abstract: Methods for generating F(ab?)2 fragments from antibodies using thermolysin as well as F(ab?)2 fragments and compositions comprising F(ab?)2 fragments generated by the method are described.

Abstract: The invention relates to: nucleic acid molecules encoding the light chain and heavy chain of feline immunoglobulin E (IgE), including species-specific regions of feline IgE; proteins encoded by the nucleic acid molecules; inhibitors to the nucleic acids and proteins; antibodies to the proteins; cells transformed with the nucleic acid molecules; assays employing the transformed cells, nucleic acids, antibodies and/or proteins or portions thereof; methods for treating IgE-mediated responses (ie. allergy) using the materials provided; methods for eliciting an immune response to IgE and kits containing the nucleic acid molecules, proteins or derivatives thereof (ie. antibodies).

Abstract: The present invention relates in general to methods and products for initiating an immune response against an antigen, and in particular relates to transepithelial delivery of antigens to provoke tolerance and immunity. The present invention further relates to methods and products for the transepithelial delivery of therapeutics. In particular, the invention relates to methods and compositions for the delivery of therapeutics conjugated to a FcRn binding partner to intestinal epithelium, mucosal epithelium and epithelium of the lung. The present invention further relates to the synthesis, preparation and use of the FcRn binding partner conjugates as, or in, pharmaceutical compositions for oral systemic delivery of drugs and vaccines.

Abstract: The present invention relates to antibodies and related molecules that specifically bind to neurokinin B. Such antibodies have uses, for example, in the prevention and treatment of cancer as well as immune system diseases and disorders including pre-eclampsia, hypertension, inflammation, asthma, gastrointestinal disorders, anxiety, depression, addiction, or pain. The invention also relates to nucleic acid molecules encoding anti-neurokinin B antibodies, vectors and host cells containing these nucleic acids, and methods for producing the same.

Abstract: The present invention concerns a recently discovered macrophage specific receptor, STIgMA, and its use in the treatment of complement-associated disorders.

Abstract: Human monoclonal antibodies and fragments thereof which bind, neutralize and provide passive immunotherapy to respiratory syncytial virus (RSV) antigenic subgroups A and B are disclosed. Also disclosed are diagnostic and immunotherapeutic methods of using the monoclonal antibodies as well as cell line producing the monoclonal antibodies.

Abstract: The invention relates to methods and products for regulating lectin complement pathway associated complement activation. The methods include both in vitro and in vivo methods for inhibiting lectin complement pathway associated complement activation. The methods are accomplished by contacting a mammalian cell having surface exposed MBL ligand with an effective amount of a mannan binding lectin inhibitor to inhibit lectin complement pathway associated complement activation. The mannan binding lectin inhibitor may be administered to a subject to prevent cellular injury mediated by lectin complement pathway associated complement activation. The products of the invention include compositions of a mannan binding lectin inhibitor. The mannan binding lectin inhibitor is an isolated mannan binding lectin binding peptide that selectively binds to a human mannan binding lectin epitope and that inhibits lectin complement pathway associated complement activation.

Abstract: The use of G class immunoglobulins, particularly immunoglobulins for intravenous use or for intramuscular use to produce a medicine for the local therapeutic treatment of dermatitis, particularly acne, contact dermatitis, atopic dermatitis, eczema and ichthyosis, psoriasis papulosquamous dermatopathies (seborrehic dermatitis, erythrodermia, etc.), as well as fungus, parasite, bacterium and virus infection dermatitis is disclosed. The pharmaceutical composition containing G class immunoglobulins suitable for topical application for the treatment of dermatitis is also disclosed.

Abstract: The present invention relates in general to methods and products for initiating an immune response against an antigen, and in particular relates to transepithelial delivery of antigens to provoke tolerance and immunity. The present invention further relates to methods and products for the transepithelial delivery of therapeutics. In particular, the invention relates to methods and compositions for the delivery of therapeutics conjugated to a FcRn binding partner to intestinal epithelium, mucosal epithelium and epithelium of the lung. The present invention further relates to the synthesis, preparation and use of the FcRn binding partner conjugates as, or in, pharmaceutical compositions for oral systemic delivery of drugs and vaccines.

Abstract: The present invention relates in general to methods and products for initiating an immune response against an antigen, and in particular relates to transepithelial delivery of antigens to provoke tolerance and immunity. The present invention further relates to methods and products for the transepithelial delivery of therapeutics. In particular, the invention relates to methods and compositions for the delivery of therapeutics conjugated to a FcRn binding partner to intestinal epithelium, mucosal epithelium and epithelium of the lung. The present invention further relates to the synthesis, preparation and use of the FcRn binding partner conjugates as, or in, pharmaceutical compositions for oral systemic delivery of drugs and vaccines.

Abstract: Chimeric antibodies for CD4 receptor comprising a variable or antigen binding region of a non-human origin specific for CD4 receptor and a constant region of human origin are disclosed. These antibodies are useful as therapeutic agents for auto-immune disorders.

Abstract: An antivenom comprising a mixture of monospecific antisera each raised against venoms of one species or sub-species is disclosed. Also disclosed is a pharmaceutical composition comprising the antivenom of the invention, and a method of treating envenomation in a mammal comprising administering the claimed antivenom.

Abstract: Specific binding members, based on the third CDR of the antibody NHS76 (SEQ ID NO: 2) are provided, together with their use in methods of treatment and diagnosis.

Abstract: The present invention is directed to a pharmaceutical composition comprising F(ab′)2 antibody fragments that are preferably free from albumin and of whole antibodies and also substantially free of pyrogens, and an effective amount of a pharmaceutically acceptable carrier. It is also directed to a method for the production of a pharmaceutical composition comprising F(ab′)2 antibody fragments using serum or blood plasma of a mammal that has been previously immunized, as a source of antibodies. The serum or blood plasma is digested with pepsin, followed by separation and purification until the pharmaceutical composition of F(ab′)2 fragments is free of albumin and complete antibodies, and substantially free of pyrogens.

Abstract: A method for providing passive immmunotherapy to respiratory syncytial virus (RSV) disease in a host is disclosed. The method includes administering to a host a human monoclonal antibody Fab fragment that neutralizes both antigenic subgroup A and subgroup B of respiratory syncytial virus (RSV), or a monoclonal antibody comprising the fragment.

Abstract: An isolated antibody that specifically binds a peptide coded by a nucleotide sequence coding for a variable region of &agr; chain of an human T lymphocyte receptor, said nucleotide sequence having a nucleotide sequence chosen from any of: V&agr; segments having any one of the sequences SEQ ID Nos. 1 to 11 or J&agr; segments having one of the sequence SEQ ID Nos. 13 or 15 to 19 and hybridomas producing said antibodies.

Abstract: The invention relates to a method of evaluating the immunological status of a subject comprising the steps of 1) determining the content of an antibody in a liquid sample from the subject using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the presence of other constituents of the sample to obtain a measurement 1, 2) determining the content of an antibody in the liquid sample using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the absence of other constituents of the sample to obtain a measurement 2, and 3) interrelating measurements 1 and 2 to express the interference and using the interference as a parameter for evaluating the immunological status of the subje

Abstract: The invention provides methods and compositions for inhibiting pathogenic binding of an pathogenic autoantibody to a myelin oligodendrocyte glycoprotein (MOG) autoantigen and screening for inhibitors of pathogenic binding of an autoantibody to a MOG autoantigen.

Abstract: Topically applicable pharmaceutical/dermatological/cosmetic compositions well suited for the therapeutic treatment or care of sensitive human skin, hair, mucous membranes, nails and/or the scalp, in particular for reducing or avoiding the skin-irritant side effects of a variety of bioactive agents, for example the &agr;-hydroxy acids, comprise a therapeutically/cosmetically effective amount of at least one calcitonin gene related peptide (“CGRP”) antagonist, e.g., CGRP 8-37 or an anti-CGRP antibody.

Abstract: This invention relates to compositions and methods useful for activating LT-&bgr; receptor signaling, which in turn elicits potent anti-proliferative effects on tumor cells. More particularly, this invention relates to lymphotoxin heteromeric complexes formed between lymphotoxin-&agr; and multiple subunits of lymphotoxin-&bgr;, which induce cytotoxic effects on tumor cells in the presence of lymphotoxin-&bgr; receptor activating agents. Also within the scope of this invention are antibodies directed against the lymphotoxin-&bgr; receptor which act as lymphotoxin-&bgr; receptor activating agents alone or in combination with other lymphotoxin-&bgr; receptor activating agents either in the presence or absence of lymphotoxin-&agr;/&bgr; complexes. A screening method for selecting such antibodies is provided.

Abstract: A compound comprises a target cell-specific portion, such as an antibody specific to tumor cell antigens, and an inactivating portion, such as an enzyme, capable of converting a substance which in its native state is able to inhibit the effect of a cytotoxic agent into a substance which has less effect against said cytotoxic agent. The prolonged action of a cytotoxic agent at tumor sites is therefore possible while protecting normal tissues from the effects of the cytotoxic agent.

Abstract: Porcine neural cells and methods for using the cells to treat neurological deficits due to neurodegeneration are described. The porcine neural cells are preferably embryonic mesencephalic, embryonic striatal cells, or embryonic cortical cells. The porcine neural cells can be modified to be suitable for transplantation into a xenogeneic subject, such as a human. For example, the porcine neural cells can be modified such that an antigen (e.g., an MHC class I antigen) on the cell surface which is capable of stimulating an immune response against the cell in a xenogeneic subject is altered (e.g., by contact with an anti-MHC class I antibody, or a fragment or derivative thereof) to inhibit rejection of the cell when introduced into the subject. In one embodiment, the porcine neural cells are obtained from a pig which is essentially free from organisms or substances which are capable of transmitting infection or disease to the recipient subject.

Abstract: The present invention provides a human glutathione s-transferase (HGST) and polynucleotides which identify and encode HGST. The invention also provides genetically engineered expression vectors and host cells comprising the nucleic acid sequences encoding HGST and a method for producing HGST. The invention also provides for agonists, antibodies, or antagonists specifically binding HGST, and their use, in the prevention and treatment of cancer and other diseases associated with the expression of HGST. Additionally, the invention provides for the use of antisense molecules to polynucleotides encoding HGST for the treatment of cancer and other diseases associated with the expression of HGST. The invention also provides diagnostic assays which utilize the polynucleotide, or fragments or the complement thereof, and antibodies specifically binding HGST.

Abstract: A composition for restoring and maintaining gastrointestinal health comprises 40-60% by weight of an immunoglobulin composition comprising concentrated immunologically active immunoglobulins and 40-60% by weight of soluble dietary fiber selected from inulin, fructo-oligosaccharides, pectin, guar gum, and mixtures thereof. The immunoglobulin and fiber-containing composition can optionally contain one or more of a beneficial human intestinal microorganism, components of a non-immune natural defense system, an iron-sequestering molecule, and gluconic acid. Preferred beneficial human intestinal microorganisms include lactobacilli and bifidobacteria. The immunologically active immunoglobulins are preferably purified from bovine milk, milk products, or whey. Methods of use are also described.

Abstract: This invention is directed to intermediates for use in the preparation of chimeric antibodies and synthetic antibody derivatives. The intermediates are open- or closed-hinge Fc fragments that have at least one alkylated external sulphydryl group. The invention is also directed to processes for making such intermediates, chimeric antibodies or synthetic antibody derivatives produced from the intermediates, and to methods of treating B-cell Lymphoma by administering chimeric antibodies or synthetic antibody derivatives produced using the intermediates of the invention.

Abstract: Compositions comprising anti-CD45RB antibodies are provided for the prevention or reversal of transplant rejection as well as therapy for autoimmune diseases.

Abstract: The invention is directed to a method and food product for achieving at least one of the following: increasing muscle protein or reducing fat in an animal. The method comprises administering to the animal an effective amount of a composition comprising a gastrointestinal neuro-modulator antibody in order to neutralize the gastrointestinal neuro-modulator.

Abstract: The invention identifies the CTLA4 receptor as a ligand for the B7 antigen. The complete amino acid sequence encoding human CTLA4 receptor gene is provided. Methods are provided for expressing CTLA4 as an immunoglobulin fusion protein, for preparing hybrid CTLA4 fusion proteins, and for using the soluble fusion proteins, fragments and derivatives thereof, including monoclonal antibodies reactive with B7 and CTLA4, to regulate T cell interactions and immune responses mediated by such interactions.

Abstract: Skin redness, rosacea and/or discreet erythema afflicting a mammalian, notably human patient, are therapeutically treated by administrating to such patient a therapeutically/cosmetically effective amount of at least one CGRP antagonist, advantageously in combinatory immixture with at least one antagonist of a neuropeptide other than CGRP, e.g., a substance P antagonist, and/or at least one inflammation mediator antagonist.

Abstract: The subject invention relates a method for the production of monoclonal antibodies. The method utilizes an immunized germfree animal. The invention also provides methods for the use of such monoclonal antibodies, and polyclonal antibodies derived from an immunized germfree animal, for in vitro and in vivo clinical diagnostics and therapeutics. Also, the subject invention provides a fibrin-specific monoclonal antibody.

Abstract: The present invention comprises a simple way of identifying the tendency towards allergy or allergy already broken out, and showing the probability of allergy in a patient, by measuring the receptor expression of the phagocytic cells of peripheral blood. With a logistic regression model a combination of variables were found which best describe the probability of allergy. Thus the invention relates to a method for detecting allergy and a test kit for accomplishing the method. The invention also relates to a sensitive and specific logistic model for determining the probability of allergy.

Abstract: A pharmaceutical composition consisting, of nontoxic components wherein the nontoxic components comprise a core element comprising an antibody which binds to an antigen wherein the core element is a compressed tablet wherein compression forces used to prepare the tablet range from about 0.1 tonnes/cm.sup.2 to about 42.1 tonnes/cm.sup.2 and the process for preparing the composition.