The present disclosure relates to an isolated anti-AAV (adeno-associated virus) antibody or an antigen-binding fragment thereof capable of specifically binding an epitope of AAVrh74 capsid protein and uses thereof.

The present disclosure relates to an isolated anti-AAV (adeno-associated virus) antibody or an antigen-binding fragment thereof capable of specifically binding an epitope of AAVrh74 capsid protein and uses thereof.

Particular aspects provide for use of the β-herpesvirus Cytomegalovirus (CMV: e.g., RhCMV and HCMV) as a uniquely evolved “vector” for safely initiating and indefinitely maintaining high level cellular and humoral immune responses (against, e.g., HIV, SIV, TB, etc.). Particular aspects provide a method for treatment or prevention of, e.g., HIV, SIV or TB, comprising infection of a subject in need thereof with at least one recombinant CMV-based vector (e.g., HCMV or RhCMV) comprising an expressible HIV/SIV/TB antigen or a variant or fusion protein thereof. In particular embodiments of the method, infection is of an to immunocompetent, HCMV or RhCMV seropositive subject. Additional aspects provide for RhCMV- and HCMV-based vaccine vectors, and versions thereof with suicide or safety means. Further aspects provide pharmaceutical compositions comprising the inventive CMV-based vaccine vectors.

The present invention is directed to T-cell epitope delivering polypeptides which deliver one or more CD8+ T-cell epitopes to the MHC class I presentation pathway of a cell, including toxin-derived polypeptides which comprise embedded T-cell epitopes and are de-immunized. The present invention provides cell-targeted, CD8+ T-cell epitope delivering molecules for the targeted delivery of cytotoxicity to certain cells, e.g., infected or malignant cells, for the targeted killing of specific cell types, and the treatment of a variety of diseases, disorders, and conditions, including cancers, immune disorders, and microbial infections. The present invention also provides methods of generating polypeptides capable of delivering one or more heterologous T-cell epitopes to the MHC class I presentation pathway, including polypeptides which are 1) B-cell and/or CD4+ T-cell de-immunized, 2) comprise embedded T-cell epitopes, and/or 3) comprises toxin effectors which retain toxin functions.

The present invention relates to Shiga toxin effector polypeptides with reduced antigenic and/or immunogenic potential. Immunogenicity can be a limitation for the repeated administration to mammals of proteins and polypeptides derived from Shiga toxins. The Shiga toxin effector polypeptides of the present invention have uses as components of therapeutics, diagnostics, and immunization materials. The cytotoxic proteins of the present invention have uses for selective killing of specific cell types and as therapeutics for the treatment of a variety of diseases, including cancers, immune disorders, and microbial infections. The proteins of the present invention also have uses for detecting specific cell types, collecting diagnostic information, and monitoring the treatment of a variety of diseases, such as, e.g., cancers, immune disorders, and microbial infections.

The present invention relates to bispecific molecules that are capable of localizing an immune effector cell that expresses an activating receptor to a virally infected cell, so as to thereby facilitate the killing of the virally infected cell. In a preferred embodiment, such localization is accomplished using bispecific molecules that are immunoreactive with an activating receptor of an immune effector cell and to an antigen expressed by a cell infected with a virus wherein the antigen is detectably present on the cell infected with the virus at a level that is greater than the level at which the antigen is detected on the virus by the bispecific molecules, and to the use of such bispecific molecules in the treatment of latent viral infections.

Provided are human antibodies that specifically bind to HBV Pre-S1 domain ligand and inhibit HBV or HDV infection, antibodies binding to a set of amino acid residues that are critical for viral receptor engagement, and uses of these antibodies to prevent, or treat or diagnose HBV or HDV infection.

The present invention relates to the composition and method of preparing an immunogen designated as I-spga consisting of a complex antigen prepared from 18 to 26 species of pathogenic microorganisms isolated from patients, inactivated with binary ethyleneamine (BEI) and formalin, diluted in a SPGA immunopotentiator mixed with QS-21 adjuvant. By inoculating the hens with the I-spga immunogen, hyperimmune eggs (Immunospga) are obtained which contain immunologically active proteins specific to the 18-26 antigens used for immunization. The immune response of the hens is specific to the used antigens by amplification of the antigenic signal by the SPGA immunopotentiator and due to a special immunization program that allows the immune system to act complex and intense: The I-spga complex antigen contains 18-26 microorganisms isolated from patients, bacterial bodies, components from bodies obtained by ultrasonography, cilia, exotoxins, endotoxins, spores, viruses, fungi or yeasts. This pathogenic material is inactivated with BEI and formalin. The I-spga antigen is of three types. The standard I-spga antigen is composed of 18 to 24 antibiotic-resistant bacterial species isolated from patients in Romania. The specific I-spga complex antigen is composed of the I-spga complex antigen containing a mixture of 7-9 strains from a single species of bacteria, fungi or yeasts isolated from patients in Romania mixed with SPGA and QS-21, used for inoculation of hens previously immunized with standard I-spga antigen. The personalized I-spga antigen is composed of patient-derived pathological material containing cellular debris and pathogenic germs inactivated with BEI and formalin and mixed with SPGA and QS-21 and is used to immunize hens previously immunized with the standard I-spga antigen. This now patented technology encompasses a new generation of biological products in which the immune response of the hens to different groups of parenterally inoculated antigens at different time intervals is overlapping. Chicken response is uniform and additional administration of immunogens and SPGA as an immunopotentiator amplifies the antigenic signal and immune response. The I-spga immunogen as well as the immune response contain two markers, G and A, which identify the I-spga antigen used for immunization against the antigens used to produce the Imunoinstant group bio-preparations or similar products. The I-spga immunogen is used to immunize the hens for obtaining immunologically active proteins that can be used to treat immune deficiencies, psoriasis, epidermolysis bullosa, other dermatitises, nosocomial infections, antibiotic-resistant infections in the urinary system of children

In certain embodiments, described herein is a method of treating a subject infected with a pathogen encoding an Fc-binding protein comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising an Fc region of an immunoglobulin G antibody. Also described herein is a method for treating cancer in a subject undergoing oncolytic viral therapy comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising an Fc region of an immunoglobulin G antibody. Further described herein is a method of activating natural killer (NK) cells in a subject infected with a pathogen, comprising administering to the subject a pharmaceutical composition comprising an Fc region of an immunoglobulin G antibody.

The invention relates to antibodies and antigen-binding fragments thereof that recognize coronavirus spike proteins(CoV-S), such asthe spike protein of Middle East respiratory syndrome coronavirusspike protein(MERS-S). In some embodiments, the antibodiesbind to CoV-Swith high affinity, inhibit CoV infection of human cells, inhibit CoV sialic acid-binding activity and/or bind to multiple types of CoV-S. In some embodiments, the antibodies provide a means of preventing, treating or ameliorating CoV infection.