The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. A first aspect of the invention relates to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titer of antibodies against the therapeutic protein, e.g. the collection of at least two samples at two different time points. A third aspect of the invention relates to the selection of the critical threshold level, which corresponds to the antibody titer of untreated patients increased by the double of the standard deviation of this control antibody titer.

This invention provides compositions and methods to treat a condition or disease without the use of exogenous targeting sequences or chemical compositions. The present invention relates to single-domain antibodies (sdAbs), proteins and polypeptides comprising the sdAbs that are directed against intracellular components that cause a condition or disease. The invention also includes nucleic acids encoding the sdAbs, proteins and polypeptides, and compositions comprising the sdAbs. The invention includes the use of the compositions, sdAbs, and nucleic acids encoding the sdAbs for prophylactic, therapeutic or diagnostic purposes.

The present invention concerns methods for treating progressive multiple sclerosis (MS) in a patient, and an article of manufacture with instructions for such use.

This invention provides compositions and methods to treat a condition or disease without the use of exogenous targeting sequences or chemical compositions. The present invention relates to single-domain antibodies (sdAbs), proteins and polypeptides comprising the sdAbs that are directed against intracellular components that cause a condition or disease. The invention also includes nucleic acids encoding the sdAbs, proteins and polypeptides, and compositions comprising the sdAbs. The invention includes the use of the compositions, sdAbs, and nucleic acids encoding the sdAbs for prophylactic, therapeutic or diagnostic purposes.

The present invention relates to methods of detecting Anti-Drug Antibodies. The present invention also relates to methods of monitoring patients undergoing therapeutic antibody treatment. The invention further relates to kits suitable for the implementation of the above methods.

Predictive biomarkers identify those patients suffering from immunoglobulin positive (Ig.sup.+) B lineage malignancies that are responsive to active immunotherapy, where the active immunotherapy comprises vaccination with a tumor-specific idiotype-immunogen. It is shown herein that patient responsiveness to the idiotype-immunogen is dependent upon the sequence of the immunogen, where an immunogen having a low number of tyrosine residues in the CDR1 (herein termed CDR1-Y.sup.10) regions of one or both of the immunogen heavy and light chains is predictive of a positive anti-tumor response, while a high number of CDR1 tyrosine residues (herein termed CDR1-Y.sup.hi) is predictive of a low anti tumor response.

Monoclonal antibodies directed against the influenza A virus are described, which have the advantageous and unpredicted property of being able to bind a plurality of subtypes of the influenza A virus. One preferred embodiment is the antibody designated as Fab28, which displays a neutralizing activity against a plurality of subtypes of the influenza A virus. Anti-idiotype antibodies directed against the monoclonal antibodies described herein, immunogenic or vaccine compositions comprising the monoclonal antibodies of the invention are also described, as well as therapeutic, prophylactic and diagnostic applications for the monoclonal antibodies described herein. The monoclonal antibodies can also be used for testing antibody preparations to be used as vaccines.

Monoclonal antibodies directed against the influenza A virus are described, which have the advantageous and unpredicted property of being able to bind a plurality of subtypes of the influenza A virus. One preferred embodiment is the antibody designated as Fab28, which displays a neutralizing activity against a plurality of subtypes of the influenza A virus. Anti-idiotype antibodies directed against the monoclonal antibodies of the invention, immunogenic or vaccine compositions comprising the monoclonal antibodies of the invention are also described, as well as therapeutic, prophylactic and diagnostic applications for the monoclonal antibodies of the invention. The monoclonal antibodies of the invention can also be used for testing antibody preparations to be used as vaccines.

The present disclosure is directed to human monoclonal IgE antibodies, and IgG antibodies engineered therefrom. Such engineered antibodies can be used to blunt pathologic IgE responses in subjects, such as in the treatment or prevention of allergies.

The disclosure provides for methods and systems for detecting antibody protein product self-association comprising inducing co-agglutination of nanoparticles and solid supports to capture the nanoparticles, each coated with a ligand specific for immunoglobulins, and utilizing a fluidic device to detect co-agglutination and antibody protein product self-association.