Provided herein are methods of treating a patient with severe insulin resistance. The methods comprise administering to a patient in need thereof a therapeutic amount of a GCG/GCGR signaling pathway inhibitor, such that blood glucose or beta-hydroxybutyrate levels are lowered or that the severe insulin resistance is mediated, or a condition or disease characterized by severe insulin resistance is mediated, or at least one symptom or complication associated with the condition or disease is alleviated or reduced in severity. The GCG/GCGR signaling pathway inhibitor can be a small molecule inhibitor of the signaling pathway, an antisense inhibitor of the signaling pathway, a GCG neutralizing monoclonal antibody, a GCGR antagonist, a peptide inhibitor of the signaling pathway, a DARPin, a Spiegelmer, an aptamer, engineered Fn type-III domains, etc. The therapeutic methods are useful for treating a human suffering from severe insulin resistance.

An antibody that specifically binds to a glucocorticoid-induced tumor necrosis factor receptor (GITR), an antibody fragment and a polymer thereof, and a conjugate and a fusion comprising the antibody or the antibody fragment are provided in the present invention. A nucleic acid encoding the antibody, the antibody fragment, the polymer, the conjugate and the fusion, a vector, and a host cell expressing the nucleic acid are also provided in the present invention. In addition, a composition comprising the antibody and the antibody fragment thereof, the polymer, the conjugate or the fusion, and use thereof in therapy and diagnosis are also provided in the present invention.

A mucosal adjuvant may have high mucosal immunogenicity and high safety and be useful in the preparation of mucosal vaccines, and a mucosal vaccine composition may include the same. Such mucosal adjuvant may include TGDK. A method for preparing the mucosal vaccine composition may include mixing TGDK with an immunogen.

A cancer vaccine composition for human leukocyte antigen (HLA)-A*0206-positive persons, comprising a protein product of the tumor suppressor gene WT1 or a partial peptide thereof.

The present specification discloses a pharmaceutical composition comprising an active agent that causes reduction of the level of systemic immunosuppression in an individual for use in treating a disease, disorder, condition or injury of the CNS. The pharmaceutical composition is administered by a dosage regimen comprising at least one course of therapy, each course of therapy comprising in sequence a treatment session followed by an interval session of non-treatment.

The present invention relates to subcutaneous formulations of anti-CD38 antibodies and their uses.

The present invention relates to subcutaneous formulations of anti-CD38 antibodies and their uses.

The present disclosure provides recombinantly manufactured fusion proteins comprising a SARS-CoV-2 Receptor Binding Domain (SARS-CoV-2-RBD) fragment or an analog thereof linked to a human Fc fragment for use in relation to the 2019 Novel Coronavirus (COVID-19). Embodiments include the administration of the fusion proteins to patients that have recovered from COVID-19 as a booster vaccination, to antibody naïve patients to produce antibodies to the SARS-CoV-2 virus to enable the patients to become convalescent plasma donors, to patients who have been infected by the SARS-CoV-2 virus and have contracted COVID-19 in order to limit the scope of the infection and ameliorate the disease, and as a prophylactic COVID-19 vaccine. Exemplary Fc fusion proteins and pharmaceutical formulations of exemplary Fc fusion proteins are provided, in addition to methods of use and preparation.

The present invention relates to vaccines comprising at least one mRNA encoding at least one antigen for use in the treatment of a disease in newborns and/or infants, preferably exhibiting an age of not more than 2 years, preferably of not more than 1 year, more preferably of not more than 9 months or even 6 months, wherein the treatment comprises vaccination of the newborn or infant and eliciting an immune response in said newborn or infant. The present invention is furthermore directed to kits and kits of parts comprising such a vaccine and/or its components and to methods applying such a vaccine or kit.

The invention features methods for preventing or treating CGRP associated disorders such as vasomotor symptoms and/or headaches (e.g., migraine, cluster headache, and tension headache) by administering an anti-CGRP antagonist antibody. Compositions for use in the disclosed methods are also provided. Antagonist antibody G1 and antibodies derived from G1 directed to CGRP are also described.