This invention relates generally to bifunctional molecules including (a) a TGFβRII or fragment thereof capable of binding TGFβ and (b) an antibody, or antigen binding fragment thereof, that binds to an immune checkpoint protein, such as Programmed Death Ligand 1 (PD-L1), uses of such molecules (e.g., for treating cancer), and methods of making such molecules.

A therapeutic agent comprising Lon protease, or a variant or active fragment thereof, alpha-hemolysin, or a variant or active fragment thereof, CK1α1, or a variant or active fragment thereof, a c-MYB inhibitor and/or a CEBP-δ inhibitor, for use in therapy, with the proviso that the therapeutic agent does not comprise a bacteria or bacterial supernatant. Methods of production and use thereof.

A therapeutic agent comprising Lon protease, or a variant or active fragment thereof, alpha-hemolysin, or a variant or active fragment thereof, CK1α1, or a variant or active fragment thereof, a c-MYB inhibitor and/or a CEBP-δ inhibitor, for use in therapy, with the proviso that the therapeutic agent does not comprise a bacteria or bacterial supernatant. Methods of production and use thereof.

The present invention relates to anti-VP 1 antibodies, antibody fragments, and their uses for the prevention and treatment of polyoma virus infection and associated diseases.

The present invention relates to improved strategies, compositions, and methods for producing shared neoplasia vaccines, including “off the shelf” pre-furnished shared neo-epitope warehouses, which can be used to enable the rapid production of bladder cancer neoantigen-based vaccines. The present invention relates to identified and designed shared neo-epitopes based on non-synonymous mutations that are present in at least 1% of subjects having bladder cancer. The strategies, compositions, and methods include the identification of neo-epitopes that are known or determined (e.g. predicted) to engage regulatory T cells and/or other detrimental T cells (including T cells with potential host cross-reactivity and/or anergic T cells) and exclusion of such identified neo-epitopes that are known or determined (e.g. predicted) to engage regulatory T cells and/or other detrimental T cells (including T cells with potential host cross-reactivity and/or anergic T cells) from the shared neo-epitopes that are to be used in the shared neoantigen-based vaccines.

The present invention relates to improved strategies, compositions, and methods for producing shared neoplasia vaccines, including “off the shelf” pre-furnished shared neo-epitope warehouses, which can be used to enable the rapid production of bladder cancer neoantigen-based vaccines. The present invention relates to identified and designed shared neo-epitopes based on non-synonymous mutations that are present in at least 1% of subjects having bladder cancer. The strategies, compositions, and methods include the identification of neo-epitopes that are known or determined (e.g. predicted) to engage regulatory T cells and/or other detrimental T cells (including T cells with potential host cross-reactivity and/or anergic T cells) and exclusion of such identified neo-epitopes that are known or determined (e.g. predicted) to engage regulatory T cells and/or other detrimental T cells (including T cells with potential host cross-reactivity and/or anergic T cells) from the shared neo-epitopes that are to be used in the shared neoantigen-based vaccines.

The disclosures herein relate to novel compounds of formula ##STR00001##
wherein R.sub.1, R.sub.2, R.sub.3 and R.sub.4 and n are defined herein, and their use in treating, preventing, ameliorating, controlling or reducing the risk of inflammation, neurological or psychiatric disorders associated with modulating mGlu5 receptor function.

Isolated human monoclonal antibodies which bind to IL-8 (e.g., human IL-8) are disclosed. The human antibodies can be produced in a hybridoma, transfectoma or in a non-human transgenic animal, e.g., a transgenic mouse, capable of producing multiple isotypes of human monoclonal antibodies by undergoing V-D-J recombination and isotype switching. Also disclosed are pharmaceutical compositions comprising the human antibodies, non-human transgenic animals, hybridomas, and transfectomas which produce the human antibodies, and therapeutic and diagnostic methods for using the human antibodies.

The present disclosure provides antibodies that specifically bind to human glucocorticoid-induced TNFR family related receptor (GITR) and compositions comprising such antibodies. In a specific aspect, the antibodies specifically bind to human GITR and modulate GITR activity, e.g., enhance, activate or induce GITR activity, utilizing such antibodies. The present disclosure also provides methods for treating disorders, such as cancer and infectious diseases, by administering an antibody that specifically binds to human GITR and modulates GITR activity e.g., enhances, activates or induces GITR activity.

Described herein is the use of Adelmidrol in the treatment of epithelial dysfunctions. In particular, described herein is Adelmidrol for use in the treatment of epithelial tissue dysfunctions in a human being or animal, wherein said Adelmidrol causes an increase of the endogenous levels of Palmitoylethanolamide without inhibiting the activity of the Palmitoylethanolamide-degrading FAAH and NAAA enzymes.