The invention relates to methods, compositions, and kits for treating a condition with an immune response modifier and a human papillomavirus (HPV) vaccine. Conditions treatable with the methods, kits and compositions include but are not limited to neoplasia, anal intraepithelial neoplasia, high-grade squamous intraepithelial neoplasia, dysplasia, anal dysplasia, dysplastic lesion, high-grade dysplastic lesion, condyloma, anal cancer, anal tumor, HPV infection, and any HPV-induced condition.

The present invention generally relates to engineered cells and compositions thereof, particularly, T cells comprising genetically engineered T Cell receptors (TCRs) and checkpoint inhibitors (CPIs). Methods for using the compositions to treat cancer are also disclosed herein. Genetically engineered T cells that recognize tumor antigen HPV E6 and simultaneously secrete a single-chain antibody that blocks Programmed Cell Death Protein 1 (PD-1). Also provided is an immunotherapy for HPV E6 expression related cancers.

Anti-BK virus antibody molecules or binding fragments thereof are disclosed. These Anti-BK virus antibody molecules or binding fragments can be used in the treatment or prevention of BK virus infection and/or BK virus associated disorder.

Systems and methods to link CD40 signaling to antigen binding, independently of CD40 ligand binding are described. The systems and methods include fusion proteins including an extracellular antigen binding domain linked to an intracellular CD40 signaling domain.

For many diseases due to microbes or the like, proliferation of microbes themselves is a cause of a symptom. However, there were cases where a substance released by the microbes is a cause of a symptom. In such cases, when attempting to treat a disease with an antibody, it was necessary to obtain an antibody against an antigen that is a substance causing the disease. However, it was difficult to find the underlying substance causing the disease among substances released by the microbes. An antibody (polyclonal) binding to not only an antigen but also to a substance, which is secreted by the antigen and accelerates the deterioration of a symptom, is obtained by immunizing birds with a lysis solution produced from lysing microbial cells as an antigen. Further, an antibody obtained with a surface protein of a virus as an antigen is expected to inhibit an infection by a virus.

The present invention pertains to antigen recognizing constructs against antigens of the Merkel cell polyomavirus (MCV). The invention in particular provides novel T cell receptor (TCR) based molecules which are selective and specific for the infected host cells and tumor cell expressed MCV derived antigens. The TCR of the invention, and antigen binding fragments derived therefrom, are of use for the diagnosis, treatment and prevention of cancerous diseases. Further provided are nucleic acids encoding the antigen recognizing constructs of the invention, vectors comprising these nucleic acids, recombinant cells expressing the antigen recognizing constructs and pharmaceutical compositions comprising the compounds of the invention.

Anti-BK virus antibody molecules or binding fragments thereof are disclosed. These Anti-BK virus antibody molecules or binding fragments can be used in the treatment or prevention of BK virus infection and/or BK virus associated disorder.

Provided are binding molecules, such as TCRs or antigen binding fragments thereof and antibodies and antigen-binding fragments thereof, such as those that recognize or bind human papilloma virus (HPV) 16, including HPV 16 E6 and HPV 16 E7. Also provided are engineered cells containing such binding molecules, compositions containing the binding molecules or engineered cells, and methods of treatment, such as administration of the binding molecules, engineered cells, or compositions.

Provided herein are binding molecules, such as those that recognize or bind a peptide epitope of a cancer antigen, such as expressed on a cancer cell, including cells infected with human papilloma virus (HPV) or that contain HPV DNA sequences and/or those that recognize or bind a peptide epitope of HPV 16 E6 or E7, in the context of a major histocompatibility complex (MHC) molecule. Among the provided binding molecules are T cell receptors (TCRs) or antibodies, including antigen-binding fragments thereof, that bind or recognize such peptide epitopes. The present disclosure further relates to engineered cells comprising such binding molecules, e.g., TCRs or antibodies (and chimeric antigen receptors containing the antibodies), and uses thereof in adoptive cell therapy.

Provided are novel human-derived antibodies specifically recognizing polyomavirus polypeptides, preferably capable of binding to polyomaviruses of the type of JC virus (JCV) and/or BK virus (BKV) as well as methods related thereto. Furthermore, assays and kits related to antibodies specific for polyomaviruses, polyomavirus VP1 and or polyomavirus VP1 Virus-Like Particles (VLPs), preferably of the type of JCV and/or BKV, are disclosed. The human-derived antibodies as well as binding fragments, derivatives and variants thereof can be used in pharmaceutical and diagnostic compositions for polyomavirus targeted immunotherapy and diagnostics.