Abstract: Provided herein are recombinant fusion polypeptides comprising one or more antigenic peptides (e.g., fused to a PEST-containing peptide) from cancer-associated proteins. The antigenic peptides can comprise one or more or all of an antigenic peptide comprising a recurrent cancer mutation, an antigenic peptide comprising a heteroclitic mutation, or an antigenic peptide fused to a ubiquitin protein. For example, provided herein are recombinant fusion polypeptides comprising two or more antigenic peptides (e.g., fused to a PEST-containing peptide), wherein each antigenic peptide comprises a recurrent cancer mutation, and wherein at least two of the antigenic peptides are fragments of the same cancer-associated protein. Also provided are nucleic acids encoding such fusion polypeptides, recombinant bacteria or Listeria strains comprising such fusion polypeptides or such nucleic acids, and cell banks comprising such recombinant bacteria or Listeria strains.

Abstract: Provided herein are recombinant fusion polypeptides comprising one or more antigenic peptides (e.g., fused to a PEST-containing peptide) from cancer-associated proteins. The antigenic peptides can comprise one or more or all of an antigenic peptide comprising a recurrent cancer mutation, an antigenic peptide comprising a heteroclitic mutation, or an antigenic peptide fused to a ubiquitin protein. For example, provided herein are recombinant fusion polypeptides comprising two or more antigenic peptides (e.g., fused to a PEST-containing peptide), wherein each antigenic peptide comprises a recurrent cancer mutation, and wherein at least two of the antigenic peptides are fragments of the same cancer-associated protein. Also provided are nucleic acids encoding such fusion polypeptides, recombinant bacteria or Listeria strains comprising such fusion polypeptides or such nucleic acids, and cell banks comprising such recombinant bacteria or Listeria strains.

Abstract: This disclosure provides compositions, including Listeria delivery vectors comprising minigene expression constructs, and methods of using the same for inducing an immune response against an antigen-expressing tumor and for treating the same, and vaccinating against the same in subjects bearing the tumors.

Abstract: This disclosure provides compositions, including Listeria delivery vectors comprising minigene expression constructs, and methods of using the same for inducing an immune response against an antigen-expressing tumor and for treating the same, and vaccinating against the same in subjects bearing the tumors.

Abstract: The invention relates to improved strategies, compositions, and methods for producing neoplasia vaccines and for their use in methods of treating cancer in a patient. In aspects, a method of treating cancer comprises: (a) administering an effective amount of one or more of the instantly-disclosed peptides or polypeptides comprising one or more identified shared neo-epitopes (including peptides or polypeptide comprising one or more peptides or polypeptides from Table A, B, and/or C and/or fragments and variants thereof); and subsequently (b) administering an effective amount of one or more of the instantly-disclosed subject-specific peptides or polypeptides comprising one or more identified subject-specific neo-epitopes. The peptides or polypeptides administered in step (a) and in step (b) are designed to exclude neo-epitopes that are known or determined (e.g.

Abstract: 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.

Abstract: The invention provides improved strategies, prognostic indicators, compositions, and methods for producing personalized neoplasia vaccines. More particularly, embodiments of the present disclosure relate to the identification of neoplasia-specific neo-epitopes to predict survival and to identify and design subject-specific neo-epitopes, further assessing the identified neo-epitopes encoded by said mutations to identify neo-epitopes that are known or determined, or 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 excluding such neo-epitopes that are known, determined, or 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 subject-specific neo-epitopes that are to be used in personalized neoplasia vaccines.

Abstract: This disclosure provides compositions, including Listeria delivery vectors comprising minigene expression constructs, and methods of using the same for inducing an immune response against an antigen-expressing tumor and for treating the same, and vaccinating against the same in subjects bearing the tumors.

Abstract: Provided herein are tumor-associated antigen peptides comprising heteroclitic mutations and fusion polypeptides comprising such heteroclitic peptide. Also provided are nucleic acids encoding such peptides and fusion polypeptides, recombinant bacteria or Listeria strains comprising such peptides, fusion polypeptides, or nucleic acids, and cell banks comprising such recombinant bacteria or Listeria strains. Also provided herein are methods of generating such peptides, fusion polypeptides, nucleic acids, and recombinant bacteria or Listeria strains. Also provided are immunogenic compositions, pharmaceutical compositions, and vaccines comprising such peptides, fusion polypeptides, nucleic acids, or recombinant bacteria or Listeria strains.

Abstract: The invention relates to improved strategies, compositions, and methods for producing neoplasia vaccines and for their use in methods of treating cancer in a patient. In aspects, a method of treating cancer comprises: (a) administering an effective amount of one or more of the instantly-disclosed peptides or polypeptides comprising one or more identified shared neo-epitopes (including peptides or polypeptide comprising one or more peptides or polypeptides from Table A, B, and/or C and/or fragments and variants thereof); and subsequently (b) administering an effective amount of one or more of the instantly-disclosed subject-specific peptides or polypeptides comprising one or more identified subject-specific neo-epitopes. The peptides or polypeptides administered in step (a) and in step (b) are designed to exclude neo-epitopes that are known or determined (e.g.

Abstract: 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.

Abstract: This disclosure provides compositions, including Listeria delivery vectors comprising minigene expression constructs, and methods of using the same for inducing an immune response against an antigen-expressing tumor and for treating the same, and vaccinating against the same in subjects bearing the tumors.

Abstract: This invention provides a system of providing and creating personalized immunotherapeutic compositions for a subject having a disease or condition, including therapeutic immunotherapy delivery vectors and methods of making the same comprising gene expression constructs expressing peptides associated with one or more neo-epitopes or peptides containing mutations that are specific to a subject's cancer or unhealthy tissue. A delivery vector of this invention includes bacterial vectors including Listeria bacterial vectors; or viral vectors, peptide immunotherapy vectors; or DNA immunotherapy vectors, comprising one or more fusion proteins comprising one or more peptides comprising one or more neo-epitopes present in disease-bearing biological samples obtained from the subject. This invention also provides methods of using the same for inducing an immune response against a disease or condition, including a tumor or cancer, or an infection, or an autoimmune disease or an organ transplant rejection in the subject.

Abstract: Provided herein are recombinant fusion polypeptides comprising one or more antigenic peptides (e.g., fused to a PEST-containing peptide) from cancer-associated proteins. The antigenic peptides can comprise one or more or all of an antigenic peptide comprising a recurrent cancer mutation, an antigenic peptide comprising a heteroclitic mutation, or an antigenic peptide fused to a ubiquitin protein. For example, provided herein are recombinant fusion polypeptides comprising two or more antigenic peptides (e.g., fused to a PEST-containing peptide), wherein each antigenic peptide comprises a recurrent cancer mutation, and wherein at least two of the antigenic peptides are fragments of the same cancer-associated protein. Also provided are nucleic acids encoding such fusion polypeptides, recombinant bacteria or Listeria strains comprising such fusion polypeptides or such nucleic acids, and cell banks comprising such recombinant bacteria or Listeria strains.

Abstract: Disclosed herein is a personalized immunotherapy composition for a subject having a disease or condition, including therapeutic vaccine delivery vectors and methods of making the same comprising gene expression constructs expressing frameshift-mutation-derived peptides associated with one or more neo-epitopes encoded by nucleic acid sequences comprising at least one frameshift mutation, wherein the frameshift mutation is specific to a subject's cancer or unhealthy tissue. A delivery vector of this disclosure includes bacterial vectors; or viral vectors, or peptide vaccine vectors; or DNA vaccine vectors including Listeria bacterial vectors comprising one or more fusion proteins comprising one or more frameshift-mutation-derived peptides comprising one or more neo-epitopes present in disease-bearing biological samples obtained from the subject.

Abstract: This disclosure provides compositions, including Listeria delivery vectors comprising minigene expression constructs, and methods of using the same for inducing an immune response against an antigen-expressing tumor and for treating the same, and vaccinating against the same in subjects bearing the tumors.

Abstract: Disclosed herein are recombinant Listeria strains comprising nucleotides encoding two or more heterologous antigens each fused to a truncated LLO, an N-terminal ActA or a PEST-sequence, methods of preparing same, and methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering same.