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: 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: 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: Provided are Listeria-based immunogenic compositions comprising Wilms tumor protein (WT1) antigens and methods for treating and vaccinating against cancer and inducing an immune response against the same in a subject. Also provided herein are recombinant fusion polypeptides or chimeric polypeptides comprising Wilms tumor protein antigens, nucleic acids encoding such chimeric polypeptides or fusion polypeptides, recombinant bacteria or Listeria strains comprising such chimeric polypeptides or fusion polypeptides or such nucleic acids, and cell banks comprising such recombinant bacteria or Listeria strains. Also provided herein are methods of generating such chimeric polypeptides or fusion polypeptides, such nucleic acids, and such recombinant bacteria or Listeria strains. Also provided are immunogenic compositions, pharmaceutical compositions, and vaccines comprising such chimeric polypeptides or fusion polypeptides, such nucleic acids, or such recombinant bacteria or Listeria strains.

Abstract: The present invention provides methods of treating, protecting against and inducing an immune response against a tumor or cancer, comprising the step of administering to a subject a recombinant Listeria strain. In one embodiment the present invention relates to a recombinant Listeria strain, said recombinant Listeria strain comprising a recombinant nucleic add, said nucleic add comprising a first open reading frame encoding a recombinant polypeptide comprising a first N-terminal fragment of an LLO protein fused to a heterologous antigen or fragment thereof, and wherein said recombinant nucleic add further comprises a second open reading frame encoding a mutant PrfA protein.

Abstract: The present invention provides methods of treating, protecting against and inducing an immune response against a tumor or cancer, comprising the step of administering to a subject a recombinant Listeria strain. In one embodiment the present invention relates to a recombinant Listeria strain, said recombinant Listeria strain comprising a recombinant nucleic add, said nucleic add comprising a first open reading frame encoding a recombinant polypeptide comprising a first N-terminal fragment of an LLO protein fused to a heterologous antigen or fragment thereof, and wherein said recombinant nucleic add further comprises a second open reading frame encoding a mutant PrfA protein.

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: The disclosure relates to the combined use of an immunotherapeutic composition comprising recombinant Listeria strains expressing a heterologous antigen fused to a truncated listeriolysin O (tLLO), a truncated ActA protein, or a PEST amino acid sequence and an antibiotic regimen, which may be sequentially administered in order to prevent the persistence, seeding of Listeria and/or formation of Listeria biofilms while allowing for an anti-tumor/anti-cancer or anti infectious disease immunotherapeutic response to take place. Disclosed are also methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering the above composition.

Abstract: This invention provides methods and compositions for using evaluating biomarker expression in a disease and providing a multi-targeted Listeria-based immunotherapeutic approach against said disease. In a related aspect, the invention relates to a method of treating a disease in a subject, the method comprising the steps of: a. obtaining a biological sample from said subject; b. evaluating the expression of a predetermined number of biomarkers in said biological sample; c. administering to said subject a composition comprising a recombinant Listeria strain, said strain comprising a nucleic acid sequence encoding at least one fusion protein, wherein said fusion protein comprises a biomarker identified in said biological sample, wherein said biomarker is associated with said disease, wherein said biomarker is fused to a PEST-containing polypeptide, and wherein each fusion protein within said Listeria comprises a different biomarker, thereby treating said disease in said subject.

Abstract: Provided herein are an apparatus and process for manufacturing a formulation comprising a drug substance, said drug substance comprising a recombinant Listeria strain comprising a prostate specific antigen (PSA) or a chimeric HER2 antigen fused to a Listeriolysin O (LLO) protein fragment.

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.