Abstract: Methods and compositions are provided for lyophilization of bacteria or Listeria strains, such as Listeria monocytogenes. Provided are methods for producing a lyophilized composition comprising a bacteria or Listeria strain, formulations for lyophilization comprising a bacteria or Listeria strain, lyophilized bacteria or Listeria strains, and methods of preparing frozen bacteria or Listeria strains for lyophilization.

Abstract: Methods and compositions are provided for lyophilization of bacteria or Listeria strains, such as Listeria monocytogenes. Provided are methods for producing a lyophilized composition comprising a bacteria or Listeria strain, formulations for lyophilization comprising a bacteria or Listeria strain, lyophilized bacteria or Listeria strains, and methods of preparing frozen bacteria or Listeria strains for lyophilization.

Abstract: Methods and compositions are provided for assessing antigen presentation and potency of Listeria-based immunotherapeutics in inducing an immune response.

Abstract: Methods and compositions are provided for assessing attenuation and/or infectivity of bacteria or Listeria strains, such as Listeria monocytogenes.

Abstract: Methods and compositions are provided for lyophilization of bacteria or Listeria strains, such as Listeria monocytogenes. Provided are methods for producing a lyophilized composition comprising a bacteria or Listeria strain, formulations for lyophilization comprising a bacteria or Listeria strain, lyophilized bacteria or Listeria strains, and methods of preparing frozen bacteria or Listeria strains for lyophilization.

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: The present invention discloses a process for manufacturing a formulation comprising a drug substance, said drug substance comprising a recombinant Listeria comprising a human papilloma virus (HPV) antigen fused to a Listeriolysin O (LLO) protein fragment. The invention further discloses methods of using treating, protecting against, and inducing an immune response against cervical cancer comprising administration of the recombinant Listeria strain. The present invention also provides methods for inducing an anti-E7 CTL response in a human subject and treating HPV-mediated diseases, disorders, and symptoms, comprising administration of the recombinant Listeria strain.

Abstract: This invention provides methods and compositions for using Listeria monocytogenes as an adjuvant for enhancing immune responses in a subject.

Abstract: This invention provides methods and compositions for using a live attenuated Listeria for inhibiting cell-mediated suppression of anti-disease infiltrating T lymphocytes in a subject having the disease.

Abstract: The disclosure is directed to compositions comprising an oncolytic virus, chimeric antigen receptor T cells (CAR T cells), a therapeutic or immunomodulating monoclonal antibody, a targeting thymidine kinase inhibitor (TKI), or an adoptively transferred cells incorporating engineered T cell receptors, and a live attenuated recombinant Listeria strain comprising a fusion protein of a Truncated LLO, a truncated ActA or a PEST-sequence peptide fused to a tumor-associated antigen. The disclosure is further directed to methods of treating, protecting against, and inducing an immune response against a tumor, comprising the step of administering the same, with or without an additional radiation therapy treatment.

Abstract: The present invention relates to compositions comprising a recombinant attenuated Listeria strain expressing a truncated ActA and fusion proteins thereof and methods of using the same for inducing anti-disease immune responses, and treatment of the same, including a tumor growth or cancer. In particular, the invention relates to the treatment of a tumor growth or cancer using a live attenuated recombinant Listeria strain that expresses a fusion protein of a truncated ActA fused to an antigen.

Abstract: The present invention is directed to compositions comprising an immune checkpoint inhibitor or a T cell stimulator or a combination thereof, and a live attenuated recombinant Listeria strain comprising a fusion polypeptide comprising a truncated Listeriolysin O protein, a truncated ActA protein, or a PEST amino acid sequence fused to a tumor-associated antigen. The invention is further directed to methods of treating, protecting against, and inducing an immune response against a tumor or a cancer, comprising the step of administering the same.

Abstract: Disclosed herein are compositions comprising use of compositions comprising a live attenuated recombinant Listeria strain comprising a fusion protein of a truncated listeriolysin O (LLO) protein, a truncated ActA protein, or a PEST amino acid sequence fused to a heterologous antigen, including a tumor-associated antigen, wherein the compositions further comprise or are co-administered with an antibody or fragment thereof. Also disclosed are combination therapies comprising use of these compositions comprising live attenuated recombinant Listeria strains, in conjunction with an antibody or fragment thereof for use in treating, protecting against, and/or inducing an immune response against a tumor, especially wherein the treating, protection against and/or inducing an immune response increases percent survival in a subject.

Abstract: Disclosed herein are recombinant nucleic acids encoding tumor antigens fused to immunogenic polypeptides and recombinant Listeria strains comprising the same, methods of preparing same, and methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering same.

Abstract: Provided herein are recombinant Listeria strains expressing a tumor-specific antigenic polypeptide and, optionally, an angiogenic polypeptide wherein a nucleic acid molecule encoding at least one of the polypeptides is operably integrated into the Listeria genome in an open reading frame with a nucleic acid sequence encoding a PEST-containing polypeptide, methods of preparing same, and methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering same.

Abstract: Provided herein are recombinant Listeria strains expressing a tumor-specific antigenic polypeptide and, optionally, an angiogenic polypeptide wherein a nucleic acid molecule encoding at least one of the polypeptides is operably integrated into the Listeria genome in an open reading frame with a nucleic acid sequence encoding a PEST-containing polypeptide, methods of preparing same, and methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering same.

Abstract: The present invention is directed to methods for increasing T-cell effector cell to regulatory T cell ratio. The invention is further directed to methods of treating, protecting against, and inducing an immune response against a tumor, comprising the step of administering to a subject a recombinant Listeria strain, comprising a fusion peptide that comprises an LLO fragment and tumor-associated antigen.

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: This invention provides compositions and methods for treating and vaccinating against a HER2/neu antigen-expressing tumor and inducing an immune response against the same in a subject.