Lysates of recombinant yeast for inducing cellular immune responses
Inventors
King, Thomas H. • Guo, Zhimin • FLEENOR, Courtney
Assignees
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Publication Number
US-12128078-B2
Publication Date
2024-10-29
Expiration Date
Abstract
Disclosed are immunogenic pharmaceutical compositions comprising yeast lysates for inducing cellular immune responses, methods of making immunogenic compositions comprising yeast lysates, methods of treatment comprising administration of said compositions, and kits comprising said yeast lysate compositions. Disclosed immunogenic compositions further comprise an antigen heterologous to the yeast, and may comprise whole yeast and immunostimulatory agents. Induced cellular immune responses comprise cytotoxic T cell activation with specificity to the antigen comprising the immunogenic composition. Various methods of formulation and administration to a patient are described herein, especially wherein the patient suffers from an infectious disease and/or cancer.
Core Innovation
The invention relates to immunogenic compositions and methods to elicit T cell immune responses using cleared yeast lysates that lack yeast membranes and yeast cell walls. The compositions comprise a lysate prepared from Saccharomyces cerevisiae yeast, wherein the lysate lacks yeast membranes and yeast cell walls, together with whole Saccharomyces cerevisiae yeast and at least one antigen that is heterologous to the yeast.
The inclusion of membrane- and wall-free yeast lysate is provided alongside whole Saccharomyces cerevisiae yeast to support cytotoxic T lymphocyte responses. The described immune outcomes include eliciting a cytotoxic T cell immune response by administering the immunogenic composition containing the cleared yeast lysate, the whole yeast, and the heterologous antigen.
The invention further provides methods to elicit both antigen-specific humoral and antigen-specific cell-mediated immune responses using the same immunogenic composition framework with a cleared Saccharomyces cerevisiae lysate lacking membranes and cell walls, whole Saccharomyces cerevisiae yeast, and at least one heterologous antigen. The described embodiments include an anti-CD40 antibody as an immunostimulatory agent.
Claims Coverage
The partial claims include two independent methods that share the same core immunogenic composition components and differ by the immune outcomes targeted: cytotoxic T cell responses versus humoral plus cell-mediated antigen-specific responses. Each independent claim includes three main inventive features, and the dependent claims further specify inclusion of an immunostimulatory anti-CD40 antibody.
Cleared Saccharomyces cerevisiae yeast lysate lacking membranes and cell walls
Administering to the subject an immunogenic composition comprising a lysate prepared from Saccharomyces cerevisiae yeast, wherein the lysate lacks yeast membranes and yeast cell walls.
Whole Saccharomyces cerevisiae yeast
Administering to the subject an immunogenic composition comprising whole Saccharomyces cerevisiae yeast.
Heterologous antigen with the cleared lysate and whole yeast
Administering to the subject an immunogenic composition comprising at least one antigen that is heterologous to the yeast.
Anti-CD40 immunostimulatory component
The method further includes an immunogenic composition that additionally includes an anti-CD40 antibody.
Across both independent methods, the inventive focus is the combination of a cleared Saccharomyces cerevisiae lysate lacking membranes and cell walls with whole Saccharomyces cerevisiae yeast, together with at least one antigen heterologous to the yeast. Dependent embodiments further specify an added immunostimulatory anti-CD40 antibody.
Stated Advantages
Elicits a cytotoxic T cell immune response in a subject.
Elicits an antigen-specific humoral immune response and an antigen-specific cell-mediated immune response in a subject.
Improves T cell responses through enhanced antigen availability and activation of innate immune pathways enabled by yeast cytoplasmic contents in the lysate.
Documented Applications
Support of CTL killing and antigen-specific CD4+ and CD8+ T cell responses by vaccinating with a heterologous antigen together with a membrane-/wall-free yeast lysate, with whole yeast included in the composition.
Tumor protection as demonstrated in a tumor model when lysate is mixed with intact yeast.
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