Combination immunotherapy compositions against cancer and methods
Inventors
Hodge, James • Schlom, Jeffrey • Franzusoff, Alex
Assignees
GlobeImmune Inc • US Department of Health and Human Services
Publication Number
US-11596675-B2
Publication Date
2023-03-07
Expiration Date
2030-04-16
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Abstract
Disclosed are immunotherapeutic compositions and the concurrent use of combinations of such compositions for the improved induction of therapeutic immune responses and/or for the prevention, amelioration and/or treatment of disease, including, but not limited to, cancer and infectious disease.
Core Innovation
The invention relates to the concurrent use of two different immunotherapeutic compositions for improved induction of therapeutic immune responses and/or for the prevention, amelioration, and/or treatment of diseases including cancer and infectious diseases. It involves administering a first immunotherapy composition comprising a recombinant virus encoding one or more costimulatory molecules and at least one antigen or immunogenic domain thereof, concurrently with a second immunotherapy composition comprising a yeast vehicle expressing at least one antigen or immunogenic domain thereof.
The problem solved addresses the urgent need for safe and effective immunotherapy strategies and adjuvants that elicit protective cell-mediated immune responses, especially for diseases like cancer and intracellular infections where conventional vaccines primarily induce humoral immunity but often fail to elicit protective cellular immunity. Existing vaccines targeting the same antigen usually rely on prime-boost strategies rather than concurrent administration, which this invention uniquely demonstrates as beneficial.
The invention further provides evidence that the vector and antigen together determine distinct and complementary T-cell populations with unique cytokine responses, T-cell receptor repertoires, and gene expression profiles, thereby enabling concurrent administration of two different vaccine platforms targeting the same antigen to induce a more diverse T-cell population and substantially improve therapeutic efficacy. This concurrent administration contrasts with the prior art, in which only sequential prime-boost regimens were used, and shows for the first time that concurrent use of two vaccine vectors targeting the same antigen synergistically enhances antitumor efficacy.
Claims Coverage
The patent includes one independent claim covering methods of reducing tumor burden or inhibiting tumor growth, and inducing therapeutic immune responses by administering two immunotherapy compositions concurrently or within a dosing period.
Concurrent administration of two immunotherapy compositions targeting CEA
Administering two immunotherapy compositions within a dosing period, comprising (a) a first immunotherapy composition of a recombinant Ad5 adenovirus encoding a CEA peptide, and (b) a second immunotherapy composition comprising a CEA peptide with either whole inactivated yeast or yeast lysate.
Definition of yeast vehicle and administration sites
The yeast vehicle is specified as whole, heat-killed yeast from Saccharomyces, and the two immunotherapy compositions can be administered to different sites or to the same or adjacent sites in the individual.
Boosting and treatment methods
The method may include boosting with one or both immunotherapy compositions, optionally adding a third immunotherapy composition with a recombinant virus different from the first, and further treatment with chemotherapy and/or radiation therapy.
Dosing period timing and administration modes
The dosing period for administering the two immunotherapy compositions is no more than 2 days and may be as short as simultaneous administration or sequential administration within minutes to hours.
The claims principally cover methods of using a recombinant Ad5 adenovirus expressing a CEA peptide concurrently with a yeast-based immunotherapy containing CEA peptide and yeast components, administered within a defined short dosing period, to reduce tumor burden or induce immune response, with further features relating to boosting, administration site, and combined therapies.
Stated Advantages
Concurrent administration of two vaccine platforms targeting the same antigen induces distinct T-cell populations and results in significantly higher antitumor immunity compared to individual vaccines.
The use of distinct vectors and the same antigen generates more diverse T-cell receptor repertoires and cytokine profiles, enhancing immunotherapeutic efficacy.
Concurrent vaccination eliminates the need for diversified prime-boost schedules used previously and maximizes immune response from initial vaccination.
Documented Applications
Preventing, ameliorating or treating cancer by reducing tumor burden or inhibiting tumor growth in an individual through induction of therapeutic immune responses.
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