Combination immunotherapy compositions against cancer and methods
Inventors
Hodge, James • Schlom, Jeffrey • Franzusoff, Alex
Assignees
GlobelImmune Inc • Usa REPRESENTED BY SECRETARY Dept Of Health And Human Services AS • GlobeImmune Inc • US Department of Health and Human Services
Publication Number
US-11590216-B2
Publication Date
2023-02-28
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 the improved induction of therapeutic immune responses and/or for the prevention, amelioration and/or treatment of disease, including cancer and infectious disease. Specifically, the compositions include recombinant virus immunotherapeutic vaccines and yeast-based immunotherapeutic vaccines targeting the same antigen or immunogenic domain thereof. The invention demonstrates that both the vaccine vectors and the antigen contribute to inducing T-cell populations with shared and unique cytokine responses, gene expression profiles, and T-cell receptor phenotypes.
The problem addressed is the need to develop safe and effective immunotherapy strategies and adjuvants that elicit protective cell-mediated immunity, particularly for treating cancer and infectious diseases. Many existing vaccines primarily stimulate humoral immunity and fail to elicit protective cellular immunity. In cancer therapy, despite advances, many cancers have high mortality and remain difficult to treat. While diversified prime-boost vaccine regimens exist, no prior reports disclose the concurrent use of vaccines targeting the same antigen to induce a more diverse T-cell population. The invention addresses this unmet need by demonstrating that concurrent administration of two distinct vaccines targeting the same antigen induces phenotypically and functionally distinct T-cell populations, thereby improving therapeutic efficacy.
Claims Coverage
The claims disclose methods and compositions involving concurrent administration of two immunotherapy compositions derived from the same antigenic proteins, with several administration and boosting protocols, focusing on simultaneous or sequential delivery within defined dosing periods.
Concurrent administration of two immunotherapy compositions derived from the same proteins
A method comprising administering within a dosing period two immunotherapy compositions: (a) a first composition comprising a recombinant Ad5 adenovirus encoding one or more peptides, and (b) a second composition comprising one or more peptides and either whole inactivated yeast or yeast lysate, wherein the peptides in both compositions are derived from the same protein(s).
Administration details and dosing period
The compositions can be administered to the same or different physical sites in the individual. The dosing period for administration is limited to no more than 2 days, with optional embodiments specifying shorter periods down to minutes. The two compositions can be administered simultaneously or sequentially within this dosing period.
Boosting strategies
Methods include boosting the individual with one or both immunotherapy compositions post initial dosing, including the use of a third immunotherapy composition comprising a recombinant virus different from the first immunotherapy composition.
Combination with other therapies
The individual may also be treated with chemotherapy and/or radiation therapy in conjunction with the immunotherapy compositions.
The claims cover methods for treating or inducing immune responses by concurrently administering two immunotherapy compositions derived from the same antigen proteins, employing specific dosing schedules, administration sites, boosting regimens, and optionally combining with chemotherapy or radiation.
Stated Advantages
Concurrent administration of two distinct immunotherapy vectors targeting the same antigen induces a more diverse T-cell population and improves antitumor efficacy.
The two vaccines elicit phenotypically and functionally distinct T-cell populations, enhancing the immune response beyond what is achieved by either vaccine alone.
Concurrent use of the immunotherapeutic vaccines makes a diversified prime-boost schedule unnecessary, maximizing immune response from the initial vaccination.
Documented Applications
Prevention, amelioration, or treatment of diseases including cancer and infectious disease by inducing therapeutic immune responses.
Treatment of a variety of cancers, including but not limited to melanomas, squamous cell carcinoma, breast cancers, head and neck carcinomas, leukemias, lymphomas, and metastatic cancers thereof.
Treatment of diseases caused by or associated with pathogens including viral, fungal, bacterial, helminth, parasitic, ectoparasitic, and protozoan infections.
Use in combination with chemotherapy and/or radiation therapy for cancer treatment.
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