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-10874729-B2
Publication Date
2020-12-29
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 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 cancer and infectious disease. Specifically, the invention discloses methods, uses, compositions, and kits involving the concurrent administration of two different immunotherapy compositions targeting the same antigen to induce a more diverse T-cell population and improve therapeutic efficacy.
The problem being solved stems from the need to develop safe and effective immunotherapy strategies for diseases such as cancer and infections. Many existing vaccines primarily stimulate humoral immune responses but fail to elicit protective cell-mediated immunity, which is important for treating cancers and intracellular pathogens. Despite various immunotherapy approaches, many cancers remain challenging to treat. Prior strategies used diversified prime-boost regimens with vaccines targeting the same antigen but have not employed concurrent administration of distinct vaccine vectors targeting that antigen.
Claims Coverage
The claims focus on a method involving two immunotherapy compositions administered concurrently. There is one independent method claim describing the concurrent administration of two specified immunotherapy compositions targeting carcinoembryonic antigen (CEA).
Concurrent administration of two immunotherapy compositions targeting CEA
A method involving administering two immunotherapy compositions within one dosing period to prime the immune system, the first comprising a recombinant Ad5 adenovirus encoding CEA or an immunogenic domain thereof, and the second comprising a whole inactivated yeast or yeast lysate that was recombinantly expressing CEA or an immunogenic domain thereof prior to administration.
Specific yeast and virus compositions for immunotherapy
The yeast is a whole, heat-killed yeast from Saccharomyces genus, and the virus is a recombinant Ad5 adenovirus encoding human full-length CEA including variants comprising CAP1-6D epitope.
Administration sites for concurrent immunotherapy compositions
The first and second immunotherapy compositions can be administered to different sites or to the same or adjacent sites in the individual.
Boosting strategies following concurrent administration
The method includes boosting the individual with one or both immunotherapy compositions, optionally boosting with both concurrently, and further includes boosting with a third immunotherapy composition comprising a recombinant virus different from the first composition.
Combination with standard cancer therapies
The method may further include treating the individual with chemotherapy and/or radiation therapy.
The claims cover a method of concurrently administering two distinct immunotherapy compositions—a recombinant Ad5 adenovirus and a recombinant yeast-based composition—targeting CEA within a single dosing period, with various administration sites, boosting regimens, and combination with chemotherapy and/or radiation, to reduce tumor burden, inhibit tumor growth, or induce therapeutic immune responses against CEA.
Stated Advantages
Concurrent administration of two distinct vaccine vectors targeting the same antigen induces distinct, phenotypically and functionally diverse T-cell populations.
The combined use of these vaccines results in improved antitumor efficacy compared to either vaccine alone.
Concurrent administration avoids the need for diversified prime-boost schedules while maximizing early induction of a broad T-cell response.
Documented Applications
Prevention, amelioration, or treatment of cancer and infectious diseases by inducing therapeutic immune responses.
Reduction of tumor burden or inhibition of tumor growth in individuals with cancer.
Increase survival of individuals with cancer through induction of therapeutic immune responses against cancer antigens such as carcinoembryonic antigen (CEA).
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