Autologous tumor vaccines and methods
AssigneeVaccinogen, Inc.
InventorMichael G. Hanna, JR.
Life of this patent
Estimating the term…
Abstract
Autologous anti-cancer vaccines and methods of manufacture and treatment are provided, including expansion of individual patient-derived tumor cells in an immune-compromised animal(s) to attain, quantitatively and qualitatively, sufficient material for efficacious vaccine production and utilization, to elicit an immune response against micrometastases and/or recurrence in the individual patient following tumor excision.
Claims32
A method for making an injectable autologous, anti-neoplastic vaccine containing at least about 107 viable, non-tumorigenic tumor cells, comprising:
- excising a solid tumor from a cancer patient to obtain at least 95% of the patient's solid tumor tissue, wherein the excised tumor tissue has a weight of less than about 3.5 grams;
- digesting the excised tumor tissue to obtain dissociated tumor cells;
- transplanting the excised tumor cells into an immune-compromised animal;
- propagating the tumor cells in the animal to obtain expanded tumor tissue;
- harvesting the expanded tumor tissue from the animal to obtain harvested tumor cells, wherein the harvested tumor tissue has a weight of at least about 3.5 grams;
- applying a dose of gamma radiation to the harvested tumor cells to render the cells non-tumorigenic;
- and
- combining the non-tumorigenic tumor cells with a pharmaceutically acceptable carrier for injection to prepare an injectable dose containing at least about 107 tumor cells.
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A method for eliciting an immune response to prevent the recurrence of metastases in a cancer patient in need, comprising:
- excising a solid tumor from a cancer patient to obtain at least about 95% of the patient's solid tumor tissue, wherein the excised tumor tissue has a weight of less than about 3.5 grams;
- digesting the excised tumor tissue to obtain dissociated tumor cells;
- transplanting the tumor cells into an immune-compromised animal;
- propagating the tumor cells in the animal to obtain expanded tumor tissue;
- harvesting the expanded tumor tissue from the animal, wherein the harvested tumor tissue has a weight of at least about 3.5 grams;
- applying a dose of gamma radiation to the harvested tumor cells to render the cells non-tumorigenic;
- combining the non-tumorigenic tumor cells with a pharmaceutically acceptable carrier for injection to prepare an injectable dose containing at least about 107 tumor cells having at least 85% sequence homology to the cells of the patient's tumor;
- and
- administering to the patient said injectable dose to elicit an immunogenic response against recurrence of said cancer.
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A whole cell autologous anti-cancer vaccine composition for administration to a patient after surgery to excise a solid tumor having a mass less than about 3.5 g, said composition comprising:
- at least about 107 viable non-tumorigenic tumor cells having at least 85% sequence homology to the cells of the excised tumor;
- and
- a pharmaceutically acceptable carrier for injection;
- wherein said composition gives rise to an immunogenic response when administered via intradermal injection to said patient.
28-30. (canceled)
A method for making an injectable, autologous, anti-neoplastic vaccine containing at least about 107 viable, non-tumorigenic tumor cells, comprising:
- excising a solid tumor from a cancer patient to obtain at least 95% of the patient's solid tumor tissue, wherein the excised tumor tissue has a weight of greater than 3.5 grams;
- digesting all of the excised tumor tissue with an enzyme to obtain dissociated tumor cells;
- mixing the dissociated tumor cells to prepare a homogeneous suspension of heterogeneous cells, wherein any aliquot of the suspension contains a full complement of antigenic material from the patient's solid tumor;
- applying a dose of gamma radiation to the homogeneous suspension of tumor cells to render the cells non-tumorigenic;
- and
- combining the non-tumorigenic tumor cells with a pharmaceutically acceptable carrier for injection to prepare an injectable dose containing at least about 107 tumor cells.
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Dependencies are inferred from the claim text.