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US 12,636,318 B2Granted
Processes for production of tumor infiltrating lymphocytes and uses of same in immunotherapy
AssigneeIovance Biotherapeutics, Inc.
InventorsSeth Wardell, James Bender, Michael T. Lotze
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Abstract
The present invention provides improved and/or shortened methods for expanding TILs and producing therapeutic populations of TILs, including novel methods for expanding TIL populations in a closed system that lead to improved efficacy, improved phenotype, and increased metabolic health of the TILs in a shorter time period, while allowing for reduced microbial contamination as well as decreased costs. Such TILs find use in therapeutic treatment regimens.
Claims24
A cryopreserved therapeutic population of tumor infiltrating lymphocytes (TILs) produced by a method comprising:
- (a) performing a first expansion by culturing a first population of TILs from tumor fragments or a tumor digest obtained from a tumor resected from a subject in a cell culture medium comprising IL-2 to produce a second population of TILs, wherein the first expansion is performed in a closed container providing a first gas-permeable surface area, wherein the first expansion is performed for a first period of about 3 to 11 days to obtain the second population of TILs;
- (b) performing a second expansion by supplementing the cell culture medium with additional IL-2, OKT-3, and antigen presenting cells (APCs), to produce a third population of TILs, wherein the second expansion is performed for a second period of about 7 to 11 days in order to obtain the third population of TILs, and wherein the third population of TILs is a therapeutic population of TILs;
- (c) harvesting the therapeutic population of TILs obtained from step (b);
- (d) transferring the harvested therapeutic population of TILs from step (c) into an infusion bag;
- and
- (e) cryopreserving the infusion bag comprising the harvested TIL population from step (d) using a cryopreservation process.
3 more elements
Dependencies are inferred from the claim text.