Enhanced Restimulation of Cryopreserved Tumor Infiltrating Lymphocytes
Legal Citation
Summary of the Inventive Concept
This inventive concept presents a novel approach to restimulating cryopreserved tumor infiltrating lymphocytes (TILs), enhancing their metabolic fitness and bioenergetic profile, thereby improving their therapeutic potential.
Background and Problem Solved
The original patent disclosed a method for expanding TILs, but it has limitations in terms of the TILs' metabolic fitness and bioenergetic profile, which can impact their in vivo longevity and therapeutic efficacy. The new inventive concept addresses these limitations by introducing novel components and methods that enhance the TILs' metabolic fitness and bioenergetic profile.
Detailed Description of the Inventive Concept
The new inventive concept comprises a system, method, composition, and device for restimulating cryopreserved TILs. The system includes a cryopreservation unit, a thawing unit, and a restimulation protocol unit that applies a novel combination of cytokines to enhance the TILs' metabolic fitness. The method involves applying a controlled oxygen tension to the TILs during restimulation, improving their glycolytic capacity. The composition includes a cryopreserved TIL population, a novel glycolysis-promoting agent, and a mitochondrial metabolism-enhancing agent, optimized to enhance the TILs' bioenergetic profile. The device monitors the metabolic fitness of restimulated TILs, providing a readout of their oxygen consumption rate and glycolytic capacity.
Novelty and Inventive Step
The new claims introduce novel components and methods that enhance the TILs' metabolic fitness and bioenergetic profile, which are not disclosed in the original patent. The inventive step lies in the combination of these components and methods, which provides a synergistic effect on the TILs' therapeutic potential.
Alternative Embodiments and Variations
Alternative embodiments may include varying the cytokine combination, oxygen tension, and glycolysis-promoting agents to optimize the TILs' metabolic fitness. Variations may include using different types of TILs, such as those derived from different tumor types or sources.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the field of adoptive T-cell therapy, particularly for the treatment of bulky, refractory cancers. The target market includes pharmaceutical companies, research institutions, and hospitals involved in cancer treatment.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Cellular immunotherapy, specifically tumor infiltrating lymphocyte (TIL) manipulation, restoration, and cryopreservation techniques in oncological treatment
Person of Ordinary Skill (PHOSITA) Profile
A skilled practitioner with advanced training in immunology, cell biology, and cancer therapeutics, possessing expertise in cell culture techniques, cryopreservation methods, and lymphocyte restimulation protocols
Obviousness Rationale
A person having ordinary skill would recognize that the PTD's proposed metabolic fitness enhancements represent predictable variations on the source patent's core TIL restimulation methodology. The disclosed techniques of controlled oxygen tension, cytokine combination, and metabolic monitoring are logical extensions of existing TIL expansion and preservation strategies. These variations would be considered routine optimization within the established framework of cellular immunotherapy research.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,573 |
|---|---|
| Title | Restimulation of cryopreserved tumor infiltrating lymphocytes |
| Assignee(s) | Iovance Biotherapeutics, Inc. |