Enhanced Restimulation of Cryopreserved Tumor Infiltrating Lymphocytes
Legal Citation
Summary of the Inventive Concept
This inventive concept relates to improved methods and systems for restimulating cryopreserved tumor infiltrating lymphocytes, enhancing their viability, potency, and metabolic state for adoptive cell therapy.
Background and Problem Solved
The original patent disclosed methods for expanding tumor infiltrating lymphocytes, but these methods have limitations, such as reduced viability and potency of the expanded lymphocytes. The new inventive concept addresses these limitations by introducing an antigen-based restimulation step, improving the overall efficacy of adoptive cell therapy.
Detailed Description of the Inventive Concept
The inventive concept encompasses a system and method for restimulating cryopreserved tumor infiltrating lymphocytes with an antigen, thereby enhancing their viability and potency. The system comprises a cryopreservation unit, a thawing unit, and a restimulation unit. The method involves thawing the cryopreserved lymphocytes, restimulating them with an antigen, and optionally, cryopreserving the restimulated lymphocytes for future use. The restimulation step increases the proportion of memory T cells in the lymphocyte population, leading to improved efficacy in adoptive cell therapy.
Novelty and Inventive Step
The new inventive concept introduces the antigen-based restimulation step, which is not disclosed in the original patent. This step is non-obvious as it requires a deep understanding of the biology of tumor infiltrating lymphocytes and the importance of antigen presentation in their activation.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept include using different antigens, varying the duration and intensity of the restimulation step, and incorporating additional components, such as sensors to monitor the metabolic state of the restimulated lymphocytes.
Potential Commercial Applications and Market
The enhanced restimulation of cryopreserved tumor infiltrating lymphocytes has significant commercial potential in the field of adoptive cell therapy, particularly for the treatment of bulky, refractory cancers. The target market includes pharmaceutical companies, biotech companies, and research institutions involved in cancer therapy development.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Immunotherapy and cellular biology, specifically focused on tumor infiltrating lymphocyte (TIL) manipulation, cryopreservation, and adoptive cell transfer techniques. Requires advanced knowledge of immunology, cell culture methods, and cancer treatment strategies.
Person of Ordinary Skill (PHOSITA) Profile
A PhD-level researcher with expertise in immunology, cell biology, and cancer therapeutics. Possesses advanced skills in cell culture techniques, understanding of T cell biology, experience with cryopreservation methods, and familiarity with adoptive cell transfer technologies.
Obviousness Rationale
A person having ordinary skill in the art would recognize that the PTD's antigen-based restimulation method represents an incremental and predictable extension of the source patent's TIL expansion and cryopreservation techniques. The proposed restimulation step follows logically from existing knowledge about T cell activation and metabolic reprogramming. A skilled practitioner would understand that introducing an antigen during TIL processing could enhance cellular potency and memory characteristics.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,573 |
|---|---|
| Title | Restimulation of cryopreserved tumor infiltrating lymphocytes |
| Assignee(s) | Iovance Biotherapeutics, Inc. |