Genetically Modified T Cells Expressing IL-2 or IL-15

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Solution Overview

Problem

Current T cell therapies for autoimmune and inflammatory diseases, as well as cancer, rely on exogenous IL-2 supplementation, which can be inadequate in patients with low IL-2 production, affecting Treg and Teff survival and function, and require repeated injections of large cell quantities.

Innovation Solution

Genetically modified Treg and Teff cells that stably express IL-2 or IL-15, using integrative viral vectors like lentiviruses or CRISPR-Cas9, to ensure constitutive or inducible expression, enhancing their survival and suppressive activity in IL-2-deprived environments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If exogenous IL-2 supplementation is used in T cell therapy, then Treg and Teff survival and function can be supported, but patients with low IL-2 production cannot benefit adequately

Engineering Contradiction:
ImproveTreg and Teff survival and functionVSAvoidEffectiveness across different patient populations
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent modifies Tregs to autonomously produce IL-2 through genetic engineering, enabling them to self-support their survival and function without relying on exogenous IL-2 supplementation. This self-service capability ensures consistent therapeutic effect across all patient populations regardless of their endogenous IL-2 production levels.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention changes the functional parameter of Tregs by genetically modifying them to express IL-2, transforming them from IL-2 consumers to IL-2 producers. This parameter change enables the therapy to work effectively in patients with low IL-2 production by altering the fundamental cytokine dependency of the therapeutic cells.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If large quantities of Tregs are injected repeatedly, then therapeutic effect can be maintained, but treatment becomes cumbersome

Engineering Contradiction:
Improvetherapeutic effectVSAvoidtreatment frequency and cell quantity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

By equipping Tregs with autonomous IL-2 production capability through genetic modification, the patent enables them to self-maintain their proliferation and survival in vivo. This self-service property allows a single injection of modified Tregs to provide sustained therapeutic effect without requiring repeated large-scale injections.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent performs preliminary genetic modification of Tregs ex vivo to establish autonomous IL-2 production before injection. This preliminary action ensures that the cells are pre-equipped with the necessary cytokine production capability, allowing them to immediately self-support upon injection and eliminating the need for subsequent booster injections.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If Tregs are cultured with large amounts of IL-2 ex vivo, then expansion can be achieved, but the cells face IL-2 deprivation upon re-injection into patients

Engineering Contradiction:
ImproveTreg expansionVSAvoidcell survival after re-injection
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent fundamentally changes the cytokine dependency parameter of Tregs by genetically modifying them to produce IL-2 autonomously. This parameter change allows the cells to be cultured with standard IL-2 levels ex vivo for expansion, while simultaneously ensuring they maintain survival capability after re-injection by having built-in IL-2 production capability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The genetically modified Tregs are designed to self-produce IL-2, making them independent of exogenous IL-2 supplementation. This self-service capability ensures that regardless of the IL-2 conditions during ex vivo culture, the cells will maintain survival and function after re-injection into the IL-2-limited patient environment.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3475413B1Genetically modified t lymphocytes
Publication Date: 2024.02.14 KLATZMANN DAVID
  • EP3475413B1 patent drawingFigure 1~2B
  • EP3475413B1 patent drawingFigure 2C
  • EP3475413B1 patent drawingFigure 2D~2E

AI summary

The invention relates to a composition comprising regulatory T (Treg) cells or effector T cells (Teff) which stably express an interleukin selected from the group consisting of interleukin-2 (IL-2) or interleukin-15 (IL-15).