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The Science of
Treg Cell Therapy

Harnessing the Power of Regulatory T Cells to Modulate the Immune System

OVERVIEW

Understanding Treg Cells

Regulatory T cells (Tregs) are a specialized subset of T cells that play a crucial role in maintaining immune homeostasis.

Unlike other immune cells that activate the immune response, Tregs function to control and suppress immune reactions, preventing excessive inflammation and autoimmunity. This ‘polypharmacy’ – the ability to act through multiple mechanisms – makes them a powerful therapeutic target.

CORE-T

CD6/CTLA4 CAR-Tregs

The CD6/CTLA4 CAR-Treg is a novel, First-in-class, engineered CAR-Treg that has shown excellent clinical proof of concept and biology in 6 GvHD patients at exceptionally low doses (100,000 and 300,000 cells/kg).

  • First CAR-Treg to ever be authorized by the FDA for Clinical evaluation.
  • First CAR-Treg to specifically target and suppress autoreactive T-cells.
  • First CAR-Treg with a Treg specific Signaling domain (CTLA4) that drives Treg function/activity.
  • Clinically validated in 6 GvHD patients with excellent safety and initial efficacy at low doses.
  • Cryopreserved. Scaleable and low COGS manufacturing via PolTREG.

CD6-CTLA4 CoRe-T: Novel CAR Target and Treg specific Signaling/Costim domain.

CD6 Targets Autoreactive Teff
  • Not Ag specific | Not HLA specific
  • Tropism to sites of inflammation
  • Immunomodulatory Effect Inhibits:
    • T-cell Proliferation
    • Pro-inflammatory Cytokines
CTLA-4 Down-regulates autoreactive T-cells.
  • Tregs: Constitutive, ↑ FOXP3 → more Tregs.
  • APCs: Ccompetes for “activating” ligands on APCs ↓ T-cell responses to self-antigens.
  • Tcells: “Off switch” prevents over-activation.
    • CTLA4 inhibitors (Ipilimumab) – oncology to
    • “release the brakes” ↑ T-cell activation. CTLA4 defects → AI diseases like SLE.
Tregs Regulate Immune Response:.
  • CD19 Tag for identification of CAR
  • IL2 consumption
  • Anti-inflammatory cytokines
  • Bystander suppression – B-cells, Macrophages, Neutrophils, T-cels.

EXPERTISE

Clinical Experience with Treg Therapies

Immuthera’s Treg-based therapies, derived from the PTG-007 platform, have been evaluated in multiple clinical trials, demonstrating safety and promising efficacy in various autoimmune diseases. These trials have provided valuable insights into the therapeutic potential of Tregs and support our ongoing development efforts.

Clinical trials have demonstrated that PTG-007 is generally well-tolerated, with a favorable safety profile observed across studies.

LOOKING AHEAD: NOVEL TREG-BASED STRATEGIES

We are actively exploring novel approaches including CAR-Tregs, Allogeneic/Multi-edited CAR-Tregs, antigen-specific Tres, and mRNA Immunotherapies to further expand the therapeutic potential fo Tregs and address a broader range of diseases.

TREG CELL ENGINEERING

CAR-Treg Cell
Therapy

Chimeric antigen receptor (CAR) Tregs are engineered to express receptor that targets specific cells or tissues.

This technology allows us to direct Tregs to sites of inflammation and enhance their therapeutic activity. Our lead CAR-Treg programs are focused on addressing neuroinflammatory diseases such as Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS).

Watch the video

NEXT GENERATION TREG CELL ENGINEERING

Multi-Edited, Allogeneic, CAR-Tregs

Next-Generation Cell Therapies for Autoimmune and Neuroinflammatory Diseases.

By combining Immuthera’s clinically validated PTG-007 platform with Antion’s modular gene editing technology, we are engineering a new class of CAR-Tregs designed to be used “off-the-shelf.” These allogeneic Tregs are enhanced through multiplex editing to closely mimic the phenotype and function of Tregs from Responder Patients in clinical trials.

This next-generation approach allows for scalable, precise, and highly targeted Treg therapies capable of treating complex disorders such as Multiple Sclerosis (MS) and Amyotrophic Lateral Sclerosis (ALS).

KEY INNOVATIONS

Multiplex
Gene Editing
Simultaenous addition of up to three „edits” along with the Chimeric Antigen Receptor (CAR) in a single construct.
Clinically
Validated
Engineered into PTG-007, a platform with up to 12 years of safety and efficacy data
Allogeneic
Silencing of HLA enables use across mismatched donors
Designed
for efficacy
Functional tuning to enhance suppression and persistence at inflammation sites

PARTNERS

Leveraging the PolTREG Collaboration

Immuthera benefits from a strong collaboration with PolTREG, a leader in Treg cell research and development.

This partnership allows us to leverage PolTREG’s extensive experience, proprietary technologies, and ongoing research to accelerate the development of novel Treg-based therapies and translate scientific discoveries into clinical breakthroughs.