Treg Cell-Based Therapies - Pipeline Insight, 2025

This “Treg Cell-Based Therapies - Pipeline Insight, 2025” report provides comprehensive insights about 51+ companies and 55+ pipeline drugs in Treg Cell-Based Therapies pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Treg Cell-Based Therapies: Understanding

Treg Cell-Based Therapies: Overview

Treg (regulatory T cell) cell-based therapies harness the immunosuppressive properties of regulatory T cells to treat a variety of conditions, including autoimmune diseases, inflammatory conditions, and transplant rejection. These therapies leverage the natural function of Tregs, which play a crucial role in maintaining immune homeostasis by suppressing excessive immune responses that can cause tissue damage and by preventing the development of autoimmunity. Tregs achieve this by modulating the activity of other immune cells, thereby maintaining a balanced immune environment essential for health.

Treg cells regulate the immune system through intricate mechanisms aimed at inhibiting the activation and proliferation of other immune cells, notably effector T cells. Their regulatory functions are executed via direct cell-to-cell contact and the secretion of various anti-inflammatory cytokines, including IL-10 and TGF-β. These processes collectively contribute to the maintenance of immune balance and suppression of excessive immune responses, crucial for preventing autoimmune reactions and promoting immune tolerance.

The combination approaches for regulatory T (Treg) cell adoptive cell transfer include the concomitant use of IL-2 receptor and signal transducer and activator of transcription 5 (STAT5) agonists, but other approaches may include debulking the intrinsic effector T cell responses (which are often associated with resistance to Treg cell-based therapies through the use of anti-T cell therapies including anti-thymocyte globulin.

Although Treg cell therapy has a clear immunologic rationale, there are many challenges at this early stage of its implementation and testing. The magnitude of ex vivo expansion of Treg cells can be highly variable depending on patient population and underlying diseases. There are also limited clinical-grade (Good Manufacturing Practice) reagents and instruments specifically designed for Treg cell manufacturing.

Treg therapies are being developed to treat various autoimmune diseases, including multiple sclerosis, rheumatoid arthritis, and type 1 diabetes, by restoring immune tolerance. Additionally, Treg therapies can prevent the immune system from attacking transplanted organs or tissues, reducing the need for long-term immunosuppressive drugs. Furthermore, Treg therapies may also be beneficial in inflammatory diseases such as inflammatory bowel disease and psoriasis, as they can mitigate chronic inflammation.

'Treg Cell-Based Therapies - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Treg Cell-Based Therapies pipeline landscape is provided which includes the disease overview and Treg Cell-Based Therapies treatment guidelines. The assessment part of the report embraces, in depth Treg Cell-Based Therapies commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Treg Cell-Based Therapies collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Treg Cell-Based Therapies R&D. The therapies under development are focused on novel approaches to treat/improve Treg Cell-Based Therapies.

Treg Cell-Based Therapies Emerging Drugs Chapters

This segment of the Treg Cell-Based Therapies report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II/III, II, I, preclinical and discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Treg Cell-Based Therapies Emerging Drugs

Orca-T: Orca Bio

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies. Currently, the drug is in the Phase III stage of its development for the treatment of acute myeloid leukaemia, Myelodysplastic syndromes, Acute Lymphoid Leukemia, and Mixed Phenotype Acute Leukemia.

NKTR-358: Nektar Therapeutics

NKTR-358 is a novel first-in-class regulatory T (Treg) cell stimulator designed to address the imbalance in the immune system underlying autoimmune disorders and chronic inflammatory conditions. NKTR-358 works by targeting the IL-2 receptor complex and preferentially stimulating the proliferation of Treg cells without stimulating cytotoxic CD8+ T and CD4+ T cells, which drive autoimmune disease. Activation of Tregs suppresses disease-causing T cells and restores the body’s self-tolerance mechanisms. The drug is currently being evaluated under Phase II clinical trial for the treatment of patients with atopic dermatitis and Alopecia Areata.

QEL-001: Quell Therapeutics

QEL-001 is a first-in-class antigen-specific CAR-Treg cell therapy candidate designed using Quell’s unique multi-modular engineered Treg platform and engineered with three proprietary modules: a chimeric antigen receptor (CAR) for tissue targeting, the Foxp3 phenotype lock module, and a safety switch. The QEL-001 CAR is specific for HLA-A2, which localizes the activity of the CAR-Tregs to the site of the transplanted organ in HLA-A2 mismatch liver transplant patients. The drug is currently being evaluated under Phase I/II clinical trial for the treatment of patients with Liver transplantation.

CUG-252: Cugene

CUG-252, developed by Cugene is an interleukin-2 replacement. The drug is currently being evaluated under Phase I clinical trial for the treatment of patients with Atopic dermatitis, Inflammatory bowel diseases, Rheumatoid arthritis, and Systemic lupus erythematosus.

Treg Cell-Based Therapies: Therapeutic Assessment

This segment of the report provides insights about the different Treg Cell-Based Therapies drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Treg Cell-Based Therapies

There are approx. 51+ key companies which are developing the therapies for Treg Cell-Based Therapies. The companies which have their Treg Cell-Based Therapies drug candidates in the most advanced stage, i.e. Phase III include, Orca Bio.

Phases

The report covers around 55+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Treg Cell-Based Therapies pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Treg Cell-Based Therapies: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Treg Cell-Based Therapies therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Treg Cell-Based Therapies drugs.

Treg Cell-Based Therapies Report Insights

• Treg Cell-Based Therapies Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Treg Cell-Based Therapies Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Treg Cell-Based Therapies drugs?
• How many Treg Cell-Based Therapies drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Treg Cell-Based Therapies?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Treg Cell-Based Therapies therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Treg Cell-Based Therapies and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Orca Bio
• Nektar Therapeutics
• Quell Therapeutics
• Cugene
• Sangamo Therapeutics
• Abata Therapeutics
• HCW Biologics
• GentiBio
• Tr1X
• PolTREG
• Cellenkos
• VT BIO
• Miltenyi Biotec GmbH
• KSQ Therapeutics
• TeraImmune

Key Products

• Orca-T
• NKTR-358
• QEL-001
• CUG-252
• TX200
• ABA-101
• HCW9302
• GNTI-122
• TRX-103
• PTG-020
• CK-0804
• VT-301
• TR-004
• Research programme
• TI-620

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