Treg Cell-Based Therapies Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, IND, ROA, MOA, NDA Approval and Companies involved by DelveInsight

(Albany, USA) DelveInsight's "Treg Cell-Based Therapies Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Treg cell-based therapies market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Treg cell-based therapies drugs, the Treg cell-based therapies pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

The Treg cell-based therapy landscape is rapidly evolving, with pioneers like Orca Bio, Quell Therapeutics, Nektar Therapeutics, and Abata Therapeutics leading the charge in developing next-generation treatments. These innovative programs are leveraging the unique immunoregulatory power of regulatory T cells to restore immune tolerance, offering promising new strategies for treating autoimmune diseases, chronic inflammation, and transplant rejection. As research progresses, Treg therapies are poised to redefine how we manage immune-related conditions and bring long-lasting relief to patients.

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Key Takeaways from the Treg Cell-Based Therapies Pipeline Report
• DelveInsight's Treg cell-based therapies pipeline analysis depicts a robust space with 51+ active players working to develop 55+ pipeline drugs for Treg cell-based therapies treatment.
• The leading Treg cell-based therapies companies include 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, and others are evaluating their lead assets to improve the Treg cell-based therapies treatment landscape.
• Key Treg cell-based therapies pipeline therapies in various stages of development include 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, and others.
• In February 2025, HCW Biologics Inc., a clinical-stage biopharmaceutical company focused on developing immunotherapies, announced FDA clearance for its Investigational New Drug (IND) application. This allows the company to begin a Phase I clinical trial of HCW9302, a leading drug candidate, in patients with moderate-to-severe alopecia areata. Alopecia areata is an autoimmune disease causing sudden hair loss, with no FDA-approved cures currently available.
• In October 2024, Quell Therapeutics partnered with eXmoor Pharma to produce supplies of its innovative CAR-Treg immunosuppressive cell therapies at a newly established cell and gene therapy facility. This strategic collaboration will enable eXmoor to manufacture Quell's candidate therapies for early-stage clinical trials targeting autoimmune diseases.
• In September 2024, Abata Therapeutics announced that its autologous Treg therapy, ABA-101, for treating progressive multiple sclerosis (MS), has received fast-track designation from the U.S. FDA, accelerating its path to clinical use.
• In September 2024, PolTREG S.A. revealed that China's National Intellectual Property Administration (CNIPA) granted a patent for the intrathecal administration of its cellular therapies, a method that delivers treatment across the blood-brain barrier for MS patients via subarachnoid space injections.
• In June 2024, Orca Bio announced the completion of enrollment in the pivotal Precision-T Phase III clinical trial, designed to evaluate survival rates free from moderate-to-severe chronic graft versus host disease (GvHD) as its primary endpoint.
• In March 2024, PolTREG shared plans to initiate Phase II trials of its Treg-based therapy, PTG-007, in individuals with multiple sclerosis (MS), advancing its research in the autoimmune space.
• In February 2024, Cellenkos reported promising safety data for its CK0803 neurotrophic Treg cell therapy, designed to treat Amyotrophic Lateral Sclerosis (ALS). Following a positive review from the Data Safety Monitoring Board (DSMB), the company has received approval to move forward with clinical trials.

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Treg Cell-Based Therapies Overview
Regulatory T cell (Treg) therapies harness the body's natural immune regulators to treat autoimmune diseases, chronic inflammation, and transplant rejection. Tregs help maintain immune balance by suppressing overactive immune responses and preventing autoimmunity through direct cell contact and anti-inflammatory cytokines like IL-10 and TGF-β.

These therapies are being explored for conditions such as multiple sclerosis, rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and to promote transplant tolerance. Combination strategies, including IL-2/STAT5 agonists or anti-T cell agents, aim to enhance efficacy.

Despite strong scientific rationale, Treg therapies face early-stage challenges like variable cell expansion, limited GMP-grade manufacturing tools, and scalability concerns. However, ongoing innovation continues to drive progress in this promising field.

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Treg Cell-Based Therapies Treatment Analysis: Drug Profile
Orca-T: Orca Bio
Orca-T is an investigational, precision-engineered allogeneic cell therapy that combines regulatory T cells, conventional T cells, and CD34+ stem cells sourced from matched related or unrelated donors. Designed to promote immune tolerance while rebuilding the blood and immune system, Orca-T has received RMAT designation from the FDA. It is currently in Phase III development for treating various hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, and mixed phenotype acute leukemia.

NKTR-358: Nektar Therapeutics
NKTR-358 is a first-in-class Treg cell stimulator developed to restore immune balance in autoimmune and inflammatory diseases. By selectively targeting the IL-2 receptor complex, it promotes the expansion of regulatory T cells while sparing cytotoxic CD8+ and CD4+ T cells that drive autoimmunity. This selective action helps re-establish immune tolerance. NKTR-358 is currently in Phase II trials for atopic dermatitis and alopecia areata.

Key Treg Cell-Based Therapies Therapies and Companies
• Orca-T: Orca Bio
• NKTR-358: Nektar Therapeutics
• QEL-001: Quell Therapeutics
• CUG-252: Cugene

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Treg Cell-Based Therapies Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Treg Cell-Based Therapies Pipeline Report
• Coverage: Global
• Key Treg Cell-Based Therapies Companies: 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, and others.
• Key Treg Cell-Based Therapies Pipeline Therapies: 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, and others.

Dive deep into rich insights for drugs used for Treg Cell-Based Therapies treatment; visit @ https://www.delveinsight.com/sample-request/treg-cell-based-therapies-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. Executive Summary
3. Treg Cell-Based Therapies Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Treg Cell-Based Therapies Pipeline Therapeutics
6. Treg Cell-Based Therapies Pipeline: Late-Stage Products (Phase III)
7. Treg Cell-Based Therapies Pipeline: Mid-Stage Products (Phase II)
8. Treg Cell-Based Therapies Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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