Treg Cell-Based Therapies Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | Rapa Therapeutics, Orca Bio, Caladrius Biosciences, Sangamo Therapeut

June 16 10:08 2025
Treg Cell-Based Therapies Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | Rapa Therapeutics, Orca Bio, Caladrius Biosciences, Sangamo Therapeut
(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Treg Cell-Based Therapies pipeline constitutes key 51+ companies continuously working towards developing 55+ Treg Cell-Based Therapies treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

The Treg Cell-Based Therapies Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Treg Cell-Based Therapies Pipeline Insight, 2025 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Treg Cell-Based Therapies Market.

 

Some of the key takeaways from the Treg Cell-Based Therapies Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Treg Cell-Based Therapies treatment therapies with a considerable amount of success over the years.

  • Treg Cell-Based Therapies companies working in the treatment market are HCW Biologics, Sangamo Therapeutics, Gentibio, Abata Therapeutics, NightHawk Biosciences, Quell Therapeutics Limited, Coya Therapeutics, Orca Bio, Caladrius Biosciences, VT BIO, Cellenkos, and others, are developing therapies for the Treg Cell-Based Therapies treatment

  • Emerging Treg Cell-Based Therapies therapies in the different phases of clinical trials are- HCW9302, KITE-037, GNTI-122, ABA-101, PTX-35, TX200, QEL-001, Coya 101, Orca-T, CLBS03, VT301, CK0804, and others are expected to have a significant impact on the Treg Cell-Based Therapies market in the coming years.

  • In October 2024, Quell Therapeutics joined forces with eXmoor Pharma to manufacture its CAR-Treg immunosuppressive cell therapies at eXmoor’s newly established cell and gene therapy facility. This partnership, forming part of a strategic alliance between the two UK-based companies, will support the production of Quell’s investigational cell therapies for autoimmune diseases intended for use in early-phase clinical trials.

  • In September 2024, Abata Therapeutics announced that the US FDA has granted fast track designation to ABA-101, an autologous regulatory T-cell (Treg) therapy developed for the treatment of patients with progressive multiple sclerosis (MS).

  • In September 2024, PolTREG S.A. announced that the China National Intellectual Property Administration (CNIPA) has granted a patent for its method of intrathecal administration of cellular therapies in multiple sclerosis (MS) patients. This technique involves delivering treatment directly into the subarachnoid space, allowing it to cross the blood-brain barrier effectively.

  • In May 2024, Orca Bio announced the presentation of new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, from May 31–June 4. The presentation highlighted outcomes of its lead investigational allogeneic T-cell immunotherapy, Orca-T, in patients with acute myeloid leukemia (AML).

 

Treg Cell-Based Therapies Overview

Treg cell-based therapies involve using regulatory T cells (Tregs) to treat various autoimmune and inflammatory diseases. Tregs are a specialized subset of T cells that play a crucial role in maintaining immune tolerance and preventing autoimmune responses. These therapies harness the natural suppressive functions of Tregs to modulate the immune system and restore balance.

 

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Emerging Treg Cell-Based Therapies Drugs Under Different Phases of Clinical Development Include:

  • HCW9302: HCW Biologics

  • KITE-037: Sangamo Therapeutics

  • GNTI-122: Gentibio

  • ABA-101: Abata Therapeutics

  • PTX-35: NightHawk Biosciences

  • TX200: Sangamo Therapeutics

  • QEL-001: Quell Therapeutics Limited

  • Coya 101: Coya Therapeutics

  • Orca-T: Orca Bio

  • CLBS03: Caladrius Biosciences

  • VT301: VT BIO

  • CK0804: Cellenkos

 

Treg Cell-Based Therapies Pipeline Therapeutics Assessment

  • Treg Cell-Based Therapies Assessment by Product Type

  • Treg Cell-Based Therapies By Stage and Product Type

  • Treg Cell-Based Therapies Assessment by Route of Administration

  • Treg Cell-Based Therapies By Stage and Route of Administration

  • Treg Cell-Based Therapies Assessment by Molecule Type

  • Treg Cell-Based Therapies by Stage and Molecule Type

 

DelveInsight’s Treg Cell-Based Therapies 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)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Treg Cell-Based Therapies product details are provided in the report. Download the Treg Cell-Based Therapies pipeline report to learn more about the emerging Treg Cell-Based Therapies therapies

 

Some of the key companies in the Treg Cell-Based Therapies Therapeutics Market include:

Key companies developing therapies for Treg Cell-Based Therapies are – Rapa Therapeutics, Orca Bio, Caladrius Biosciences, Sangamo Therapeutics, Quell Therapeutics, Coya Therapeutics, Sonoma Biotherapeutics, GentiBio, AstraZeneca, TCR² Therapeutics, Cellenkos, VT BIO, KSQ Therapeutics, Kyverna Therapeutics, Astellas, Abata Therapeutics, TRACT Therapeutics, Adaptive Biotechnologies, PolTREG, TeraImmune, and others.

 

Treg Cell-Based Therapies Pipeline Analysis:

The Treg Cell-Based Therapies pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Treg Cell-Based Therapies with aggregate therapies developed by each company for the same.

  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Treg Cell-Based Therapies Treatment.

  • Treg Cell-Based Therapies key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

  • Treg Cell-Based Therapies Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Treg Cell-Based Therapies market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Treg Cell-Based Therapies drugs and therapies

 

Treg Cell-Based Therapies Pipeline Market Drivers

  • High prevalence of autoimmune and inflammatory diseases, the emergence of new techniques such as next-generation T-cells immunotherapy are some of the important factors that are fueling the Treg Cell-Based Therapies Market.

 

Treg Cell-Based Therapies Pipeline Market Barriers

  • However, high cost associated with the Treg Cell-Based Therapies, the complex manufacturing of regulatory T-cell immunotherapies and other factors are creating obstacles in the Treg Cell-Based Therapies Market growth.

 

Scope of Treg Cell-Based Therapies Pipeline Drug Insight

  • Coverage: Global

  • Key Treg Cell-Based Therapies Companies: HCW Biologics, Sangamo Therapeutics, Gentibio, Abata Therapeutics, NightHawk Biosciences, Quell Therapeutics Limited, Coya Therapeutics, Orca Bio, Caladrius Biosciences, VT BIO, Cellenkos, and others

  • Key Treg Cell-Based Therapies Therapies: HCW9302, KITE-037, GNTI-122, ABA-101, PTX-35, TX200, QEL-001, Coya 101, Orca-T, CLBS03, VT301, CK0804, and others

  • Treg Cell-Based Therapies Therapeutic Assessment: Treg Cell-Based Therapies current marketed and Treg Cell-Based Therapies emerging therapies

  • Treg Cell-Based Therapies Market Dynamics: Treg Cell-Based Therapies market drivers and Treg Cell-Based Therapies market barriers

 

Request for Sample PDF Report for Treg Cell-Based Therapies Pipeline Assessment and clinical trials

 

Table of Contents

1. Treg Cell-Based Therapies Report Introduction

2. Treg Cell-Based Therapies Executive Summary

3. Treg Cell-Based Therapies Overview

4. Treg Cell-Based Therapies- Analytical Perspective In-depth Commercial Assessment

5. Treg Cell-Based Therapies Pipeline Therapeutics

6. Treg Cell-Based Therapies Late Stage Products (Phase II/III)

7. Treg Cell-Based Therapies Mid Stage Products (Phase II)

8. Treg Cell-Based Therapies Early Stage Products (Phase I)

9. Treg Cell-Based Therapies Preclinical Stage Products

10. Treg Cell-Based Therapies Therapeutics Assessment

11. Treg Cell-Based Therapies Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Treg Cell-Based Therapies Key Companies

14. Treg Cell-Based Therapies Key Products

15. Treg Cell-Based Therapies Unmet Needs

16 . Treg Cell-Based Therapies Market Drivers and Barriers

17. Treg Cell-Based Therapies Future Perspectives and Conclusion

18. Treg Cell-Based Therapies Analyst Views

19. Appendix

20. About DelveInsight

 

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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