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Treg Cell-based Therapies Clinical Trial Pipeline Appears Robust With 51+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

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DelveInsight Business Research, LLP

28 Oct, 2024, 21:31 GMT

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Treg Cell-based Therapies refer to therapeutic approaches that utilize regulatory T cells (Tregs) to modulate the immune system. Innovations in cell expansion and engineering techniques have greatly enhanced the ability to isolate, expand, and deliver functional Tregs. Ex vivo expansion technologies and genetic engineering (such as CAR-Tregs) have opened up new possibilities for enhancing the stability, specificity, and effectiveness of Treg therapies.

LAS VEGAS, Oct. 28, 2024 /PRNewswire/ -- DelveInsight's 'Treg Cell-based Therapies Pipeline Insight 2024' report provides comprehensive global coverage of available, marketed, and pipeline Treg cell-based therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Treg cell-based therapies pipeline domain.

Key Takeaways from the Treg Cell-based Therapies Pipeline Report

  • DelveInsight's Treg cell-based therapies pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for various indications. 
  • Key Treg cell-based therapies companies such as 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, Tract Therapeutics, and others are evaluating new Treg cell-based therapies to improve the treatment landscape.
  • Promising Treg cell-based therapies in the pipeline 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, KSQ 001, TI-620, TRK 001, and others.
  • In October 2024, Quell Therapeutics hired eXmoor Pharma to make supplies of its pipeline of novel immunosuppressive cell therapies—called CAR-Tregs—at its new cell and gene therapy facility. Quell recently teamed with fellow U.K.-based eXmoor in a strategic partnership that will see the contractor make its candidate autoimmune disease cell therapies for early-phase clinical studies. 
  • In September 2024, Abata Therapeutics announced that ABA-101, an autologous regulatory T-cell (Treg) therapy for the treatment of patients with progressive multiple sclerosis (MS), has received fast-track designation from the US FDA.
  • In September 2024, PolTREG S.A. announced that China's National Intellectual Property Administration, PRC (CNIPA) had issued a notification to grant a patent for the intrathecal administration of the company's cellular therapies in patients with multiple sclerosis (MS). The intrathecal administration is an established method used to deliver therapy across the blood-brain barrier via injection into the subarachnoid space.
  • In June 2024, Orca Bio announced that it had completed enrollment in the pivotal Precision-T Phase III clinical study. The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD).
  • In March 2024, PolTREG announced that the company is planning to launch Phase II trials testing its Tregs therapy — the T-cell-based treatment PTG-007 in people with multiple sclerosis (MS).
  • In February 2024, Cellenkos announced encouraging safety data from its innovative CK0803 neurotrophic T regulatory (Treg) cell therapy, being developed to help treat individuals with Amyotrophic Lateral Sclerosis (ALS). The company was given the green light to move ahead following a review of safety data by the Data Safety Monitoring Board (DSMB). 
  • In August 2023, BlueRock Therapeutics LP, a wholly owned, independently operated subsidiary of Bayer AG, and bit.bio, the company coding human cells for novel cures announced a collaboration and option agreement for the discovery and manufacture of iPSC-derived regulatory T cells (Tregs) for use in creating therapeutics.

Request a sample and discover the recent advances in Treg cell-based therapies @ Treg Cell-based Therapies Pipeline Outlook

The Treg cell-based therapies pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Treg cell-based therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Treg cell-based therapies pipeline landscape.

Treg Cell-based Therapies Overview

Treg cell-based therapies represent a promising frontier in immunotherapy, focusing on harnessing regulatory T cells (Tregs) to modulate the immune response in various clinical settings. Tregs play a crucial role in maintaining immune homeostasis and preventing autoimmune reactions by suppressing excessive immune responses. In the context of autoimmune diseases, these therapies aim to restore balance by expanding or enhancing Tregs to dampen inappropriate immune activity. For instance, in diseases like type 1 diabetes or multiple sclerosis, Treg cell-based treatments seek to prevent or slow disease progression by reestablishing immune tolerance.

Beyond autoimmune disorders, Treg cell-based therapies are also being explored in cancer treatment. Tumors often exploit Tregs to evade immune detection, and by manipulating these cells, it's possible to enhance the anti-tumor immune response. Strategies include expanding Tregs ex vivo and reinfusing them to boost their numbers or modifying them to more effectively target tumor-associated antigens. These approaches hold the potential to improve the efficacy of existing immunotherapies and offer new avenues for treating cancers that are currently resistant to conventional treatments.

Find out more about Treg cell-based therapies @ Treg Cell-based Therapies in Development 

A snapshot of the Treg Cell-based Therapies Pipeline Drugs mentioned in the report:

Drugs

Company

Phase 

Indication

MoA

RoA

Orca-T

Orca Bio

Phase III

Acute myeloid leukemia; Myelodysplastic syndromes; Precursor cell lymphoblastic leukemia-lymphoma

Immunologic cytotoxicity; T lymphocyte replacements

Parenteral

NKTR-358

Nektar Therapeutics

Phase II

Alopecia areata; Atopic dermatitis; Systemic lupus erythematosus

Interleukin 2 replacements

Subcutaneous

CLBS03

Caladrius Biosciences

Phase II

Type 1 diabetes mellitus

T lymphocyte replacements

Intravenous

QEL-001

Quell Therapeutics

Phase I/II

Liver transplant rejection

Immunologic cytotoxicity; Regulatory T-lymphocyte replacements

Intravenous

CUG-252

Cugene

Phase I

Atopic dermatitis; Inflammatory bowel diseases; Rheumatoid arthritis; Systemic lupus erythematosus

Interleukin 2 replacements

Subcutaneous

VT301

VT BIO

Phase I

Alzheimer's disease

Cell replacements

Parenteral

Learn more about the emerging Treg cell-based therapies @ Treg Cell-based Therapies Clinical Trials

Treg Cell-based Therapies Therapeutics Assessment

The Treg cell-based therapies pipeline report proffers an integral view of the emerging Treg cell-based therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the Treg Cell-based Therapies Pipeline Report 

  • Coverage: Global 
  • Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
  • Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
  • Therapeutics Assessment By Route of Administration: Intravenous, Subcutaneous, Oral, Intramuscular
  • Therapeutics Assessment By Molecule Type:  Monoclonal antibody, Small molecule, Peptide
  • Therapeutics Assessment By Mechanism of Action: Immunologic cytotoxicity, T lymphocyte replacements, Interleukin 2 replacements, Cell replacements
  • 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, Tract Therapeutics, and others.
  • Key Treg Cell-based Therapies in Pipeline:  Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others.

Dive deep into rich insights for Treg cell-based therapies assessment, visit @ Treg Cell-based Therapies Therapeutics Assessment

Table of Contents

1.

Treg Cell-based Therapies Pipeline Report Introduction

2.

Treg Cell-based Therapies Pipeline Report 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 (Pre-registration)

7.

Treg Cell-based Therapies Pipeline: Late Stage Products (Phase III)

8.

Treg Cell-based Therapies Pipeline: Mid Stage Products (Phase II)

9

Treg Cell-based Therapies Pipeline: Early Stage Products (Phase I)

10.

Treg Cell-based Therapies Pipeline Therapeutics Assessment

11.

Inactive Products in the Treg Cell-based Therapies Pipeline

12.

Company-University Collaborations (Licensing/Partnering) Analysis

13.

Key Companies

14.

Key Products in the Treg Cell-based Therapies Pipeline

15.

Unmet Needs

16.

Market Drivers and Barriers

17.

Future Perspectives and Conclusion

18.

Analyst Views

19.

Appendix

For further information on the Treg cell-based therapies pipeline therapeutics, reach out @ Treg Cell-based Therapies Pipeline Landscape

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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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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