Treg Cell-based Therapies Pipeline Landscape Analysis of 22+ Companies by DelveInsight

DelveInsight Business Research LLP
DelveInsight Business Research LLP

Given the various benefits offered, including high target specificity, customization potential and ability to generate immunological memory, regulatory T-cell (Treg) therapies have garnered significant attention among key industry stakeholders for the treatment of various oncological and non-oncological disease indications.

New York, USA, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Treg Cell-based Therapies Pipeline Landscape Analysis of 22+ Companies by DelveInsight

Given the various benefits offered, including high target specificity, customization potential and ability to generate immunological memory, regulatory T-cell (Treg) therapies have garnered significant attention among key industry stakeholders for the treatment of various oncological and non-oncological disease indications.

DelveInsight’s 'Treg Cell-based Therapies Pipeline Insight 2022' 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 22+ active players working to develop 25+ pipeline therapies for various indications.

  • Key Treg cell-based therapies companies such as Orca Bio, Caladrius Biosciences, Sangamo Therapeutics, Cellenkos, VT BIO, Rapa Therapeutics, Quell Therapeutics, Coya Therapeutics, Sonoma Biotherapeutics, GentiBio, AstraZeneca, TCR² Therapeutics, KSQ Therapeutics, Kyverna Therapeutics, Astellas, Abata Therapeutics, TRACT Therapeutics, Adaptive Biotechnologies, PolTREG, TeraImmune, 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, CLBS03, TX200, CK0804, VT301, RAPA 501, QEL-001, CK 0804, COYA 101, SBT-77-7200 series, SBT-77-7101, TRuC Tregs, Treg Program, KYV-101,TRK 001, TCR-Treg,  TI-168, TI-235, TI-495, and others.

  • In April 2022, Quell Therapeutics Ltd and Cellistic™ announced they had entered into a strategic collaboration for the co-development of an iPSC-derived Treg cell therapy platform. The goal of the partnership is to facilitate the future expansion of Quell’s autologous Treg cell therapy pipeline by adding off-the-shelf, allogeneic Treg cell therapy products, leveraging Cellistic™’s expertise in differentiation and scale-up of iPSC processes for allogeneic cell therapy applications.

  • In August 2022, Sonoma Biotherapeutics, Inc. announced that it had entered into a lease agreement to develop an approximately 83,000 square-foot Research and Development (R&D) and Manufacturing Center to expand its operations in Seattle and complement its existing R&D enterprise in South San Francisco.The state-of-the-art Center supported the R&D and manufacturing of Sonoma Bio’s pipeline of gene-modified Treg therapies for autoimmune and inflammatory diseases at scale.

  • In August 2022, GentiBio, Inc. announced that it had entered into a collaboration with Bristol Myers Squibb to develop new engineered Treg therapies to re-establish immune tolerance and repair tissue in patients living with inflammatory bowel diseases (IBD). The collaboration brings together GentiBio’s proprietary engineered Treg platform for generating scalable, stable, highly-selective, and durable Tregs with Bristol Myers Squibb’s leadership in cell therapies and immunology.

  • In August 2022, Orca Bio, announced Precision-T, its pivotal Phase III study, is open, enrolling and treating patients at clinical trial sites including Stanford Health Care, City of Hope, Winship Cancer Institute of Emory University, Sarah Cannon Research Institute, Ronald Reagan UCLA Medical Center and Oregon Health & Science University. Precision-T is expected to enroll approximately 174 patients at more than 20 transplant centers across the U.S. The pivotal Precision-T Study evaluates the safety and efficacy of Orca Bio’s investigational Orca-T compared to standard of care allogeneic hematopoietic stem cell transplant.

  • In June 2022, Coya Therapeutics, Inc. announced that it had raised approximately $10.3 million from institutional and accredited investors. The financing brings the total funding to date to over $20 million. The financing is used to advance multiple Treg programs into Phase I and Phase IIb clinical studies targeting neurodegenerative and autoimmune diseases

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 cells, which account for 5-7% of CD4+ T cells, develop both directly in the thymus (tTreg cells) and peripherally (pTreg cells). pTreg cells develop from CD4+ conventional T cells, particularly in the gut, in the presence of high levels of transforming growth factor (TGF) and retinoic acid in the environment or in response to metabolites produced by microbiota.

Clinical trials for cellular therapies based on regulatory T (Treg) cells are currently underway for the treatment of autoimmune diseases, transplant rejection, and graft-versus-host disease. Early Treg cell therapy experiences in patients with graft-versus-host disease, type 1 diabetes, and organ transplantation have demonstrated that it is feasible, safe, and potentially efficacious in some settings.

Although there is a clear immunologic rationale for Treg cell therapy, there are numerous challenges at this early stage of implementation and testing. The magnitude of Treg cell ex vivo expansion can vary greatly depending on the patient population and underlying diseases.


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

CLBS03

Caladrius Biosciences

Phase II

Type 1 diabetes mellitus

T lymphocyte replacements

Intravenous

TX200

Sangamo Therapeutics

Phase I/II

Transplant rejection

Immunologic cytotoxicity; T lymphocyte replacements

Intravenous

VT301

VT BIO

Phase I

Alzheimer's disease

Cell replacements

Parenteral

CK0804

Cellenkos

Preclinical

Myelofibrosis

T lymphocyte replacements

Intravenous

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, Parenteral

  • Therapeutics Assessment By Molecule Type:  CAR-T cell therapy, T lymphocyte cell therapy, Regulatory T lymphocyte cell therapy.

  • Therapeutics Assessment By Mechanism of Action: Immunologic cytotoxicity, T lymphocyte replacement, Cell replacement, Regulatory T-lymphocyte replacements.

  • Key Treg Cell-based Therapies Companies: Orca Bio, Caladrius Biosciences, Sangamo Therapeutics, Cellenkos, VT BIO, Rapa Therapeutics, Quell Therapeutics, Coya Therapeutics, Sonoma Biotherapeutics, GentiBio, AstraZeneca, TCR² Therapeutics, KSQ Therapeutics, Kyverna Therapeutics, Astellas, Abata Therapeutics, TRACT Therapeutics, Adaptive Biotechnologies, PolTREG, TeraImmune, and others

  • Key Treg Cell-based Therapies in Pipeline:  Orca-T, CLBS03, TX200, CK0804, VT301, RAPA 501, QEL-001, CK 0804, COYA 101, SBT-77-7200 series, SBT-77-7101, TRuC Tregs, Treg Program, KYV-101,TRK 001, TCR-Treg,  TI-168, TI-235, TI-495, 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)

7.1

Orca-T: Orca Bio

8.

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

8.1

CLBS03: Caladrius Biosciences

9

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

9.1

VT301: VT BIO

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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