RESHAPE | Reshaping undesired Inflammation in challenged Tissue Homeostasis by Next-Generation regulatory T cell (Treg) Approaches – from Advanced Technology Developments to First-in-Human Trials

Summary
Adoptive transfer of regulatory T cells (Treg) is a promising new therapeutic option to reshape undesired intra-tissue immune imbalance in immune-related disease entities. It supports long-term function of allografts and use of Advanced Therapy Medicinal Products (ATMP) by overcoming the challenge of unwanted immune reaction by the recipient of the ATMP. Therefore, adoptive Treg therapy is a potential game changer in health care, particularly in immune diseases, organ & hematopoietic stem cell (HSC) transplantation, and regenerative medicine, including gene therapy.
Based on the Triple-T concept - Transdisciplinarity, Technology, Translation - the major goal of RESHAPE is to transform the treatment of patients suffering from undesired immunity/inflammation, who presently have limited curative treatment options, by applying novel Treg approaches that overcome the limitations of 1st generation Treg product developments.
Members of the consortium, with academic & biotech backgrounds, are pioneers in the development of Treg therapy from basic science to very recent encouraging First-In-Human (FIH) clinical trials of the 1st generation Treg products. They have a longtrack record of collaboration, including in EC-funded projects. The first clinical trials were performed to combat organ transplant rejection and Graft-versus-Host-Disease. However, promising preclinical studies offer a broad application field of Treg therapy beyond allotransplantation.
Based on our preclinical & clinical data, we have identified several opportunities for improving Treg therapy, such as enhanced antigen specificity & functional stability, and recipient conditioning, that will be addressed by RESHAPE. The next-generation Treg products, developed by advanced technologies including CRISPR/Cas9, will be tested on platforms applying new methods for cell characteristics in both in vivo /in vitro models, and finally proven in FIH-clinical trials accompanied by biomarker and health economic studies
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/825392
Start date: 01-01-2019
End date: 31-12-2024
Total budget - Public funding: 13 137 396,00 Euro - 13 137 396,00 Euro
Cordis data

Original description

Adoptive transfer of regulatory T cells (Treg) is a promising new therapeutic option to reshape undesired intra-tissue immune imbalance in immune-related disease entities. It supports long-term function of allografts and use of Advanced Therapy Medicinal Products (ATMP) by overcoming the challenge of unwanted immune reaction by the recipient of the ATMP. Therefore, adoptive Treg therapy is a potential game changer in health care, particularly in immune diseases, organ & hematopoietic stem cell (HSC) transplantation, and regenerative medicine, including gene therapy.
Based on the Triple-T concept - Transdisciplinarity, Technology, Translation - the major goal of RESHAPE is to transform the treatment of patients suffering from undesired immunity/inflammation, who presently have limited curative treatment options, by applying novel Treg approaches that overcome the limitations of 1st generation Treg product developments.
Members of the consortium, with academic & biotech backgrounds, are pioneers in the development of Treg therapy from basic science to very recent encouraging First-In-Human (FIH) clinical trials of the 1st generation Treg products. They have a longtrack record of collaboration, including in EC-funded projects. The first clinical trials were performed to combat organ transplant rejection and Graft-versus-Host-Disease. However, promising preclinical studies offer a broad application field of Treg therapy beyond allotransplantation.
Based on our preclinical & clinical data, we have identified several opportunities for improving Treg therapy, such as enhanced antigen specificity & functional stability, and recipient conditioning, that will be addressed by RESHAPE. The next-generation Treg products, developed by advanced technologies including CRISPR/Cas9, will be tested on platforms applying new methods for cell characteristics in both in vivo /in vitro models, and finally proven in FIH-clinical trials accompanied by biomarker and health economic studies

Status

SIGNED

Call topic

SC1-BHC-09-2018

Update Date

26-10-2022
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Horizon 2020
H2020-EU.3. SOCIETAL CHALLENGES
H2020-EU.3.1. SOCIETAL CHALLENGES - Health, demographic change and well-being
H2020-EU.3.1.3. Treating and managing disease
H2020-EU.3.1.3.0. Cross-cutting call topics
H2020-SC1-2018-Single-Stage-RTD
SC1-BHC-09-2018 Innovation platforms for advanced therapies of the future