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

Project description

Advancing regulatory T-cell therapies

Immune-related diseases, such as autoimmunity and chronic inflammation, pose a significant socioeconomic burden. Treatment of these diseases usually involves immunosuppressive drugs, while regulatory T cells have also been proposed as a promising therapy. The EU-funded RESHAPE project aims to exploit the central role that regulatory T cells play in immune system homeostasis by suppressing excessive immune responses and maintaining peripheral tolerance. The key objective is to develop advanced regulatory T cell-based therapies and demonstrate their efficacy in restoring immunological balance following clinical adoptive transfer in patients with immunological disorders.

Objective

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

Call for proposal

H2020-SC1-BHC-2018-2020

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Sub call

H2020-SC1-2018-Single-Stage-RTD

Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Net EU contribution
€ 4 238 425,00
Address
Chariteplatz 1
10117 Berlin
Germany

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Region
Berlin Berlin Berlin
Activity type
Higher or Secondary Education Establishments
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Total cost
€ 4 238 425,00

Participants (10)