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ADVANCED ANTIGEN-SPECIFIC DENDRITIC CELL-BASED THERAPY TO RE-ESTABLISH TOLERANCE IN IMMUNE-MEDIATED DISEASES

Project description

Vitamin D3-modified tolerogenic dendritic cell-based immunotherapy for MS

Autoimmune diseases often require lifelong immunosuppressive treatment but lack effective therapies. Tolerogenic dendritic cell (DC) therapies, particularly those modified with vitamin D3, have been shown to improve treatment outcomes in Multiple Sclerosis (MS) patients. The EU-funded IMMUTOL project will accelerate the development of an advanced therapeutic medicinal product (ATMP) using vitamin D3-modified tolerogenic DCs for immunotherapy. This initiative will develop a more effective treatment for MS and other autoimmune inflammatory diseases while gathering insights into tolerance mechanisms and patient-specific manufacturing needs. The findings will help establish a clinical protocol that meets regulatory standards for the use of engineered vitamin D3 DCs in MS patients.

Objective

Autoimmune diseases are currently treated with immunosuppressive and supportive therapies, which dampen inflammation, but do not stop the cause of the disease and are required life-long. Thus, there is an unmet need for safe and effective therapies for these diseases, which are well-tolerated and targeting the cause of disease. Tolerogenic dendritic (DC) cell-based therapies, offer the possibility of restoring immune regulation leading to long-lasting effects. Vitamin (Vit)D3-modified tolerogenic DC have been recently applied to Multiple Sclerosis (MS) patients in Phase I trials, demonstrating safety, tolerability, feasibility, and preliminary evidence of an effect. Molecular characterization of VitD3DC from MS patients suggests that they own less tolerogenic properties than those from healthy individuals. Thus, correcting these deficiencies through gene transfer could improve their effectiveness. The aim of IMMUTOL is the fast-track development and validation of an advanced therapeutic medicinal product (ATMP) based on VitD3-modified tolerogenic DC for immunotherapy approaches. Through a multidisciplinary approach, IMMUTOL will leverage the power of tolerogenic VitD3DC-based immunotherapy to develop a more potent and durable treatment for MS and, in turn other autoimmune inflammatory diseases with an unmet medical need. In parallel, it will bring information about tolerance mechanisms and patient-specific requirements for manufacturing effective tolDC products. Results will lead to design of a clinical protocol according to the regulatory requirements for the first-in-man application of engineered tolerogenic VitD3DC in MS patients.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

(opens in new window) HORIZON-HLTH-2022-DISEASE-06-two-stage

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Coordinator

FONDAZIONE TELETHON ETS
Net EU contribution
€ 737 541,25
Address
VIA VARESE 16/B
00185 ROMA
Italy
Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Links
Total cost
€ 1 336 720,00

Participants (10)