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Gene-edited T cells combating IgA Nephropathy. A blueprint approach for safe & efficient genome editing of T cells to sustainably combat several immune diseases and cancers related to B-cell pathology

Objective

"There is an increasing prevalence of chronic diseases caused by undesired immune reactions (>10%) with high burden for the both patients (chronicity, organ failure, early death, decreased QoL) and society (EU:>100 bn €/a direct health costs) as current therapies are limited in efficacy and do not reshape sustainably the disturbed immune balance.
Our ultimative goal is to develop a safe and efficient cell therapy based on genome-edited T cells with redirected specificity to sustainably combat IgA nephropathy (IgAN) - the most common glomerulonephritis and one of the most common causes of end-stage renal disease with unmet medical need. Our specific cell therapy approach is also suitable for other diseases with selective B-cell pathogenesis, such as IgA myeloma, IgA related celiac disease and rheumatoid arthritis, but as a blueprint also for diseases of other Ig classes (e.g. IgG4).
Our novel concept offers a specific form of immunosuppression via Ig-(sub)class targeting & glycosylation targeting with redirected T cells in autoimmune diseases. Methodically, we benchmark three promising genome editing technologies, develop new standards for safety assessment and preclinical performance evaluation.
At the end we will have a lead candidate of a new ""living drug"" product envisioned as a one-time treatment for IgAN and other IgA-associated that will be ready to enter clinical FIH trials (entry into TRL6). In addition, geneTIGA delivers enabling technology toolboxes with exploitation options beyond of the core project. They might de-risk and accelerate the development of next-generation gene and cell products in general. The project has thus, besides its scientific value, a high impact not only on the affected patients with IgAN and related immune diseases, but also for the European society by reducing the health economic burden caused by progressive chronic kidney disease, as well as by triggering innovation and business options in Europe's biotech and pharma field."

Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Net EU contribution
€ 1 696 250,00
Address
Chariteplatz 1
10117 Berlin
Germany

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Region
Berlin Berlin Berlin
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (8)

UNIVERSITAETSKLINIKUM FREIBURG
Germany
Net EU contribution
€ 1 000 312,00
Address
Hugstetter Strasse 49
79106 Freiburg

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Region
Baden-Württemberg Freiburg Freiburg im Breisgau, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
TECHNISCHE UNIVERSITAET BRAUNSCHWEIG
Germany
Net EU contribution
€ 294 800,00
Address
Universitaetsplatz 2
38106 Braunschweig

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Region
Niedersachsen Braunschweig Braunschweig, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
OSLO UNIVERSITETSSYKEHUS HF
Norway
Net EU contribution
€ 548 125,00
Address
Kirkeveien 166 Tarnbygget
0450 Oslo

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Region
Norge Oslo og Viken Oslo
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
AARHUS UNIVERSITET
Denmark
Net EU contribution
€ 187 500,00
Address
Nordre Ringgade 1
8000 Aarhus C

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Region
Danmark Midtjylland Østjylland
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
TISSUSE GMBH
Germany
Net EU contribution
€ 872 500,00
Address
Oudenarder Strasse 16
13347 Berlin

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
CHECKIMMUNE GMBH
Germany
Net EU contribution
€ 498 833,00
Address
Campus Virchow Klinikum, Cranach Haus Augustenburg Platz 1
13353 Berlin

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Europaischer Nierenpatientenverband
Austria
Net EU contribution
€ 39 908,00
Non-EU contribution
€ 0,75
INNOVATION ACTA S.R.L.
Italy
Net EU contribution
€ 598 631,00
Address
Via D.a. Azuni, 9
00196 Roma

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Centro (IT) Lazio Roma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00