EASYGEN

Easy workflow integration for gene therapy

Summary

CAR-T therapy is a cutting-edge cancer treatment that involves transforming a patient’s immune cells into weapons capable of identifying and destroying cancer cells. Although it is highly effective, it involves a complex and lengthy manufacture process which can only be carried out at a limited number of sites. This, coupled with the high price of treatment (including long hospital stays during the manufacture process), means that many patients do not have access to CAR-T therapy.

CAR-T (chimeric antigen receptor T) therapies are manufactured individually for each patient. The first step entails collecting white blood cells from the patient. These are then sent off to an accredited centre where the cells are modified to allow them to target specific proteins found only on the surface of the cancer cells. The modified cells are then tested and expanded before being returned to the hospital, where they are administered to the patient via infusion. The manufacture process typically takes four to six weeks, and during this time, patients require significant levels of monitoring, bridging therapy and care as their condition is at risk of deteriorating further. Furthermore, the delay between cell collection and administration means some patients may not be prescribed CAR-T therapy at all.

On the hospital staff side, every step in the process requires a lot of training and represents a huge workload, from collecting the white blood cells and preparing and sending them for manufacture, to caring for patients during manufacture and then handling and administering the CAR-T cells once they are ready.

EASYGEN aims to revolutionise CAR-T cell manufacture by developing an automated, modular, point-of-care cell and gene therapy manufacturing platform that would allow hospitals to generate CAR-T cells on site. The device would automate all manual steps between blood cell collection and administration of the modified cells, dramatically cutting the manufacture time to 24 hours. For hospital staff, this would dramatically reduce the workload associated with CAR-T cell therapy. On the cost front, EASYGEN expects its device to cut the cost of treatment in half.

The EASYGEN device would allow any hospital that can carry out blood cell collection to manufacture CAR-T cells, making these promising treatments accessible to a much larger number of patients. Patients would also benefit immensely from the shorter manufacture time.

Meanwhile the modular nature of the device could allow it to be adapted to manufacture other types of cell therapy. This is significant as today, CAR-T cells are only used for blood cancers; EASYGEN aims to advance the development of next-generation CAR-T cells capable of targeting solid tumours such as prostate cancer.

EASYGEN will collaborate with a wide range of stakeholders to ensure regulatory compliance and, importantly, to manage the seamless integration of its device into hospital workflows.

Participants

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Universities, research organisations, public bodies, non-profit groups
  • Bar Ilan University, Ramat Gan, Israel
  • Danmarks Tekniske Universitet, Kongens Lyngby, Denmark
  • European Society For Blood And Marrow Transplantation, Leiden, Netherlands
  • Frankfurt School Of Finance & Management Gemeinnutzige GMBH, Frankfurt Am Main, Germany
  • Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., Munchen, Germany
  • Universidad De Navarra, Pamplona, Spain
  • University Of Glasgow, Glasgow, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • PRO-LIANCE GLOBAL SOLUTIONS GmbH, Munster, Germany
Private companies
  • Tq Therapeutics GMBH, Munchen, Germany
IHI industry partners
  • Charles River Discovery Research Services Germany GMBH, Freiburg, Germany
  • Fenwal Inc, Lake Zurich, United States
  • Fresenius Se & Co Kgaa, Bad Homburg, Germany
  • Helios Klinikum Berlin-Buch GmbH, Berlin, Germany
  • Idcq Hospitales Y Sanidad SL, Madrid, Spain
  • Philips Electronics Nederland BV, Eindhoven, Netherlands
Contributing partners
  • Cellix Limited, Dublin, Ireland

Participants
NameEU funding in €
Bar Ilan University509 851
Cellix Limited675 928
Charles River Discovery Research Services Germany GMBH482 750
Danmarks Tekniske Universitet692 746
European Society For Blood And Marrow Transplantation380 784
Frankfurt School Of Finance & Management Gemeinnutzige GMBH150 875
Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.1 509 329
Fresenius Se & Co Kgaa1 292 465
Helios Klinikum Berlin-Buch GmbH300 000
Philips Electronics Nederland BV442 344
PRO-LIANCE GLOBAL SOLUTIONS GmbH360 000
Tq Therapeutics GMBH445 875
Universidad De Navarra352 750
University Of Glasgow399 999
Total Cost7 995 696