AMBITION

To take tolerogenic dendritic cell-based therapies to the next level

  • By considering recent clinical and functional/transcriptomic data demonstrating that the disease context can by itself affect cell potency.
  • By developing bench to bedside pathway for clinical translation of a 2nd generation VitD3DC product where product optimization, testing, and manufacturing are guided by regulatory and HTA science from the start of the project.

OBJECTIVES

To fast-track cell development of a 2nd generation VitD3DC product for clinical application

  • Apply artificial intelligence to predict and optimize the quality of the 2nd generation VitD3DC product.
  • Define the optimized 2nd generation VitD3DC product.
  • Assessment of advanced VitD3DC-based cell therapy effectiveness based on definition of mode-of-action and to achieve pre-clinical proof of concept.
  • Accomplish robust and optimized GMP manufacturing of our 2nd generation VitD3DC product.
  • Build a clinical roadmap for testing of the 2nd generation VitD3DC for human therapy.
  • Ensure economic viability of the project development within and beyond the grant period.

INNOVATION

IMMUTOL approach for the 2nd generation VitD3DC product vs current approach for ATMP development

WORKPLAN

Aimed to provide Europe with advanced protocols for the 2nd generation VitD3DC product for cell-based approaches to treat MS

Organized in 8 WPs with focus on:

  • Research and Demonstration – WP2, WP3, and WP4
  • GMP compliant manufacturing procedures of the 2nd generation VitD3DC product – WP5
  • Regulatory affairs – WP6
  • HTA that will guide all the research and development activities – WP7
  • Communication, Dissemination and Exploitation – WP8
  • Management and coordination – WP1

EXPECTED IMPACT

  • Scientific – breakthrough scientific discovery on cell tolerogenic therapies for MS and other diseases.
  • Economic – decreased average annual healthcare cost per patient by developing a better treatment to delay MS patients’ disability.
  • Social – improving the quality of life of MS patients, their families and caregivers by lowering the disability-adjusted life year (DALY), decreasing morbidity and reducing the need for life-long therapy.