AML-VACCiN is developing a novel treatment strategy for the rare disease Acute Myeoloid Leukaemia (AML).

Aim of the project

AML is a deadly rare disease that affects both children and adults. Approximately 55% of younger AML patients and 85% of older patients ( >60 years of age), will relapse and die within 2 years. This is attributed to subclinical levels of leukaemic cells that remain or become resistent to chemotherapy, which is referred to as Minimal Residual Disease (MRD). Immunotherapy has great potential for treating MRD and dendritic cell (DC) therapy is at the forefront of immunotherapy.

Consortium

AML-VACCiN is the orchestrated action of three innovative companies and internationally renowned top medical scientists representing nine European medical institutes. In line with the IRDiRC objectives, this public-private consortium can bring a powerful AML-vaccine very close to clinical practice.

Aim of the project

The AML-VACCiN consortium takes this to the next level through clinical development of a highly innovative DC vaccine – DCP-001. The aim is to vaccinate post-remission AML patients, eradicate MRD and effectively reduce the risk of relapse. DCP-001 is designated as an orphan medicinal product in the EU and a Phase I/IIa study has been completed with DCP-001. The AML-VACCiN consortium will advance the clinical development of this vaccine further, from early-stage (current status) towards proof of concept for safety and efficacy in a Phase IIb clinical study. In addition, the study will be accompanied by an extensive immune-monitoring program so as to enable evaluation of clinical responses in relation to immunological responses. The deliverables resulting from this project can be used to assemble a data package to apply for conditional approval in Europe.