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Clinical development of a dendritic-cell vaccine therapy for acute myeloid leukaemia

Objective

Eradicating minimal residual disease (MRD) in patients with acute myeloid leukaemia (AML) is an area of high unmet medical need. AML is a deadly rare disease that affects both children and adults. Approximately 45% of younger AML patients who are treated will be cured, and in older patients (>60 years of age), 85% will relapse and die within 2 years.

Immunotherapy has great potential for treating MRD and dendritic cell (DC) therapy is at the forefront of immunotherapy. The AML-VACCiN consortium takes this to the next level through clinical development of a highly-innovative DC vaccine - DCP-001 - that can be produced off-the-shelf and has a powerful preclinical and clinical profile. The aim is to vaccinate AML patients that have been brought into remission through standard induction or consolidation therapy, and to eradicate MRD and effectively reduce the risk of relapse.

In a clinical Phase I/IIa study, the DCP-001 vaccine has already shown to be safe, non-toxic and capable of inducing an AML-targeted immune response. DCP-001 is designated as an orphan medicinal product in the EU.

The AML-VACCiN consortium will advance the clinical development of the vaccine from early-stage (current status) towards proof of concept for safety and efficacy in a Phase IIb clinical study (intended outcome of this project). In addition, a biomarker program will be developed that enables more effective treatment monitoring, selective patient enrolment in future studies and ultimately personalised AML treatment. The deliverables resulting from this project can be used to assemble a data package to apply for conditional approval in Europe.

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.
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Coordinator

STICHTING VUMC

Address

De Boelelaan 1117
1081 Hv Amsterdam

Netherlands

Activity type

Research Organisations

EU Contribution

€ 364 640

Participants (13)

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BIONTECH INNOVATIVE MANUFACTURING SERVICES GMBH

Germany

EU Contribution

€ 2 057 500

IMMATICS BIOTECHNOLOGIES GMBH

Germany

EU Contribution

€ 1 300 650

UNIVERSITETET I BERGEN

Norway

EU Contribution

€ 184 989

DCPRIME BV

Netherlands

EU Contribution

€ 495 150

ACADEMISCH ZIEKENHUIS GRONINGEN

Netherlands

EU Contribution

€ 82 320

UNIVERSITATSKLINIKUM BONN

Germany

EU Contribution

€ 82 320

HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL

Norway

EU Contribution

€ 82 320

UNIVERSITAETSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITAET MAINZ

Germany

EU Contribution

€ 82 320

TECHNISCHE UNIVERSITAET DRESDEN

Germany

EU Contribution

€ 82 320

UPPSALA UNIVERSITET

Sweden

EU Contribution

€ 82 320

HELSINGIN YLIOPISTO

Finland

EU Contribution

€ 82 320

STICHTING VU

Netherlands

LINICAL ACCELOVANCE EUROPE BV

Netherlands

EU Contribution

€ 1 022 313

Project information

Grant agreement ID: 667713

Status

Ongoing project

  • Start date

    1 January 2016

  • End date

    31 March 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 8 278 716,25

  • EU contribution

    € 6 001 482

Coordinated by:

STICHTING VUMC

Netherlands