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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.

Call for proposal

H2020-PHC-2015-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

STICHTING VUMC
Address
De Boelelaan 1117
1081 HV Amsterdam
Netherlands
Activity type
Research Organisations
EU contribution
€ 364 640

Participants (14)

BIONTECH INNOVATIVE MANUFACTURING SERVICES GMBH

Participation ended

Germany
EU contribution
€ 550 111,10
Address
Vollmersbachstrasse 66
55743 Idar Oberstein
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
IMMATICS BIOTECHNOLOGIES GMBH
Germany
EU contribution
€ 1 300 650
Address
Paul Ehrlich Str 15
72076 Tuebingen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITETET I BERGEN
Norway
EU contribution
€ 184 989
Address
Museplassen 1
5020 Bergen
Activity type
Higher or Secondary Education Establishments
DCPRIME BV
Netherlands
EU contribution
€ 2 002 538,90
Address
Galileiweg 8
2333 BD Leiden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 82 320
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
UNIVERSITATSKLINIKUM BONN
Germany
EU contribution
€ 82 320
Address
Venusberg-campus 1
53127 Bonn
Activity type
Higher or Secondary Education Establishments
HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL
Norway
EU contribution
€ 82 320
Address
Jonas Lies Vei 65
5021 Bergen
Activity type
Higher or Secondary Education Establishments
UNIVERSITAETSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITAET MAINZ
Germany
EU contribution
€ 82 320
Address
Langenbeckstrasse 1
55131 Mainz
Activity type
Higher or Secondary Education Establishments
TECHNISCHE UNIVERSITAET DRESDEN

Participation ended

Germany
EU contribution
€ 0
Address
Helmholtzstrasse 10
01069 Dresden
Activity type
Higher or Secondary Education Establishments
UPPSALA UNIVERSITET
Sweden
EU contribution
€ 82 320
Address
Von Kraemers Alle 4
751 05 Uppsala
Activity type
Higher or Secondary Education Establishments
HELSINGIN YLIOPISTO
Finland
EU contribution
€ 82 320
Address
Yliopistonkatu 3
00014 Helsingin Yliopisto
Activity type
Higher or Secondary Education Establishments
STICHTING VU

Participation ended

Netherlands
EU contribution
€ 0
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments
LINICAL NETHERLANDS B.V.
Netherlands
EU contribution
€ 1 022 313
Address
Victorialaan 15
5213 JG 'S-hertogenbosch
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITAET LEIPZIG
Germany
EU contribution
€ 82 320
Address
Ritterstrasse 26
04109 Leipzig
Activity type
Higher or Secondary Education Establishments