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

Periodic Reporting for period 2 - AML-VACCiN (Clinical development of a dendritic-cell vaccine therapy for acute myeloid leukaemia)

Reporting period: 2017-07-01 to 2018-12-31

AML-VACCiN is an international consortium that aims at developing a novel treatment strategy for the rare disease acute myeoloid leukaemia (AML). The main objective of AML-VACCiN is to test the potential of a novel vaccine treatment to prevent relapse in post-remission AML patients, by eradicating minimal residual disease (MRD). The objectives of the project are: 1) Determine the clinical response to vaccination with DCP-001, a multi-antigen dendritic cell vaccine (DCP-001) in postremission AML patients with MRD, via a Phase IIb study; 2) Identify and validate (immunological) biomarkers to predict a patient's response to vaccination with DCP-001; and 3) Gain further insights into the mode of action of DCP-001, and identify potential synergy of DCP-001 vaccination and other treatment modalities.
In the first 18 months of AML-VACCiN, multiple crucial preparatory steps have been taken, in particular in clinical dossier building, vaccine preparation, development of biomarkers assays, and development of an animal model which allows further mode of action studies. Partner Immatics finalized all assay development (see WP2) needed to be able to perform the immune-monitoring of the patients in the clinical trial. Partners DCPrime and VUmc finalized the clinical dossier (WP1). With joining partner Accelovance, all the CRO related activities are being set up (see WP1), and partner University of Bergen, Dr Emmet McCormack (see WP3), has succeeded in establishing conditions for the most appropriate humanized mouse model with which to perform the intended translational work on DCP-001 vaccination plus established the imaging tools which allow visualization of the impact of vaccination on tumor growth.
AML is an orphan disease in which there is a high unmet medical need for novel treatments. Chemotherapy is effective in helping many people with AML, but it seldomly completely cures the disease. Although the outlook for AML patients has improved considerably in the past 30 years, much of this progress is attributable to refinement of supportive treatments, rather than to the introduction of new drugs or other treatment modalities. Cancer immunotherapy can add substantial value for treatment of AML: it is a non-toxic treatment which does not attack the leukaemia directly, but first triggers the immune system, which then attacks the leukaemia. In addition, it specifically targets leukaemia cells and therefore leaves healthy cells unaffected. Finally, the immunological biomarker programme developed here will enable more effective treatment monitoring in future clinical studies. This will help to identify the characteristics of patients that are most likely to respond to therapeutic vaccination and benefit from these treatments. This will strongly support (cost)-effective implementation of DCP-001 vaccination in post-remission AML and helps to establish reimbursement schemes. This project will position DCP-001 close to market introduction in the EU, either upon conditional approval by the EMA or after a final Phase III clinical study in collaboration with industry.