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Clinical Trials

Date: 2014-10-16

Type of information: Publication of results in a medical journal

phase: preclinical

Announcement: publication of results in Cancer Immunology, Immunotherapy

Company: Medigene (Germany)

Product: dendritic cell (DC) vaccine

Action mechanism:

cell therapy/immunotherapy. Medigene's dendritic cell product platform allows the design of new generation dendritic cell vaccines. Dendritic cells can take up antigens efficiently, process them and present them on their surface in a form that can induce antigen-specific T cells to proliferate and mature. This way T cells can recognize and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to become active and attack tumour cells. Scientists of Medigene Immunotherapies have developed new, fast and efficient methods for preparing autologous (patient-specific) mature dendritic cells which have relevant characteristics to activate both T cells and NK cells. The dendritic cells can be loaded with various tumour antigens to treat different types of cancer and are suited for treatment of minimal residual disease or use in combination therapies.

Disease:

acute myeloid leukemia

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

* On October 16, 2014, Medigene announced that a scientific article on its dendritic cell (DC) vaccine approach has been published in the October 2014 volume of \"Cancer Immunology, Immunotherapy\" (DOI 10.1007/s00262-014-1600-5) at the journal\'s invitation. This DC vaccine is currently examined in an investigator-initiated clinical Phase I/II trial in acute myeloid leukemia (AML). The article titled \"New generation dendritic cell vaccine for immunotherapy of acute myeloid leukemia\" outlines the extensive pre-clinical research made during the development of fast and polarized DC vaccines for clinical studies. The clinical protocol combines a fast three-day manufacturing process with Toll-like receptor-signaling-induced cell maturation, yielding DCs with improved immunogenicity and optimized for the use in cell-based immunotherapy. In vitro as well as in vivo studies are discussed, demonstrating the enhanced capacity of these improved DCs for the induction of tumor-specific immune responses. These new generation DCs are loaded with RNA encoding the leukemia-associated antigens WT1 and PRAME in order to stimulate AML-specific T-cell-based immune responses.

The article introduces the investigator-initiated proof-of-concept Phase I/II clinical trial for post-remission AML patients with high risk for disease relapse, currently ongoing at the Ludwig-Maximilians University Hospital Großhadern, Munich, addressing the rational for antigen selection, route of DC vaccination as well as dosing and schedule of application. On the basis of the DC formulation described in this publication, Medigene is currently planning to start a company-sponsored clinical trial in AML by the end of 2014.

 

Is general: Yes