Martinsried/Munich, 16 October 2014. Medigene AG (MDG1, Frankfurt, Prime Standard) announced today 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" [link.springer.com/article/10.1007%2Fs00262-014-1600-5] 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.
About Medigene's DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced platform of the three highly innovative and complementary immunotherapy platforms of Trianta Immunotherapies, which was recently acquired by Medigene AG. Currently the DC vaccines are being evaluated in two ongoing investigator-initiated trials in clinical phases II (prostate cancer) and I/II (AML, acute myeloid leukaemia). Medigene concentrates on the further development of DC vaccines in hematological malignancies and plans to initiate a further clinical study in AML in 2014.
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 T cells to divide and mature. Dendritic cells can also induce natural killer cells to become active and attack tumour cells. Medigene/Trianta has established new, fast and efficient methods for preparation of autologous (patient-specific) mature dendritic cells that have relevant characteristics to activate both T cells and natural killer cells. They are developed to carry multiple tumour antigens to treat various types of cancer, suited for treatment of minimal residual disease or use in combination therapies.
Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. Medigene concentrates on the development of personalized T cell immunotherapies with a focus on haematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, which is distributed by commercial partner companies. Medigene has advanced drug candidates which are licensed to partners and additional candidates in clinical development. The company is developing highly innovative treatment platforms concentrating on cancer and autoimmune diseases. For more information, please visit www.medigene.com.
This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® and Veregen® are registered trademarks of Medigene AG. Polyphenon E® is a trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in select locations only.
Julia Hofmann, Anja Clausnitzer
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