Clinical data for DC vaccine in prostate cancer IIT study presented by Oslo University

Planegg – Medigene AG (FSE: MDG1, Prime Standard, TecDAX) announced that researchers from Oslo University Hospital in Norway presented an update on data of a first in man Phase I/II investigator initiated trial (“IIT”). The data showed that adjuvant dendritic cell vaccines in high-risk prostate cancer patients following radical surgery can reduce the incidence of biochemical relapse. The poster was presented at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, USA. The clinical data was collected at the Department of Cellular Therapy at the Oslo University Hospital, Norway, under the responsibility of Prof. Gunnar Kvalheim, partially utilizing Medigene’s DC vaccine technology.

Twenty patients were included in the trial. Fifteen patients received DCs generated according to a standard protocol. Five patients were treated with DCs generated with Medigene’s proprietary maturation cocktail. All patients, except two, have completed vaccination.

Of the 15 first patients receiving the standard DCs, three patients developed PSA relapse (biochemical relapse) during the vaccination period and two patients relapsed after completing 3 years of vaccination. Of the 5 patients treated with the new type of DCs, none have experienced a PSA relapse.

Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer of Medigene, commented: “The clinical results from Prof. Kvalheim’s research team show that DC vaccination in prostate cancer patients, in order to prevent biochemical relapse, is safe and feasible in this early clinical trial. The subset data from the DC vaccines produced utilizing Medigene’s DC vaccine technology are encouraging for this patient population with limited curative options.”

To view the abstract of the poster entitled “A first in man phase I/II adjuvant dendritic cell vaccine trial in high-risk prostate cancer patients following radical surgery reduce the incidence of biochemical relapse” please visit:

The Oslo University Hospital has an agreement with Medigene for use of Medigene ` s new generation DC vaccines for their ongoing academic clinical studies.

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced of Medigene’s highly innovative and complementary immunotherapy platforms. Currently Medigene evaluates its DC vaccines in a company-sponsored Phase I/II clinical trial in acute myeloid leukaemia (AML).

Dendritic cells (DCs) are the most potent antigen-presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognize and eliminate antigen-bearing tumor cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumor cells. The team of Medigene Immunotherapies scientists has developed new, fast and effective methods for generating dendritic cells ex-vivo, which are able to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-derived) precursor cells, isolated from the patient’s blood, and can be loaded with tumor-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or for use in combination therapies.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies with a focus on TCR-modified T cells, with associated projects in clinical development.

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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® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

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