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Clinical data from IIT using Medigene's dendritic cell (DC) vaccines in prostate cancer presented at AACR conference

Martinsried/Munich, 19 April 2016. Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immune-oncology company focusing on the development of T cell immuno-therapies for the treatment of cancer, announces that clinical data of a dendritic cell (DC) vaccine trial for the treatment of prostate cancer were presented at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA, USA.

The clinical data were collected, utilising Medigene's DC vaccine technology in part, in an ongoing clinical phase I/II study on dendritic cell (DC) vaccines for the treatment of prostate cancer at the Department of Cellular Therapy at the Oslo University Hospital, Norway, under the responsibility of Prof. Gunnar Kvalheim. The poster presented was entitled "Clinical results of a Phase I/II trial of adjuvant therapeutic vaccination in high risk resected prostate cancer patients using autologous dendritic cells loaded with mRNA from primary prostate cancer tissue, hTERT and survivin".

More than 50% of high risk prostate cancer patients will develop an early biochemical relapse, with no curative therapy presently available. Therefore, Prof. Gunnar Kvalheim and his team have chosen this patient population for their ongoing Phase I/II dendritic cell (DC) vaccine study. Dendritic cells from each of the 20 enrolled patients were differentiated from enriched monocytes and matured with one of two different maturation cocktails. The DCs were then transfected with mRNA from primary prostate cancer tissue, hTERT and Survivin and then frozen and stored until use. Based on encouraging clinical results with a new type of DCs in patients with different types of tumours treated in a compassionate use[1] programme, the DC vaccine protocol was changed to the use of new generation DCs. The last five of 20 treated patients received DCs that were matured with a new TLR7/8-agonist maturation cocktail developed by Medigene. Three of 15 patients given DC vaccines derived with the old (standard) maturation cocktail have experienced a biochemical relapse (raised levels of prostate-specific antigen, PSA) during the vaccination period of 3 years. None of the patients given the new type of DC vaccines has so far experienced a rise in PSA levels.

Prof. Gunnar Kvalheim, Head of Department of Cellular Therapy, Oslo University Hospital concluded on the results: "To our knowledge this is the first adjuvant DC vaccine study in high risk prostate cancer and we conclude that the study is feasible, safe and utmost promising."

Prof. Dolores J. Schendel, CEO/CSO of Medigene AG added: "We feel very encouraged by these preliminary data. The advanced method of making DC vaccines is identical with the method Medigene is also using in its own ongoing DC vaccine study in acute myeloid leukaemia."

More detailed information on the presented data can be found under the following link: www.abstractsonline.com/Plan/ViewAbstract.aspx

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 platform of the highly innovative and complementary immunotherapy platforms of Medigene Immunotherapies. Currently, Medigene evaluates its DC vaccines in a company-sponsored phase I/II clinical trial in acute myeloid leukaemia (AML). Further studies utilising Medigene's DC vaccine technology include two ongoing clinical investigator-initiated trials (IITs): a clinical phase I/II trial for treating acute myeloid leukaemia (AML) at Ludwig Maximilians University Hospital Grosshadern, Munich, and a clinical phase II trial of a treatment for prostate cancer at Oslo University Hospital. Moreover, compassionate use patients are treated with DC vaccines at the Department of Cellular Therapy at Oslo University Hospital.

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 recognise and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumour cells. The team of Medigene Immunotherapies GmbH's scientists has developed new, fast and efficient methods for generating dendritic cells ex-vivo, which have relevant characteristics 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 tumour-specific antigens to treat different types of cancer. Medigene's DC vaccines are in development for the treatment of minimal residual disease or use in combination therapies.

Further audio-visual education about Medigene's DC-Vaccines at:
vimeo.com/123005832

Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative, complementary treatment platforms to target various types and stages of cancer with candidates in clinical and pre-clinical development. Medigene concentrates on the development of personalized T cell-based immunotherapies.

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

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[1] Compassionate Use: Prescription of as-yet unapproved drugs in particularly severe cases where there are no treatment alternatives