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Medigene announces milestone payment in phase I/II trial with dendritic cell (DC) vaccines for AML

Pressemitteilung

Payment of EUR 700,000 to be made through the issuance of new shares

Martinsried/Munich, 11 May 2015. Biotechnology company Medigene AG (MDG1, Frankfurt, Prime Standard) has announced that the progress achieved in its recently initiated clinical phase I/II trial with dendritic cell (DC) vaccines for the treatment of acute myeloid leukaemia (AML) gives rise to a milestone payment amounting to EUR 700,000 to former contributing shareholders of Medigene Immunotherapies GmbH (formerly: Trianta Immunotherapies GmbH) to be made within the next five months. Medigene intends to settle this payment through the issuance of new shares from authorised capital. The number of new shares will be calculated based on the average value of Medigene's share price over the 30 days both before and from today's announcement. The milestone payment was an agreed part of the purchase price in the acquisition of Trianta in January 2014. 

Medigene's phase I/II multi-centre, open-label trial will include a total of 20 AML patients after completion of standard chemotherapy to reduce the risk of recurrence of leukaemia by using Medigene's DC vaccines. To date, the first patients have been enrolled and a number of additional patients have been identified for inclusion in the trial. The primary objective is to prove feasibility and safety of active immunotherapy with Medigene's DCs. Secondary objectives are induction of immune responses, control of minimal residual disease (MRD) and clinical response/time to progression (TTP).

Dr Frank Mathias, Chief Executive Officer (CEO) of Medigene AG, comments: "Reaching this milestone is once again proof of the progress Medigene has made since acquiring Trianta. The start and continuation of the clinical phase I/II trial enables us to further validate our new generation of DC vaccines in the clinic and will therefore contribute to the intrinsic value of this technology and our company."

Further studies utilizing Medigene's DC vaccine technologies include two ongoing clinical investigator-initiated trials (IITs), a clinical phase II trial (prostate cancer) at Oslo University Hospital and a clinical phase I/II trial (AML) at the Ludwig-Maximilians University Hospital Großhadern, Munich, as well as a compassionate use programme[1] including patients with diverse malignancies.

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 Medigene Immunotherapies.

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 designed for treatment of minimal residual disease or use in combination therapies.

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

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 hematological 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 licenced 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® is a registered trademark of Medigene AG. Medigene ImmunotherapiesTM is a registered trademark of Medigene Immunotherapies GmbH. Trianta ImmunotherapiesTM is a registered trademark of Medigene Immunotherapies GmbH. These trademarks may be owned or licensed in select locations only.

Contact Medigene
Julia Hofmann, Anja Clausnitzer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

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