Martinsried/Munich, 24 March 2015. Biotechnology company Medigene AG (MDG1, Frankfurt, Prime Standard) announces that the company's phase I/II clinical trial with its dendritic cell (DC) vaccine for the treatment of acute myeloid leukaemia (AML) has started. Oslo University Hospital, Norway, the main trial centre, has begun to identify potentially eligible patients for enrollment. The study enables Medigene to evaluate its personalised DC vaccines in its first company-sponsored trial and generate further clinical feasibility and safety data of active immunotherapy, complementing ongoing academic clinical phase I/II and phase II studies.
Study design: Medigene's phase I/II multi-centre, open-label trial will include 20 AML patients after completion of standard chemotherapy to reduce the risk of recurrence of leukaemia by using Medigene's DC vaccines. Patients will be vaccinated for 50 weeks, with a follow-up period of one year or until progression. 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).
Prof. Dolores J. Schendel, Chief Scientific Officer of Medigene AG, comments: "We are proud that the first company-sponsored clinical trial with Medigene's new immunotherapy programs has started. The initiation of this trial is testament to the hard work by Medigene associates with our clinical partners in Oslo over the past years to develop this individualized DC vaccine approach for patients without further treatment options."
Prof. Gunnar Kvalheim, Head of Department of Cellular Therapy, Oslo University Hospital: "Our success in developing a production process for these precision vaccines combined with initial clinical data from our ongoing investigator-initiated clinical trials with Medigene's DC vaccine approach encourage us to further evaluate these promising new generation dendritic cells to efficiently activate T cell responses for the treatment of cancer."
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 (formerly Trianta Immunotherapies): DC vaccines, TCR-based adoptive T cell therapy (TCRs) and T cell-specific monoclonal antibodies (TABs).
The DC vaccines are currently being evaluated in two ongoing clinical investigator-initiated trials: a clinical phase I/II trial in acute myeloid leukaemia (AML) at the Ludwig-Maximilian University Hospital Großhadern, Munich, and a clinical phase II trial in prostate cancer at the Oslo University Hospital. Moreover, a compassionate use programme is being conducted at the Department of Cellular Therapy at the Oslo University Hospital. Medigene concentrates on the further development of DC vaccines in hematological malignancies.
Data on patients with solid tumours who have received DC vaccines based on Medigene's approach will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting taking place from April 18-22 2015 in Philadelphia, USA (see Medigene's press release from 19 March 2015).
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.
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.
Julia Hofmann, Anja Clausnitzer
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 Compassionate Use: Prescription of as-yet unapproved drugs in particularly severe cases where there are no treatment alternatives