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Medigene AG: Data and Safety Monitoring Board recommends advance of current DC vaccine clinical trial in AML into Phase II

  • Patient recruitment for clinical Phase I in Phase I/II DC vaccine study successfully completed
  • All patients treated with DC vaccine at least four times
  • Data and Safety Monitoring Board positively evaluates data on safety and tolerability and gives green light for transition of study into Phase II
  • Phase II in preparation

Martinsried/Munich, 10 March 2016. Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T-cell immunotherapies for the treatment of cancer, announces the successful recruitment of the planned patients for Phase I of its current clinical trial of dendritic cell (DC) vaccines in acute myeloid leukaemia (AML). The independent Data and Safety Monitoring Board (DSMB) recommended advancing the study to Phase II. The DSMB came to a positive evaluation of the obtained safety and tolerability data, after the first six patients were treated with the DC vaccine at least four times.

In the Phase II part of the study, the treatment of the first six patients will continue, and an additional 14 new patients will be recruited. In Phase II, more data will be collected as to the safety profile of the DC vaccines, the induction of tumour-specific immune responses by the vaccine, as well as first signs of efficacy. Medigene's first company-sponsored DC vaccine trial started at the Oslo University Hospital in March 2015.

Prof. Dolores Schendel, CEO and CSO of Medigene, explains: "We are very pleased that the first part of our study proceeds as scheduled, and we are already preparing the start of Phase II to generate further clinical data on our patients' response to the treatment. We hope that AML can be better controlled or even eliminated through immune responses induced by our DC vaccines."

Study design: Medigene's Phase I/II trial (NCT02405338) will include 20 AML patients who show complete remission after standard chemotherapy but are not eligible for stem cell transplantation that would reduce the risk of a relapse. Patients will be vaccinated with Medigene's DC vaccines for 50 weeks with a follow-up period of one year or until progression of the disease. The primary objective is to prove feasibility and safety of active immunotherapy with Medigene's dendritic cells. Secondary objectives of the study are induction of tumour-specific immune response, control of minimal residual disease (MRD), and clinical response/time to progression (TTP).

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). Further studies utilising Medigene's DC vaccine technology include two ongoing clinical investigator-initiated trials (IITs), i.e. a clinical Phase I/II trial for the treatment of acute myeloid leukaemia (AML) at Ludwig Maximilians University Hospital Grosshadern, Munich, and a clinical Phase II trial for prostate cancer treatment at Oslo University Hospital. Moreover, compassionate use[1] 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 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 tumour-specific antigens to treat different types of cancer. Medigene's DC vaccines are in development for the treatment of minimal residual disease or for the use in combination therapies.

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

About acute myeloid leukaemia (AML)
Acute myeloid leukaemia is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age. In Germany, about 3,600 incidences are registered annually.
AML is caused by uncontrolled growth of dysfunctional hematopoietic precursor cells in the bone marrow. These cells prevent the generation of normal blood cells, causing a drop in erythrocytes and platelets, for example. Typical symptoms of AML include anaemia, fever, increased risk of infection, and blood coagulation disorder. AML progresses rapidly and may be fatal within a few weeks if untreated.
AML is treated initially with intensive chemotherapy. Another treatment option is allogeneic hematopoietic stem cell transplantation. Unfortunately the majority of patients suffer a relapse. Only about 15 - 20 % of the patients show long-term remission after conventional chemotherapy. Allogeneic hematopoietic stem cell transplantation is the only treatment option that offers a more positive prognosis.

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.

Contact Medigene
Julia Hofmann, Dr. Robert Mayer
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