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2016-05-11

Medigene AG: Clinical data of Medigene's dendritic cell (DC) vaccines in AML presented at CIMT conference

Medigene AG / Clinical data of Medigene's dendritic cell (DC) vaccines in AML
presented atCIMT conference . Processed and transmitted by NASDAQ OMX
Corporate Solutions.The issuer is solely responsible for the content of this
announcement.
Martinsried/Munich, 11 May 2016.
Medigene AG(MDG1, Frankfurt, Prime Standard), a clinical stage immune-oncology
company focusing on the development of T cell immunotherapies for the
treatment of cancer, informs that the academic group of Prof. Gunnar Kvalheim
at the Department of Cellular Therapy at the Oslo University Hospital,
Norway, has presented clinical data on Compassionate Use[1]patients receiving
dendritic cell (DC) vaccines for the treatment of acute myeloid leukaemia
(AML) utilizing Medigene's DC vaccine technology at the 14thCancer
Immunotherapy Conference (CIMT) in Mainz, Germany. CIMT is Europe's largest
meeting focused on cancer immunotherapy research and development.

The poster presentation of the Oslo University Hospital showed preliminary
data from five AML patients receiving DC vaccines targeting the antigens
Wilm's tumor-1 (WT-1) and preferentially expressed antigen in melanoma
(PRAME) employing Medigene's new generation monocyte-derived fast dendritic
cells. The poster is entitled "WT-1 and PRAME mRNA transfected TLR 7/8
polarized fast DCs vaccines in AML patients raise specific immune responses
that correlate with clinical outcome".

AML is frequently diagnosed in elderly patients, who normally cannot tolerate
intensive chemotherapy and/or stem cell transplantation, making curative
treatment difficult and rates of early relapse high.

Results reported here are from five patients, where DC vaccination was started
after hematopoietic recovery from first line chemotherapy treatment.

Data from the first four patients has already been reported at the 57th Annual
Meeting of the American Society of Hematology (ASH) in December 2015. Those
four patients have now been treated between 16 and 26 months.

Prof. Gunnar Kvalheim,
Head of Department of Cellular Therapy, Oslo University Hospital
, explains: "Altogether, these results show that fast TLR- polarized DCs can
induce or enhance specific T cell responses with a patient individual
pattern. Clinical responses are related to immune responses and can result in
prolonged survival in AML patients not eligible for curative treatment."

Prof. Dolores J. Schendel, CEO and CSO of Medigene AG
, adds: "These positive results encourage us in pursuing our proprietary DC
vaccine development program for which we are currently conducting our own
Phase I/II clinical AML trial, expanding the ongoing academic clinical
studies."

The Oslo University Hospital has an agreement with Medigene for the use of
Medigene`s new generation DC vaccines for their ongoing academic clinical
studies. Medigene's DC vaccines are produced according to GMP guidelines at
the Department of Cellular Therapy at the Oslo University Hospital. Acute
myeloid leukaemia is Medigene's lead indication in its DC vaccine program.

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 utilizing 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 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 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 tumor-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:
https://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 visitwww.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

In case you no longer wish to receive any information about Medigene, please
inform us by e-mail (investor@medigene.com). We will then delete your address
from our distribution list.
---------------------------------------[1]Compassionate Use: Prescription of as-yet unapproved drugs in particularly
severe cases where there are no treatment alternatives

Press release English PDF
http://hugin.info/132073/R/2011139/744470.pdf

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medigene AG via Globenewswire

HUG#2011139

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