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MOLOGEN AG: EMA supports development strategy of lefitolimod (MGN1703)

DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: EMA supports development strategy of lefitolimod (MGN1703)

25.02.2016 / 08:22
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PRESS RELEASE N 3 / 2016 of 02/25/2016

MOLOGEN AG: EMA supports development strategy of lefitolimod (MGN1703)

Berlin, 25 February 2016 - The biotech company MOLOGEN AG (ISIN
DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today
that the European Medicines Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP) has confirmed the development strategy of lefitolimod
(MGN1703) with the pivotal IMPALA study by scientific advice. "We are
pleased with EMA's agreement to our development program and we are making
good progress to finalize the recruitment phase of the study by the end of
the year", said Dr. Mariola Söhngen, Chief Executive Officer of MOLOGEN AG.

About IMPALA
IMPALA is a randomized, international, multicenter, open-label phase III
trial. The study aims to prove that a switch maintenance therapy with an
active immunotherapy leads to an increased overall survival of patients who
have achieved a response during their first line treatment of metastatic
colorectal cancer. The primary endpoint is overall survival and secondary
study endpoints include progression-free survival, toxicity and safety, and
Quality of Life (QoL).

Recruitment of the IMPALA study started in September 2014 and is expected
to enroll 540 patients in 8 European countries. Patient recruitment is
expected to be completed by the end of 2016.

Leading medical associations will collaborate: Arbeitsgemeinschaft
Internistische Onkologie (AIO) in Germany, Grupo Españiol de Tratamiento de
Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire
en Oncologie (GERCOR) in France. The steering committee consists of
international medical experts; among others the coordinating study
investigator Prof. David Cunningham, MD, Department of Medicine and
Director of Clinical Research, Royal Marsden Hospital in London.

For more information on the trial IMPALA please visit
www.clinicaltrials.gov.

MOLOGEN AG
With new and unique technologies and active substances, the biotech company
MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a
focus on immuno-oncology, MOLOGEN also develops immunotherapies for the
treatment of infectious diseases.

The cancer immunotherapy lefitolimod (MGN1703) is the company's lead
product and best-in-class TLR9 agonist. Treatment with lefitolimod
(MGN1703) triggers a broad and strong activation of the immune system. Due