DGAP-News: 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
The issuer is solely responsible for the content of this announcement.


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.

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

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
to this mechanism of action, lefitolimod (MGN1703) has the potential to be
applied to various indications. Lefitolimod (MGN1703) is currently being
developed for first-line maintenance treatment of colorectal cancer
(pivotal study) and small cell lung cancer (randomized controlled trial).
Furthermore, it is also being investigated in a phase I study in HIV and a
phase I combination study with the checkpoint inhibitor Yervoy(R)
(ipilimumab) is expected to start within the first half 2016.

MOLOGEN’s pipeline focus is on new innovative immunotherapies to treat
diseases for which there is a high medical need.


Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V.
| DECHEMA – Society for chemical technology and biotechnology e.V. |
German industrial association of biotechnology (DIB) | Association for
the Promotion of Science and Humanities in Germany | Association of
German biotechnology companies (VBU) | Association of researching
manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical
industry e.V. (VCI)

MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of

Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 – 30 – 84 17 88 – 38
Fax: +49 – 30 – 84 17 88 – 50

Note about risk for future predictions
Certain information in this report contains forward-looking statements or
the corresponding statements with negation or versions deviating from this
or comparable terminology. These are described as forward-looking
statements. In addition, all of the information given here that refers to
planned or future results of business areas, key financial figures,
developments of the financial situation or other financial figures or
statistical data, is to be understood as such forward-looking statements.
The company points out to investors that they should not rely on these
forward-looking statements as predictions about actual future events. The
company is not obligated and refuses to accept any liability for the
forward-looking statements and has no obligation to update such statements
in order to accurately reflect the current situation.


25.02.2016 Dissemination of a Corporate News, transmitted by DGAP – a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de


Language: English
Fabeckstraße 30
14195 Berlin
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,

End of News DGAP News Service

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