DGAP-News

MOLOGEN AG: All key milestones achieved in 2015 - Seite 2

patients in collaboration with the Aarhus University Hospital (Denmark) as
part of the phase I/IIa TEACH study since the second quarter of 2015. This
is the first time a MOLOGEN active agent is being clinically tested in an
indication other than cancer. Initial results showed that lefitolimod
(MGN1703) triggers a widespread activation of treated patients' immune
systems. Accordingly, the study protocol for the TEACH study was amended
and now additional patients will be treated for a longer period of six
months with lefitolimod. Recruitment of these patients will start in the
next few weeks.

The enrollment of 100 patients for the IMPULSE lung cancer study was
completed in October 2015. Progress was also made, as planned, in enrolling
patients for the third ongoing clinical study involving lefitolimod
(MGN1703), the international phase III IMPALA pivotal study in the
indication colorectal cancer. Around 540 patients in more than 100 centers
in eight European countries, including the five most important European
pharmaceutical markets, are planned to participate in the study. The aim of
the study is to show that treatment with lefitolimod (MGN1703) results in a
prolongation of overall survival in patients with metastatic colorectal
cancer. In February 2016, MOLOGEN reported that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
confirmed the development strategy of lefitolimod (MGN1703) with the IMPALA
pivotal study within the framework of a scientific consultation.

Successful contract for the combination study with MD Anderson
In January 2016, MOLOGEN concluded a cooperation agreement with the
renowned MD Anderson Cancer Center at the University of Texas. The
agreement relates to a phase I trial with lefitolimod (MGN1703) in
combination with the immunotherapy Yervoy(R) in patients with advanced
solid tumors, mainly melanoma. Yervoy(R), a recombinant, human monoclonal
antibody works as an immune checkpoint inhibitor. Lefitolimod (MGN1703)
will therefore be evaluated in combination with a checkpoint inhibitor for
the first time. Should the efficacy of Yervoy(R) be boosted, this would
also expand the potential range of applications for lefitolimod (MGN1703).
The trial is expected to start in the first half of 2016 and include around
50 to 60 patients. MOLOGEN will provide lefitolimod (MGN1703) and funding
for the trial.

Presentation of results at international congresses
In the last financial year, MOLOGEN presented new research and development
results of clinical trials at various renowned international conferences.