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MOLOGEN at SITC 2015: Preliminary data from IMPALA trial confirm mode of action of MGN1703 (news with additional features)

DGAP-News: MOLOGEN AG / Key word(s): Conference
MOLOGEN at SITC 2015: Preliminary data from IMPALA trial confirm mode
of action of MGN1703 (news with additional features)

09.11.2015 / 09:30

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PRESS RELEASE N 18 / 2015 of 11/09/2015

MOLOGEN at SITC 2015: Preliminary data from IMPALA trial confirm mode of
action of MGN1703

Berlin, 9 November 2015 - The biotechnology company MOLOGEN AG (ISIN
DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) presented data
on the immunotherapy MGN1703 at 2015 Annual Meeting of the Society for
Immunotherapy of Cancer (SITC) in National Harbor, Maryland/US (November 4
- 8, 2015). The exploratory immunological data from a preliminary analysis
of the IMPALA pivotal study in patients with colorectal cancer confirm the
mode of action of MGN1703, the activation of the immune system.

Promising data from the previous phase II IMPACT study in colorectal cancer
suggest that the overall survival of a subgroup of patients who responded
to induction therapy could be increased. Based on these findings, the
pivotal IMPALA study aims to prove that a switch maintenance treatment with
an active immunotherapy could increase the overall survival of patients who
respond to prior induction therapy.

The activation of the immune system as seen in the IMPACT trial is now
confirmed by the preliminary analyses of immunological data of the phase
III IMPALA trial. The identified activation profile of immune cells like
monocytes, natural killer T cells (NKT), natural killer cells and T cells
prove the mode of action of the TLR9 agonist MGN1703.

Further translational data will be generated and correlated to the clinical
outcome which may help identifying useful biomarkers. These biomarkers can
be used for defining subgroups of patients who benefit the most from
MGN1703 therapy.

Recruitment of the IMPALA study started in September 2014 and is expected
to enroll 540 patients in 8 European countries by the second half of 2016.

Further to the IMPALA trial in colorectal cancer, MGN1703 is being
investigated for first-line maintenance treatment of extensive-stage small
cell lung cancer, a serious cancer disease with high unmet medical need.
IMPULSE, an international randomized controlled trial, completed just
recently the enrolment of 100 patients.

Abstract details:
Title: "Mode of action of maintenance immunotherapy therapy with the TLR-9
agonist MGN1703 in metastatic colorectal carcinoma: The phase 3 IMPALA