Press Releases

09.11.2015

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

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 study"

For more information on the Society for Immunotherapy of Cancer Conference (SITC 2015) please visit the website www.sitcancer.org.

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).

Approximately 540 patients from more than 100 European centers, including the five major pharma markets, will participate in the study. IMPALA started to treat the first patients in mid-September 2014.

For more information on the trials IMPACT and IMPALA please visit www.clinicaltrials.gov.


MGN1703
MGN1703 is an innovative DNA-based TLR9 agonist developed by MOLOGEN that broadly activates the immune system. This activation can be utilized to enable the immune system to increase the recognition and combat of cancer cells. Due to this mechanism of action, it is predicted that MGN1703 can be applied to a number of diseases.

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 MGN1703 is the company’s lead product and best-in-class TLR9 agonist. Treatment with MGN1703 triggers a broad and strong activation of the immune system. Due to this mechanism of action, MGN1703 has the potential to be applied to various indications. 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.

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

MOLOGEN AG is listed on the stock exchange and its headquarters are located in Berlin, Germany.

www.mologen.com

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®, dSLIM®, EnanDIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.

Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel:    +49 - 30 - 84 17 88 – 38
Fax:    +49 - 30 - 84 17 88 - 50
investor@mologen.com

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.




Contact:
Claudia Nickolaus
Head of Investor Relations & Corporate Communications

T. +49 (0) 30 - 84 17 88 - 86
F. +49 (0) 30 - 84 17 88 - 50

investor@mologen.com