Mologen AG Will Next Clinically Investigate the Efficacy of MGN1703 in Lung Cancer

Berlin, 6 June 2011 – MOLOGEN AG will now clinically investigate its DNA immunomodulator MGN1703 in the treatment of advanced lung cancer. With this MOLOGEN will be expanding its attractive product pipeline by one more blockbuster candidate. Work is currently underway on the application for the pivotal phase II/III clinical trial.

The basis for the active principle which will be applied in the clinical trial is provided by the company’s own dSLIM® platform technology. This technology, comprehensively patented, offers diverse application possibilities in the treatment of cancer. Here, the unique structure of the immunomodulator, which is exclusively composed of natural DNA components, is the decisive differentiator to comparable approaches from competitors. To date, no technology from the competition has been able to feature the extremely good compatibility while concurrently activating the immune system in such a broad and efficacious way. With the effective decision to clinically investigate lung cancer as further indication, MOLOGEN AG is actively pursuing the path to further implement the potential of the dSLIM® technology consistently and specifically .

Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG: “Following our advance to clinical phase II/III with our DNA immunomodulator MGN1703 in colorectal cancer, we now want to proof the indications of efficacy of the compound in further cancer indications and apply its active principle in the treatment of lung cancer. Similar to colorectal cancer, we will investigate the efficacy in lung cancer with a pivotal phase II/III clinical trial. Lung cancer is one of the most prevalent forms of cancer and non-small cell lung cancer is the most common and very aggressive type of lung cancer. With MGN1703 we have the potential to play a prominent role in this important market segment.”

Active principle of MGN1703 usable in numerous cancers

The first indications of the efficacy of the immunomodulator MGN1703 in the treatment of cancer became apparent during the comprehensive pre-clinical studies, and also from the results of the phase Ib clinical trial concluded in 2009. The universal active principle of MGN1703 is based on the broad activation of the immune system in a manner that is necessary for successful treatment of cancer. Thus, MOLOGEN AG is in a position to use MGN1703 in different cancer indications. Similar to the colorectal cancer trial, this new clinical trial on lung cancer will be started directly in the pivotal phase II/III. This means that the international trial will be placebo-controlled, randomized and blinded.

During the study, the efficacy of MGN1703 in the treatment of metastatic non-small cell lung cancer (NSCLC) will be examined. The aim of the study is to prevent progression of the disease for longer than is possible with existing therapy forms. Among other goals, so-called progression-free survival is to be measured on approximately 200 patients during the study.

DNA Medicine with blockbuster potential

Lung cancer is one of the most common forms of cancer in the world. In the EU and USA alone, about 500,000 people develop this form of cancer every year. Within the same time period, about 460,000 people die of the disease. The demand for more efficacious therapy options is correspondingly high. Due to the market size, which is comparable to colorectal cancer, MGN1703 also has a blockbuster potential in the indication lung cancer.

Information for patients

Further information about the clinical study is available on the homepage of MOLOGEN AG: www.mologen.com/data/English/03_08_Patientinfo.

Study registers

The study is registered on www.clinicaltrials.gov and www.cancer.gov.

Hotline

A study hotline at MOLOGEN AG for MGN1703 provides information individually and in strict confidence in accordance with medical discretion to interested doctors and patients on: +49 (0)800 646 1703

About MOLOGEN AG

MOLOGEN AG, a German biopharmaceutical company with headquarters in Berlin specializes in the research and development of innovative medicines on the basis of DNA structures. The activities focus on numerous product developments which are relevant to the immune system; on the one hand vaccines against infectious diseases and on the other hand cancer therapies. MOLOGEN AG is globally one of the few biotechnology companies with well tolerated DNA-based cancer treatment in the clinical development phase.

The stocks of MOLOGEN AG are listed in the Prime Standard of the German stock exchange (ISIN DE0006637200).

Memberships in associations:

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® and MOLOGEN® are registered trademarks of MOLOGEN AG.

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