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MOLOGEN AG - Excellent outcome for phase 2 colorectal cancer study with MGN1703 - primary endpoint achieved

• Proof of concept confirmed:
- significantly prolonged progression-free survival
- highly significant efficacy
- excellent safety and tolerability

Berlin, May 14, 2012 - The biotechnology company MOLOGEN AG has conducted an initial assessment of the phase 2 colorectal cancer study with MGN1703. The assessment of 55 patients showed that the primary endpoint, the prolongation of the median progression-free survival, was achieved. Progression-free survival describes the period in which a cancer disease is not getting worse. Median progression-free survival in the pre-defined target population (46 patients) was even more than doubled compared to the placebo control group with high statistical significance (p

A randomized, double-blind and placebo-controlled phase 2 clinical study was conducted to determine the efficacy of the DNA-based immunomodulator MGN1703. Patients with metastatic colorectal cancer (mCRC) were treated with MGN1703 as maintenance therapy following the standardized first-line therapy.

In addition, the study re-confirmed the excellent safety profile for MGN1703. Treatment was well tolerated also over longer periods. For the most part minor to moderate side-effects such as minor episodes of fever, fatigue and reddening of the injection site occurred.

From diligent observation of the study development and following consultations with their scientific advisors, management decided to terminate patient recruitment prematurely. A total of 58 patients were enrolled in the study. Treatment of patients who are still in the study will be continued according to the protocol. Data on overall survival of all patients will continue to be collected.
MOLOGEN AG will consult with the FDA and EMA on the basis of these data to agree on additional steps required for approval. Parallel to this, talks with potential partners regarding out-licensing of MGN1703 will be continued.
In addition, a detailed presentation of the results of the study for the medical community is planned at an international congress for clinical oncology and cancer research.

Dr. Matthias Schroff, Chief Executive Officer and Chief Scientific Officer of MOLOGEN AG explains: "This is a special day for our research team and the entire company. These excellent results have even surpassed our own expectations. Due to the high reliability of the data, especially regarding the placebo-controlled study design, the results go way beyond a proof-of-concept, as normally demonstrated in a phase 2 study. They confirm the enormous potential of immunotherapeutic concepts for the treatment of cancer. Our special thanks go to the patients and everyone who contributed to these studies."

About the clinical study with MGN1703 (IMPACT study)
The study is a phase 2, randomized, placebo-controlled, double-blind, multicenter clinical study (IMPACT study) to determine the efficacy of MGN1703 as maintenance therapy following successful first-line therapy in advanced colorectal cancer. Patients included had stabilization, or partial, or complete remission of their bowel cancer from receiving first-line therapy for 4.5 to 6 months, beforehand. The first-line therapy is a typical combination of chemotherapy and bevacizumab, which is typically associated with significant adverse effects. During the study, patients were treated twice per week with MGN1703. In the control arm patients received a placebo. The treatment was continued until tumor progression was radiologically confirmed. The primary endpoint of the study is to determine progression-free survival of the patient. Secondary study endpoints include determining the overall survival, progression-free and overall survival rates, as well as collecting immunological and pharmacodynamic data.

About MGN1703
MGN1703 is based on dSLIM® ("double Stem Loop Immunomodulator"), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM® activates the immune system against tumor-associated antigens by targeting various receptors on certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM®, the immune system is able to overcome its fatal tolerance toward cancer cells and TAA and attacks them selectively.
Due to this universal mechanism of action, MGN1703 can be applied to different indications of cancer. An application is currently being submitted for an additional phase 2 clinical study with MGN1703, this time for the treatment of advanced lung cancer (NSCLC). The study should begin immediately after approval.

MOLOGEN AG, a German biopharmaceutical company with headquarters in Berlin specializes in the research and development of innovative medications 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 medications. 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.


Prof. Peter W. Huebner
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Posted: May 2012