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Mologen AG (MOLGF.PK): First Approvals For Phase III IMPALA Colorectal Cancer Study



8/4/2014 8:32:15 AM

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Berlin, August 4, 2014 – MOLOGEN AG, a biotechnology company focused on cancer immunotherapy, has received first approvals from the countries participating in the phase III pivotal trial IMPALA. The company expects the first patient in the study (FPI) in the third quarter 2014. The trial is investigating the efficacy of the immunotherapy MGN1703 to improve overall survival (OS) in patients with metastatic colorectal carcinoma.

MOLOGEN initiated the approval process for the IMPALA trial in the second quarter of 2014. Study applications were submitted to the corresponding authorities in eight European countries, including the five major pharma markets. As expected, first approvals have been obtained in the meantime. The company assumes to start patient recruitment in the course of the third quarter 2014, as planned.

IMPALA is a randomized, international, multicenter and controlled phase III trial. Patients to be enrolled must have achieved a response during their first line treatment of metastatic colorectal cancer. The study aim is to prove that a switch maintenance therapy with the cancer immunotherapy MGN1703 leads to an increased overall survival. The study will include approximately 540 patients from more than 100 European centers.

Dr. Alfredo Zurlo, Chief Medical Officer of MOLOGEN AG, commented, “The clinical development program of MGN1703 is progressing as planned. We are confident to enroll the first patient in the IMPALA trial in the next few weeks.”

According to the World Health Organization (WHO), colorectal cancer is among the top three cancer indications worldwide and there are approx. 1.4 million newly diagnosed colorectal cancer cases per year. Furthermore, MGN1703 is being developed for first-line maintenance treatment of extensive-stage small cell lung cancer, a serious cancer disease with high unmet medical need. IMPULSE, a randomized controlled trial, is currently enrolling patients.

About IMPALA

IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is an international phase III, randomized, open-label, two-arms, and multicenter clinical study. Based on the findings from IMPACT, the study will include patients with metastatic colorectal cancer who had tumor reduction after receiving first-line chemotherapy with or without biological agents. The study will include around 540 patients in eight European countries from more than 100 centers, including the five major European pharma markets.

The primary endpoint is overall survival and secondary study endpoints include progression-free survival from start of induction therapy, toxicity and safety, and Quality of Life (QoL).

The coordinating study investigators are Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, head of Klinik für Tumorbiologie Freiburg at the Albert Ludwigs University in Freiburg.

About MGN1703

MGN1703 is an innovative DNA-based TLR-9 agonist developed by MOLOGEN. It broadly activates the immune system against tumor-associated antigens (TAA) which are released by cancer cells. Once activated by MGN1703, the immune system is able to overcome its fatal tolerance toward cancer cells and attacks them selectively. Due to this mechanism of action, MGN1703 can be applied to different indications of cancer.

About MOLOGEN AG

MOLOGEN AG is a biotechnology company specialized in the research and clinical development of cancer immune therapies and DNA vaccines against infectious diseases.

The cancer immune therapy MGN1703 is the company’s lead product and best-in-class TLR-9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and lung cancer (randomized controlled trial). Second clinical-stage product is MGN1601, a therapeutic vaccination for the treatment of renal cancer. A phase I/II clinical study has already been completed successfully.

With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies.

MOLOGEN AG is a publicly listed company, headquartered in Berlin. The shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange.

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.

MOLOGEN AG

PRESS SERVICE:
Prof. h.c. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
huebner@mologen.com

INVESTOR RELATIONS:
Claudia Nickolaus
Head of Investor Relations
Tel: +49 - 30 - 84 17 88 - 86
Fax: +49 - 30 - 84 17 88 - 50
nickolaus@mologen.com

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