Mologen AG Presented Subgroup Analysis From IMPACT Study And Design Of Pivotal IMPALA Trial At Gastrointestinal Cancers Symposium 2015

Berlin, January 19, 2015 – The biotechnology company MOLOGEN AG presented two posters on the cancer immunotherapy MGN1703 at the Gastrointestinal Cancers Symposium 2015 in San Francisco, California. The first poster featured promising data on overall survival of patient subgroups from the IMPACT study in colorectal cancer. The data suggests that responders to induction therapy may benefit the most from a switch maintenance treatment with MGN1703. This is reflected in the pivotal study IMPALA where ‘response to induction therapy’ is one of the main inclusion criteria. The second poster outlined the design of the IMPALA trial, which has been already started in 2014 and is currently enrolling patients.

"We are pleased that the predictive factors previously shown to indicate a more promising progression free survival are also applicable for overall survival. The IMPALA study design is based on these findings. IMPALA will only include patients with response after induction therapy. These patients seem to be the best candidates to benefit most from the MGN1703 immunotherapy,” said Prof. Dr. Dirk Arnold, MD, Director of the Clinic for Medical Oncology, Klinik für Tumorbiologie, Freiburg, Germany. He is one of the study investigators of IMPACT, one of the coordinating study investigators of IMPALA and also a member of the steering committee of IMPALA.

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, is currently enrolling patients as well.

About IMPACT

IMPACT (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with Disease Control after Initial First-line Therapy) was a phase II, randomized, placebo-controlled, double-blind, multicenter clinical study aiming to determine the efficacy of MGN1703 as switch maintenance therapy following first-line chemotherapy with or without the antibody bevacizumab in patients with metastatic colorectal cancer.

Patients included in the IMPACT study had stabilization, or partial or complete remission of their disease after receiving first-line therapy for 4.5 to 6 months. The patients were randomized to receive either MGN1703 or placebo twice per week. The treatment was continued until tumor progression was observed. The primary endpoint of the study was to determine progression-free survival of the patients. Secondary study endpoints included overall survival, progression-free survival from start of induction therapy, response rates and safety, as well as collection of immunological and pharmacodynamic data.

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.

Leading medical associations will collaborate: Arbeitsgemeinschaft Internistische Onkologie (AIO) in Germany, Grupo Españiol de Tratamiento de Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) in France. The steering committee consists of international medical experts; among others the coordinating study investigators Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, MD, Director of the Clinic for Medical Oncology, Klinik für Tumorbiologie, Freiburg, Germany.

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

About MGN1703

MGN1703 is an innovative DNA-based TLR9 agonist developed by MOLOGEN. It broadly activates the immune system. This activation can be utilized to enable the immune system to better recognize and combat cancer cells. Due to this mechanism of action, MGN1703 can be applied to different indications of cancer.

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 TLR9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and lung cancer (randomized controlled trial). A 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.

Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 – 86
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com

Help employers find you! Check out all the jobs and post your resume.
MORE ON THIS TOPIC