Berlin, March 5, 2010 – The Berlin biotech company MOLOGEN has received approval from the competent German and Austrian health authorities at the Paul Ehrlich Institute and the Federal Office for Safety in Health Care (“Bundesamt für Sicherheit im Gesundheitswesen”), respectively, to conduct a phase 2 study on the cancer drug MGN1703. MGN1703 is a DNA-based immunomodulator, which is being developed for DNA immunotherapy in patients with metastasized tumor diseases. After the cancer drug already demonstrated excellent tolerability in the phase 1b study, this phase 2 study will now investigate the efficacy of the drug in the treatment of metastatic colorectal cancer.
The clinical study is supposed to begin soon at several study centers in Germany and Austria. Professor Hans-Joachim Schmoll, Director of the Halle University Hospital and Polyclinic for Internal Medicine IV, will act as the study coordinator. The study will be initiated as soon as the responsible Ethics Committees have issued their approval, which is anticipated to occur by March.
Additional study centers shall begin enrollment in Great Britain, Russia, and other countries as soon as the conduct of the study has been approved there.
“We are optimistic that MGN1703 can help patients by delaying the progression of cancer diseases for longer periods than has been possible up to now with other cancer drugs,” according to Professor Burghardt Wittig, Chairman of the Scientific Advisory Board and Co-founder of MOLOGEN. “After a long way through the fundamental research phase, preclinical developments, and an initial, very successful phase 1b study, our dSLIM® DNA molecule will now be put to its most significant clinical test yet.”
“In 2009 we were already able to prove the safety and excellent tolerability of MGN1703. The approval of this phase 2 study for MGN1703 is another triumph for MOLOGEN“, said Dr. Matthias Schroff, CEO of MOLOGEN AG. “We are thrilled that the investigators will soon be able to begin treatment of the first patients.”
The phase 2, randomized, placebo-controlled, double-blind, multicenter clinical study (IMPACT study) is designed as a licensing-relevant confirmatory study and is intended to verify the efficacy of MGN1703 with statistical significance. The primary objective of the study is to determine progression-free survival among patients with advanced colorectal cancer. Secondary study objectives include determining the overall survival of patients and collecting data on immunological and pharmacodynamic parameters. Initial evidence on the achievement of the study objectives is anticipated to become available in the form of an interim report as early as nine to ten months following the start of the study. The study could have an overall duration of up to three years.
About the clinical study with MGN1703
The study is a phase 2, randomized, placebo-controlled, double-blind, multicenter clinical study to determine the efficacy and safety of subcutaneously administered MGN1703 for the treatment of metastatic colorectal cancer patients who responded to first-line therapy (IMPACT-study). The 60-mg dose of MGN1703 is administered twice weekly. Treatment is continued until a progression of the cancer disease is identified.
The primary endpoint is the identification of median progression-free survival among patients based on radiological and clinical results. Secondary endpoints include the analysis of the responsiveness of the immune system, pharmacodynamics, and the safety profile of MGN1703.
The patients to be enrolled in the phase 2 study will only have been treated with a standard chemo-immunotherapy as first-line therapy. Therefore, in contrast to the patients in the preceding phase 1b study, the immune systems of the patients in this study will not have already been damaged by multiple prior lines of therapy and higher tumor burden. It is anticipated that these patients will respond even better to treatment with MGN1703.
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 “danger” sensing receptors on certain immune cells, primarily TLR. 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.
The results of the completed phase 1b study demonstrate an excellent safety profile for MGN1703. Treatment with the investigational drug was well tolerated and no dose-limiting or serious side-effects were identified.
Very promising signs of efficacy were also found. MGN1703 was able to delay the progression of cancer diseases by at least six weeks in many cases, including patients with advanced metastatic tumor diseases with no further standard treatment options like the ones selected for the phase 1b study.
About metastatic colorectal cancer
Over 1 million new cases of colorectal cancer are diagnosed each year worldwide, making it one of the most commonly occurring types of cancer there is. In Europe, 412,900 new cases were diagnosed in 2006 (Van Cutsem, Oliveira, 2009). That is 12.9% of all cancer cases. With over 70,000 new cases each year, the disease is the second most common cancer disease in Germany. People over 50 years of age are most commonly affected. In 25% of patients the disease is already at an advanced stage by the time it is diagnosed.
First-line therapy for cases of advanced colorectal cancer usually involves treatment with chemotherapy in combination with bevacizumab or cetuximab antibodies, depending on the patient’s baseline data. The standard combination therapy enables a considerable extension of progression-free survival among patients but is accompanied by serious side effects and resistance problems, which have a negative impact on the quality of life of the patient. The median overall survival for patients suffering from metastatic colorectal cancer is approx. 20-23 months. Median progression-free survival with first-line therapy is approx. 9-10 months.
About MOLOGEN
MOLOGEN AG, a biopharmaceutical company based in Berlin, specializes in the research and development of innovative medicines based on DNA structures. Activities focus on product developments for the treatment of cancer and vaccines for serious infections.
MOLOGEN was founded in 1998 and is among the few biotechnology companies in the world with well-tolerated, DNA-based cancer treatment in the clinical development stage.
MOLOGEN AG shares are listed in the Prime Standard of Deutsche Börse (ISIN DE 0006637200).
