Press release

 

Berlin, June 22, 2010 – Today, the Berlin biotech company MOLOGEN has begun its phase 2 clinical study with its cancer medicine MGN1703. After having received the approval of the competent authorities, MOLOGEN has now received the necessary approval of the Ethics Committees in Germany and Austria. This study will investigate the efficacy of MGN1703 in the treatment of patients with metastatic colorectal cancer. The study centers have already begun treating the first patients, with more to be enrolled soon. A total of 129 patients are to be treated. Initial evidence on the achievement of the study goals is anticipated to become available in the first quarter 2011, when an interim analysis is to be performed. 

“We want to use MGN1703 to help people suffering from colorectal cancer by delaying the progression of the cancer disease for longer periods than has been possible up to now with other cancer drugs,” explains Dr. Matthias Schroff, CEO of MOLOGEN AG. “Last year we were already able to prove the safety and excellent tolerability of MGN1703. Now begins the most important clinical test phase for our DNA-based medicine.”

MGN1703 is a DNA-based immunomodulator, which is being developed for DNA immunotherapy in patients with advanced tumor diseases.

The clinical study will be conducted at several study centers and could have an overall duration of up to three years. Professor Hans-Joachim Schmoll, Director of the Halle University Hospital and Polyclinic for Internal Medicine IV, will act as the study coordinator. In addition to the study centers in Germany and Austria, other study centers are expected to begin enrollment in Great Britain, Russia, and other countries once they have received approval as well.

 

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 further 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 one 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.