Clinical development program with MGN1703

 

The cancer medicine MGN1703 is a DNA-based immunomodulator and TLR9 agonist which is being developed for immunotherapy in patients with metastatic, solid tumors. After the successful completion of the clinical phase Ib study with MGN1703, the cancer medicine is now in the next phase of clinical development. The phase Ib study was executed as an open, multi-center single dosage and multiple dosage escalation study. In the study, each patient group received different doses of MGN1703 in single dosage or multiple dosage situations. Treatment with multiple dosages took altogether 6 weeks. The treatment was extended by an extra 6 weeks if the patient had a positive response to it. The primary goal of the study was the investigation of the safety and tolerability of subcutaneously administered MGN1703 for patients with metastatic tumor illnesses. Further goals were the investigation of the pharmacokinetics and pharmacodynamics and the temporary evaluation of the anti-tumor-effect of MGN1703 after a multiple dosage. The evaluation of the study was based on radiological, clinical and immunological parameters. The previous results from the study show a very good safety profile and a promising potential.

 

In June 2010, the phase II study with MGN1703 could start. The study will initially be conducted at several study centers in Germany and Austria. In this study, the efficacy of MGN1703 will be investigated for patients with advanced colorectal cancer where the tumor growth was either stopped or even reduced after an executed anti-tumor induction therapy. The goal of the study is to show that MGN1703 can considerably delay the time interval until the further progression of a tumor. Furthermore, additional efficacy parameters and safety data will be evaluated. The beginning of the study marks another important milestone in the clinical development program of the company.

 

MOLOGEN hopes to establish MGN1703 on the market as an effective and safe medicine for the treatment of the most commonly occurring cancers.

 

About metastasized colorectal cancer

 

Colorectal cancer is one of the most frequent cancer diseases worldwide, and is the second most frequent cause of death from cancer in western industrialized countries. The number of new cases of the disease, about 500,000 annually, is also one of the highest of all cancer indications.

 

Metastasized colorectal cancer is usually treated in first-line therapy with chemotherapy, combined with the antibodies Bevacizumab or Cetuximab, depending on the baseline condition of the patient. The standard combination therapy makes possible a substantial lengthening of progression-free survival of patients, but is accompanied by severe side effects and resistance problems, and thus detracts from the patient's quality of life. The median overall survival of patients who suffer from metastasized colorectal cancer amounts to about 20-23 months. The median progression-free survival for the first-line therapy amounts to about 9-10 months.

 

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