MOLOGEN reaches primary end points in MGN1703 study

· Cancer drug MGN1703 demonstrates excellent tolerability in phase 1b study
· Application for phase 2 study on drug approval to be submitted soon

Berlin, GERMANY | November 4, 2009 | MOLOGEN AG has reached the primary objectives of the phase 1b clinical study. The cancer drug MGN1703 caused no serious side-effects in any of the tested doses. This means that the primary objective of the study – to demonstrate the safety and tolerability of the innovative new cancer drug – has been reached. Toxicity, i.e. serious intolerability, that would limit the dose has not been found. MOLOGEN will therefore be able to use the maximum dosage of 60 mg twice a week that has been tested in the planned phase 2 clinical study.

MOLOGEN will now be completing the application for implementation of a phase 2 study to investigate the effectiveness of MGN1703 for the treatment of metastasized colorectal cancer and will be submitting it to the authorities responsible as planned before the end of this year. This study will be designed as a phase 2 study as required for drug approval and aims to provide statistically significant evidence of the effectiveness of the drug. In the context of the phase 2 study, patients will be investigated who have only been given standardized chemotherapy / immune treatment beforehand. This means that the immune system of the patients in the phase 2 study will not have been damaged by previous treatment and more intensive tumor problems – in contrast to the patients in the current phase 1b study. As a result, it is expected that the patients will respond to treatment with MGN1703 even better.

The cancer drug MGN1703 is a DNA-based immunomodulator that is being developed for DNA immune therapy with patients who are suffering from metastasized tumors. The provisional evaluation of effectiveness that has been made in the current phase 1b clinical study and the positive safety profile suggest that MGN1703 has high potential. The illness was at least stabilized even with patients of the kind chosen for the phase 1b study who have metastasized tumors in very advanced stages of development. A total of 15 patients in different dosing groups were treated with MGN1703 over a period of six weeks.

After completion of the six-week course of treatment, six patients were found to be in a stable condition. So far, the condition of two of these six patients was stable after 12 weeks of treatment too. The investigation of drug effectiveness is continuing in the current study. These data are not needed to apply for the phase 2 study, however.

"We are delighted that we have now been able to demonstrate the very good tolerability of our innovative new cancer drug MGN1703 so convincingly also in the context of a clinical study", explains the CEO Dr Matthias Schroff. "The maximum dosage that patients found very tolerable is many times higher than at other companies with comparable product candidates. In view of the indications of effectiveness that we have also observed, we are very optimistic about the phase 2 study, which we will be starting as soon as we have received approval of the study from the authorities and ethics commissions responsible."

About the clinical study with MGN1703

The study was designed to be an open-label, multicentre, single- and multiple-dose phase 1b escalation study that aimed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered MGN1703 with patients suffering from illnesses involving metastasized tumors. Each group of patients received different doses of MGN1703 in single- or multiple-dose situations. Treatment in the multiple-dose situation lasted 6 weeks and could be extended by a further 6 weeks with patients who responded. The primary end points were the safety and tolerability of larger single and multiple doses of subcutaneously administered MGN1703. Secondary end points were evaluation of the pharmacokinetics and pharmacodynamics of MGN1703 as well as of the provisional anti-tumor effect of MGN1703 following multiple dosage on the basis of radiological, clinical and immunological parameters.

About MGN1703

MGN1703 is based on MOLOGEN’S proprietary dSLIM® immunomodulator. In dSLIM® (“double Stem Loop Immunomodulator”), MOLOGEN has developed an innovative DNA-based TLR9 agonist. Use of dSLIM® activates the immune system against tumor-associated antigens by targeting the different receptors, primarily TLR9, on certain immune cells. As a result of chemotherapy and radiotherapy, tumor-associated antigens (TAA) are released by cancer cells. The immune system activated by dSLIM® is in a position to overcome its fatal tolerance towards cancer cells and TAA and advance against them strategically.

About MOLOGEN

MOLOGEN AG, a biopharmaceutical com-pany 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.

SOURCE: MOLOGEN AG

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