Berlin, 18 September 2009 – MOLOGEN AG has reached another major milestone in the clinical study with the cancer drug MGN1703. The investigation of the safety and tolerability of a very high dosage of 60 mg per treatment has been completed with positive results. As was already the case with all the previous dosing groups as well, the product candidate demonstrated excellent tolerability in single application.

Multiple administration of this dosage of MGN1703 is now being investigated in the current and final group of the phase 1 clinical study. In this case, the patients are being treated with MGN1703 twice a week over a period of 6 weeks. After these courses of treatment have been completed and following a subsequent observation period – probably the end of October 2009 – the application for implementation of a phase 2 clinical study is to be submitted to the authorities responsible promptly.

The phase 2 study is designed to be a "proof of concept" study. The aim of it is to demonstrate the statistically significant effectiveness of MGN1703 with patients who are suffering from metastasised colorectal cancer and have only been treated with standardised chemo immune therapy so far. This means that the immune system of the patients in the phase 2 study will not have been damaged by previous treatment – in contrast to the patients in the current phase 1 study. It is expected that the patients will respond to treatment with MGN1703 even better as a result.

The cancer drug MGN1703 is a DNA-based immune modulator that is being developed for DNA immune therapy with patients who are suffering from metastasised tumours. The provisional evaluation of effectiveness that has been made in the current clinical study and its positive safety profile suggest that MGN1703 has high potential. The illness was at least stabilised even with patients of the kind chosen for the phase 1b study who have metastasised tumours in very advanced stages of development. After completion of the 6-week course of treatment, more than 40 per cent of these patients have so far been found to be in a stable condition.

About the clinical study with MGN1703

The study is designed as a phase 1b, open-label, multi-centre, single and multiple dose escalation study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered MGN1703 in patients with metastasised malignant solid tumours. Each group of patients receive different doses of MGN1703 in a single dose or multiple dose settings. The treatment in the multiple dose setting lasts 6 weeks and, in responded patients, can be extended for further 6 weeks. Primary endpoints are the safety and tolerability of escalating single and multiple doses of subcutaneously administered MGN1703. Secondary endpoints include evaluation of pharmacokinetics and pharmacodynamics of MGN1703 as well as to evaluate preliminary anti-tumour activity of MGN1703 after multiple dosing based on 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 tumour-associated antigens by targeting the different receptors, primarily TLR9, on certain immune cells. As a result of chemotherapy and radiotherapy, tumour-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.