MOLOGEN AG: Treatment with renal cancer therapy MGN1601 generates clear survival benefit for patients

Press Release No. 3/2012 of 03/30/2012

MOLOGEN AG: Treatment with renal cancer therapy MGN1601 generates clear survival benefit for patients

- First evaluation of survival times provides results that exceed expectations

- Immunological active principle proven in an exemplary manner

- Data presented at the annual meeting of the American Association for Cancer Research

In a further evaluation of the phase I/II renal cancer study with MGN1601, the biotechnology company MOLOGEN AG has analyzed the survival times of patients enrolled in the study and the first data of the accompanying immunological tests. The result: patients that were able to completely finish the twelve-week therapy scheme scheduled in the study protocol with the study drug MGN1601 (PP group) have an unexpectedly clear survival benefit in comparison with patients that had to terminate their study therapy early (non-PP group).

Thus far, the ten patients in the PP group already survived more than ten months on average. Since only one patient in this group has died by now, this parameter will continue to improve. In the non-PP group, the median survival time is a little over two months; all nine patients had died at the latest after six months. With regard to historical clinical data and statistical models, a median survival time of five to seven months was expected. Hence, this was clearly exceeded in this study.

Furthermore it is very remarkable that for two patients who are currently being treated in the extension phase of the study at fixed intervals, the disease has not progressed in over ten months.

Immunological principle proven in an exemplary manner
With the evaluation of immunological data it was possible to prove in an exemplary manner that those patients that completed the entire planned three-month treatment cycle with MGN1601 in accordance with the study protocol have generated a clear immune response. The strength of the immune response increased with continued treatment. With these results, the mechanism of action demonstrated in preclinical studies could also be confirmed in patients. In the view of MOLOGEN AG, the observed positive effects with respect to overall survival can thus be attributed to the treatment with MGN1601.

Concurrently to the evaluation of the study, MOLOGEN has also applied for scientific advice at the Paul-Ehrlich-Institut, to discuss, amongst others, questions relating to the design of future clinical studies. Subsequent clinical studies with MGN1601 will then be applied for.

Prof. Dr. Burghardt Wittig, Chairman of the Scientific Advisory Board of MOLOGEN AG, states: 'As a scientist, I am delighted that our molecular biological and immunological concepts for active therapeutic vaccination against cancer were able to prove their efficacy so impressively with MGN1601. I find it particularly noteworthy that we were now able to clearly show what we had hitherto only been able to assume: active immunotherapies against cancer, like MGN1601, need time before they can show their effect. Tragically, all patients for whom the therapy with MGN1601 came too late have already died, while all other patients - apart from one, who survived for more than eleven months - are still alive today.'

Dr. Matthias Schroff, Chief Executive Officer at MOLOGEN AG, adds: 'It is a very positive surprise that our second oncological product candidate MGN1601 is already showing such excellent efficacy data in phase I/II. Thereby, our product pipeline has taken a great step forward. For this reason I am very confident with regard to our further clinical studies, both for MGN1703, our immunomodulator, which we are applying in the field of colorectal cancer and lung cancer, and also for MGN1601, our renal cancer therapy.'

Presentation at the annual congress of the American Association for Cancer Research
MOLOGEN project manager Ekaterina Weith is to present the data together with Prof. Dr. Burghardt Wittig (Chairman of the Scientific Advisory Board of MOLOGEN AG) at the annual meeting of the American Association for Cancer Research (AACR) as part of a 'Late-Breaking Poster Session' on April 3, 2012 in Chicago, USA (poster no. LB-233). The AACR is the world's oldest and largest scientific organization that is dedicated to all aspects of high-quality, innovative cancer research.
 
About the phase I/II clinical study (ASET study)
Within the framework of the ASET study, patients receive a total of eight treatments with MGN1601 over a period of twelve weeks. The patients are examined after completion of the treatment phase. If the patients have at least responded to the treatment with stabilization of the originally progressing cancer disease after twelve weeks, they can be treated further within an extension phase. In this extension phase, the patients receive up to five further treatments distributed over two years at increasing intervals. As reported, patient recruitment was finalized ahead of schedule after acceptance of 19 patients into the study, since it had already been possible to achieve the primary goal of the study, namely to verify the safety and tolerability of the compound.

About MGN1601
The tumor therapy with MGN1601 is a therapeutic vaccination to fight advanced renal cancer and to prevent their recurrence after operation and medical treatment.

MGN1601 is a cell-based cancer therapy based on genetically modified tumor cells. A cell bank established by MOLOGEN AG from human renal cancer cells in accordance with pharmaceutical regulations forms the basis. These cancer cells from the cell bank, foreign (allogeneic) to the patient, are 'genetically modified' with additional genetic information with the help of four different MIDGE(R) vectors developed by MOLOGEN and are combined with the DNA immunomodulator dSLIM(R), also developed by MOLOGEN, as an adjuvant.

The active principle of the cell-based gene therapy involves induction of a cross-reaction of the patient's immune system against their own cancer cells after the immune system has learned what cancer cells typically look like via its response to the genetically-modified foreign cancer cells.

About renal cancer
Renal cancer is the most frequently occurring malignant tumor of the kidneys with 200,000 incidences annually throughout the world. According to the Robert Koch Institute, there are 15,000 patients affected by this disease in Germany alone. Among these patients, around 30% already have distant metastases at the time of initial diagnosis, which significantly reduces the success of a therapy. The tumor is known for not responding to radiation or chemotherapy. The use of medications which are currently available on the market are accompanied by considerable side effects. Thus there is still a great medical need for new, effective medications with low side effects for the treatment of renal cancer. Exactly this approach is followed with MGN1601.
Orphan Drug Status

The cell-based gene therapy against renal cancer has received the Orphan Drug Status from the European Medical Agency (EMA). This enables MOLOGEN AG to market the product exclusively within the European Union within a period of ten years. The Orphan Drug Program of the European Union is supposed to promote the development of therapies for rare and serious diseases.

About MOLOGEN AG
MOLOGEN AG, a German biopharmaceutical company with headquarters in Berlin specializes in the research and development of innovative medications on the basis of DNA structures. The activities focus on numerous product developments which are relevant to the immune system; on the one hand vaccines against infectious diseases and on the other hand cancer medications. MOLOGEN AG is globally one of the few biotechnology companies with well tolerated DNA-based cancer treatment in the clinical development phase.

The stocks of MOLOGEN AG are listed in the Prime Standard of the German stock exchange (ISIN DE0006637200).

Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI)

MIDGE(R), dSLIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG.

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