Updated data on renal cancer therapy MGN1601 with further improved results

  • Median overall survival now over 16 months
  • Presentation at the ESMO Meeting in Vienna

BERLIN, Germany I October 1, 2012 I Updated data on the overall survival of patients participating in the ASET study was presented within the framework of a scientific poster at this year’s meeting of the European Society for Medical Oncology (ESMO). The clinical study with the renal cancer therapy MGN1601 has progressed further and now shows a median overall survival in the PP group of over 16 months.

In patients who were able to fully complete the three-month therapy program provided for in the study protocol (PP group) the survival benefit observed showed an impressive increase. The ten patients in the PP group so far survived on average more than 16 months. In this group also only three patients have died, so the median overall survival in this group can improve still further. In the patients who had to cancel their study therapy prematurely (non-PP group) the median period of survival was only a little more than two months; all nine patients in this group died within six months.

Two patients from the PP group, in which the disease was under control after conclusion of the three-month therapy program, were treated further withinan extension phase of the study at set intervals. In one of the two patients a progression of the cancer could be stopped for 14 months. The second patient exhibited a regression of metastases for around 17 months.

Ekaterina Weith, Project Manager in the Department of Clinical Development at MOLOGEN AG, added: “The course of our clinical study with MGN1601 confirms not only our forecast, but has now gone further. What we are presenting at the ESMO meeting is the data from the remainder of the study. That is, of course, neither a complete nor final picture, but one that can really be looked at.“

The phase I/II ASET study primarily examines the safety and tolerability of MGN1601 in the treatment of patients with advanced renal cancer. As previously reported, treating the patients with MGN1601 was well tolerated. In addition, the active principle of the therapy could be proven in an exemplary manner.

ESMO is the leading European non-profit organisation for internal oncology. It is committed to a multidisciplinary approach to the treatment of cancer and joins under its roof the leading oncologists in Europe.

Further information on the ESMO poster
Poster No. 813P is entitled “The novel cancer vaccine MGN1601, consisting of genetically modified allogeneic tumor cells and immunomodulator dSLIM: updated results of a phase 1-2 study in patients with advanced renal cell carcinoma“. It was presented on September 29th, 2012.

Further details on the ESMO Meeting can be found at
www.esmo.org/events/vienna-2012-congress

About the ESMO Annual Meeting in Vienna
The 37th Annual Meeting of the European Society for Medical Oncology (ESMO) is being held at the ACV (Austria Center Vienna) in Vienna, Austria from September 28th until October 2nd, 2012. More than 17,000 participants from around the world are expected to discuss the newest scientific results in the field of cancer research. The meeting is the most important platform for the exchange of professional experience in addition to the Annual Meeting of the American Society for Clinical Oncology (ASCO). Here, among other things, the world’s current research results are presented and discussed with experts but also with the attending pharmaceutical industry.

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® vectors developed by MOLOGEN and are combined with the DNA immunomodulator dSLIM®, 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.

SOURCE: Mologen

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