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| Datum : | 07.05.2014 |
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DGAP-News: MOLOGEN AG: Immunological data on renal cancer therapy MGN1601 presented at CIMT |
| Meldung : | DGAP-News: MOLOGEN AG / Key word(s): Study MOLOGEN AG: Immunological data on renal cancer therapy MGN1601 presented at CIMT 07.05.2014 / 07:30 --------------------------------------------------------------------- MOLOGEN AG: Immunological data on renal cancer therapy MGN1601 presented at CIMT - Activation of the immune system after treatment with MGN1601 observed - Favorable safety and tolerability profile - Promising median overall survival data in a subgroup of patients Berlin, May 7, 2014 - MOLOGEN AG announced today that further immunological data from the phase I/II ASET renal cancer study with MGN1601 have been presented in a poster at the 12th CIMT Annual Meeting (The Association for Cancer Immunotherapy) in Mainz, Germany. The activation of the immune system after treatment with the tumor cell-based cancer vaccine MGN1601 reflects the expected mode-of-action and was supported by the immunological findings. Furthermore, a good safety profile and promising median overall survival data in a subgroup of patients were demonstrated. One patient remained up to 48 weeks with stable disease and another patient achieved a long-term partial response of more than 120 weeks. In the trial 19 heavily pretreated patients with advanced renal cancer were enrolled to assess safety, tolerability and immunological effects of MGN1601. The evaluation of T-cell responses in subgroups of patients showed first evidence of cytotoxic antitumor immune response after MGN1601 vaccination. Moreover, significant improvement of the cellular immune function during the course of the treatment was observed. The coordinating study investigator of the ASET trial PD Dr. Viktor Grünwald, Medical School Hannover, Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, commented: "These results exceeded our expectations. In particular, I am especially impressed by one of my patients who is being treated for more than 30 months and is still progression-free. At the same time we see that MGN1601 is safe and well tolerated. I look forward to participating in the future development program of this promising drug candidate." The monotherapy with tumor cell-based cancer vaccine MGN1601 was well tolerated and safe. Furthermore, treatment with MGN1601 resulted in promising median overall survival of 115.3 weeks in a subgroup of patients who completed the study per protocol. Overall, two patients achieved prolonged disease control. One patient with stable disease eventually progressed after 48 weeks. The other patient with partial response on treatment was still free of progression at the end of the study and now receives treatment in a so-called Named Patient Program (NPP). Potential predictive biomarkers were identified from pre-treatment characteristics, which were associated with longer overall survival. Those may allow identifying patients more likely to benefit from this innovative vaccination approach with MGN1601. About the ASET study ASET (Clinical trial to Assess Safety and Efficacy of a Tumor Vaccine) is a phase I/II, proof-of-principle, multi-center, open-label, single-arm, clinical study of the tumor vaccine MGN1601, administered intradermally. The study was conducted in patients with advanced renal cell carcinoma who failed multiple previous systemic therapies. The aim of the study was the assessment of safety and efficacy of the study drug. About MGN1601 MGN1601 is a therapeutic vaccination to fight advanced renal cancer. It is a cell-based cancer therapy based on genetically modified, allogeneic tumor cells. A cell bank established by MOLOGEN AG from human renal cancer cells forms the basis. These cancer cells from the cell bank, foreign (allogeneic) to the patients, 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 is to induce of a cross-reaction of the patients' 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 cell 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. Orphan designation MOLOGEN AG obtained the orphan designation from the European Medicines Agency (EMA) for the renal cancer vaccine MGN1601. The orphan drug program of the European Union is supposed to promote the development of therapies for rare life-threatening or very serious diseases. The orphan designation offers a number of incentives, including protocol assistance and EU market exclusivity once the medicine is on the market. About MOLOGEN AG MOLOGEN AG is a publicly listed biotechnology company headquartered in Berlin and specializes in the research and clinical development of innovative drugs in the fields of oncology and infectious diseases. One of the company's most important product candidates is the DNA immunomodulator MGN1703, which is being clinically developed for colorectal cancer and lung cancer. The cell-based cancer therapy MGN1601 for the treatment of renal cancer is also currently at the stage of clinical development. With unique, patented technologies and innovative product developments, MOLOGEN is one of the leading biotechnology companies in the fields of DNA medicine and cell-based therapies. MOLOGEN AG shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange. www.mologen.com 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. MOLOGEN AG PRESS SERVICE: Prof. h.c. Peter W. Huebner Head of Corporate Communications Tel: +49 - 30 - 84 17 88 - 38 Fax: +49 - 30 - 84 17 88 - 50 huebner@mologen.com INVESTOR RELATIONS: Joerg Petrass Tel: +49 - 30 - 84 17 88 - 13 Fax: +49 - 30 - 84 17 88 - 50 investor@mologen.com External Investor Relations: Kirchhoff Consult AG Sebastian Bucher Tel: +49 - 40 - 60 91 86 - 18 Fax: +49 - 40 - 60 91 86 -16 sebastian.bucher@kirchhoff.de Note about risk for future predictions Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation. End of Corporate News --------------------------------------------------------------------- 07.05.2014 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------- Language: English Company: MOLOGEN AG Fabeckstraße 30 14195 Berlin Germany Phone: 030 / 841788-0 Fax: 030 / 841788-50 E-mail: info@mologen.com Internet: www.mologen.com ISIN: DE0006637200 WKN: 663720 Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, München, Stuttgart End of News DGAP News-Service --------------------------------------------------------------------- 266872 07.05.2014 |
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