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Treatment with MGN1601 was well tolerated and safe
-
Patient subgroup showed promising survival benefit
BERLIN, Germany I September 30, 2013 I The MOLOGEN AG performed the final analysis of the clinical trial phase I/II with cancer vaccine MGN1601. The study evaluated safety and tolerability of MGN1601 in 19 advanced renal cancer patients which had no other treatment options. The data confirm the preliminary findings presented at last year’s “ESMO 2012 Congress”. The primary endpoints safety and tolerability were met.
A subgroup of patients showed a promising benefit from the treatment with MGN1601, and some of them are still alive with follow-up ongoing. Such response patterns are comparable to the observations from other cancer immune therapies.
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG comments, “In this early stage trial the results of our cancer vaccine MGN1601 look promising and the treatment with MGN1601 was well tolerated. Furthermore, the survival observed in some of these late stage renal cancer patients is above our expectations. With these data at hand, we are very much looking forward to the next stage of clinical testing of MGN1601.”
The full data set from this analysis will be presented at future oncology conferences.
About the phase I/II clinical trial (ASET study)
In the ASET study patients received a total of eight treatments with MGN1601 over a period of twelve weeks. The patients were examined after completion of the treatment phase. If the patients had at least responded to the treatment with stabilization of the originally progressing cancer disease after twelve weeks, they could be treated further within an extension phase. In this extension phase, the patients received up to five further treatments distributed over two years at increasing intervals.
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® 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 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 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.
SOURCE: Mologen
Post Views: 194
-
Treatment with MGN1601 was well tolerated and safe
-
Patient subgroup showed promising survival benefit
BERLIN, Germany I September 30, 2013 I The MOLOGEN AG performed the final analysis of the clinical trial phase I/II with cancer vaccine MGN1601. The study evaluated safety and tolerability of MGN1601 in 19 advanced renal cancer patients which had no other treatment options. The data confirm the preliminary findings presented at last year’s “ESMO 2012 Congress”. The primary endpoints safety and tolerability were met.
A subgroup of patients showed a promising benefit from the treatment with MGN1601, and some of them are still alive with follow-up ongoing. Such response patterns are comparable to the observations from other cancer immune therapies.
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG comments, “In this early stage trial the results of our cancer vaccine MGN1601 look promising and the treatment with MGN1601 was well tolerated. Furthermore, the survival observed in some of these late stage renal cancer patients is above our expectations. With these data at hand, we are very much looking forward to the next stage of clinical testing of MGN1601.”
The full data set from this analysis will be presented at future oncology conferences.
About the phase I/II clinical trial (ASET study)
In the ASET study patients received a total of eight treatments with MGN1601 over a period of twelve weeks. The patients were examined after completion of the treatment phase. If the patients had at least responded to the treatment with stabilization of the originally progressing cancer disease after twelve weeks, they could be treated further within an extension phase. In this extension phase, the patients received up to five further treatments distributed over two years at increasing intervals.
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® 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 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 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.
SOURCE: Mologen
Post Views: 194
