- Treatment with MGN1601 safe and well tolerated
- Promising median overall survival data in a subgroup of patients
- Presentation at ASCO – GU attracted great interest
BERLIN, Germany I February 3, 2014 I Final results from the phase I/II clinical study with MGN1601 (ASET trial) have been presented in a poster at the 2014 Genitourinary Cancers Symposium. The trial evaluated safety and tolerability of MGN1601 in 19 heavily pretreated patients with advanced renal cancer which had no other treatment options. The monotherapy with tumor cell-based cancer vaccine MGN1601 was well tolerated and safe. Furthermore, treatment with MGN1601 resulted in promising median overall survival data in a subgroup of patients. One patient achieved a long term partial response and another patient up to 60 weeks with disease control. Putative 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.
In total 19 patients were included into the study and received at least one MGN1601 injection (ITT population). 10 patients completed the study per protocol (PP population). 9 patients discontinued the study early without completing the planned treatment phase due to the worsening of their tumor disease (non-PP population).
During the study 109 adverse events (AE) were documented. Only 10 (9.2%) AE were assessed having a relationship to MGN1601: 8 AE were mild (grade 1) and 2 AE moderate (grade 2). Mainly administration site reactions and skin disorders were observed. 16 serious adverse events (SAE) have been reported of which none was assessed as drug related.
Overall, 2 patients of the PP population achieved disease control after 12 treatment weeks and continued treatment in the extension phase of the trial. One patient had tumor progression after further 60 weeks, the other completed all 5 vaccinations of the extension phase with an objective tumor response and was still in tumor remission after more than 132 weeks of treatment (12 weeks treatment phase + 120 weeks extension phase). The median overall survival (OS) was 24.8 weeks in the ITT population and 115.3 weeks in the PP population.
All 19 patients of the ITT population were included in the biomarker evaluation. The analysis of pre-treatment characteristics showed that MSKCC score and neutrophil-lymphocyte ratios (NLR) amongst others may have some predictive value for longer overall survival.
In addition the findings from the evaluation of T-cell responses in subgroups of patients showed first evidence of cytotoxic antitumor immune response after MGN1601 vaccination and significant improvement of the cellular immune function during the course of the treatment.
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG comments, “Our cancer vaccine MGN1601 demonstrated in this phase I/II trial a very favorable safety and tolerability profile. Furthermore the promising overall survival observed in a subgroup of these late stage renal cancer patients exceeded our expectations. We eagerly want to further evaluate these promising data in a larger, controlled clinical trial. Thus, we are very much looking forward to the next stage of clinical testing of MGN1601.”
About the phase I/II clinical trial (ASET study)
In the ASET study patients were scheduled to receive 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 could receive 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 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.
SOURCE: Mologen
Post Views: 317
- Treatment with MGN1601 safe and well tolerated
- Promising median overall survival data in a subgroup of patients
- Presentation at ASCO – GU attracted great interest
BERLIN, Germany I February 3, 2014 I Final results from the phase I/II clinical study with MGN1601 (ASET trial) have been presented in a poster at the 2014 Genitourinary Cancers Symposium. The trial evaluated safety and tolerability of MGN1601 in 19 heavily pretreated patients with advanced renal cancer which had no other treatment options. The monotherapy with tumor cell-based cancer vaccine MGN1601 was well tolerated and safe. Furthermore, treatment with MGN1601 resulted in promising median overall survival data in a subgroup of patients. One patient achieved a long term partial response and another patient up to 60 weeks with disease control. Putative 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.
In total 19 patients were included into the study and received at least one MGN1601 injection (ITT population). 10 patients completed the study per protocol (PP population). 9 patients discontinued the study early without completing the planned treatment phase due to the worsening of their tumor disease (non-PP population).
During the study 109 adverse events (AE) were documented. Only 10 (9.2%) AE were assessed having a relationship to MGN1601: 8 AE were mild (grade 1) and 2 AE moderate (grade 2). Mainly administration site reactions and skin disorders were observed. 16 serious adverse events (SAE) have been reported of which none was assessed as drug related.
Overall, 2 patients of the PP population achieved disease control after 12 treatment weeks and continued treatment in the extension phase of the trial. One patient had tumor progression after further 60 weeks, the other completed all 5 vaccinations of the extension phase with an objective tumor response and was still in tumor remission after more than 132 weeks of treatment (12 weeks treatment phase + 120 weeks extension phase). The median overall survival (OS) was 24.8 weeks in the ITT population and 115.3 weeks in the PP population.
All 19 patients of the ITT population were included in the biomarker evaluation. The analysis of pre-treatment characteristics showed that MSKCC score and neutrophil-lymphocyte ratios (NLR) amongst others may have some predictive value for longer overall survival.
In addition the findings from the evaluation of T-cell responses in subgroups of patients showed first evidence of cytotoxic antitumor immune response after MGN1601 vaccination and significant improvement of the cellular immune function during the course of the treatment.
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG comments, “Our cancer vaccine MGN1601 demonstrated in this phase I/II trial a very favorable safety and tolerability profile. Furthermore the promising overall survival observed in a subgroup of these late stage renal cancer patients exceeded our expectations. We eagerly want to further evaluate these promising data in a larger, controlled clinical trial. Thus, we are very much looking forward to the next stage of clinical testing of MGN1601.”
About the phase I/II clinical trial (ASET study)
In the ASET study patients were scheduled to receive 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 could receive 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 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.
SOURCE: Mologen
Post Views: 317
