BERLIN, Germany I July 5, 2013 I MOLOGEN AG today announced that Prof. Dr. Hans-Joachim Schmoll has given an oral presentation at ESMO World Congress on Gastroinstestinal Cancer on the final analysis of the IMPACT trial with MGN1703. The abstract “Updated results of the phase 2 IMPACT trial: Maintenance with MGN1703 vs
placebo in patients with advanced colorectal carcincoma (mCRC)” had been chosen by ESMO to be among the most noteworthy ones this year.
Prof. Schmoll, study coordinator and Director of the Oncological and Hematological Department at Martin-Luther-Universitaet Halle-Wittenberg, presented the results on the primary and secondary endpoints median progression-free survival (PFS) and overall survival (OS). In addition he reported on long-term responders which had been observed in the trial.Moreover, Prof. Schmoll presented new data from a pre-planned analysis on immunological biomarkers. These data showed that patients selected according to a certain biomarker, namely Natural Killer T-cells (NKT-cells), might benefit even more from treatment with MGN1703. The analysis on patients with a proportion of activated NKT-cells above a threshold resulted in a PFS hazard ratio of 0.27 with a p-value of 0.007 in favor of MGN1703. As reported at the ASCO Annual Meeting 2013, other analyses showed that CEA normalization and radiological response after induction chemotherapy may similarly help identify patients with greater benefit when treated with MGN1703.Professor Schmoll commented, “The PFS curves show that a subgroup of patients may benefit with this innovative treatment approach. Immune cells activation status or other biomarkers may allow to tailor in the future the maintenance treatment for metastatic CRC patients.”“In the IMPACT trial we could show the efficacy of MGN1703 in activating the immune system and inducing very prolonged responses in a subgroup of patients, as reported by other immunotherapeutic approaches such as the so called “checkpoint blockers”. Differently from these however, we did not observe any severe auto immune adverse effect, even in patients treated for more than a year with MGN1703,” stated Dr. Alfredo Zurlo, Chief Medical Officer of MOLOGEN AG.In summary the now completed final analysis of the IMPACT study has strengthened the proof-of-concept for MGN1703 in terms of efficacy and safety due to the considerably longer follow up. Based on this, MOLOGEN is currently preparing a pivotal international trial to confirm these results in a larger number of patients. In parallel, MOLOGEN pushes forwards its licensing activities for this very promising drug candidate.About the clinical study with MGN1703 (IMPACT study)
The IMPACT study is a phase 2, randomized, placebo-controlled, double-blind, multicenter clinical study aiming to determine the efficacy of MGN1703 as maintenance therapy following first-line chemotherapy with or without bevacizumab in patients with metastatic colorectal cancer. Patients included in the IMPACT study had stabilization, or partial or complete remission of their disease after receiving first-line therapy for 4.5 to 6 months.
During the study, patients were randomized to receive either MGN1703 or placebo twice per week. The treatment was continued until tumor progression was radiologically confirmed. Overall 59 patients were enrolled in the study. Patients’ characteristics were globally balanced between treatment groups. The Hazard Ratio (HR) for Progression-Free Survival on maintenance therapy (primary endpoint of the study) was 0.56 (p= 0.07) and the HR for Progression-Free Survival from start of induction therapy (secondary endpoint) was 0.49 (p= 0.03), when using the assessment of response and progression performed by two independent reviewers. Taking into account also the assessment by the local investigators, the HR for Progression-Free Survival on maintenance was 0.55 (p= 0.04) and the HR for Progression-Free Survival from start of induction therapy was 0.50 (p= 0.02). Notably, some prolonged responses to treatment with MGN1703 were observed. As of June 2013 four patients are still not progressing and receiving MGN1703 in compassionate use in excess of 15-30 months. This pattern of very prolonged responses is not common with chemotherapy but has been increasingly reported with other immuno-therapeutic agents in different tumor types. About MGN1703
MGN1703 is based on dSLIM® (“double Stem Loop Immunomodulator”), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM® activates the immune system against tumor-associated antigens by targeting various receptors on certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM®, the immune system is able to overcome its fatal tolerance toward cancer cells and TAA and attacks them selectively.
Due to this universal mechanism of action, MGN1703 can be applied to different indications of cancer.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: 203
BERLIN, Germany I July 5, 2013 I MOLOGEN AG today announced that Prof. Dr. Hans-Joachim Schmoll has given an oral presentation at ESMO World Congress on Gastroinstestinal Cancer on the final analysis of the IMPACT trial with MGN1703. The abstract “Updated results of the phase 2 IMPACT trial: Maintenance with MGN1703 vs
placebo in patients with advanced colorectal carcincoma (mCRC)” had been chosen by ESMO to be among the most noteworthy ones this year.
Prof. Schmoll, study coordinator and Director of the Oncological and Hematological Department at Martin-Luther-Universitaet Halle-Wittenberg, presented the results on the primary and secondary endpoints median progression-free survival (PFS) and overall survival (OS). In addition he reported on long-term responders which had been observed in the trial.Moreover, Prof. Schmoll presented new data from a pre-planned analysis on immunological biomarkers. These data showed that patients selected according to a certain biomarker, namely Natural Killer T-cells (NKT-cells), might benefit even more from treatment with MGN1703. The analysis on patients with a proportion of activated NKT-cells above a threshold resulted in a PFS hazard ratio of 0.27 with a p-value of 0.007 in favor of MGN1703. As reported at the ASCO Annual Meeting 2013, other analyses showed that CEA normalization and radiological response after induction chemotherapy may similarly help identify patients with greater benefit when treated with MGN1703.Professor Schmoll commented, “The PFS curves show that a subgroup of patients may benefit with this innovative treatment approach. Immune cells activation status or other biomarkers may allow to tailor in the future the maintenance treatment for metastatic CRC patients.”“In the IMPACT trial we could show the efficacy of MGN1703 in activating the immune system and inducing very prolonged responses in a subgroup of patients, as reported by other immunotherapeutic approaches such as the so called “checkpoint blockers”. Differently from these however, we did not observe any severe auto immune adverse effect, even in patients treated for more than a year with MGN1703,” stated Dr. Alfredo Zurlo, Chief Medical Officer of MOLOGEN AG.In summary the now completed final analysis of the IMPACT study has strengthened the proof-of-concept for MGN1703 in terms of efficacy and safety due to the considerably longer follow up. Based on this, MOLOGEN is currently preparing a pivotal international trial to confirm these results in a larger number of patients. In parallel, MOLOGEN pushes forwards its licensing activities for this very promising drug candidate.About the clinical study with MGN1703 (IMPACT study)
The IMPACT study is a phase 2, randomized, placebo-controlled, double-blind, multicenter clinical study aiming to determine the efficacy of MGN1703 as maintenance therapy following first-line chemotherapy with or without bevacizumab in patients with metastatic colorectal cancer. Patients included in the IMPACT study had stabilization, or partial or complete remission of their disease after receiving first-line therapy for 4.5 to 6 months.
During the study, patients were randomized to receive either MGN1703 or placebo twice per week. The treatment was continued until tumor progression was radiologically confirmed. Overall 59 patients were enrolled in the study. Patients’ characteristics were globally balanced between treatment groups. The Hazard Ratio (HR) for Progression-Free Survival on maintenance therapy (primary endpoint of the study) was 0.56 (p= 0.07) and the HR for Progression-Free Survival from start of induction therapy (secondary endpoint) was 0.49 (p= 0.03), when using the assessment of response and progression performed by two independent reviewers. Taking into account also the assessment by the local investigators, the HR for Progression-Free Survival on maintenance was 0.55 (p= 0.04) and the HR for Progression-Free Survival from start of induction therapy was 0.50 (p= 0.02). Notably, some prolonged responses to treatment with MGN1703 were observed. As of June 2013 four patients are still not progressing and receiving MGN1703 in compassionate use in excess of 15-30 months. This pattern of very prolonged responses is not common with chemotherapy but has been increasingly reported with other immuno-therapeutic agents in different tumor types. About MGN1703
MGN1703 is based on dSLIM® (“double Stem Loop Immunomodulator”), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM® activates the immune system against tumor-associated antigens by targeting various receptors on certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM®, the immune system is able to overcome its fatal tolerance toward cancer cells and TAA and attacks them selectively.
Due to this universal mechanism of action, MGN1703 can be applied to different indications of cancer.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: 203
