BERLIN, Germany I April 28, 2014 I MOLOGEN AG has announced the final data of the U.S. phase I study for MGN1703 in healthy volunteers. The primary objectives of the study were to investigate the cardiac safety and the pharmacokinetics of MGN1703. The final data confirmed the positive trend of the preliminary data on cardiac safety and tolerability, presented in December 2013. No significant side effects were observed.
The placebo-controlled, double-blind study evaluated the cardiac and general safety as well as pharmacokinetics and pharmacodynamics of MGN1703. The final results demonstrated that the drug candidate MGN1703 was safe and well tolerated. The results also show that MGN1703 has a favorable pharmacokinetic profile and leads to consistent immune activation. MGN1703 is a TLR9 agonist, entirely consisting of natural DNA components, designed to activate the immune system to fight cancer. The outcome of this study adds to the evidence collected so far with regard to the mechanism of action, efficacy and safety of MGN1703.
The Chief Medical Officer of MOLOGEN AG, Dr. Alfredo Zurlo, stated, “We have once more proven that MGN1703 acts as a potent immune activator, and is the best in class TLR9 agonist currently in development – not only preclinically as recently presented at the American Association for Cancer Research (AACR) 2014 Meeting in San Diego, but also in humans. At the same time, the good tolerability profile of MGN1703 was also confirmed in this trial. Thus, we look forward to starting a phase III study in colorectal cancer in the second half of this year.”
MGN1703 has successfully completed a phase II study in metastatic colorectal cancer (mCRC) in Europe. Based on these results, MOLOGEN is currently preparing an international pivotal study in mCRC. In addition, a randomized controlled trial to assess the efficacy of MGN1703 in small cell lung cancer has already been started to extend the scope of the MGN1703 development program.
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 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.
SOURCE: Mologen
Post Views: 211
BERLIN, Germany I April 28, 2014 I MOLOGEN AG has announced the final data of the U.S. phase I study for MGN1703 in healthy volunteers. The primary objectives of the study were to investigate the cardiac safety and the pharmacokinetics of MGN1703. The final data confirmed the positive trend of the preliminary data on cardiac safety and tolerability, presented in December 2013. No significant side effects were observed.
The placebo-controlled, double-blind study evaluated the cardiac and general safety as well as pharmacokinetics and pharmacodynamics of MGN1703. The final results demonstrated that the drug candidate MGN1703 was safe and well tolerated. The results also show that MGN1703 has a favorable pharmacokinetic profile and leads to consistent immune activation. MGN1703 is a TLR9 agonist, entirely consisting of natural DNA components, designed to activate the immune system to fight cancer. The outcome of this study adds to the evidence collected so far with regard to the mechanism of action, efficacy and safety of MGN1703.
The Chief Medical Officer of MOLOGEN AG, Dr. Alfredo Zurlo, stated, “We have once more proven that MGN1703 acts as a potent immune activator, and is the best in class TLR9 agonist currently in development – not only preclinically as recently presented at the American Association for Cancer Research (AACR) 2014 Meeting in San Diego, but also in humans. At the same time, the good tolerability profile of MGN1703 was also confirmed in this trial. Thus, we look forward to starting a phase III study in colorectal cancer in the second half of this year.”
MGN1703 has successfully completed a phase II study in metastatic colorectal cancer (mCRC) in Europe. Based on these results, MOLOGEN is currently preparing an international pivotal study in mCRC. In addition, a randomized controlled trial to assess the efficacy of MGN1703 in small cell lung cancer has already been started to extend the scope of the MGN1703 development program.
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 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.
SOURCE: Mologen
Post Views: 211
