MOLOGEN AG submitted clinical trial application (IND) for MGN1703 to the FDA
• Investigational New Drug (IND) application for the treatment of solid tumors
• Phase I clinical study in the U.S. to determine cardiac safety of MGN1703
Berlin, September 24, 2013 - MOLOGEN AG filed an Investigational New Drug (IND) application for MGN1703 with the U.S. Food and Drug Administration (FDA) to initiate a phase I clinical trial. The placebo-controlled, double-blind study is designed to determine the cardiac safety of MGN1703 and to evaluate pharmacokinetic parameters in healthy volunteers. The trial is expected to start as soon as the FDA has granted its approval.
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG stated, “With the IND application we are preparing the ground to develop our lead drug candidate MGN1703 for the treatment of solid tumors also in the USA. After the very promising final results of the IMPACT trial presented earlier this year we are now very much looking forward to proceeding with our clinical development program for MGN1703.”
MGN1703 has already successfully completed a phase II study in metastatic colorectal cancer (mCRC) in Europe. MOLOGEN is currently also preparing a pivotal study in mCRC and a phase II study in lung cancer for MGN1703. In parallel licensing activities for MGN1703 are ongoing.
About IMPACT study with MGN1703
The IMPACT study was a phase II, randomized, placebo-controlled, double-blind, multicenter clinical study 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 detected. Overall 59 patients were enrolled in the study. Patients’ characteristics were globally balanced between treatment groups.
At ESMO World Congress on Gastrointestinal Cancer 2013 the data from the final analysis of the study was presented: The Hazard Ratio (HR) for Progression-Free Survival on maintenance therapy (primary endpoint of the study) was 0.55 (p= 0.04) when using the assessment of response and progression performed by the local investigators and 0.56 (p= 0.07) when taking into account the independent assessment by two radiologists. Notably, some prolonged responses to treatment with MGN1703 were observed. Four patients were still not progressing and received MGN1703 in compassionate use in excess of 15-30 months. This pattern of very prolonged disease control is not common with chemotherapy but has been increasingly reported with other immuno-therapeutic agents in different tumor types. Overall survival data was immature due to a lack of events.
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.
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.
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®, dSLIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.
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Posted: September 2013