Date: 2013-10-18
Type of information:
phase: 1
Announcement: initiation of the study
Company: Mologen (Germany)
Product: MGN1404 - MIDGE® vector
Action
mechanism: MGN1404 is a minimalistic, non-viral DNA expression vector encoding for TNF-alpha, based on MOLOGEN’S proprietary MIDGE® platform technology. The needle-free, intratumoral jet injection of MGN1404 conveys the MIDGE® vectors directly into the tumor cells. The expression of TNF-alpha is triggered there by the MIDGE® vectors aiming to induce cell death in the tumor.
Tumor necrosis factor-alpha (TNF-alpha) is a signaling molecule (cytokine) produced by the immune system. Among its effects, TNF-alpha can induce cell death, and thus has direct antitumor effects when applied to tumors. Furthermore, it leads to the sensitization of tumors to other therapies, such as chemotherapy or radiotherapy. MGN1404 is a MIDGE®-based (non-viral) expression vector. The needle-free intra-tumor jet injection of MGN1404 transports MIDGE® vectors directly into the tumor cells. There, the expression of TNF-alpha is triggered by the MIDGE® vector and cell death is induced in the tumor cells.
Disease: melanoma
Therapeutic area: Cancer - Oncology
Country: Germany
Trial details: The study is a translational project for non-viral gene therapy and will be conducted by Charité in collaboration with Charité Comprehensive Cancer Center (CCCC), Experimental and Clinical Research Center (ECRC), Max Delbrueck Center for Molecular Medicine Berlin-Buch (MDC) as well as Skin Cancer Center Charité (SCCC). Principial investigator is Dr. med. Felix Kiecker, Specialist of Dermatology and Venerology, Skin Cancer Center Charité and scientific coordinator is Prof. Wolfgang Walther, ECRC, Charité.
Latest
news: * On October 18, 2013, Mologen has announced that the phase I clinical trial with the cancer immune therapy MGN1404 has been started. The trial evaluates the safety and tolerability of MGN1404 for the treatment of malignant melanoma. Furthermore data on the mechanism of action will be collected. MGN1404 will be applied in different dosages needle-free by jet-injection into skin metastases. It is planned to overall enroll nine patients in the trial.
* On April 15, 2013, Mologen has announced that the Paul-Ehrlich Institute has granted approval for a phase I clinical study of a gene therapy with MGN1404 for the treatment of melanomas. The study is entitled \"Phase I trial of TNF-alpha expressing MIDGE-vector non-viral gene transfer in skin metastases of melanoma.\" The study will be conducted by collaborative partners Charité Comprehensive Cancer Center (CCCC), the Berlin Experimental and Clinical Research Center of the Charité (ECRC), the Max Delbrück Center for Molecular Medicine (MDC) in Berlin-Buch and the skin cancer center of the Charité (Hauttumorcentrum, HTCC).The study will examine whether the MIDGE® vector is safe and well tolerated when applied by intra-tumor jet injector, and whether the application leads to efficient expression of the hTNF-alpha gene. Further, the magnitude and extent of gene expression and the distribution of the MIDGE® vector within and outside the injected tumor will be examined. Three different doses of the MIDGE® vector will be used. This study is a first step towards the clinical use of local gene therapy for malignant melanomas.
