Martinsried/Munich (pta026/26.02.2019/12:35) - Medigene AG (FSE: MDG1, Prime Standard, SDAX), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, announced today that it has dosed the first patient in its first-in-human clinical trial with its TCR therapy candidate MDG1011. The Phase I/II trial investigates the safety and feasibility of MDG1011 for the treatment of various types of blood cancer, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). MDG1011 is a novel immunotherapy candidate using patient-derived, T cell receptor (TCR)-modified T cells targeting the tumor antigen PRAME and was administered for the first time to a multiple myeloma patient. MDG1011 is designed as a one-time treatment.
In the Phase I portion of the trial, approximately 12 patients who are suffering from advanced stage AML, MDS and MM and have previously undergone several cycles of standard therapies will be treated with MDG1011. PRAME expression on the tumor cells as well as a certain blood serotype are further inclusion criteria for patients. Three to four dose cohorts of 3 patients each will be treated in this dose escalation trial. After completing treatment of all patients in a dose cohort and a four-week safety follow-up period, dose escalation will be determined by an independent Data and Safety Monitoring Board (DSMB). The primary endpoint for the Phase I portion of this clinical trial will be safety and feasibility. Several secondary endpoints (i.e. overall re-sponse rate (ORR)) will be assessed as well.
In the Phase II portion of the trial, presumably two of the three indications will be carried forward and in total 80 patients will be included. Co-primary endpoints of the Phase II portion are safety and preliminary efficacy (ORR). Several secondary endpoints will be assessed here as well.
The clinical trial is being conducted by the University Hospital Regensburg, as well as by the University Hospitals of Erlangen and Würzburg, Germany. Up to five additional clinical centers in Germany are currently being opened and are anticipated to open recruitment within the next three to five months and screen additional patients for their suitability to participate in the study.
Contact Medigene AG
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01,
Lochhamer Straße 11
|contact person:||Julia Hofmann, Head of Public and Investor Relations|
|phone:||+49 89 200033-3301|
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