Medigene AG

Medigene receives approvals for its first clinical trial with TCR therapy MDG1011 - Seite 2

Two of the three indications will subsequently be carried forward into the Phase II part of the clinical trial, after a positive DSMB assessment regarding the safety of MDG1011 and review by the competent authority and central ethics committee. In the Phase II part, 40 HLA-A*02:01 and PRAME positive patients will be treated with MDG1011; another 40 patients, who are positive for PRAME but negative for HLA-A*02:01, will be included into the control groups (20 treated and 20 control patients per indication) and treated with investigator choice therapy. Co-primary endpoints of the Phase II part are safety and efficacy, where efficacy is measured as ORR at 3 months. The trial will have a follow-up period of up to 12 months. Secondary endpoints will include duration of response (DoR), time to progression (TTP), progression-free survival (PFS), overall survival (OS), quality of life (QoL) and the correlation of PRAME expression with the antitumor response.

The clinical trial will be performed by the Department of Internal Medicine III of the University Hospital Regensburg (Director: Prof. Dr. Wolfgang Herr) under the leadership of the coordinating investigator PD Dr. Simone Thomas, as well as by the University Hospitals of Erlangen and Würzburg, Germany.

About Medigene's TCR technology: The TCR technology aims at arming the patient's own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient's tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient's T cells outside the body (ex vivo).

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.
For more information, please visit http://www.medigene.com

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

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emitter: Medigene AG
address: Lochhamer Straße 11, 82152 Planegg
country: Germany
contact person: Medigene PR/IR
phone: [phone]
e-mail: [e-mail]
website: www.medigene.de

ISIN(s): DE000A1X3W00 (share)
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[ source: http://www.pressetext.com/news/20180221007 ]