Planegg/Martinsried (pta025/28.01.2021/14:10) - 28 January 2021. The Executive Management of Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, with approval of the Supervisory Board decided today that, consistent with the company's recent decision to focus its development efforts on solid tumors, the MDG1021 development program is to be discontinued.
Recruitment for the Phase I clinical trial of the T cell receptor-modified T cell (TCR-T) therapy MDG1021 directed against the antigen HA-1 in patients suffering from relapsed or persistent blood cancers after allogeneic (non-self) hematopoietic stem cell transplantation, which was initiated at the Leiden University Medical Centre (LUMC) in the Netherlands in mid-2020, will be put on hold with immediate effect. Discussions are ongoing with the LUMC regarding the potential assumption of the sponsorship role by the LUMC with continuation of the study under LUMC's responsibility and return of the development and commercialization rights to the HA-1-specific TCR acquired from LUMC in November 2018.
The impact of Medigene's discontinuation of the MDG1021 development program will be taken into account when preparing the 2021 financial guidance, which will be published as part of the Annual Report 2020 in March 2021.
Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer at Medigene: "While HA-1 represents a potentially effective antigen target for certain hematological cancers, our current expectation, and the experience of others, suggests that the timeline for the efficient development of MDG1021 is likely to be more protracted than previously anticipated. We believe the challenges of recruiting patients for this program have been exacerbated under the prevailing pandemic conditions and that this situation is unlikely to improve substantially over the coming months, leading us to this difficult decision. We thank our collaborators and their teams for all their efforts and contributions despite the challenging circumstances."
Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "The action taken to discontinue MDG1021 underscores our aim to focus our development efforts on advancing functionally enhanced TCR-T cells as treatments for solid cancer indications within our MDG10XX program. On the basis of patient numbers and unmet medical needs, we believe this is the most significant commercial opportunity for our clearly differentiated technologies including our PD1-41BB switch receptor and our non-mutated, highly-specific TCRs. We look forward to providing updates on progress in our other programs in due course."
The Management Board will hold a conference call in English today at 3.00 pm CET (9.00 am ET). Please register at least 5 minutes prior to the event:
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Medigene AG (FSE: MDG1, Prime Standard, ISIN DE000A1X3W00) 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 www.medigene.com
About Medigene's TCR-Ts
TCR-T technology arms a patient's own T cells with tumor-specific T cell receptors. The T cell receptor-modified T cells (TCR-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 is conducting a Phase I/II clinical trial of its TCR-T candidate MDG1011 in the blood cancer indications acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). In addition, Medigene is establishing a pipeline of TCRs and has collaborations with bluebird bio, Inc. and Cytovant Sciences HK Ltd. addressing solid tumor indications.
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.
Dr. Gary Waanders, Dr. Anna Niedl
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