Martinsried/Munich - * MDG1021 becomes Medigene's second proprietary clinical TCR-T candidate
* Clinical trial approval from Dutch regulatory authority
* Phase I clinical trial in cancer patients suffering from relapse/persistence after allogeneic hematopoietic stem cell transplantation
* Leiden University Medical Center, the Netherlands, as principal trial site
Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, has received approval from the Dutch regulatory authority (the Central Committee on Research Involving Human Subjects, CCMO) to begin a first clinical trial of MDG1021. MDG1021, which targets the antigen HA-1, thus becomes Medigene's second proprietary T cell receptor-modified T cell (TCR-T) immunotherapy candidate to enter clinical development. The Phase I study of MDG1021 will be initiated at the Leiden University Medical Center (LUMC), the Netherlands, and will enroll patients suffering from relapsed or persistent blood cancers after allogeneic (non-self) hematopoietic stem cell transplantation (allo-HSCT), an area with high unmet medical need.
Currently, patients suffering from blood cancers are treated with chemotherapy. Where possible this chemotherapy is followed by an allo-HSCT as the preferred treatment option where the donor stem cells re-establish a blood forming system in the patient. However, patients who suffer from a relapse of their cancers after allo-HSCT currently have few treatment options.
MDG1021 is a TCR-T immunotherapy targeting a specific, immunogenic form of the antigen HA-1. HA-1 is exclusively expressed on cells of the hematopoietic system. If the patient's blood-cells, and thus lymphoma or leukemic cells, carry the immunogenic version of the HA-1 antigen on their surface and the donor stem cells do not, MDG1021 TCR-T cells could eradicate the patient's cancer cells and allow the donor stem cells to repopulate the patient's blood forming system.
Phase I trial design: According to the clinical trial authorization, the trial will assess the safety and feasibility of MDG1021 immunotherapy, with secondary endpoints including preliminary efficacy. In the dose-escalation portion of the trial, at least 9 patients will be treated with MDG1021 at 3 different doses to assess the safety and the maximum tolerated dose using a standard 3+3 cohort design. MDG1021 will be administered as a single IV infusion.
After each dose cohort, safety data will be assessed by an independent data and safety monitoring board. Upon completion of the dose escalation part and selection of the optimal dose, an expansion part of the study will evaluate MDG1021's safety in 20 additional patients.
Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer at Medigene, says: "We are excited about the approval of our next company-sponsored clinical trial with a TCR-T immunotherapy and to reach this milestone despite the challenging circumstances due to COVID-19. We thank our collaborators at the LUMC for all their efforts in preparing this study. We aim to develop MDG1021 for blood cancer patients experiencing recurrent disease after allogeneic HSCT, who have a very poor prognosis and a severe lack of further treatment options. In parallel to our ongoing clinical trial of the TCR-T therapy MDG1011 in patients suffering from acute myeloid leukemia or myelodysplastic syndrome, this study is an important step for Medigene in our program for hematological malignancies towards delivering safe and efficacious T cell-based cancer immunotherapies to patients and physicians."
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About Medigene's TCR therapy
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 first Phase I/II clinical trial of its TCR-T candidate MDG1011 in the blood cancer indications AML and MDS as well as a second Phase I clinical trial of MDG1021 in patients suffering from relapsed or persistent blood cancer after allogeneic (non-self) hematopoietic stem cell transplantation (allo-HSCT). 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
HA-1 is a well-characterized minor histocompatibility antigen, based on the variable expression of the HMHA1 gene in certain individuals. It is present on all cells of the hematopoietic system, but not on other normal cells. It is also present on leukemia and lymphoma cells, as well as on various solid tumors. The immunogenic variant of HA-1 exists in approximately 50% of individuals and, in the setting of allogeneic hematopoietic stem cell transplantation (allo-HSCT) and an HLA-A*02:01 background, has been associated with positive clinical benefit through a 'graft versus leukemia/lymphoma' mechanism, without causing severe side effects.
Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) 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 https://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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Dr Gary Waanders, Claudia Burmester, Dr Anna Niedl
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