Improving Cell Therapies for Hematological Malignancies


Dolores Schendel, PhD, chief executive and chief scientific officer, Medigene, discussed the phase 1/2 study evaluating MDG1011.

“In such patients whose hematopoiesis is challenged from the disease itself, they've had a lot of chemotherapy to try to bring the disease under control. They tend to be elderly patients and a lot of them have hadmultiple lines of therapy. That's a very challenging situation then to ask, can we make good T-cell products for these patients?”

MDG1011, a T cell receptor-modified (TCR-T) therapy from Medigene, has demonstrated positive safety, tolerability, and feasibility data in patients with blood cancers, according to the phase 1 part of a phase 1/2 clinical trial (NCT03503968). Exploratory efficacy and biologic activity data from the trial is expected in the first quarter of 2022.

The multi-center, open-label, dose escalation study evaluated the PRAME-directed MDG1011 in heavily pretreated patients with acute myeloid leukemia, myelodysplastic syndrome or multiple myeloma.All patients experienced adverse events (AEs). Treatment-related AEs included grade 1-2 transient cytokine release syndrome in 2 patients. No immune effector cell-associated neurotoxicity syndrome or dose-limiting toxicities were reported.

GeneTherapyLive spoke with Dolores Schendel, PhD, chief executive and chief scientific officer, Medigene, to learn more about MDG1011 and the studies evaluating the candidate. She also discussed Medigene’s company goals and background in cancer research, including their work on dendritic cell vaccines.

Medigene achieves positive preliminary results in phase I of phase I/II trial Of TCR-T therapy MDG1011 in blood cancers. News release. Medigene. December 21, 2021.
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